E13100 0 09 10 - MaschR PDF

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Machinery
Directive
2006/42/EC
Information on
Implementation
and Application
E 13.100.0/09.10
HYDAC
Information
Product requirements
Laws
Regulations
Directives
Regulatory framework
Standards
Specifications
Hydraulic Components
Subsystems and
Systems
New Machinery Directive 2006/42/EC
Editorial information
HYDAC International GmbH
Central Quality Department
(Zentrales Qualitätswesen)
Industriegebiet
66280 Sulzbach / Saar
Germany
www.hydac.com
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2
Contents (Rev.0, Issue date 04.01.2009) Page
1. Legal foundation 4- 9
(Legal requirements
at product level)
1.1 Equipment and Product Safety Act 4- 7
(GPSG in Germany)
1.2 Machinery Directive 8- 9
(implementation into German law, 9th GPSGV)
2. Categorisation 10 - 13
(What is machinery?)
2.1 Categorisation of the 11 - 12
HYDAC product range
2.2 Conformity assessment 13
3. External documents 14 - 17
3.1 Declaration of conformity and 14 - 15
Declaration of incorporation
3.2 Operating instructions and 16 - 17
Installation instructions
4. Standards in hydraulics 18
5. Risk assessment 19
(from risk analysis to
risk avoidance)
6. SIL or PL - Safety-related 20 - 24
parts for control systems
7. Internal documentation 25 - 29
Machinery Protection
Article 95 Article 137
(Article 100 / 100a) (Article 118 / 118 a)
EC Treaty EC Treaty
(Internal Market) (Social Security)
Framework directive on Health and Safety for

Workers at Work (89/391/EEC)
Individual Directive
Machinery Directive
Other possible on Use of Work Other possible
(93/37/EC)
applicable directives Equipment individual directives
2006/42/EC
(89/655/EEC)
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Harmonised European Standards National Regulations
Manufacturer User
3
1. Legal foundations
Legal requirements of products
1.1 Equipment and Product Safety Act (GPSG)

Under the Equipment and Product Safety Act (GSPG), the European directives which
contain requirements of certain product groups (e.g. also for technical equipment) are
implemented nationally (in Germany) in the form of regulations.
For the HYDAC Group in particular, the following laws must be complied with:
1st GPSGV Electrical equipment Low voltage directive 2006/95/EC
6th GPSGV Simple pressure vessels SPV Directive 2009/105/EC
9th GPSGV Machinery Machinery Directive 2006/42/EC
11th GPSGV Equipt. for potentially ex. areas ATEX Directive 94/9/EC
14th GPSGV Pressure equipment PED Directive 97/23/EC
In addition to the GPSG, there are other parallel statutory regulations such as the laws
on EMC, Construction Products or Medicinal Products which can apply.
Substructure of the
*
GPSG
Acts
SGV
GV 2nd GP
1st GPS SGV
SGV 7th GP
SGV 6th GP SGV
3rd GP SGV 11th GP
SGV 10th GP
9th GP SGV
SGV 14th GP
8th GP GV
th GPS
13 s
12th GP
SGV
rov ision
rat ive p
inist
Adm s
ctive
Dire dards
Stan
*GPSG = Equipment and Product Safety Act

Fig. 1: Substructure of the Equipment and Product Safety Act for technical equipment
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The standards applicable to the directives enacted according to EC Treaty Article 95

(internal market) are listed by the EU Commission in the Official Journal. These are
harmonised standards (valid throughout the EU). Particularly when applying what are
known as Type C standards, a presumption of conformity is implied.
4
The harmonised standards (see Fig. 3) compiled by the European Committee for
Standardization CEN (Comité Européen de Normalisation) on behalf of the EU
Commission under the Machinery Directive – selected examples are also listed below
the particular types - are subdivided as follows (see Fig. 2)
Type A standards Safety basis standards
General principles for design
[DIN] EN ISO 12100 Part 1 and 2 (formerly EN 292 Part 1 and 2)
[DIN] EN ISO 14121 Part 1 (formerly EN 1050)
Type B standards Specific safety standards (Generic safety standards)
Type B1 Particular general overriding safety aspects
[DIN] EN 982 (in future EN ISO 4413) Safety requirements
for fluid technology systems and their components.
Hydraulics
[DIN] EN ISO 13489 Part 1 Safety-related parts of control systems
[DIN] EN IEC 60204 Electrical equipment of machines
Type B2 Specification of particular safeguards
[DIN] EN 574 Two-hand control devices
[DIN] EN ISO 13850 (formerly EN 418) Emergency stop –
Principles for design
Type C standards Machinery safety standards
Specific safety requirements of individual machinery
[DIN] EN 693 Machine tools – Safety –
Hydraulic presses
[DIN] EN 12417 Machine tools – Safety –
Machining centres
e Safety
Typ rds
t a n d a Basis standards
A s esign ld
Generales and riskinery
principent for mach
s m ms
asses and syste
e Safety
Typ rds
B st a n d a :
ndards tc. Generic standards
B2 sta e
cation
: Specifi guards
ndards of safe
B1 sta eric
Gen ects
as p
safety Safety
e
Typ rds Product standards
a n d a
C st nts
eme pes
quir
f e t y re inery ty
sa mach
cific r
Spe rticula
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r p a
f o
Fig. 2: Hierarchy of standards - harmonised standards relating to the Machinery Directive
5
8.9.2009 EN Official Journal of the European Union C 214/1
IV
(Notices)
NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES
COMMISSION
Commission communication in the framework of the implementation of the Directive 2006/42/EC

of the European Parliament and of the Council of 17 May 2006 on machinery, and amending
Directive 95/16/EC
(recast)
(Text with EEA relevance)
(Publication of titles and references of harmonised standards under the Directive)

(2009/C 214/01)
Date of cessation of
European
Reference and title of the harmonised standard Reference of superseded presumption of conformity
Standards First publication OJ
(and reference document) standard of superseded standard
Organisation (1)
Note 1
CEN EN 81-3:2000+A1:2008 This is the first

Safety rules for the construction and installation of lifts publication
— Part 3: Electric and hydraulic service lifts
CEN EN 81-40:2008 This is the first

— Special lifts for the transport of persons and goods —
Part 40: Stairlifts and inclined lifting platforms intended
for persons with impaired mobility

— Special lifts for the transport of persons and goods —
Part 43: Lifts for cranes

Safety of escalators and moving walks — Part 1: publication
Construction and installation
Fig. 3: List of harmonised standards – Official Journal of the EU

CEN EN 289:2004+A1:2008 This is the first
Plastics and rubber machines — Presses — Safety publication
requirements
CEN EN 349:1993+A1:2008 This is the first

Safety of machinery — Minimum gaps to avoid crushing publication
of parts of the human body
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6
The new Machinery Directive 2006/42/EC replaces the previous Machinery Directive
98/37/EC with effect from 29.12.2009 without a transitional period (Fig. 4). Much of the
content, particularly for machinery, remains unchanged (Fig. 5).
Publication Nat. implementation

Enactment EU Off. Journal
in Germ.: "new 9th GPSGV" Application
published on 18.06.2008
MRL 2006/42/EC
MRL 98/37/EC / "old" 9th GPSGV
and "new" 9th GPSGV
No transitional period!
Fig. 4: Legislative procedure for the new Machinery Directive
2006/42/EC 98/37/EC
Recitals Recitals
No. 1 - 30 No. 1 - 25
Operative part Operative part

Articles 1 - 29 Article 1 - 16
Annexes Annexes
No. I - XII No. I - IX
Fig. 5. Structure of the new Machinery Directive 2006/42/EC
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1.2 Machinery Directive (implementation into German law 9th GPSGV)
The scope of the new Machinery Directive includes, amongst others, the following
groups which are also defined in the Definition of Terms (Art. 2):
Machinery:
An assembly consisting of linked parts, at least one of which moves (and also
machine systems, i.e. assemblies of machinery, which are arranged and controlled so
that they function as an integral whole).
Partly completed machinery (formerly part-machines):
…cannot in itself perform a specific function, and will only be complete once
incorporated into a complete machine including all necessary protective means.
Safety components (Art. 2, c and Ann. V – non-exhaustive list):
Components which fulfil a safety function e. g. light barriers, safety mats, automatic
mobile protective devices.
Interchangeable equipment:
changes the function of machinery, e.g. accessories or attachments (swivel, turning,
tipping devices) for a basic machine.
etc.
Some exceptions are listed in Article 3 of the new Machinery Directive. Further
limits are set in this case ("Where, for machinery, the hazards referred to in Annex I
are wholly or partly covered more specifically by other Community Directives, this
Directive shall not apply, or shall cease to apply, to that machinery in respect of such
hazards from the date of implementation of those other Directives.").
In the HYDAC Group, the Machinery Directive is implemented by product group in the
individual Departments or Product Divisions. In particular there are changes in the
scope of the directive.
The scope of the directive has been more precisely defined. For example, lifting
accessories are included in the scope (Art. 1). The borderline between the scopes
of other directives, e.g. the Low Voltage Directive 2006/95/EC, has been better
defined. In respect of partly completed machinery (formerly part-machines) there
are new regulations regarding the scope of documentation (now a risk assessment
must also be carried out) and the submission of a written declaration. The previous
manufacturer's declaration has been replaced by a Declaration of Incorporation in
accordance with Annex II B. Installation instructions shall accompany partly completed
machinery. A person authorised to compile the documentation shall ensure the
necessary technical documentation is presented to the authorities for inspection, on
request, within a reasonable period of time (interpretation depends on the complexity:
five to ten working days).
HYDAC has assessed its product categories and product classes (Fig. 8) in respect
of the new Machinery Directive on the basis of the VDMA position paper (Fig. 6)
dated 29.07.2009 (Version 1 dated 28.01.2009) and the CETOP position paper dated
26.06.2009. In addition, the development of the "Guide to application of the Machinery
Directive 2006/42/EC" of the EU Commission (Fig. 7) has been followed carefully.
Amongst other things, valves and hydraulic cylinders are, for example, excluded from
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Art. 2 of the Machinery Directive because they are components.
8
Fig. 6: VDMA Position Paper on
Fluid Power dated 29th July 2009
VDMA-Positionspapier
Fluidtechnik
VDMA-Positionspapier
zur Umsetzung der
Maschinenrichtlinie 2006/42/EG
in der Fluidtechnik
Stand: 29.07.2009
Verband Deutscher Maschinen- Fachverband Fluidtechnik Lyoner Straße 18 VDMA

und Anlagenbau e.V. Vorsitzender: 60528 Frankfurt am Main, Germany Wir, die Investitionsgüterindustrie
Christian H. Kienzle Telefon +49 69 66 03-13 32
Geschäftsführer: Telefax +49 69 66 03-14 59
Hartmut Rauen E-Mail fluid@vdma.org
Internet www.vdma.org
Fig. 7: Guide to the Application of the

new Machinery Directive
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2. Categorisation (What is machinery?)
Machinery Directive 2006/42/EC

Also supplied by HYDAC
Machinery
• Declaration of conformity
• CE marking
• Operating instructions
Partly completed machinery

• Declaration of
incorporation
• Installation instructions
Assembly / Components
• Delivery note
with relevant
text blocks
Fig. 8: Simple overview of HYDAC Group products
a) Machinery;
b) Interchangeable equipment;
Old M
a
c) Safety components; c
h
d) Lifting accessories;
i
New n
e
e) Chains, ropes and webbing; r
y
f) Removable mechanical transmission devices;
g) Partly completed machinery;
Fig. 9: Scope of Directive 2006/42/EC for comparison

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2.1 Categorisation of the HYDAC product range
As a manufacturer, HYDAC has a wide range of products (see Table 1), and supplies
products ranging from components to machinery. Generally speaking, components
are not specified in directives in more detail and form the largest proportion of the
product range.
For machinery and safety components a Declaration of Conformity shall continue
to be issued and Operating Instructions shall continue to accompany the products.
The original operating instructions are generally issued in German. Other versions
are simply a translation of the original documents. If the HYDAC machinery is placed
directly on the market in another country of the EU, then the customer will receive a
translation of the original in the official language of the user country. In principle there
is almost no change to the previous procedure. The machinery is labelled with the CE-
mark at the end of what is known as the conformity assessment procedure.
In the case of partly completed machinery, it is now clear that there are extensive
responsibilities. These responsibilities include an appropriate procedure for the
conformity assessment. The essential health and safety at work requirements from
Annexe I must be selected. In order to do this, the input for a risk assessment
(in accordance with EN ISO 14121) shall be provided. The residual risks shall be
communicated. Within the framework of drawing up the documentation (relevant
technical documentation) a Declaration of Incorporation shall be issued in an official
language. The customer receives installation instructions in an official language. The
languages German, English and French are provided as standard. Other languages
can be agreed contractually. The Machinery Directive does not stipulate that these
instructions be made available in the language of the user country. Partly completed
machinery shall not bear the CE mark.
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12
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Scope of application Old Machinery Directive New Machinery Directive HYDAC Applications
"Complete" machinery –– Declaration of conformity –– Declaration of conformity –– Fluid service equipment

–– Ready for operation –– CE marking –– CE marking –– Test rigs
–– Can be operated –– Operating manual –– Operating instructions –– Nitrogen charging units
independently –– Actuators (with mounting)
Partly completed –– Manufacturer's declaration –– Declaration of –– Hydraulic power units

machinery incorporation –– Oil lubrication systems
–– Sub-system intended for –– Installation instructions –– Tank packs
incorporation –– Sub-assembly with control
system (with mounting)
Safety components Not included or only limited –– Declaration of conformity –– 2-out-of-3 safety valve
–– Components which fulfil a inclusion –– CE marking Is relevant for HYDAC as
safety function and which (affected, however, on the –– Operating instructions long as no specific
are placed on the market basis of the guidelines or directive applies.
separately for this purpose included in the guidelines.) –– e.g. for pressure relief
by the manufacturer. valve according to
Pressure Equipment
Directive
Parts / Components Are not covered by the Are not covered by the Approximately 90 % of the
Machinery Directive Machinery Directive HYDAC portfolio.
(but: (but:
Equipment and Product Equipment and Product
Safety Act must be taken into Safety Act must be taken into
account) account)
Table 1: Scope of application of the Machinery Directive - Categorisation with focus on HYDAC products
Components (and assemblies) such as filters, filter elements, hydraulic accumulators,
pumps, valves, cylinders etc are normally excluded from the scope of the Machinery
Directive. There are, however, standards e.g. EN 982, covering the safety
requirements for hydraulic systems. If no other directive applies as a legal basis, they
are subject to the (German) Equipment and Product Safety act. On the delivery note
we advise that the products supplied by us are intended to be incorporated into other
systems (plant, vehicles or similar).
2.2 Conformity assessment

The technical file (Ann. VII A) for machinery or the relevant technical documentation
(Ann. VII B) for partly completed machinery are documents which the manufacturer
has drawn up and which remain on his premises (for more information, see Point 7
Internal documentation) because these also contain his relevant technical know-how.
Only the conformity declaration, operating instructions, declaration of incorporation
and installation instructions are supplied to the customer with the products.
The conformity assessment procedure is a means for the manufacturer to ensure that
the machinery conforms to the requirements of the Machinery Directive. Annex VIII
also sets out the "procedure" and creates the link with the necessary documentation
(technical documentation).
Extract from Annex VIII of the Directive:

Assessment of conformity with internal checks on the manufacture of machinery
1. This Annex describes the procedure by which the manufacturer or his authorised
representative who carries out the obligations laid down in points 2 and 3, ensures
and declares that the machinery concerned satisfies the relevant requirements of
this directive.
2. For each representative type of the series in question, the manufacturer or his
authorised representative shall draw up the technical files referred to in Annex VII,
part A.
3. The manufacturer must take all measures necessary in order that the manufacturing
process ensures compliance of the manufactured machinery with the technical file
referred to in Annex VII, part A, and the requirements of this Directive.
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3. External documents
3.1 Declaration of conformity and declaration of incorporation
The new Machinery Directive controls the (minimum) content of the Declaration of
Conformity and Declaration of Incorporation in Annex II. The form and position of the
content on the documents is a matter of choice.
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Fig. 10: Example of a Declaration of Conformity (Machinery)

14
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Fig. 11: Example of a Declaration of Incorporation (Partly completed machinery)

15
3.2 Operating instructions and installation instructions
In the operating instructions (for sample, see Fig. 12) all the relevant stages of the life
of a machine are taken into account. The instructions also give information on relevant
residual risks.
Description of
–– Transport, packing
–– Installation
FluidAqua Mobil
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FAM 25/45/60/75/95
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Operating and Maintenance Instructions –– Normal operation
English (translation of original instructions)
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Document No.: 3402054c –– Maintenance
(trouble-shooting and fault
elimination)
–– Dismantling and disposal
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Operating instructions
16
To some extent the installation instructions for partly completed machinery also
provide further information (Fig. 13), and are not just confined to installation.
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Fig. 13: Example of installation instructions with user information

17
4. Standards in hydraulics
Standards regulate technical issues and represent the state-of-the-art in many
technical areas. In this connection there are two essential aspects, the performance
and safety.
EN 982 (Safety of machinery, Safety requirements of fluid power systems and their
components, Hydraulics) and DIN 24346 (Hydraulic fluid power, Hydraulic systems,
General rules for application) serve as a basis when the machinery is not a specific
individual machine such as a machine tool, for which the relevant Type C standards
are available (e. g. EN 693 Safety – Hydraulic Presses). Currently the draft EN ISO
4413 incorporates Hydraulic fluid power, General rules and safety requirements for
systems and their components. It is however not yet implemented as a standard and
has not yet been published in the Official Journal of the EU.
Within the Company Group, these standards are implemented in the form of HYDAC
Works Standards (HN 25-01 and HN 25-02).
To date there is no individual product safety standard for hydraulic components. Basic
safety requirements are covered by the application of the following standards in the
Company Group.
Type A:
EN ISO 14121 Part 1 Risk assessment
EN ISO 12100 Part 1 and 2 General Principles for Design
Type B:
EN 982 Safety requirements for fluid power systems and their
components - Hydraulics.
After publication in the Official Journal, later EN ISO 4413
EN 983 Safety requirements for fluid power systems and their
components - Pneumatics
EN IEC 60204 Electrical Equipment of Machines
EN 954 Part 1 Safety-related parts of control systems – Design, or
The customer must stipulate his level of requirement –
Category (applies until 31.12.2011 alongside EN 13849)
EN 13849 Part 1 and 2 Safety-related parts of control systems – General
principles of design
The customer must stipulate his level of requirement – PLr
DIN 24346 Just general rules for application!
If pressure equipment is also involved, harmonised standards according to the

Pressure Equipment Directive 97/23/EC, such as those listed below, shall also be
taken into consideration.
EN 13445 Part 1 to 8 Unfired pressure equipment

EN 14359 Hydraulic accumulators for hydraulic applications
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If there are no harmonised standards or they are missing, or they do not exist for a
product, then the design engineer must use (appropriate) national or international
standards or specifications.
18
5. Risk assessment -
(from risk analysis to risk avoidance)
The risk assessment is explained in Recital 23 of the Machinery Directive and is
introduced via the General Principles given in Annex I. The risk assessment is
therefore an elementary component of the conformity assessment procedure of
the (machinery) manufacturer and forms part of the internal documentation, i.e.
it is a component of the technical file for machinery and the relevant technical
documentation for partly completed machinery.
In order to carry out a risk assessment, there are different procedures (see Information
Annex B for the former harmonised standard EN 1050 - Safety of machinery. Risk
assessment. Principles, B.1 to B.8).
–– PHA Preliminary Hazard Analysis
–– WHAT-IF Method
–– FMEA: Failure Mode and Effects Analysis
–– FTA: Fault Tree Analysis
–– Fault Simulation for Control Systems
–– MOSAR: Method Organized for a Systematic Analysis of Risks
–– DELPHI: DELPHI Method
Survey conducted amongst a group of experts
The text of the machinery directive itself does not set out specific requirements on this
point. EN ISO 14121 Part 1 (formerly DIN EN 1050) is introduced as state-of-the-art
for the Machinery Directive using the guidelines and the harmonised standards of the
Official Journal of the EU . The annex of the standard contains a check-list of possible
risks. The basic Works Standard is HN 18-01 (adoption of EN ISO 14121-1).
Procedure for the design engineer in system design

Start
Determine system limits

Risk analysis
Hazard identification
Risk assessment
Risk estimation
Risk evaluation
No
Is the machine Risk reduction
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adequately safe? necessary
Yes
EN 1050 and EN ISO 14121 End
Fig. 14: Flow chart of the risk assessment
19
6. SIL or PL –
Safety-related parts for control systems
Functional Safety
A control system can initiate, or cannot prevent, a hazard-causing movement.
Therefore control systems of machines must also be included in the risk assessment.
These control systems are constructed of individual components, in this case
therefore safety-related parts (SRP/CS - Safety Related Part of a Control System). In
this context this is also known as functional safety, i.e. a safety function is fulfilled. A
control system can ultimately include one or several safety functions. The components
which are built into a control system are themselves not necessarily always part of a
control system or even safety components (see Fig. 20). If they are however built into
a control system, they affect the reliability of the whole control system on the basis of
their reliability.
To assess control systems, there are two options:
Machinery Process
industry industry
SRP/CS as
Electrical/Electronic/
Programmable SRECS SIS
Electronic
Hydraulic DIN EN DIN EN
Pneumatic
Mechanical system
62061 61511
…
E/E/PES as
DIN EN ISO Electrical/Electronic/
DIN EN 61508 Programmable
13849 Electronic system
Fig. 15: Assignment of standards to machine controls
For hydraulic or electrohydraulic control systems, EN 954-1, or its successor EN

13849-1, is applied because the hydraulics are not covered by the electrotechnical
standards EN IEC 62061 (based on EN IEC 61508) (see Fig. 15). The "BGIA Report
2/2008 Functional Safety of Machine Controls – Application of DIN EN ISO 13849 –"
describes in detail the application of EN ISO 13849.
A typical parameter for components which are to be used in controls is the MTTFd
(Mean Time to Dangerous Failure) or also B10d for electrotechnical components (in
this case the MTTFd depends on the number of cycles). They represent an equipment
characteristic type or a "quality standard" (see Fig. 16 and Table 2). These are values
for the statistical probability of the failure of components (Table 3) and are inversely
E 13.100.0/09.10
proportional to the failure rates.

MTTFd = 1/λd
20
Premature Random Wear failures
failures failures Remedy:
Remedy: Sizing, preventive
Burn-in, process replacement
optimisation
Failure Operating life

rate TM or T10d
λ
0 Time
Fig. 16: Wear characteristics of components
Machine control system (CS)
Non safety-related parts
Complete SRP/CS, fulfils safety function(s)
SRP/CS1 SRP/CS2 SRP/CS3

(as subsystem) (as subsystem) (as subsystem)
Fig. 17: Interaction of parts (components) in a machine

E 13.100.0/09.10
The necessary calculations can be made using the free software SISTEMA from BGIA
(a research/testing institution based in Germany)(http://www.dguv.de/bgia/en/pra/en13849/index.jsp).
This software contains the mathematical models/interfaces for the components.
21
A machine builder also determines the PLr (required Performance Level) from the
risk graphs. Based on the reliability of the components (MTTFd or B10d values of the
manufacturer or values from the table for the Standard EN ISO 13849-1*) the actual
PL of the planned control system can be determined. PL must always be greater than
or equal to PLr.
The control systems are represented in EN ISO 13849-1 in the form of categories; in
other words they are available as designated system architectures.
Tried and tested Other Typical values:

safety principles according to relevant MTTFd (years)
DIN EN ISO 13849-2:2003 standards B10d (cycles)
or
Fault exclusion
Mechanical components Tables A.1 and A.2 – MTTFd = 150
Hydraulic components Tables C.1 and C.2 EN 982 MTTFd = 150
Pneumatic components Tables B.1 and B.2 EN 983 B10d = 20 000 000
Relays and contactor relays with Tables D.1 and D.2 EN 20205 B10d = 20 000 000
negligible load IEC61810
IEC60947
Relays and contactor relays with Tables D.1 and D.2 EN 20205 B10d = 400 000
maximum load IEC61810
IEC60947
Emergency stop devices when used in Tables D.1 and D.2 IEC60947 Fault exclusion up to
areas exposed to low environmental ISO 13850 100 000 cycles, provided
contamination, e.g. in laboratories a) manufacturer's
certification is available
Emergency stop devices when used in Tables D.1 and D.2 IEC60947 Fault exclusion
areas exposed to normal environmental ISO 13850 up to 6 050 cycles
contamination, e.g. on machinery a)
Enabling switches (3-stage) Tables D.1 and D.2 IEC 60947 Fault exclusion
irrespective of the load a) up to 100 000 cycles
a) if fault exclusion for positive opening is possible
Table 2: Typical reliability parameters of components
II LL O
O
Input
Eingang
Eingang Logic
Logik
Logik Output
Ausgang
Ausgang
Connection
Fig. 18: Example based on categories B and 1
E 13.100.0/09.10
* The parameter data from EN ISO 13849-1 for individual components can be applied
if the conditions from EN ISO 13849-2 and the manufacturer's data are complied with.
22
hazard-causing
fluidic actuator
movement
Electronic Fluidic control

control logic system
Light barrier
Category 2 [class 2] Category 3 Category 1

PL c PL d PL c
II LL O
O I1
I1 L1
L1
L1 O1
O1
O1
II LL O
O
TE
TE OTE
OTE
OTE I2
I2 L2
L2 O2
O2
O2
Fig. 19: System example of a "complete" control system
Drive elements
Components fulfilling Viewing area of the safety-

safety function e.g. related part of the control
valves system
Potentially relevant
for compliance with
Energy converter, tried and tested safety
energy transfer principles
E 13.100.0/09.10
Fig. 20: Example of a system of valves as a hydraulic control system (subsystem)
23
Fig. 21: SISTEMA user interface
(calculation of parameters and input of parameters)
Designation of the Range of the

MTTFd for each channel MTTFd for each channel
low 3 years ≤ MTTFd < 10 years
medium 10 years ≤ MTTFd < 30 years
high 30 years ≤ MTTFd < 100 years

Table 3: Ranges for the reliability of control channels
MTTFd:
100 % 3 years
expected hazard-causing failures
not 10 years
accept-
80 % able
low 63% line 30 years
60 %
medium
40 %
high 100 years
20 %
cap
0%
0 5 10 15 20 25 30
Time [years]
Fig. 22: Reliability in years – MTTFd values

E 13.100.0/09.10
24
7. Internal documentation
The Machinery Directive sets out in Annex VII which documentation is required. It
lists the technical file for machinery and the essential technical documentation for
partly completed machinery (see Table 4). The majority of the documentation remains
at the manufacturer's premises and on reasoned request must be made available
to the relevant supervisory authority within a reasonable time period. These will be
documents which for the most part come up in any case within the context of design
work. In addition, the directive requires that there must be an authorised person for
documentation (person authorised to compile technical documentation).
Extract from Annex VII of the Directive:

A. Technical file for machinery
This part describes the procedure for compiling a technical file. The technical file must
demonstrate that the machinery complies with the requirements of this Directive. It
must cover the design, manufacture and operation of the machinery to the extent
necessary for this assessment. The technical file must be compiled in one or more
official Community languages; except for the instructions for the machinery, for which
the special provisions of Annex I, section 1.7.4.1 apply.
1. The technical file shall comprise the following:

a) a construction file including:
– a general description of the machinery,
– the overall drawing of the machinery and drawings of the control circuits as well as the
pertinent descriptions and explanations necessary for understanding the operation of the
machinery,
– full detailed drawings, accompanied by any calculation notes, test results, certificates etc.,
required to check the conformity of the machinery with the essential health and safety
requirements,
– the documentation on risk assessment demonstrating the procedure followed, including:
i) a list of the essential health and safety requirements which apply to the machinery,
ii) the description of the protective measures implemented to eliminate identified hazards or to
reduce risks and, when appropriate, the indication of the residual risks associated with the
machinery,
– the standards and other technical specifications used, indicating the essential health and
safety requirements covered by these standards,
– any technical report giving the results of the tests carried out either by the manufacturer or by
a body chosen by the manufacturer or his authorised representative,
– a copy of the instructions for the machinery,
– where appropriate, the declaration of incorporation for included partly completed machinery
and the relevant assembly instructions for such machinery,
– where appropriate, copies of the EC declaration of conformity of machinery or other products
incorporated into the machinery,
– a copy of the EC declaration of conformity;
E 13.100.0/09.10
25
b) for series manufacture, the internal measures that will be implemented to ensure that the
machinery remains in conformity with the provisions of this Directive.
The manufacturer must carry out necessary research and tests on components, fittings or the
completed machinery to determine whether by its design or construction it is capable of being
assembled and put into service safely. The relevant reports and results shall be included in the
technical file.
2. The technical file referred to in point 1 must be made available to the competent authorities of
the Member States for at least 10 years following the date of manufacture of the machinery or, in
the case of series manufacture, of the last unit produced.
The technical file does not have to be located in the territory of the Community, nor does it have
to be permanently available in material form. However, it must be capable of being assembled
and made available with a period of time commensurate with its complexity by the person
designated in the EC declaration of conformity.
The technical file does not have to include detailed plans or any other specific information as
regards the subassemblies used for the manufacture of the machinery unless a knowledge of
them is essential for verification of conformity with the essential health and safety requirements.
3. Failure to present the technical file in response to a duly reasoned request by the competent
national authorities may constitute sufficient grounds for doubting the conformity of the
machinery in question with the essential health and safety requirements.
B. Relevant technical documentation for partly completed machinery

This part describes the procedure for compiling relevant technical documentation.
The documentation must show which requirements of this Directive are applied and
fulfilled. It must cover the design, manufacture and operation of the partly completed
machinery to the extent necessary for this assessment of conformity with the essential
health and safety requirements applied. The documentation must be compiled in one
or more official Community languages. It shall comprise the following:
a) a construction file including:

– the overall drawing of the partly completed machinery and drawings of the control circuits,
– full detailed drawings, accompanied by any calculation notes, test results, certificates etc.,
required to check the conformity of the partly completed machinery with the applied essential
health and safety requirements,
– the risk assessment documentation demonstrating the procedure followed, including:
i) a list of the essential health and safety requirements applied and fulfilled,
ii) the description of the protective measures implemented to eliminate identified hazards or to
reduce risks and, when appropriate, the indication of the residual risks associated with the
machinery,
iii) the standards and other technical specifications used, indicating the essential health and
safety requirements covered by these standards,
iv) any technical report giving the results of the tests carried out either by the manufacturer or by
a body chosen by the manufacturer or his authorised representative,
v) copy of the assembly instructions for the partly completed machinery;
E 13.100.0/09.10
26
b) for series manufacture, the internal measures that will be implemented to ensure that
the partly completed machinery remains in conformity with the essential health and safety
requirements applied.
The manufacturer must carry out necessary research and tests on components, fittings or the
partly completed machinery to determine whether by its design or construction it is capable
of being assembled and used safely. The relevant reports and results shall be included in the
technical documentation.
The relevant technical documentation must be available for at least 10 years following the date
of manufacture of the partly completed machinery or, in the case of series manufacture, of
the last unit produced, and on request presented to the competent authorities of the Member
States. It does not have to be located in the territory of the Community, nor does it have to be
permanently available in material form. It must be capable of being assembled and presented to
the relevant authority by the person designated in the declaration for incorporation.
Failure to present the relevant technical documentation in response to a duly reasoned request
by the competent national authorities may constitute sufficient grounds for doubting the
conformity of the partly completed machinery with the essential health and safety requirements
applied and attested.
Type Machinery Partly completed

machinery
What / where? In-house incl. in In-house incl. in
doc. del. doc. del.
General description of the machinery X – – –
Overall drawing X X –
Full detailed drgs, poss. with calcs X – X –
Documents for risk assessment: list of X – X –
essential health and safety requirements
Documents for risk assessment: X – X –
description of risk avoidance, risk
reduction
Applied standards, specifications , ... X – X –
Technical reports with test results X – X –
Copy of the operating instructions X X – –
Copy of the installation instructions – – X X
Where necess. copies of incorporation X – – –
decl. & conformity decl. for bought-in
prod.
(Copy) Decl. of conformity X X – –
Declaration of Incorporation – – – X
List of measures to ensure conformity X – X –
with the Directive
Table 4: Overview of internal and external manufacturer's documentation
E 13.100.0/09.10
27
E 13.100.0/09.10
Fig. 24: KAN Report No. 40_01 - The new Machinery Directive
28
E 13.100.0/09.10
Fig. 25: Order Form for the booklet "The new EC Machinery Directive 2006"
29
Index of Diagrams and Tables
1) Fig. below Table of Contents: taken from Vortrag_Zenit_Teil2czichy.pdf Page 5
(Source: Siemens) (adapted) now from Maschinenschutz.ppt
2) Fig. 1 on Page 4: from RM Legal Basis of GPSG 20081126 Slide 4
(Source: HYDAC)
3) Fig. 2 on Page 5: from Vortrag_Zenit_Teil2czichy.pdf Page 9 (Source: Siemens)
4) Fig. 3 on Page 6: from Official Journal 2009-C214-01 on Machinery Directive – Extract from Pg. 1
(Source EU Commission)
5) Fig. 4 and 5 on Page 7: from Vortrag_1_-_Vorberg_Maschinenrichtlinie Slide 10 and 11
(Source: Regional Council Karlsruhe)
6) Fig. 6 on Page 9: from VDMA-PP_MRL_Fluidtechnik_20090729 Front Page (Page 1)
(Source: VDMA)
7) Fig. 7 on Page 10: from guide_application_directive_2006-42-ec-1st_edit__12-2009_en.pdf Front
Cover (Page 1) (Source EU Commission)
8) Fig. 8 on Page 11: from MRL 2006_42_EG HYDAC-Kurzübersicht 20090831.ppt Slide 3
(Source: HYDAC)
9) Fig. 9 on Page 11: from 034_MFS_A2008_MRL_neu Page 1 (Source: BGM, MFS)
10) Table 1 on Page 12: from MRL 2006_42_EG HYDAC-Kurzübersicht 20090831.ppt Slide 2
(Source: HYDAC)
11) Fig. 10 on Page 14: from Konformitätserklärung 98_ 37_EG.pdf (Source: HYDAC)
12) Fig. 11 on Page 15: from Einbauerklärung - Muster auf Formblatt.pdf (Source: HYDAC)
13) Fig. 12 on Page 16: from Operating and Maintenance Instructions FAM 20 to 100
20100104.pdf Composition made from Front Cover Page 1 and Page 10 (Source: HYDAC)
14) Fig. 13 on Page 17: from Installation Instructions CA 20091216.pdf Front Cover (Page 1)
(Source: HYDAC)
15) Fig. 14 on Page 19: from zvei_brochuere.de Page 8 (Source: ZVEI)
16) Fig. 15 on Page 20: from rep2_08.pdf Page 15 (Source: DGUV, BGIA)
17) Fig. 16 and 17 on Page 21: from rep2_08.pdf Page 221 and Page 38
(Source: DGUV, BGIA)
18) Table 2 on Page 22: from rep2_08.pdf Page 227 – Extract (Source: DGUV, BGIA)
21) Fig. 20 on Page 23: from 06_HydraulischeSteuerungen.pdf Page 3
(Source: DGUV, BGIA)
22) Fig. 21 on Page 24: from 2007_230 Fig. 2 Page 5 (Source: DGUV, BGIA)
23) Table 3 on Page 24: from rep2_08.pdf Page 222 (Source: DGUV, BGIA)
25) Table 4 on Page 27: from aus MRL 2006_42_EG HYDAC-Kurzübersicht 20090831.ppt Slide 8
(Source: HYDAC)
26) Fig. 23 on Page 28: from Beri40_01 Neue MRL KAN.pdf Front Cover (Page 1)
(Source: KAN)
27) Fig. 24 on Page 29: from Bestellformular Buch.pdf (Source: VDMA)
E 13.100.0/09.10
30
Notes
E 13.100.0/09.10
31
Cat.: Accumulators E 30.000
Global Presence.
Local Expertise.
Catalogue: Fluid Filters E 70.000
Bro.: Compact Hydraulics DEF 5.300 Catalogue: Filter Systems E 79.000 Cat.: Process Technology E 77.000
www.hydac.com
HYDAC Headquarters
HYDAC Companies
HYDAC Distributors and Service Partners
Catalogue: Accessories E 61.000
Head Office Industriegebiet

HYDAC INTERNATIONAL 66280 Sulzbach/Saar
Catalogue: Electronics E 180.000
GMBH Germany
Telephone:
+49 6897 509-1001
Fax:
+49 6897 509-1009
Internet: www.hydac.com
E 13.100.0/09.10
E-Mail: info@hydac.com
Bro.: Cooling Systems DEF 5.700

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1 0

New Machinery Directive 2006/42/EC

Framework directive on Health and Safety for

Harmonised European Standards National Regulations

1.1 Equipment and Product Safety Act (GPSG)

*GPSG = Equipment and Product Safety Act

The standards applicable to the directives enacted according to EC Treaty Article 95

Fig. 2: Hierarchy of standards - harmonised standards relating to the Machinery Directive

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission communication in the framework of the implementation of the Directive 2006/42/EC

(Text with EEA relevance)

(Publication of titles and references of harmonised standards under the Directive)

CEN EN 81-3:2000+A1:2008 This is the first

CEN EN 81-40:2008 This is the first

CEN EN 81-43:2009 This is the first

CEN EN 115-1:2008 This is the first

Fig. 3: List of harmonised standards – Official Journal of the EU

CEN EN 349:1993+A1:2008 This is the first

Publication Nat. implementation

Operative part Operative part

Art. 2 of the Machinery Directive because they are components.

Verband Deutscher Maschinen- Fachverband Fluidtechnik Lyoner Straße 18 VDMA

Fig. 7: Guide to the Application of the

Machinery Directive 2006/42/EC

Partly completed machinery

Fig. 8: Simple overview of HYDAC Group products

g) Partly completed machinery;

Fig. 9: Scope of Directive 2006/42/EC for comparison

"Complete" machinery –– Declaration of conformity –– Declaration of conformity –– Fluid service equipment

Partly completed –– Manufacturer's declaration –– Declaration of –– Hydraulic power units

2.2 Conformity assessment

Extract from Annex VIII of the Directive:

Fig. 10: Example of a Declaration of Conformity (Machinery)

Fig. 11: Example of a Declaration of Incorporation (Partly completed machinery)

Fig. 12: AC FILTER

Fig. 13: Example of installation instructions with user information

DIN 24346 Just general rules for application!

If pressure equipment is also involved, harmonised standards according to the

EN 13445 Part 1 to 8 Unfired pressure equipment

Procedure for the design engineer in system design

Determine system limits

adequately safe? necessary

EN 1050 and EN ISO 14121 End

Fig. 14: Flow chart of the risk assessment

For hydraulic or electrohydraulic control systems, EN 954-1, or its successor EN

proportional to the failure rates.

Failure Operating life

Machine control system (CS)

Non safety-related parts

Complete SRP/CS, fulfils safety function(s)

SRP/CS1 SRP/CS2 SRP/CS3

Fig. 17: Interaction of parts (components) in a machine

Tried and tested Other Typical values:

Table 2: Typical reliability parameters of components

Electronic Fluidic control

Category 2 [class 2] Category 3 Category 1

Fig. 19: System example of a "complete" control system

Components fulfilling Viewing area of the safety-

Fig. 20: Example of a system of valves as a hydraulic control system (subsystem)

Designation of the Range of the

low 3 years ≤ MTTFd < 10 years

medium 10 years ≤ MTTFd < 30 years

high 30 years ≤ MTTFd < 100 years