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Validation of the Cleaning and Disinfection or

Sterilization Process
of
DAC UNIVERSAL

According to the guideline

Validation and Routine Monitoring of Automated Cleaning and Disinfection Processes for
Heat- Resistant Medical Devices as well as Advice on Selecting Washer-Disinfectors
by
Deutsche Gesellschaft fr Krankenhaushygiene (DGKH), Germany
Deutsche Gesellschaft fr Sterilgutversorgung (DGSV), Germany
Arbeitskreis Instrumentenaufbereitung (AKI), Germany

and

Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten as of 2012


by
Kommission fr Krankenhaushygiene und Infektionsprvention (KRINKO) beim
Robert Koch Institut (RKI) und des Bundesinstitutes fr Arzneimittel und Medizinprodukte
(BfArM), Germany

and

Leitlinie zur Prozessvalidierung des DAC UNIVERSAL


by
sterreichische Gesellschaft fr Hygiene in der Zahnheilkunde (GHZ), Austria

and

Health Technical Memorendum HTM 01-05: Decontamination in primare care dental practices
by
Department of Health (DH), United Kingdom

Sirona Dental A/S


Rho 10
DK-8382 Hinnerup

Denmark
QR20 Validation of the Cleaning and Disinfection or Sterilization
Process of DAC UNIVERSAL V6.1

Table of Contents

1 Scope .................................................................................................................................... 3
2 Intended use ........................................................................................................................ 3
3 Relevant Scientific Literature ............................................................................................. 4
4 Legal Aspects and Competences ...................................................................................... 6
5 Performed Type Test and Validation ................................................................................. 6
6 Identification of the Device................................................................................................. 7
7 Description of Reference Load .......................................................................................... 9
7.1 Loads Definition ............................................................................................................. 9
7.2 Worst Case Instruments................................................................................................. 9
7.3 Borderline of the Smallest Loading .............................................................................. 10
7.4 Adapters ....................................................................................................................... 11
7.5 Worst Case for Loading According to EN13060 .......................................................... 13
7.6 Sample of Loading ....................................................................................................... 14
7.6.1 Unwrapped Handpieces ....................................................................................... 14
7.6.2 Wrapped Handpieces ........................................................................................... 15
7.6.3 Unwrapped Solid Instruments ............................................................................... 16
7.6.4 Wrapped Solid Instruments .................................................................................. 17
7.6.5 Unwrapped Ultrasonic Scaler Handpieces, Scaler Tips & Sprayvit Nozzles........ 18
7.7 Risk Classification: ....................................................................................................... 19
8 Process and Equipment Characterization ...................................................................... 21
9 Cleaning ............................................................................................................................. 25
9.1 Water Quality ............................................................................................................... 25
9.2 Dosing of detergent ...................................................................................................... 25
9.3 Requirement for cleaning ............................................................................................. 26
9.4 Control of the Cleaning Process .................................................................................. 26
9.5 Routine Testing for Residual Protein ........................................................................... 28
9.6 Testing for Residual of Detergent ................................................................................ 28
9.7 The Ao Concept ........................................................................................................... 28
9.8 Installation and Operational Qualifications ................................................................... 29
10 Sterilization Process ..................................................................................................... 30
10.1 Removal of Air: Back-flush ....................................................................................... 30
10.2 High level disinfection ............................................................................................... 30
10.3 Sterilization/ Disinfection .......................................................................................... 30
10.4 Thermo-electrical Measurements ............................................................................. 31
10.5 Control for Presence of Saturated Steam ................................................................ 35
10.6 Requirement for Sterilization .................................................................................... 36
10.7 The Fo Concept ........................................................................................................ 36
10.8 Sterilization of Wrapped Instrument ......................................................................... 38
10.9 Drying ....................................................................................................................... 39
10.10 Product Release from Sterilization ........................................................................... 39
10.11 Instruments for Decontamination After Use ............................................................. 40
11 Technical Test ................................................................................................................ 41
11.1 Installation Qualification (IQ) .................................................................................... 41
11.2 Operating and Installation Instructions ..................................................................... 41
11.3 Operational Qualification (OQ) ................................................................................. 41
11.4 Security Test ............................................................................................................. 43
11.5 Performance Qualification (PQ) Work Test ........................................................... 44
12 Summary and Determination for the Alternative Method of Validation ................... 45
13 Process Step for Type Test used in the Validation .................................................... 46
13.1 Validation of Cleaning Process ................................................................................ 46
13.2 Validation of Sterilization/ disinfection Process ........................................................ 46
14 Conclusion ..................................................................................................................... 47
15 Annexes .......................................................................................................................... 48

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1 Scope
This report describes the type test for the cleaning and disinfection or sterilization process as
an alternative for first validation of the DAC UNIVERSAL autoclave. Sirona Dental A/S is
approved by Lloyds Register Quality Assurance (LRQA) according to management system
standards ISO 9001 and ISO 13485. The assessment of LRQA is done against the
requirements of Annex II of the Medical Devices Directive, which means possession of a full
quality assurance system. This is a statement that the manufacturer can conduct the type test
himself if he disposes of a qualified quality assurance department. The manufacturer can also
have all or some of the test carried out by a suitable accredited test laboratory.

This validation involves many norms where the main norms are ISO 15883 for validation of the
cleaning and disinfection process and the norms EN13060 for the validation of the sterilization
process.

The DAC UNIVERSAL treats only dental instruments as handpieces, turbines , solid
instruments, ultrasonic scaler handpieces, scaler tips,sprayvit nozzles and solid instruments
(see chapter 2 Intended use).

The requirement for the process validation according to the guidelines by DGKH, DGSV, AKI,
RKI, BfArM, GHZ and DH is to prove the suitability of the cleaning and the disinfection/
sterilization parameters. This proof is necessary to show the equivalence of the concrete
loading with same type sterilizers under indication of protein indicators for the cleaning, chemo
indicators for the sterilization and inspection pieces.

The type test is divided into a technical and a hygienic part.

2 Intended use
The DAC UNIVERSAL is intended to clean, lubricate and steam sterilize dental handpieces.
Dental handpieces is defined as rotating instruments split up into the categories straight
handpieces, contra angles and turbines.
The DAC UNIVERSAL is intended to clean and steam sterilize solid dental instruments.
The DAC UNIVERSAL is intended to clean and thermally disinfect Sirona ultrasonic scaler
handpieces of type Sirosonic, Sirosonic L, Sirosonic TL, Periosonic and similar dental ultrasonic
scaler handpieces, which are comparable concerning weight, materials, surface, construction
principles, gaps and geometry.
The DAC UNIVERSAL is intended to clean and thermally disinfect Sirona Scaler tips of the
types Instrument L, PE, PS, SIRORETRO, SIROPREP and similar dental scaler tips, which are
comparable concerning weight, materials, surface, construction principles, gaps and geometry
including the associated torque wrench.
The DAC UNIVERSAL is intended to clean and thermally disinfect Sirona Sprayvit nozzles of
the types SPRAYVIT, SPRAYVIT 4000, SPRAYVIT 4000E and similar dental sprayvit nozzles,
which are comparable concerning weight, materials, surface, construction principles, gaps and
geometry.
The DAC UNIVERSAL is intended to clean and steam sterilize EMS Piezon ultrasonic scaler
handpieces of type EN-041, EN-060 and similar dental ultrasonic scaler handpieces, which are
comparable concerning
weight, materials, surface, construction principles, gaps and geometry. The DAC UNIVERSAL
is intended to sterilize wrapped solid instruments, straight handpieces, contra angles and
turbines.

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3 Relevant Scientific Literature


93/42/EEC council Directive of 14 June 1993 concerning medical devices, and
2007/47/EEC amendment.

ISO 9001:2008 Quality management-Requirements

ISO 13485:2003 Medical devices-Quality management systems - Requirement for regulatory


purposes.

ISO 13485:2012 Medical devices-Quality management systems - Requirement for regulatory


purposes.

EN 13060 + A2:2010 Small steam sterilizers

IEC 61010-1 Safety requirements for electrical equipment for measurement, control and
laboratory user Part1 General requirements.

IEC 61010-2-40 Safety requirements for electrical equipment laboratory use

AAMI ST55:2010 Table tops steam sterilizers

EN556-1:2001 Sterilization of medical devices - Requirements for medical devices to be


designated "STERILE"

EN 17664:2004 Sterilization of medical devices Information to be provided by the


manufacturer for the processing of re-sterilizable medical devices

ISO 15883-1:2009 Disinfectors General requirements, terms, definition and test

ISO 15883-2:2009 Requirements and tests for washer-disinfectors employing thermal


disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils,
glassware, etc.

ISO/TS 15883-5:2005 Disinfectors Test soils and methods for demonstrating cleaning efficacy

EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator
systems and process challenge devices for use in performance testing for small sterilizers Type
B and Type S.

Robert Koch Institut (RKI) und des Bundesinstitutes fr Arzneimittel und Medizinprodukte
(BfArM): Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten, 2012

Robert Koch Institut (RKI) und des Bundesinstitutes fr Arzneimittel und Medizinprodukte
(BfArM): Infektionsprvention in der Zahnheilkunde Anforderungen an die Hygiene, 2006

Deutsche Gesellschaft fr Krankenhaushygiene (DGKH), Deutsche Gesellschaft fr


Sterilgutversorgung (DGSV), Arbeitskreis Instrumentenaufbereitung (AKI): Validation and
Routine Monitoring of Automated Cleaning and Disinfection Processes for Heat- Resistant
Medical Devices as well as Advice on Selecting Washer-Disinfectors, 2014

Department of Health: HTM01-05 Decontamination in primary care dental practices, 2013


edition

EN 11607:2006 Packaging materials and systems for medical for medical devices that are to be
sterilized.

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EN ISO 17665-1:2006 Sterilization of health care products. Moist heat. Requirements for the
development, validation and routine control of a sterilization process for medical devices

EN ISO 11140-1:2014 Sterilization of health care products. Chemical indicators. General


requirements

DIN SPEC 58929:2012-08 Operation of small steam sterilizers in the health-care system -
Guidance for validation and routine control of sterilization processes

sterreichische Gesellschaft fr Hygiene in der Zahnheilkunde (GHZ): Leitlinie zur


Prozessvalidierung des DAC UNIVERSAL

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4 Legal Aspects and Competences


Sirona Dental A/S quality management is approved by LRQA according to quality management
system standard ISO 9001:2008, ISO 13485:2003 and ISO 13485:2012.
DAC UNIVERSAL is CE-marked. This CE-mark is approved by the Sirona Dental A/S notified
body LRQA (0088).

Sirona Dental A/S is registered as manufacturer of medical devices by the Danish Health
Authorities. This means that Sirona Dental A/S can produce and distribute medical products to
EU as long as its quality system complies with the requirements in the standards above. LRQA
surveys the quality system once a year to ensure the compliance with the directives norms and
standards according to Sirona Dental A/S declaration of conformity.

5 Performed Type Test and Validation


The tables below show reports for performed separate type test for the cleaning process,
disinfection and sterilization by accredited laboratories. These tables are updated regularly, but
not every time a new test is performed.

Type test for cleaning:


Report no. Test description Norm Carried out by
SN 12014.1 Ib - VIb Turbines, handpieces and ISO/TS 15883-5 HygCen, Germany
contra angles
SN 1319b Universal Piezon ISO/TS 15883-5 HygCen, Germany
Handpiece EN-041A
SN15037 Solid instruments in ISO/TS 15883-5 HygCen, Germany
basket
SN17159 III-IV Surfaces: Aluminium, ISO/TS 15883-5 HygCen, Germany
Rough
SN 18041 I-VI FlexLid ISO/TS 15883-5 HygCen, Germany
SN15037c Cytotoxicity: Solid ISO/TS 10993-5 HygCen, Germany
instruments in basket
SN 17414 I Type test and Flex lid ISO 15883-1 HygCen, Germany
ISO 15883-2

Type test for disinfection:


Report no. Test description Norm Carried out by
SN 17414 I-VI FlexLid ISO/TS 15883-5 HygCen, Germany

Type test for sterilization:


Report no. Test description Norm Carried out by
SN 12014.1 Ia VIa Turbines, handpieces and EN 13060 HygCen, Germany
contra angles
SN 12014.1 Ic VIc Wrapped instruments EN 13060 HygCen, Germany
SN 1319a Universal Piezon EN 13060 HygCen, Germany
Handpiece EN-041A
SN15037b Solid instruments in EN 13060 HygCen, Germany
basket
SN17159 III-IV Surfaces: Aluminium, EN 13060 HygCen, Germany
Rough
21-10-2011 Type test for sterilization EN 13060 Sirona Dental A/S
Serial no. of Works test EN 13060 Sirona Dental A/S
autoclave
E231164 Safety test IEC 61010-1 UL, Denmark
IEC 61010-2-40

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6 Identification of the Device


Manufacturer Sirona Dental A/S
Type DAC UNIVERSAL
Serial no.
Year of construction 2009
Year of graphical update 2015
Chamber volume 2 litres
Max working pressure 3.2 Bar
Max working temperature 134 C
Mains supply 90-120 or 190-240V AC 50/60Hz 1100W

The device exists in two different versions. These versions have different user interfaces and
are operated differently. In all other aspects they are exactly the same, they use the same
software and clean, disinfect or sterilize exactly the same.

A Lid
B Oil bottle and oil dispenser
C Water tank
D Display with keyboard
E Safety ring

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The DAC UNIVERSAL fulfils the following regulations and norms:


Directive 93/42/EEC Medical Devices Directive (MDD)
Directive 2007/47/EC Medical Directive Amendment
Directive 97/23/EC Pressure Equipment Directive (PED)
Directive 2006/42/EC Machine Directive
Directive 2004/108/EC Electromagnetic compatibility (EMC)
Directive 2006/95/EC Low Voltage Directive (LVD)
Directive 2011/65/EU RoHS Directive
Washer-disinfectors - Part 1: General requirements, terms and
Norm ISO 15883-1
definitions and tests
Washer-disinfectors - Part 2: Requirements and tests for
washer-disinfectors employing thermal disinfection for surgical
Norm ISO 15883-2
instruments, anaesthetic equipment, bowls, dishes, receivers,
utensils, glassware, etc.
Washer-disinfectors - Part 5: Test soils and methods for
Norm ISO/TS 15883-5
demonstrating cleaning efficacy
Norm EN 13060 + A2 Small Steam Sterilizers

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7 Description of Reference Load


7.1 Loads Definition
Solid and wrapped instruments:
The solid instruments are placed in a special basket lid for cleaning and sterilization in the DAC
UNIVERSAL. A number of maximum 5 solid instruments are to be placed into the basket lid.
The wrapped instruments are placed in a special wrapped instrument lid for sterilization of
wrapped instruments. A number of maximum 3 wrapped instruments are to be placed onto the
wrapped lid.
For the 121 C program, all components of the instruments must be able to be exposed for
saturated steam at a minimum temperature of 124 C. For the 134 C program, all components
of the instruments must be able to be exposed for saturated steam at a minimum temperature
of 137 C.

Note:
It is not allowed to decontaminate single-use instruments after use. After the treatment of the
patient these instruments must be disposed. Single-used instruments should be marked on
packaging by instruments manufacturer.

7.2 Worst Case Instruments


Scientifically, it is not necessary and economically unreasonable to test all instruments. The
technical literature recommends selecting a reference load, which is the worst case to clean
and disinfect or sterilize.

The guideline called Validation and Routine Monitoring of Automated Cleaning and
Disinfection Processes for Heat- Resistant Medical Devices as well as Advice on Selecting
Washer-Disinfectors by Deutsche Gesellschaft fr Krankenhaushygiene (DGKH), Deutsche
Gesellschaft fr Sterilgutversorgung (DGSV), Arbeitskreis Instrumentenaufbereitung (AKI)
describe that the worst case loading is depending of:

- the quantity and arrangement of the instruments to be sterilized/ disinfected


- the sort and nature of the sterile good packing which can be sterilized
- the quantity and arrangement of the instruments in the sterilization/ disinfection
chamber

In the DAC UNIVERSAL, the maximum load of dental handpieces and turbines for sterilization
is six. The maximum load of ultrasonic scaler handpieces, scaler tips and sprayvit nozzles for
disinfection is six, with maximum 3 scaler tips at a time. The arrangement of the instruments in
the chamber of the DAC UNIVERSAL is not criteria for worst case, because the position of the
instruments is irrelevant. The only parameter to choose the worst case from is the sort and
weight of the whole instrument.

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It is easier for the manufacturer of the instruments to determine the worst case of instruments
that are difficult to clean and sterilize/ disinfect due to the fact that the manufacturer knows the
internal design of the instruments better.
Therefore, the worst case load for the Standard lid is defined as:

- SIRONA T1 Classic S40L


- SIRONA T2 Revo RH40
- SIRONA Endo 6:1
- SIRONA T2 Control S
- SIRONA T2 Racer S
- SIRONA T1 Line C200L
And dental rotating instruments, which are comparable concerning weight,
materials, surface, construction principles, gaps and geometry.

The worst case load for the Flex lid is defined as:

- 1 SIRONA Sirosonic L
- 1 SIRONA Sirosonic TL
- 1 SIRONA Sprayvit 4000
- 1 SIRONA Sprayvit G
- 2 SIRONA Ultrasonic tips (including the associated torque wrench)
And similar dental instruments, which are comparable concerning weight,
materials, surface, construction principles, gaps and geometry.

The worst case load for the Basket lid is defined as:

- Probes
- Curettes
- and similar solid dental instrument, which are comparable concerning weight,
materials, surface, construction principles, gaps and geometry.

The worst case load for the Wrapped lid is defined as:

- Wrapped rotating handpieces (see Standard lid)


- Wrapped solid dental instruments (see Basket lid)

7.3 Borderline of the Smallest Loading


According to the norm EN13060, a test of empty chamber with or without a single instrument
must be done.

This test is relevant for the user of the autoclave for being able to treat only one instrument.
The test is done by thermoelectric measurement of the empty sterilization chamber as proof
that the sterilization conditions are reached reproducibly, spatially and evenly, even without any
instruments in the sterilization chamber.

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7.4 Adapters
The adapters design is constructional similar to the adapters placed on the unit used in the
treatment centre. The function of the adapter is very important because it gives possibility for
the cleaning water to reach the internal channels of the instruments in order to remove
residuals of soils and detergents. For the Standard lid during lubricating, the adapter allows
passage of oil through the drive channel to the rotating parts of the instruments. The removal of
air in the instruments (back-flush) is also done through the adapter allowing the steam to reach
all internal surfaces of the drive (if present) and spray channels in order to ensure proper
disinfection or sterilization. The air for drying the internal channels of the instruments is also
conducted through the adapters.

For different type and brands of instruments, the DAC UNIVERSAL can be configured with
different type of adapters. Handpieces can only be mounted on the respective fitting adapter.
Mismatching is not possible. The adapter type for each of the 6 adapters can be individually
chosen by the dental clinic when ordering the DAC UNIVERSAL.

Example of adapters mounted on the Standard lid.

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Example of adapters mounted on the Flex lid.

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7.5 Worst Case for Loading According to EN13060

Placement of Charge 1 on the lid: PCD Test (spore tester) and 5 bolts:

PCD Instrument (Process Challenge Device) 3 visible bolts + 2 not visible bolts

Five massive M12x100 bolts simulate the solid loads, according to requirement of the norm
EN13060 clause 8.7 and a Process Challenge Device, PCD, simulating a reference load of
rotating handpieces with chemical indicator system.
Temperature sensors are measuring the temperature of the surface of the loads also inside the
PCD and the holding time with means of a data logger. Later on these data are used for
calculating the Ao and Fo values in order to demonstrate the compliance with the norm.
The total weight for the reference load is 482 g.

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7.6 Sample of Loading


7.6.1 Unwrapped Handpieces
Loading the autoclaves with handpieces and turbines without wrapping in order to clean,
lubricate and sterilization.

Sirona W&H
Turbines and Handpieces Turbines and Handpieces
Semi-critical B Semi-critical B
Weight: 360 g Weight: 420 g

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7.6.2 Wrapped Handpieces

Loading the autoclave with wrapped handpieces and turbines for second sterilization.
(Cleaning and lubricating is disabled.)

The loads are placed on a special lid suitable for carrying wrapped instrument.

Only three handpieces and/or turbines shall be placed on the lid.


Critical B
Weight: 210 g

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7.6.3 Unwrapped Solid Instruments


Loading the autoclave with solid instruments for cleaning and sterilization.
The instruments are placed on a special lid with basket suitable for unwrapped instruments.

Example of types of solid instruments.

The maximum load of the basket is five solid instruments.


The weight of the loads must not exceed the weight of the worst case.
Semi-critical A
Weight: 64 g

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7.6.4 Wrapped Solid Instruments


Loading the autoclave with wrapped solid instruments for second sterilization.

The instruments are placed on a special lid suitable for single wrapped instruments.

Only three solid instruments shall be placed on the lid.


Critical A
Weight: 32 g

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7.6.5 Unwrapped Ultrasonic Scaler Handpieces, Scaler Tips & Sprayvit Nozzles
Loading the autoclaves with ultrasonic scaler handpieces, scaler tips and sprayvit nozzles
without wrapping in order to clean and disinfect.
The instruments are placed on the Flex lid. This lid is suitable for internal cleaning, external
cleaning and disinfection of unwrapped instruments.

Flex lid with 2 ultrasonic handpieces, 2 Scaler-Spitzen and 2 syringe nozzle


Semi-critical B / critical B
Weight: 180 g

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7.7 Risk Classification:


Below is the 2013 revised version of the Deutsche Gesellschaft fr Sterilgutversorgung (DGSV) flow
chart for classification of medical devices:

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According to the RKI guideline, medical products which are in contact with mucous membranes
or significantly changed skin caused by disease are classified as semi-critical. If the instruments
have a lumen or are difficult to clean, they are classified as semi-critical B. Otherwise they are
semi-critical A.

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Semi-critical products must cleaned and disinfected, or sterilized. These instruments must be
used immediately or wrapped after disinfection/sterilization for later use. By using the
instrument immediately after the disinfection/sterilization, the transport of disinfected/sterilized
instruments from the hygiene room to the patient must be taken into consideration.

Medical product used for permeation of the skin or mucous membrane contact with wounds and
the use of blood, blood products, sterile products are classified as critical. If the instruments
have a lumen or are difficult to clean they are classified as critical B, otherwise critical A. Critical
products must be clean and disinfected, or sterilized and afterwards sterilized wrapped.

The instruments treated with the DAC UNIVERSAL are semi-critical A, semi-critical B, critical A
and critical B.

8 Process and Equipment Characterization


The processes of the DAC UNIVERSAL during one cycle are as follow:
Pressure test, lubrication of the instruments(If applicable), internal and external cleaning,
removing of air (back-flush), disinfection/sterilization, second back-flush, and removing of
residual water from the instrument called expel and drying. All the processes are done
automatically only by pressing the start button and the safety ring. The display situated on the
front of the autoclave indicates what part of the cycle the autoclave is currently performing with
the respective pressure and temperature. The entire cycle takes approximately 16 minutes in a
standard program with the DAC UNIVERSAL, depending on the type of instrument to sterilize/
disinfect. For example sterilization of solid instruments, which are placed in the basket, have no
need for either lubrication or residual water removing. Therefore, the cycle for those
instruments will be shorter. For sterilization of turbines, handpieces and contra-angles the cycle
is in full length approximately 16 minutes. For cleaning and disinfection of ultrasonic scaler
handpieces, scaler tips and sprayvit nozzles the cycle is in full length approximately 20 minutes.
The processes and equipment are described in our instruction manual. The processes are
shown in the following diagram. The capacity of the DAC UNIVERSAL is six instruments pr.
cycle.

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The cycle diagram shows a standard cycle with holding time of 3 minutes at 134 C the total
cycle time is 16 minutes.

Mild cycle (holdingtime: 15 min. at 121 C)

Prion cycle (holdingtime: 18 min. at 134 C)

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Basket lid (holdingtime: 3 min. at 134 C)

Wrapped lid (holdingtime: 3 min. at 134 C)

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Flex lid (holdingtime: 3 min at 134 C)

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9 Cleaning
The purpose of the cleaning is to ensure removal of organic material and soil.
The cleaning is performed in the internal and external part of the instrument. The flushing stage
and cold rinse are used in order to avoid protein coagulation.

The spray system of the DAC UNIVERSAL is specially designed to be suitable for rinsing
instruments in a small chamber, as in our case two litres. After filling water approximately 0.2
litres into the bottom of the chamber, pulsed pressurized air is blown through four channels at
the bottom of the chamber. A very effective system influencing that all external surfaces of the
load and the chamber as well are flushed properly.
For the washing of the internal channels of the load, the water is conducted through the special
definite adapters and air is used to force the water through the instruments. In this way, it is
ensured that the organic material, soil and residual detergent are removed from the load and
the sterilization chamber trough the drain.

9.1 Water Quality


The norm ISO15883-1 required a test for chemical purity of the water for each program step.
The water used in the DAC UNIVERSAL is drinking water which has been demineralized and
has a conductivity of 3 S/cm. The conductivity of the water is measured during the cycles. If
the conductivity exceeds the conductivity level of maximum 10 S/cm, a message will appears
in the display and the process is stopped. The norm EN13060 Annex C suggests conductivity
(at 20 C) of maximum 15 S/cm in feed water and a maximum of 3 S/cm in condensate
produced from steam that has been taken from the empty sterilizer chamber.

Note:
According to HTM01-05 4.1,3 the water in the reservoir must be filled at least daily using fresh
distilled water. At the end of the working day the device should be cleaned, dried and left empty
with the door kept open.

9.2 Dosing of detergent


A detergent tablet called NitraClean is used with every cleaning cycle with the Basket lid. The
detergent NitraClean is neutral with a PH value 7,.5 -8,.5 at (20 C, 30 g/l). After cleaning, the
detergent will be completely rinsed before the disinfection/ sterilization will be started. A
detergent with neutral PH value is used in order to protect the lubrication of rotating
handpieces.

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9.3 Requirement for cleaning


The DGKH, RKI and UK Department of Healths guidelines require that the instruments must be
properly clean before sterilization. Properly clean means removal of organic material or soil
from the load.
The norm ISO15883-1 describes in Annex C, three different methods for detecting residual of
protein.
1) The Ninhydrin method,
2) The semi-quantitative biuret BCA method
3) The ortho-phthalic dialdehyde OPA method.

Sirona Dental A/S uses Medisafe Medi-Check detectors for the type test. This method is
equivalent to the Ninhydrin methods of the norm ISO15883-1 Annex C.

9.4 Control of the Cleaning Process


In order to control the cleaning efficacy, the norm ISO15883-5 indicates the type of soil to be
used for the test in different countries.

The following table shows example of different test soils to use in different countries that are
relevant in connection with test of cleaning efficacy of dental instruments.

Table of Soil Type

Country Reference Constituents of Soil Load Type ISO 15883-5


Austria Hygiene und Heparinised sheep Surgical
Medizin 20 blood coagulated with instruments Annex A
protamine
Germany Bundesge- Sheep blood, E. faecium Surgical Annex G
sundheitblatt Egg yolk, E. faecium instrument
23 Semolina, butter, sugar,
Hller C, milk powder, E.
b
Krger S. faecium
Germany Hyg Med 22 & Tetramethylbenzidine, Surgical Annex J
28, Australian Hydrogen peroxid instruments
dental journal solution,
43 Bovine haemoglobin
Nederland Orzechowski Bovine serum albumin Surgical Annex K
T.J.H. & DE fraction 5 Porcine instruments
Bruin A.C.P gastric mucin type 3,
Bovine fibrinogen
fraction 1 Bovine
thrombin.
Sweden SIS- TR3:2002 Citrated cattle blood Surgical Annex M
coagulated with calcium instruments
chloride
United BS2745- Defibrinated Surgical Annex N
Kingdom 3:1993 horse/sheep blood, egg instruments
HTM 2030 yolk, dehydrated hog
HTM 01-05 mucin
USA ASTM Protein/organic soil(user Surgical Annex S
E2314:03 reference) instruments
B. attrophaeus
AAMI TRI30: endospores
2003 Albumin, haemoglobin,
fibrinogen, Thrombin

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The soil used in the type test is both bovine haemoglobin as stated in ISO EN 15883-5 annex J
for Germany.
For testing the instrument for residual of protein in hollow instruments, the soil is placed on the
outer as well as on the inner surfaces of the hollow load. The inner surfaces mean both in the
drive and the spray channels of the handpieces and turbines, as well as in the lumen of
ultrasonic handpieces, scaler tips and sprayvit nozzles. A special adapter is designed for the
purpose of introducing the blood into the internal channels.

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9.5 Routine Testing for Residual Protein


The control for the residual of protein after the cleaning phase is done with Medisafe Medi-
Check Protein residue. A green result means that the instrument is clean and ready for the
sterilization/ disinfection process. If the colour is grey or purple, it means there is protein
remaining on the instrument and it is not ready for disinfection/sterilization.
The Medisafe MediCheck Protein residue test is equivalent to the Ninhydrin method.

The picture shows the Medisafe MediCheck Protein residue test.

9.6 Testing for Residual of Detergent


The test is performed on a bolt M12x100. The method to detect residual of detergent is by
measuring the conductivity of demineralised water before and after the bolt is subject to a
whole cycle by use of the detergent in the autoclave. The value of the conductivity is then
transmitted to a weight. The procedure and result is described in the type test for validation of
cleaning and sterilization, document no. QR21 (Validation report for DAC UNIVERSAL).

9.7 The Ao Concept


The norm ISO15883 introduces the term Ao for moist heat disinfection. This term is defined as
the equivalent time in second at 80 C needed to produce a given disinfection effect. According
to the DGKH-guideline, the use of an Ao value of 600 is deemed to be a minimum requirement
for uncritical medical device. The Ao value of at least 3000 must be employed for medical
devices contaminated with heat-resistant viruses for example hepatitis B virus. For Critical
medical device the Robert Koch Institute RKI recommends thermal disinfection with an Ao
value of at least 3000.
During the whole cycle in the DAC UNIVERSAL, the temperature for all process steps was
registered for each second. The data only for the cleaning process from approximately 65 C,
which is the lower temperature limit according to ISO15883 Annex B, and before the sterilizing
process begin, are inserted in the Ao formula.

A0 10[( T 80) / Z * t

Where
Ao is the A value when Z is 10 C
t is the chosen time in seconds
T is the temperature in the load in degrees Celsius

Calculating the Ao value the lower limit of the temperature is 65 C, since for temperature below
the 55 C the value of thermophilic organism change dramatically and there are a number of
organisms which will actively replicate.

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The result of Ao value from a test is shown in the following table.

Temperature [C] Hold time [sec.] Ao value [sec.]


64.7 6 sec. 0.18
77.6 6 sec. 3.45
87.5 6 sec. 33.74
93.8 6 sec. 143.93
98.1 6 sec. 387.39
101.9 6 sec. 929.29
105.3 6 sec. 2033.06
Total Hold time = 42 sec. Total Ao = 3531.05

The table shows the temperature inside the Process Challenge Device, PCD, which stimulates
the hollow instruments (see part 7.5 for instruction for PCD). The temperatures shown are only
a part of the whole cycles which are suitable for the calculation of the Ao Value. Each step of
temperature is measured during six seconds.
The calculation for the Ao Value is done for the temperature range of 64.7 to 105.3 C during
42 seconds. The calculated Ao value is 3531.05, which is greater than the required 3000.
The calculation of the Ao is done here only to see if the value of 3000 is reached. The cycle of
the DAC UNIVERSAL continue to the sterilization process and a similar method is used to
calculate the Fo value.

9.8 Installation and Operational Qualifications


Installation and operational qualifications are documented process to demonstrate that the DAC
UNIVERSAL complies with the specification of the norm ISO15883-1/2. The compliance is
documented in the report QR22. The test reports for validation of the combination autoclave
furnish documentary proof that the DAC UNIVERSAL has been installed and is being operated
in accordance with the process sequences continually complies with the specified criteria and
thus produces devices that meet the requirements (see also chapter 10).

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10 Sterilization Process
10.1 Removal of Air: Back-flush
Prior to the sterilization process the back-flush function takes care of the removable of air from
the internal parts of the load. This is done by opening and closing valves where the steam flows
through the spray and drive channels. This process is repeated four times for the spray channel
and four times for the drive channel to ensure that only steam is present so that the sterilization
process is performed properly.

10.2 High level disinfection


Ultrasonic scaler handpieces, scaler tips and sprayvit nozzles are reprocess able in the DAC
UNIVERSAL with the Flex lid. The hygiene tests SN 17414 I-VI carried out by HygCen,
Germany confirm these instruments as being disinfected on a higher level. The instruments are
still exposed to exactly the same sterilization/ disinfection process as handpieces, turbines,
solid instruments and wrapped instruments.

10.3 Sterilization/ Disinfection


Proper sterilization requires that all air is exhausted from the chamber and the load and
replaced by steam. The pressure and the temperature of the saturated steam must correspond
to the steam tables. The physical monitors include time, temperature and pressure recorder,
displays, digital printouts and gauges. The printouts make it possible to check and verify that
the parameters as serial number, cycle number, pressure, temperature and time are met in
order to ensure the presence of saturated steam during the cycle (see printout clause 9.4).
The use of chemical indicators assists in the detection of potential sterilization failure that could
result from malfunction of the sterilizer. External calibrated pressure and temperature sensors
control the in-build instruments for proper function at the work shop and when validating the
sterilization process on site.

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10.4 Thermo-electrical Measurements


According to the Norm EN13060 4.6.3, the relationship between the sterilization temperature
and the holding time must be documented.

Sterilization temperature Minimum holding time


C Min.
121 15
126 10
134 3
143 1

According to EN13060 5.3.3 states that for hollow load A and B only the presence of saturated
steam shall be demonstrated to be adequate by a satisfactory colour change in the chemical
indicator system used, as specified by the indicator system manufacturer.

In the DAC UNIVERSAL, it is possible to choose between three different sterilization programs:
1) 121 C with a sterilization time of 15 min.
2) 134 C with a sterilization time of 3 min.
3) 134 C with a sterilization time of 18 min.

The data logger Almemo 2690-8 is used for measuring temperature and pressure in the
chamber. The picture below shows the logger and the lid. Alternatively, Ebro loggers can be
used for data logging.

The data logger has four temperature sensors connected. It is thermocouples Type T. They are
connected to the sterilization chamber through a special lid. In addition to the four temperature
sensors, an absolute pressure sensor is also connected through the lid. The picture below
shows the lid.

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One of the four temperature sensors must be placed inside a custom made Spore Tester in
order to simulate the conditions inside an instrument. The following pictures show the sensor
placed inside the Spore Tester.

External, wireless temperature and


pressure sensors mounted.

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Placement of the temperature sensors:

The bolt for the temperature sensor must be undone to be able to raise and to lower the
temperature sensor in the chamber. After that the bolt is screwed in tight again.

Since the temperature profile of the chamber cannot define the coldest point in the chamber,
the 3 other temperature sensors can be inserted in 3 different depths into the chamber Top,
middle and bottom of the chamber.

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10.5 Control for Presence of Saturated Steam


Control of complete chamber and hollow filling with saturated steam is done by the use of
chemical indicators according to ISO11140. For this purpose the customer needs to use a
holder for indicator or a process challenge device PCD (Spore Tester). The same procedure
must be done at the clinic. The routine for daily and weekly monitoring is described on the
instruction manual.
Another method used for monitoring of the sterilization process is by controlling the pressure
and the temperature to ensure the present of saturated steam during the cycle. A Sirona printer
can be connected to the autoclave for monitoring the pressure and temperature of the steam
during the cycle.
Monitoring control for the pressure and temperature sensors is done according to EN 13060 in
the works test with calibrated equipment for every manufactured autoclave.

The figure shows an example of printout after a whole cycle (standard lid)..

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The figure shows an example of printout after a whole cycle (Flex lid).

10.6 Requirement for Sterilization


DAC UNIVERSAL is reliably fulfilling the requirements for sterilization/disinfection when the
parameters for pressure and temperature are met. This has been tested and proved by an
accredited hygiene laboratory.

For testing the steam sterilization/ disinfection, the germ suspension from Bacillus
stearothermophilus ATCC 7953 is used. The selection of Bacillus stearothermophilus places a
worst case condition see HygCen report SN 12014.1 Ia -VIa.

10.7 The Fo Concept


The norm EN 13060 states that the term Fo for moist heat sterilization can be used. This term
is defined as the equivalent time in minutes at 121.11 C needed to produce a given
sterilizations effect. The Fo equal to 15 minutes have to be achieved in order to meet the
requirements of the norm 13060.
During the whole cycle in the DAC UNIVERSAL, the temperature for all process steps was
registered for each second. Since the DAC UNIVERSAL is a combination of a disinfector and a

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sterilizer, the data used for the calculation of the F value is the temperature and time after the
removable of air when the sterilization begins. The data are inserted in the Fo formula.

F0 10[( T 121) / Z * t

Where
Fo is the F value when Z is 10 C
t is the chosen time in minutes
T is the temperature in the load in degrees Celsius

Temperature [C] Hold time [min.] Fo value [min.]


135.3 12 sec. = 02 min 5.83
135.2 6 sec. = 0.10 min 2.63
135.3 6 sec. = 0.10 min 2.69
135.2 7 sec. = 0.12 min 3.07
135.3 44 sec. = 0.73 min 19.74
135.2 29 sec. = 0.48 min 12.71
135.3 29 sec. = 0.48 min 13.01
135.2 6 sec. = 0.10 min 2.63
135.3 6 sec. = 0.10 min 2.69
135.2 31sec. = 0.52 min 13.59
134.6 6 sec. = 0.1 min 2.29
135.6 6 sec. = 0.1 min 2.88
Total Hold time = 3.13 min. Total Fo = 83.76 min.

The total Fo value 83.75 min is greater than the required 15 min.

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10.8 Sterilization of Wrapped Instrument


Since the DAC UNIVERSAL is a combined machine which cleans, lubricates and
sterilizes/disinfects, the sterilization of wrapped instruments must be done in two steps.
The first step is the cleaning, lubrication, and sterilization without wrapping. After this step the
instrument can be used by the dentist and is considered as semi-critical B (non-invasive).
The second step is the sterilization with wrapping. In this process, the cleaning and lubricating
function are disabled. The wrapping material is according to EN868 and the indicators
according to EN867 Class 5. After this sterilization process the loads are dried, and can be
stored, and is considered as critical A (invasive).
Bacteriological test for sterilization of wrapped instruments is done by HygCen, German, see
HygCen report SN 12014.1 Ic VIc

The pouch is supplied with indicator showing if the package was exposed for the sterilization
process.

Indicators

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10.9 Drying
The most effective way to dry especially hollow instruments in the DAC UNIVERSAL appears to
be by blowing air through them. The air is supplied directly from the pressure regulator in the
DAC UNIVERSAL through an air filter and a device which is named Expel-Unit. To avoid
cross contaminating, this valve (V12) is isolated from the channels connected to the chamber.
During expel the drain valves are opened, so there is no pressure in the sterilization chamber.
Microbiological studies after the drying process has been done by the Danish Technology
Institute.

The norm EN 13060 Clause 5.5 required 0.2% of residual water for solid instruments and for
wrapped instruments using the following equation:
m2 m1
C *100
m1

where
C is the change in moisture content, in per cent
m1 is the mass of the test load before sterilization, in grams.
m2 is the mass of the load after sterilization, in grams.

10.10 Product Release from Sterilization


When the cycle is completed, the machine opens automatically and the machine will indicate
that the cycle is complete. If the cycle is not completed an error code appears in the display.
The lid will now be open only half way up and the instruments cannot be removed until accept
of the operator by pressing button C or Down-Key depending on the user interface version.
Afterwards the autoclave will be open and the instruments can be removed from the machine
cleaned, disinfected or sterilized and dried.

Note:
Before releasing the instruments, the operator shall control the data from the sterilization/
disinfection process on the printout to ensure that all sterilization parameters are met. The
printout should be put on archive for batch release and documentation.

Storage of Wrapped Instruments


Wrapped instruments processed in the DAC UNIVERSAL can be stored in a clean dry room on
a shelf. In order to avoid re-colonisation, it is recommended to record the date and cycle
number on the packaging or pouch.

According to HTM 01-05:2013 2.4k, the storage of wrapped instrument must not exceed 1
year. The management approached will ensure that commonly used instruments are dealt with
on (FIFO) a first in first out principle and less frequently used instrument are stored for clear
identification and reprocessed if not used within the designated storage periods.

If the wrapping or sterilization pouch becomes wet during storage, the content will no longer be
sterile and will require re-sterilization.

The norm ANSI/AAMI ST79:2006 recommends that the temperature in storage areas should be
24 C (75 F), at least four air exchange pr. hour and the relative humidity should be controlled
so that it does not exceed 70 %.

The shelf life of a packaged sterile item is event-related and depends on the quality of the
packaging material, the storage conditions, the conditions during transport and the amount of
handling.

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10.11 Instruments for Decontamination After Use


The transfer of used instruments to the decontamination area must be done carefully and
procedure for personal protective equipment as secure transport, wearing of gloves to minimize
the risk of infection etc. has to be applied.
In order to make the cleaning easier, we recommend decontaminating the instruments
immediately after use. Where the reprocessing process is left for number of hours, manual
washing with potable water is to be considered. This may avoid degradation including
discoloration, staining, corrosion and pitting on the instruments surfaces.

Note:
If the instruments are visibly contaminated and not processed right away, it is recommendable
to pre-clean under a running tab. In order to avoid instrument damage, do not uses wire
brushes. Wire brushes may give rise to surface abrasion and they damage the protective
passivation layer from the surface of the instrument which protect against corrosion.

Note:
The use of alcohol with dental instrument should be avoided because alcohol has been shown
to bind blood and protein to stainless steel (HTM-01-05 Clause 6.57).

Note:
Instruments may become damaged during use or suffer from general wear and tear over their
lifespan. These instruments should be decontaminated before sent to repair.

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11 Technical Test
Before leaving the production, all autoclaves are subject to a technical test, a security test
called flash test and a works test according to the requirements of the norm EN13060 and
ISO15883-1/2. The tests and control measures are carried out as part of installation
qualification.

11.1 Installation Qualification (IQ)


The installation qualification is carried out to ensure that the DAC UNIVERSAL has been
properly delivered and installed, and also to ensure that the available utilities meet the specified
requirement.
The tests and control measures consist among other, verification of the order and delivery and
verification of connections and supplies e.g. electricity, water, air and drain.
The tests and control measures are carried out according to the checklist documents no. QR
22. These tests and control measures are a part of installation qualification. Documentation,
maintenance plan, precautions, and technical data are described in the chapter of operating
and installation instructions.

11.2 Operating and Installation Instructions


Following instruction in the suitable language are sent with the autoclave on delivery:

Instruction for use (electronically on a CD-ROM)


Short Instruction for use (paper + electronically on a CD-ROM)
Display message overview (for select versions)
Installation instructions (electronically on a CD-ROM)
QR22 Installation report
QR20 Validation of the Cleaning and Disinfection or Sterilization Process (electronically on a
CD-ROM)
Check & Clean
Works test documentation
Declaration of conformity
Manufacturer certificate
Check list Practice handover (electronically on a CD-ROM)

11.3 Operational Qualification (OQ)


Operational qualification is carried out to ensure that the DAC UNIVERSAL and supplies meet
the Sirona Dental A/S specifications and the requirements of the norms ISO 15883 and
EN13060.

All units have performed 40 flawless runs without casing and 40 flawless runs with casing
mounted. If the test is interrupted by error code or if a component failed, the data is registered
in a database in order to perform the necessary corrective action. If a machine failed the test, a
corrective action takes place and the whole test is repeated from the beginning. In this step all
sterilization/ disinfection programs are tested.

A part of the check list documents QP10 and QP04 is for controlling the operational
qualification. A part of the works test described below is also to demonstrate operational
qualification.

Operational qualification of components as valves, pumps, motor, oil dispenser and processes
pressure and temperature etc. are tested and controlled by means of the service software both
at the production and on site by the engineer responsible for the installation of the autoclave.

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The picture shows some of the possibilities for controlling components.


More detailed information for all tabs is described in the service manual.

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11.4 Security Test


The safety requirements for the electric parts comply with the requirements of the norms
EN61010 and the electromagnetic compatibility comply with the requirements of the norm EN
60601-1 and EN 606061-2-40.
The studies for electricity safety have and electromagnetic compatibility been done by
accredited laboratories.
Every autoclave is subject to electrical test at the work shop before delivery to the customer.

Procedure for Electrical Test at the Production


Every autoclave is subject for an electrical test before delivery to the customer.

Earth Bond
25A is applied between the earth pin of the mains supply plug and the earth bond test lead clip
for 5 seconds The limit is 0.10 .

Insulation
500V DC is applied between the earth pin and both the live and neutral pins of the appliance
mains supply plug for 5 seconds. The limit is 2.00 .

Flash Test
1.5 KV ac RMS is applied between the earth pin, and both the live and neutral pins of the
appliance mains supply plug for 5 sec. The limit is 2.25 mA.

Leakage Test
Shows the current being lost through leakage as the difference in the currents flowing in the live
and neutral conductors. Leakage is shown in mA. The limit is 0.75 mA.

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11.5 Performance Qualification (PQ) Work Test


The performance qualification is documentation indicating that the process is reproducible,
stable, and efficient for all required operating circumstances. This should incorporate items
such as operating condition under maximum predictable situations and worst-case predictable
process parameters. The parameters and processes to perform this test are described above
and the results of the test are shown in the type test for validation of cleaning and sterilizing/
disinfection using the steps described in Clause 12.

The cleaning efficacy and the sterilization/ disinfection achievement are documented in the type
test for validation.

Reference: Type test for validation Report no. QR21-00 and works test.

According to EN13060 clause 7.3.1 a works test must be performed for every program of the
autoclave. The work test is carried through every program on every unit at the production. This
work test is to demonstrate the conformity with the requirements of the norm EN13060.

The work test or installation test is the final test before use of the autoclave. The result of the
work test is sent with every autoclave on delivery. A record of the test is saved on a database
for traceability and for later documentation if necessary.

On-site the machine is to be installed according to the description in the document Installation
instruction as provide with the product. After installation, the QR22 Installation report must be
filled in and signed by both the user and the authorized service technician.

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12 Summary and Determination for the Alternative


Method of Validation
As described by the Robert Koch Institute, the final thermal disinfection of rotating instruments
must be carried out in a steam sterilizer DAC UNIVERSAL. Instruments that are sterilized
without wrapping are disinfected but not sterile after removing them for the sterilizer. These
instruments can be used only if they will be taking in use immediately under consideration of the
transport to the patient. These instruments are considered as semi-critical B. A second
sterilization is performed with wrapped instruments. The validation type tests for sterilization are
done both with and without wrapping.

The DAC UNIVERSAL complies both with the EN15883 and EN13060 norms, in Annexes the
checklist from the RKI guideline Anforderungen an die Hygiene bei der Aufbereitung von
Medizinprodukten and the HTM 01-05 guideline are proven to compliance with the DAC
UNIVERSAL.

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13 Process Step for Type Test used in the Validation
The process steps for test of cleaning and sterilization/disinfection as alternative for first validation.
The purpose of validation is to establish that the cleaning and the sterilization processes developed in
process definition can be delivered effectively and reproducibly to the treated load according to norm
EN17664.
The type test for validation of the autoclave will also furnish documentary proof that the DAC
UNIVERSAL, as it has been installed and is being operated in accordance with the process sequences,
continually complies with the specified criteria and thus produces devices that meet the requirements.

13.1 Validation of Cleaning Process


Since the DAC UNIVERSAL is a combined machine with a cycle including cleaning and sterilization/
disinfection, it is necessary to interrupt the cycle after the cleaning process, in order to perform the
validation of the cleaning process.

The cleaning efficacy is validated according to the norm ISO15883-1 clause 6.10 and the concept
includes following steps.

1) Use validation lid (with load according to EN 13060) together with the PCD instruments
2) Use of test soil
3) Positive test using Ninhydrin method
4) Charging the autoclave (load references)
5) Choose of program 121 C, 134 C
6) If the special basket lid is used, please follow the cleaning process with detergent
7) Stop the process prior to sterilization to evaluate the cleaning process
8) Visual inspection
9) Negative test for residual of protein using Ninhydrin method
10) Test for residual detergent (if wipes where used for pre-cleaning or if the basket were used)
11) Temperature-time curves
12) Calculating Ao value

13.2 Validation of Sterilization/ disinfection Process


The sterilization process is done in done in two steps: First without wrapping and second with wrapping.

1) Choose of worst case hollow and solid instruments


2) Weighing of loads
2) Charging the autoclave (load references)
3) Use of 3M Class 5 Chemical indicator
4) Choose of sterilizations program 121 C, 134 C (without wrapping)
5) Temperature-time curves
6) Visual inspection of 3M indicator
7) Wrapping of instruments
9) Choose of sterilization program 121 C, 134 C (with wrapping)
10) Weighing of loads after drying
11) Calculation of residual of water
12) Calculation of Fo value (use external datalogger in order to calculate the value)

D3472.201.07.02.01 6324920 4.2015


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14 Conclusion
This documents demonstrates the validity of the works test as a reference for a first validation if the
DAC UNIVERSAL is used with the described reference load and in conformity with its indended use.
The document shows that cleaning and sterilization/ disinfection performance requirements will be
reliably fulfilled and that a complete validation on-site in the dental clinic can be replaced by a short
validation procedure including the work test report for validation documentation.

In accordance with the studies mentioned above, our long time experience and the feedback from the
market, the DAC UNIVERSAL is clinically accepted and approved in many countries since many years.
In order to keep it clinical, the DAC UNIVERSAL must be revalidated periodically. The interval of
performing revalidations depends on the requirement of the different countries. Sirona Dental A/S
recommends performing the revalidation test at least once every two years or every 3000 cycles. The
validation test has to be signed from the dentist or authorities as acceptance for its clinical condition.

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15 Annexes
1) RKI - DIN EN ISO 15883 - Installation (IQ) and Operational Qualification (OQ)
2) RKI - DIN EN ISO 13060 - Installation (IQ) and Operational Qualification (OQ)
3) HTM 01-05 - DIN EN ISO 13060
4) Installation report QR22 Germany
5) Installation report QR22 United Kingdom
6) Works test example
7) Checklist for first and second test (Example)
8) Checklist for End-test (Example)

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Annex 1) RKI - DIN EN ISO 15883 - Installation (IQ) and Operational Qualification (OQ)

Installation and operational qualifications are documented process to demonstrate that the DAC
UNIVERSAL complies with the specification of the norm EN15883. The compliance is documented on a
separate document. The test report QR21 for validation of the autoclave will also furnish documentary
proof that the DAC UNIVERSAL as it has been installed and is being operated in accordance with the
process sequences continually complies with the specified criteria and thus produces devices that meet
the requirements.
The fundamental requirements of water disinfectors are described in appendix 3 of the RKI guideline
Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten (Hygiene requirements for
the reprocessing of medical devices). The fulfilment of these requirements is showed on the tables
below.

The below table is to demonstrate that Installation and operational qualification of the DAC UNIVERSAL
are in compliance with the RKI-guideline.

RKI Requirement Compli Remark Documentation


ance

15.1.1 Documentation of the


suitability of the WD

a) Type test Yes a) Report nr. SN


CE mark see 17414 I.
section 4 of this
b) Suitability for specific Yes report.
reprocessed medical b) See section 7.7 of
devices semi-critical Surveillance twice a this report.
category A / B or critical A / year by notified
B body LRQA.

c) Such additional equipment Yes Type test according c) See section 7.1
such as for medical devices to ISO 15883-1 & Loads Definition of this
Category semi-critical and ISO 15883-2 is report and Instructions
critical B (F. ex. special done (only for Flex for use.
connectors / nozzles, lid)
loading trays etc.)

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15.1.2 Documentation of the


suitability of the installation
site and connections.

a) Coordination of the process a) See section Fehler!


chemicals used in the Yes erweisquelle konnte
Treatment process of the nicht gefunden
WD werden. of this report.
Also available in
Product data sheets,
Safety data sheets,
b) Installation Qualification Instructions for use.
(IQ)
i. Consistency in
ordering and Yes b) Is ensured by
delivery. Installation report no.
QR22 and certified
ii. Proper installation. technicians.
Yes

iii. Examination of
supplies, content Yes
supply and quality.
Compliance with
the rules of the
installation plan.

iv. Empty chamber


test. Yes

v. Test run with test


load. Yes

vi. Verification of
safety equipment Yes

vii. Handover of
Operating and Yes
Maintenance
Instructions

viii. Instruction in the


operation of the Yes
device and
behavior during
faults

ix. Installation and


handover protocol Yes

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c) Operational Qualification
(OQ)
i. Operating
conditions and
equipment during Yes
the test. i. See section 7 & 13
in this report and
ii. Positioning of the instructions for use
sensors.
Yes
ii. See section 10.4 of
iii. Disinfection this report.
conditions
(suitability of the Yes
load carrier, load
and temperature iii. See section 7 of this
control function) report and instructions
for use.
iv. Doors and locking
Yes
v. Dosing of iv. See instructions for
chemicals use.
Yes
vi. There is a v. See section 9.2 of
vi. Water quality control of the feed this report and
Yes water integrated in instructions for use.
the sterilizer.
vi. See section 9.1 of
vii. Examination of the this report.
free flow of
pipelines Yes

vii. See the Cleaning


viii. Check the and maintenance
calibration of the part of the
measuring Yes instructions for use
instruments and Check & Clean.

ix. Correctness of the viii. Checked at works


process flow Yes test.

x. Reproducibility
Yes
xi. Fault indicator ix. Verified in works
Yes test.

x. See section 13 of
this report.

xi. Faults are displayed


on screen, see
instructions for use.

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15.1.3 Documentation of the


performance of the WD and
the training of personnel
assigned to the operating
personnel in the proper
operation of the WD

a) Instructions for use Yes a) DAC UNIVERSAL is


released with
instructions for use.
b) Description of all
application-relevant loading Yes b) See instructions for
configurations and naming use.
of the most difficult to clean
and disinfect medical
devices (including
justification)

c) Performance Qualification c) Insured by


(PQ) Yes validation report
no. QR21 and
i. List of loading certified
patterns with Yes technicians.
attribution to the
validated
programs.

ii. Operating
conditions and Yes
equipment during
the test

iii. Function of the


spray system Yes

iv. If applicable
recordings of Yes
rinsing pressure

v. Positioning of the
sensors Yes

vi. Effectiveness of Supported by tests


Cleaning (test and Yes performed at
real loading HygCen, Germany
including the see section 5 of this
chamber walls and report.
load carrier)

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vii. Description of the


disinfection Yes
conditions

viii. Effectiveness of Yes


disinfection (incl.
Chamber walls,
loading racks,
boilers, tanks)

ix. Effectiveness of Yes


drying

x. Process residues Yes

xi. Dosing of Yes


chemicals

The maintenance
d) Maintenance Yes frequency is d) See the Cleaning
weekly, every four and maintenance part
weeks, every third of the instructions for
month, and every use.
two years or 3000
cycles.

15.1.4 Daily tests

a) Visual inspection (for a) See the Cleaning


example chamber, spray Yes and maintenance
arms, connectors, seals, part of the
sieves) instructions for use.
The maintenance
b) Functional testing of frequency is
moving parts N/A weekly, every four
weeks, every third
c) Filling state chemical month, and every
containers, daily N/A two years or 3000
consumption cycles.

d) Other tests Yes d) See the Cleaning


and maintenance
part of the
instructions for
use.

15.1.5 Periodic checks and


procedures for deviations
from rule-based process flow
and related conditions

a) Periodic checks Yes Insured by


validation report
b) Scope of checks Yes no. QR21 and
certified
technicians.

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Annex 2) RKI - DIN EN ISO 13060 - Installation (IQ) and Operational Qualification (OQ)

Installation and operational qualifications are documented process to demonstrate that the DAC
UNIVERSAL complies with the specification of the norm EN13060. The compliance is documented on a
separate document. The test report QR21 for validation of the autoclave will also furnish documentary
proof that the DAC UNIVERSAL as it has been installed and is being operated in accordance with the
process sequences continually complies with the specified criteria and thus produces devices that meet
the requirements.
The fundamental requirements of small steam sterilizers are described in appendix 4 of the RKI
guideline Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten (Hygiene
requirements for the reprocessing of medical devices). The fulfilment of these requirements is showed
on the tables below.

The below table is to demonstrate that Installation and operational qualification of the DAC UNIVERSAL
are in compliance with the RKI-guideline.

RKI Requirement Compli Remark Documentation


ance

15.1.6 Documentation of the


suitability of the sterilizer

a) Type test Yes CE mark see a) Report nr. 21-10-


section 4 of this 2011.
report.

b) Process type S sterilizer for Surveillance once a b) See section 7.1


products by manufacturer Yes year by notified Loads Definition of this
specifications body LRQA. report and Instructions
for use.
Type test with bolts
according to
EN13060 is done.

15.1.7 Documentation of the


suitability of the installation
site and connections.

a) Installation Qualification Yes a) Is ensured by


(IQ) Instructions for use,
i. Consistency in service manual,
ordering and Yes Installation report no.
delivery. QR22 and certified
technicians.
ii. Proper installation. Yes

iii. Examination of air


leakage, empty Yes
chamber test.

iv. Empty chamber


test. Yes

v. Test run with test

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load. Yes

vi. Verification of Yes


safety equipment

vii. Handover of
Operating and Yes
Maintenance
Instructions

viii. Instruction in the Yes


operation of the
device and
behavior during
faults

ix. Installation and Yes


handover protocol

b) Operational Qualification b) Is ensured by


(OQ) Instructions for use,
i. Process evaluation service manual,
system (DIN EN Yes Installation report no.
13060, Appendix QR22 and certified
B). technicians.

ii. Consideration of ii. See section 7.2 of


process sequence Yes this report.
at a defined load
(difficult sterilized
medical devices
and packaging).

iii. Examination of air iii. See section 7.5 of


removal and steam Yes this report and
penetration with instructions for use.
appropriate PCD
(hollow)

iv. Testing the fault iv. See service


detection system Yes manual.
according to the
manufacturer's
instructions

v. Documentation of
the results in a Yes
qualification report

vi. By the
manufacturer Yes
provided data and
test results are

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taken into account

15.1.8 Documentation of the


performance of the sterilizer
and the training of personnel
assigned to the operating
personnel in the proper
operation of the sterilizer

a) Instructions for use a) DAC UNIVERSAL is


(including installation and Yes released with
handover protocol) instructions for use,
service manual and
b) Description of all loading praxis handover
configurations incl. The Yes Supported by protocol.
"most difficult" load (s) tests performed
at HygCen, b) See section 7 of this
Germany see report and
section 5 of this instructions for use.
report.

c) Maintenance and repair if Yes The c) See the Cleaning


necessary and re- maintenance and maintenance part
performance qualification frequency is of the instructions for
for a particular reason weekly, every use. Re-performance
four weeks, qualification with
every third QR21.
month, and
every two years
or 3000 cycles.

15.1.9 Daily tests

a) Visual inspection of a) There is a a) See the Cleaning


- Chamber and seals Yes control of the and maintenance part
- Feed water feed water of the instructions for
integrated in the use.
b) Functional testing of sterilizer.
- steam penetration with a Yes b) Specification of
suitable PCD Sirona suitable chemical
- Recording device recommends using Indicators and PCD
a chemical indicator device are mentioned
in a PCD test in section 10.4 of this
device once report.
a week to simulate The successfully
a steam penetration bacteriological tests
test and confirm done by the mentioned
and ensure proper third parties show the

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sterilization. capability of the DAC


UNIVERSAL in terms
The maintenance of the safe,
frequency is reproducible
weekly, every four sterilization of different
weeks, every third dental instruments.
month, and every Also see instructions
two years or 3000 for use.
cycles.

15.1.10 Periodic checks and


procedures for deviations
from rule-based process flow
and related conditions

a) Periodic checks Yes Insured by validation


report no. QR21
b) Scope of checks Yes and certified
technicians.

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Annex 3) HTM 01-05 - DIN EN ISO 13060

Installation and operational qualifications are a documented process to demonstrate that the DAC
UNIVERSAL complies with the specification of the norm EN13060. The compliance is documented on a
separate document. The test report QR21 for validation of the autoclave will also furnish documentary
proof that the DAC UNIVERSAL as it has been installed and is being operated in accordance with the
process sequences continually complies with the specified criteria and thus produces devices that meet
the requirements.
The fundamental requirements of small steam sterilizers are described in chapter 12 of the Health
Technical Memorandum 01-05 Decontamination in primary care dental practices. The fulfilment of
these requirements is showed on the tables below.

The below table is to demonstrate that works tests of the DAC UNIVERSAL S type autoclave are in
compliance with the HTM-guideline.

HTM Requirement Compli Remark Documentation


ance

15.2.1

a) Dynamic chamber pressure


Yes

b) Air leakage Yes b) & c) Part of works


test and type test, see
c) Empty chamber Yes annex 5 of this report
and report nr. 21-10-
2011.

15.2.2 Solid load

a) Non-wrapped Yes a) & b) Part of type


test, see report nr. 21-
b) Single-wrapped Yes 10-2011.

c) Double-wrapped N/A

15.2.3 Small porous items

a) Single-wrapped N/A

b) Double-wrapped N/A

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15.2.4 Small porous load

a) Single-wrapped N/A

b) Double-wrapped N/A

15.2.5 Full porous load

a) Single-wrapped N/A

b) Double-wrapped N/A

Specification of
15.2.6 Hollow load N/A Sirona suitable chemical
recommends using Indicators and PCD
a chemical indicator device are mentioned
in a PCD test in section 10.4 of this
device once report.
a week to simulate The successfully
a steam penetration bacteriological tests
test and confirm done by the mentioned
and ensure proper third parties show the
sterilization. capability of the DAC
UNIVERSAL in terms
of the safe,
reproducible
sterilization of different
dental instruments.
Also see instructions
for use.

15.2.7 Solid load dryness


a) Non-wrapped
Yes a) & b) Part of type
b) Single-wrapped test, see report nr. 21-
Yes 10-2011.
c) Double-wrapped
N/A

15.2.8 Small porous items: dryness


a) Single-wrapped a) Part of type test,
N/A see report nr. 21-10-
b) Double-wrapped 2011.
N/A

15.2.9 Small porous load: dryness


a) Single-wrapped a) Part of type test,
N/A see report nr. 21-10-
b) Double-wrapped 2011.
N/A

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15.2.10 Full porous load: dryness


a) Single-wrapped a) Part of type test,
N/A see report nr. 21-10-
b) Double-wrapped 2011.
N/A

15.2.11 Residual air Yes


a) Part of type test,
see report nr. 21-10-
2011.

See section 10.9 of


15.2.12 Microbiological test this report.
(optional) Yes

15.2.13 Daily tests

c) Visual inspection of b) There is a a) See the Cleaning


- Chamber and seals Yes control of the and maintenance part
- Feed water feed water of the instructions for
integrated in the use.
d) Functional testing of sterilizer.
- steam penetration with a Yes b) Specification of
suitable PCD Sirona suitable chemical
- Recording device recommends using Indicators and PCD
a chemical indicator device are mentioned
in a PCD test in section 10.4 of this
device once report.
a week to simulate The successfully
a steam penetration bacteriological tests
test and confirm done by the mentioned
and ensure proper third parties show the
sterilization. capability of the DAC
UNIVERSAL in terms
The maintenance of the safe,
frequency is reproducible
weekly, every four sterilization of different
weeks, every third dental instruments.
month, and every Also see instructions
two years or 3000 for use.
cycles.

15.2.14 Periodic checks and


procedures for deviations
from rule-based process flow
and related conditions

c) Periodic checks Yes Insured by validation


report no. QR21
Yes

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d) Scope of checks and certified


technicians.

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Annex 4) Installation report QR22 Germany(One copy for dealer, one for customer) (page 1/2)

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Annex 4) Installation report QR22(One copy for dealer, one for customer) (page 2/2)

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Annex 5) Installation report QR22 United Kingdom (One copy for dealer, one for customer) (page 1/2)

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Annex 5) Installation report QR22 United Kingdom (One copy for dealer, one for customer) (page 2/2)

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Annex 6) Works test example (page 1/4)

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Annex 6) Works test example (page 2/4)

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Annex 6) Works test example (page 3/4)

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Annex 6) Works test example (page 4/4)

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Annex 7) Checklist for Test 1 and test 2

ID v/1.test ID v/2.test
Start date: Serial number.: OK = OK =
Step Overview SOP Sub items Registration
1 Service software 1. test Download of software Version

Setpoint
2 Hardware 1. test Control of huba-sensor Huba sensor Bar
Barometer Bar
3 Pressure test Test of safety valve (Min. 4,5 bar - Max. 5,2 bar) Pressure
4 Fluid control Oil bottle is weighed prior to prolonged test in test room (min. 76 g). Note weight
in control scheme
5 Prolonged test 1. test v/230 volt (w/o casing) Date (2. test)
40 runs 2. test v/110 volt (w/ casing) Number of runs prior
to casing
6 If applicable special

feature SOP
If applicable special

feature SOP
7 End test Test sheet end test is used when step 6 is completed

Rep. performed
Initials Date Error code Rap.nr Correction by: Date of rep.
Control scheme for oil use (40 runs)
Consumption
Before After (Min 20 g , Max 26 g)
1. test performed by (ID): ________ ______________________________________________
Date and signature
2. test performed by (ID): ________ ______________________________________________
Date and signature

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Annex 8) Checklist for End-Test

Sirona Dental A/S 510673_6.1_S_EN


12.2015/QR20_v6.1 EN 6553684 D.3472.201.07.03.02