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Electrical Safety in medically used rooms according

IEC 60364-7-710:2002-11
Amin Shabou
 opportunities with integrated solutions (Systems)

Past only components trend/future market: systems

BENDER > Electrical Safety in medically used rooms 2

Solutions presented by BENDER Group

Complete Solutions

BENDER > Electrical Safety in medically used rooms 3

Electrical safety

BENDER > Electrical Safety in medically used rooms 4

Why electrical safety?

BENDER > Electrical Safety in medically used rooms 5

Why electrical safety?

BENDER > Electrical Safety in medically used rooms 6

History of the Standards
1962: 1981:
VDE 0107/12.62 DIN 57107/VDE
Bestimmungen für das 0107/6.81
Errichten und Instand- Errichten und Prüfen
setzen elektrischer von elektrischen
Anlagen in medizinisch Anlagen in medizinisch
genutzten Bereichen genutzten Räumen
1960 1970 1980
1968: 1989:
VDE 0107/03.68 DIN VDE
Bestimmungen für das 0107:1989-11
Errichten elektrischer Starkstromanlagen in
Anlagen in medizinisch Krankenhäusern und
genutzten Bereichen medizinisch genutzten
Räumen außerhalb von
Krankenhäusern
BENDER > Electrical Safety in medically used rooms
1994: DIN VDE 2002: DIN VDE 0710
107 (VDE 0710):2002-11
(VDE 0107):1994-10 Errichten von Nieder-
Starkstromanlagen in spannungsanlagen –
Krankenhäusern und Anforderung für
medizinisch genutzten Betriebsstätten, Räume und
Räumen außerhalb Anlagen besonderer Art – Teil
von Krankenhäusern 710: Medizinisch genutzte
Bereiche
1990 2000 2010 2018
2002: 2012:
IEC 60364-7- HD 60364-7-
710:2002-11 710:2012
Electrical Installations of Low-voltage electrical
buildings – Part 7-710; installation - Part 7-710:
Requirements for special Requirements for special
installations or locations – installlations or locations
Medical locations – Medical locations
7
What does the standard say?

IEC 60364-7-710:2001-11 Electrical installations of buildings –

Part 7-710: Requirements for special installations or locations – Medical locations
This standard is applicable for:
Hospitals
Private Clinics
Medical and dental practices
Health care centres
Dedicated Medical Rooms in the work place
This IEC 60364-7-710 is a part of the IEC 60364-…. Series. This means, the other parts
of the IEC 60364-… series must be taken into account as far as necessary
How can I identify which other parts of the standard must be taken into account
Example 1
710.41 Protection against electric shock
corresponding chapters of IEC 60364-4-41 are to be taken into account
Example 2
710.556 Safety Services
corresponding chapters of IEC 60364-5-56 are to be taken into account

BENDER > Electrical Safety in medically used rooms 8

Standards which requires a medical IT system

Hospital standard worldwide

International UK Ireland
IEC 60364-7-710 BS 7671 GN7 / HTM2007 ETCI 10.1
Germany Norway Netherlands
DIN VDE 0100-710 64/747/FDIS NEN 3134
Austria Spain Slovakia
ÖVE / ÖNORM E 8007 UNEE 2 0-615-80 STN 33 2140
France Belgium South-Africa
NFC 15-211 T 013 SANS 10142-1
Italy Finland Russia
CEI 64-4 SFS6000 GOST P 50571
Brazil Hungary China
NBR 13543 MSZ 2040 GB16895/GB5033-2002

NFPA99 Solutions are also available

BENDER > Electrical Safety in medically used rooms 9

Power in electrical safety

Solutions for
electrical safety
according to IEC 60364-7-710

Source: www.trilux.com

BENDER > Electrical Safety in medically used rooms 10

Classification of medical locations
710.3.5 Group 0
Applied Medical location where
part no Applied parts are
intended to be used
Power Discontinuity cannot
supply cause danger of life
Example  Massage room
 Office
BENDER > Electrical Safety in medically used rooms
710.3.6 Group 1
Medical location where applied
parts are intended to be used as
follows:
 Externally
 Invasively to any part of the
body, except where 710.3.7
applies
Discontinuity of electrical supply does
not represent a threat to safety of the
patient
 Bedroom
 Haemodialysis room
 Physiotherapy room
710.3.7 Group 2
Medical location where applied parts
are intended to be used in applications
such as intra-cardiac procedures,
operating theatres and vital treatment.
Discontinuity (failure) of the supply can
cause danger of life
 Operating theatre
 Intensive care room
 Premature baby room
11
 Danger related to the electrical current

Impact of the electrical current on the human body

A human being is in danger already when, after the occasional touch of a powered piece of
metal, a current of more than 30mA is flowing through parts of the body.

Cardiac Arrest

Cardiac Arrhythmia
Irreversible Defects of the Heart

Paralysition
Apnoea

Irreversible Defects
Contraction of the muscles
Reversible Defects
Shock

BENDER > Electrical Safety in medically used rooms 12

 Danger related to the electrical current

Impact of the electrical current on the human body

Inside an ICU, an OR, a premature baby room or a dialysis room and while insertion of pipes and tubes …
the critical limit is reduced down to about 10µA !!

Cardiac Arrest

Cardiac Arrhythmia
Irreversible Defects of the Heart

Paralysition
Apnoea

Irreversible Defects
Contraction of the muscles
Reversible Defects
Shock
0,01 mA

BENDER > Electrical Safety in medically used rooms 13

In the medical sector there is also
the special situation of the patient …

The risks for the patients in hospitals ...

 The patient`s natural reactions to hazards
are reduced or switched-off
 The heart muscle is highly sensitive to
electric currents (currents > 10 µA)

 Simultaneous application of similar ME on the patient

 The insertion of catheters and the like into the body may
reduce the electrical resistance of the skin
 Body functions are temporarily or continuously supported or substituted
by medical electrical devices
 Fire and explosion risks through the use of
anaesthetics, disinfectants or cleaning
 Additional risks by secondary effects
(Downfall, Burn …..)

BENDER > Electrical Safety in medically used rooms 14

The power in electrical safety

 How can the medical IT system

and the power supply of medical
locations perfectly monitored ?

BENDER > Electrical Safety in medically used rooms 15

Transformers for medical IT systems (710.512.1.1)

Requirements for the transformer

 Transformers shall be
 installed in close proximity to, inside or outside, the
medical location
 placed in cabinets or enclosures to prevent unintentional
contact with live parts.

 Rated voltage Un on the secondary side of transformers ≤ 250 VAC

 Transformers according IEC 61558-2-15, with additional requirements:

 The leakage current of the output winding to earth and the leakage current of the enclosure, when
measured in no-load condition and the transformer supplied at rated voltage and rated frequency, ≤ 0.5
mA.
 Rated output of the transformers 0.5 kVA … 10 kVA.
 For three-phase loads with an IT system a separate three-phase transformer shall be provided for this
purpose with output line-to-line voltage not exceeding 250 V.

BENDER > Electrical Safety in medically used rooms 16

Transformers for medical IT systems

Requirements for the transformer

 IEC 61558-2-15
Safety of power transformers,
power supply units and similar
 Part 2-15: Particular requirements for isolating
transformers for the supply of medical locations:
 short circuit voltage ≤ 3%
 no-load input current ≤ 3%
 inrush current ≤ 12 x rated input current

 Single phase transformers

 ES0710 series
 acc. to IEC 61558-2-15
 1…10 kVA
 Vertical or horizontal version,
or installed in an enclosure

BENDER > Electrical Safety in medically used rooms 17

Transformers for medical IT systems

BENDER > Electrical Safety in medically used rooms 18

Monitoring of medical IT system

What does the standard say ?

710.413.1.5 Medical IT system
For each group of rooms serving the same function, at least one separate medical IT system is necessary
The medical IT system shall be equipped with an insulation monitoring device in accordance with IEC 61557-8
with the following specific requirements:
the a.c. internal impedance shall be at least 100 kΩ;
the test voltage shall not be greater than 25 V d.c.;
the injected current, even under fault conditions, shall not be greater
than 1 mA peak;
indication shall take place at the latest when the insulation resistance
has decreased to 50 kΩ. A test device shall be provided;
NOTE 2
In Germany, an indication is required if the earth or wiring connection is lost.
Monitoring of overload and high temperature for the
medical IT transformer is required.

BENDER > Electrical Safety in medically used rooms 19

IEC 61557-8 Annex A

BENDER > Electrical Safety in medically used rooms 20

Load- and temperature monitoring

Note:
In the main feeder of the
IT system transformer over-current
protective devices are only used for
protection against short-circuits, so that an
overload does not lead to a power failure !

1st advantage – monitoring of load current IL 2nd advantage – monitoring of temperature

 Measurement of the load current using a
measuring current transformer
 If the transformer power is exceeded
(load current) there is immediate signalling on
plugging in ME equipment
 Shut down of unnecessary equipment
 Measurement using a PTC resistor in the
transformer winding
 A slow increase in the temperature
of the winding core is detected
 Fire risk and damage
due to overheating are prevented

BENDER > Electrical Safety in medically used rooms 21

Medical Insulation Monitoring Device (Med-IMD)
isoMED427P

 Clear indication  Clear Textdisplay Technical features

by bright LEDs  Sealable Cover Bender Standard
Nominal voltage AC 70…264 V -
 Test- and  Setup keys Response value 50…500 kΩ 50 kΩ
Resetbutton
intern./extern Response time ≤1s -
 Communication
Measuring voltage Um ≤ 12 V DC ≤ 25 V
Interface for
 Two separate indication and Internal impedance ≥ 240 kΩ ≥ 100 kΩ
response operation panels
values for pre- Measuring current ≤ 50 µA ≤ 1mA
warning/alarm Load current 5…50 A -
 Space saving
enclosure, Transformer temperature 4kΩ (PTC acc. DIN 44081)
 2 separate
only 35 mm Test / Reset button Int. / ext.
Output Relays
Interface BMS (2…90)

 Application + additional features

 Medical IT systems in medical locations  Indication, if earth connection or
of group 2 according to IEC 60364-7-710:2002 connection to system be monitored is lost
 Medical IMD for monitoring of  Integrated test puls generator for insulation
 Insulation resistance fault location in combination with EDS 151
 Load current  Fullfills Annex A IEC 61557-8:2007 medical IMD
BENDER 
> Electrical Safety in medically
Transformer used rooms
temperature  Password protected setup 22
Why Insulation fault location system?

In intensive care locations several socket-outlets are

arranged at every patient place, sometimes up to 24 socket
outlets and more

In an intensive care unit with 4 beds, for example, these are

more than 90 socket outlets

In intensive care units usually no technical experts are

present, but medical personnel

If a defective device causes an insulation fault,

it will be very difficult to locate the associated
socket outlet

In order to guarantee the patient's safety,

the insulation fault must be found as
quick as possible.

BENDER > Electrical Safety in medically used rooms 23

Where is the insulation fault?

IEC 60364-7-710: 413.1.5.4

It is recommended that the first fault be eliminated with the shortest practicable time

But how ?

The solution
Earth fault detection system
EDS151
BENDER > Electrical Safety in medically used rooms 24
 Insulation fault locator (IFLS) EDS151
with 6 integrated measuring transformers
 CT
 On/Com LED Technical data
openings
and bus activity
10 mm AC 17…24 V
Supply voltage
DC 14…28 V
Response value 0,5 mA
Response time ≤8s
Scanning time for all channels approx. 72 s
No. of measuring channels 6 / 528
 Setup for Interface RS-485 / BMS
 Alarm LED  Plugable
BMS
per channel Connector
address

 Application + Additional features

 Medical locations of group 2 according to IEC 60364-7-  Space-saving construction
710:2002, e.g. ICU  Easy installation inside distribution boards
 Up to 528 measuring channels  Wide assembling opening for cables and wires
 Scanning time for all channesls approx. 72 s  IFLS according IEC 61557-9:2007
in combination with Isometer iso427PG
 Cyclical self test
BENDER > Electrical Safety in medically used rooms 25
Intensive care units based on IEC 60364-7-710

Requirements from IEC 60364-7-710

 710.413.1.5
 Alarm system
at a suitable
place
 Permanently
monitored by medical
staff

 IEC 60364-4-41
Protection against
electric shock
 413.1.5.4
Its recommended that the
first fault be eliminated with
the shortest practicable time

BENDER > Electrical Safety in medically used rooms 26

Complete Solution
ICU according IEC 60364-7-710

 IEC 60364-4-41
Protection against
electric shock
 413.1.5.4
Its recommended that
the first fault be
eliminated with the
shortest practicable
time
 IFLS system acc.
IEC 61557-9

 710.413.1.5
 Alarm system at
a suitable place
 Permanently
monitored by
medical staff

BENDER > Electrical Safety in medically used rooms 27

How do you inform your staff?

Requirements for Remote alarm indications

 For each medical IT system, an acoustic and visual alarm system

shall be arranged at a suitable place so that it can be permanently
monitored by the medical staff:

 A green signal lamp to indicate normal operation

 A yellow signal lamp which lights when the minimum value
set for the insulation resistance is reached. It shall not be
possible for this light to be cancelled or disconnected
 An audible alarm which sounds when the minimum value
set for the insulation resistance is reached. This audible
alarm may be silenced.
 The yellow signal shall go out on removal of the fault and
when the normal condition is restored
 Note: Additionally overload and overtemperature of the IT
system transformer must be indicated.

BENDER > Electrical Safety in medically used rooms 28

Indication and control panel MK2430

 20
languages
 Information Technical data
assessment
by coloured Supply voltage AC/DC 24 V
 Freely progr. LED green,
message yellow, red Display Four-line, 4 x20 characters
texts Programmable text
 Illuminated 200
messages
text display
 History buffer 4x20
250 entries
History buffer 250 messages
characters
1 change-over contact
 Test button
Alarm relay
(type -11)
 Large
buttons  Acknowledge Digital inputs 12 (type -11)
button
Interface RS485 / BMS
 Easy-to-
clean  12 digital Address range 1…150
front foil inputs
Master support Yes
 Application  + Additional features
 Display of status and alarm messages  For flush and surface mounting
in medical locations of group 2  Standard texts in 20 languages
according to IEC 60364-7-710:2002
 Straightforward setup of information networks
 Preparation of custom message texts
due to bus connection  Simple IMD function test
 Straightforward commissioning due to  Data logging with time stamp (250 events)
BENDER > Electrical Safety in medically used rooms 29
pre-defined message texts  Digital inputs for transfer of other messages
Communcation structure

BENDER > Electrical Safety in medically used rooms 30

BMS Ethernet Gateway COM460IP

 Bright Technical data

LEDs  Info button:
to call up Supply voltage AC/DC 76…276 V
standard
information Baud rate / BMS 9,6 kbit / s / 57,6 bits/s

Ethernet connection 2 x RJ45

Data rate 10/100 Mbit/s, autodetect

Protocols
TCP/IP, ModBus/TCP,
 Micro SC (depending on the options
 LC DHCP, SMTP, NTP
card selected)
Display
slot
 Additional features
 Application  Commissioning and diagnostic functions for BMS
 Modular, expandable gateway between systems
BMS bus and TCP/IP  Output of system-specific text codes for devices and
 Gateway between BMS bus and Ethernet metering points
 Remote access via LAN, WAN or Internet Logging and display of alarms with a time stamp
 Display of BMS data via a standard web browser with (history memory)
Silverlight  Comprehensive data logger functions
 Range of functions customisable through options
 E-mail/SMS notifications to various use groups in
event of alarms and system faults
BENDER > Electrical Safety in medically used rooms  Report function (file export) 31
 The complete solutions
Isolating Insulation monitoring Indication and Control panel Change-
transformer Devices (IMD) over

Typ ES710 DS0107 IR427 107TD isoMED427P MK7 MK2430 MK2007 Touch ATICS
1ph X - X - X - - - - X
System

3ph - X - LSD470 - - - - - X
Insulation - - X X X X X X X X
Overload - - X X X X X X X X
Monitoring

Temperature - - X X X X X X X X
Fault location - - - - EDS151 - X - X EDS151
Change-over - - - - - - X - X X
LED - - X X X X X X - X
Text display - - - Dot - - Grafik - Grafik X
matrix
Indication

7-Segment - - X - X - - X - -
Data logging - - - - - - X - X X
BENDER > Electrical Safety in medically used rooms 32
Individual text - - - - - - X - X -
Three levels of value propositions

Bender offer Device Basic Standard Complete

IMD Type IR427 n
Ensure patient safety
and service continuity
IMD Type
isoMED427P - n -
ATICS module - n n
Improving efficiency
of operating room MK7 MK2430 Touch panel
personnel
Indication and
Improving efficiency operation panels Touch panel
of maintenance personnel - MK2430
COM460IP

Improve efficiency Touch panel

of suppervisory personnel - -
COM460IP

Events tracebility
COM460IP Touch panel
Hospital BMS - -
Touch panel COM460IP

BENDER > Electrical Safety in medically used rooms 33

…to summarize

Summarize
 Ungrounded Power Systems
acc. to IEC60364-7-710 offer
and guarantee a higher protection for
patients and staff !

 Fault location systems offer precise and fast

localisation of defective electrical equipment
offer and guarantee a higher protection for patients
and staff !

 modern and sophisticated indication panels and

visualization possibilities offer precise and fast
information to medical and technical staff

 BENDER offers solutions for the power supply

of hospitals according IEC 60364-7-710
Source: www.trilux.com

BENDER > Electrical Safety in medically used rooms 34

 References

BENDER > Electrical Safety in medically used rooms 35

 Hospitals using Bender in Brazil, US, UK, China,
Germany (for illustration)

BENDER > Electrical Safety in medically used rooms 36

 Former and actual Projects

Prince Hamza Hospital, Amman, JO (IEC)

SIDRA-Hospital, Doha, QA (IEC)

Al-Mansoura-Hospital, Tanta, EG (IEC)

King Fahd Medical City, Riyadh, KSA (NFPA)

and many more for IEC and NFPA …

Österreich - Zentralklinikum St. Pölten

Belgien – Universitätsklinik Brüssel
Norwegen – Aker Sykehus Oslo
Deutschland – Charité Berlin
Deutschland – Universitätsklinik Hamburg
England – Kings College Hospital London
Luxemburg – Universitätsklinik Luxemburg
Irland – Königin Victoria Krankenhaus Belfast
Qatar – Al Wakrah Hospital Doha

BENDER > Electrical Safety in medically used rooms 37

Thank You!

Dipl. Ing. Amin Shabou

Bender GmbH & Co. KG
Londorfer Strasse 65
35305 Gruenberg – Germany

www.bender.de

phone: +49 6401 807-280

Fax: +49 6401 807-259
E-mail: amin.shabou@bender.de

BENDER > Electrical Safety in medically used rooms 38