Machinery Directive2006/42/ec

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Information on Implementation and Application

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HYDACInformation

Product requirements

LawsRegulationsDirectivesRegulatory frameworkStandardsSpecifications

Hydraulic ComponentsSubsystems andSystems

New Machinery Directive 2006/42/EC

Editorial informationHYDAC International GmbHCentral Quality Department (Zentrales Qualitätswesen)Industriegebiet66280 Sulzbach / SaarGermanywww.hydac.com

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Contents (Rev.0, Issue date 04.01.2009) Page1. Legalfoundation 4 - 9

(Legalrequirementsatproductlevel)

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(Whatismachinery?)

2.1 Categorisation of the 11 - 12HYDAC product range

2.2 Conformity assessment 13

3. Externaldocuments 14 - 17

3.1 Declaration of conformity and 14 - 15Declaration of incorporation

3.2 Operating instructions and 16 - 17Installation instructions

4. Standardsinhydraulics 18

5. Riskassessment 19(fromriskanalysistoriskavoidance)

6. SILorPL-Safety-related 20 - 24partsforcontrolsystems

7. Internaldocumentation 25 - 29

Machinery ProtectionArticle 95

(Article 100 / 100a)EC Treaty

(Internal Market)

Article 137(Article 118 / 118 a)

EC Treaty(Social Security)

Framework directive on Health and Safety for Workers at Work (89/391/EEC)

Other possible applicable directives

Machinery Directive(93/37/EC)2006/42/EC

Individual Directive on Use of Work Equipment(89/655/EEC)

Other possible individual directives

Harmonised European Standards National Regulations

Manufacturer User

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GPSG*

Acts

1st GPSGV 2nd GPSGV

3rd GPSGV 6th GPSGV 7th GPSGV

8th GPSGV 9th GPSGV 10th GPSGV 11th GPSGV

12th GPSGV 13th GPSGV 14th GPSGV

Administrative provisions

Directives

Standards

Substructure of the

1.LegalfoundationsLegal 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/EC6th GPSGV Simple pressure vessels SPV Directive 2009/105/EC9th GPSGV Machinery Machinery Directive 2006/42/EC11th GPSGV Equipt. for potentially ex. areas ATEX Directive 94/9/EC14th 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.

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.

Fig. 1: Substructure of the Equipment and Product Safety Act for technical equipment*GPSG = Equipment and Product Safety Act

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Type

A standards

General design

principles and risk

assessment for machinery

and systems

Type

B standards

B1 standards:

Generic

safety aspects

B2 standards:

Specification etc.

of safeguards

Type

C standards

Specific safety requirements

for particular machinery types

Safety Basis standards

Safety Generic standards

Safety Product standards

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

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 standardsSpecific safety requirements of individual machinery [DIN] EN 693 Machine tools – Safety –Hydraulic presses[DIN] EN 12417 Machine tools – Safety –Machining centres

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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)

European Standards

Organisation ( 1 )

Reference and title of the harmonised standard (and reference document) First publication OJ Reference of superseded

standard

Date of cessation of presumption of conformity

of superseded standard Note 1

CEN EN 81-3:2000+A1:2008 Safety rules for the construction and installation of lifts — Part 3: Electric and hydraulic service lifts

This is the first publication

CEN EN 81-40:2008 Safety rules for the construction and installation of lifts — Special lifts for the transport of persons and goods — Part 40: Stairlifts and inclined lifting platforms intended for persons with impaired mobility

This is the first publication

CEN EN 81-43:2009 Safety rules for the construction and installation of lifts — Special lifts for the transport of persons and goods — Part 43: Lifts for cranes

This is the first publication

CEN EN 115-1:2008 Safety of escalators and moving walks — Part 1: Construction and installation

This is the first publication

CEN EN 289:2004+A1:2008 Plastics and rubber machines — Presses — Safety requirements

This is the first publication

CEN EN 349:1993+A1:2008 Safety of machinery — Minimum gaps to avoid crushing of parts of the human body

This is the first publication

EN 8.9.2009 Official Journal of the European Union C 214/1

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

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Fig. 4: Legislative procedure for the new Machinery Directive

Fig. 5. Structure of the new Machinery Directive 2006/42/EC

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).

Enactment

MRL 98/37/EC / "old" 9th GPSGV MRL 2006/42/EC and "new" 9th GPSGV

ApplicationPublication EU Off. Journal

Nat. implementation in Germ.: "new 9th GPSGV"

published on 18.06.2008

No transitional period!

RecitalsNo. 1 - 30

RecitalsNo. 1 - 25

Operative partArticles 1 - 29

Operative partArticle 1 - 16

AnnexesNo. I - XII

AnnexesNo. I - IX

2006/42/EC 98/37/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 Art. 2 of the Machinery Directive because they are components.

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VDMA-Positionspapier

VDMA-Positionspapierzur Umsetzung der

Maschinenrichtlinie 2006/42/EGin der Fluidtechnik

Stand: 29.07.2009

Fluidtechnik

Verband Deutscher Maschinen- und Anlagenbau e.V.

Fachverband Fluidtechnik Vorsitzender: Christian H. Kienzle Geschäftsführer: Hartmut Rauen

Lyoner Straße 18 60528 Frankfurt am Main, Germany Telefon +49 69 66 03-13 32 Telefax +49 69 66 03-14 59 E-Mail fluid@vdma.org Internet www.vdma.org

VDMA Wir, die Investitionsgüterindustrie

Fig. 6: VDMA Position Paper on Fluid Power dated 29th July 2009

Fig. 7: Guide to the Application of the new Machinery Directive

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Fig. 8: Simple overview of HYDAC Group products

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

a) Machinery;

Old

New

M a c h i n e r y

b) Interchangeable equipment;

c) Safety components;

d) Lifting accessories;

e) Chains, ropes and webbing;

f) Removable mechanical transmission devices;

g) Partly completed machinery;

2.Categorisation(Whatismachinery?)

Machinery Directive 2006/42/ECMachinery

Partly completed machinery

Assembly / Components

Also supplied by HYDAC

• Declaration of conformity• CE marking• Operating instructions

• Declaration of incorporation

• Installation instructions

• Delivery note with relevant text blocks

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2.1 Categorisation of the HYDAC product rangeAs 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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Scop

e of

app

licat

ion

Old

Mac

hine

ry D

irect

ive

New

Mac

hine

ry D

irect

ive

HYD

AC

App

licat

ions

"Com

plet

e" m

achi

nery

–R

eady

for o

pera

tion

–C

an b

e op

erat

ed

inde

pend

ently

–D

ecla

ratio

n of

con

form

ity –C

E m

arki

ng –O

pera

ting

man

ual

–D

ecla

ratio

n of

con

form

ity –C

E m

arki

ng –O

pera

ting

inst

ruct

ions

–Fl

uid

serv

ice

equi

pmen

t –Te

st ri

gs –N

itrog

en c

harg

ing

units

–A

ctua

tors

(with

mou

ntin

g)

Part

ly c

ompl

eted

m

achi

nery

–S

ub-s

yste

m in

tend

ed fo

r in

corp

orat

ion

–M

anuf

actu

rer's

dec

lara

tion

–D

ecla

ratio

n of

in

corp

orat

ion

–In

stal

latio

n in

stru

ctio

ns

–H

ydra

ulic

pow

er u

nits

–O

il lu

bric

atio

n sy

stem

s –Ta

nk p

acks

–S

ub-a

ssem

bly

with

con

trol

syst

em (w

ith m

ount

ing)

Safe

ty c

ompo

nent

s –C

ompo

nent

s w

hich

fulfi

l a

safe

ty fu

nctio

n an

d w

hich

ar

e pl

aced

on

the

mar

ket

sepa

rate

ly fo

r thi

s pu

rpos

e by

the

man

ufac

ture

r.

Not

incl

uded

or o

nly

limite

d in

clus

ion

(affe

cted

, how

ever

, on

the

basi

s of

the

guid

elin

es o

r in

clud

ed in

the

guid

elin

es.)

– D

ecla

ratio

n of

con

form

ity – C

E m

arki

ng – O

pera

ting

inst

ruct

ions

–2-

out-o

f-3 s

afet

y va

lve

Is re

leva

nt fo

r HY

DA

C a

s lo

ng a

s no

spe

cific

di

rect

ive

appl

ies.

–e.

g. fo

r pre

ssur

e re

lief

valv

e ac

cord

ing

to

Pre

ssur

e E

quip

men

t D

irect

ive

Part

s / C

ompo

nent

sA

re n

ot c

over

ed b

y th

e M

achi

nery

Dire

ctiv

e(b

ut:

Equ

ipm

ent a

nd P

rodu

ct

Saf

ety

Act

mus

t be

take

n in

to

acco

unt)

Are

not

cov

ered

by

the

Mac

hine

ry D

irect

ive

(but

: E

quip

men

t and

Pro

duct

S

afet

y A

ct m

ust b

e ta

ken

into

ac

coun

t)

App

roxi

mat

ely

90 %

of t

he

HY

DA

C p

ortfo

lio.

Tabl

e 1:

Sco

pe o

f app

licat

ion

of th

e M

achi

nery

Dire

ctiv

e - C

ateg

oris

atio

n w

ith fo

cus

on H

YD

AC

pro

duct

s

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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 assessmentThe 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 machinery1. 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.Externaldocuments3.1 Declaration of conformity and declaration of incorporationThe 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.

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

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

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3.2 Operating instructions and installation instructionsIn 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 – Commissioning – Setting and tooling – Normal operation – Maintenance and cleaning – Maintenance (trouble-shooting and fault elimination)

– Dismantling and disposal

Fig. 12: Example of Instructions - Operating instructions

FluidAqua Mobil

FAM 25/45/60/75/95

Operating and Maintenance Instructions

English (translation of original instructions)

Document No.: 3402054c

FAM 25/45/60/75/95

Trademarks

HYDAC FILTER SYSTEMS GMBH en

Page 2 / 140

BEWA FAM25-95 3402054c en 2010-02-09.doc

2010-02-09

Trademarks

The trademarks of other companies are exclusively used for the products of those

companies.

Copyright © 2010 by

HYDAC FILTER SYSTMES GMBH

all rights reserved

All rights reserved. This manual may not be reproduced in part or whole without the

express written consent of HYDAC Filter Systems GmbH. Contraventions are liable

to compensation.

Exclusion of Liability

We have made every endeavor to ensure the accuracy of the contents of this

document. However, errors cannot be ruled out. Consequently, we accept no

liability for such errors as may exist nor for any damage or loss whatsoever which

may arise as a result of such errors. The content of the manual is checked regularly.

Any corrections required will be incorporated in future editions. We welcome any

suggestions for improvements.

All details are subject to technical modifications.

Technical specifications are subject to change without notice.

HYDAC FILTER SYSTEMS GMBH

Postfach 12 51

66273 Sulzbach / Saar

Germany

Documentation Representative

Günter Harge

c/o HYDAC International GmbH, Industriegebiet , 66280 Sulzbach / Saar

Telephone:

++49 (0)6897 509 1511

Fax:

++49 (0)6897 509 1394

E-Mail:

guenter.harge@hydac.com

FAM 25/45/60/75/95 Safety Information and Instructions

HYDAC FILTER SYSTEMS GMBH en Page 16 / 140

BEWA FAM25-95 3402054c en 2010-02-09.doc

2010-02-09

Electrical Hazards

DANGER

Electric shock

Bodily injury leading to death

Any work involving electrical equipment may only

be done by a properly trained, certified electrician.

Check the FAM electrical equipment on a monthly basis. Immediately replace loose

connections, damaged cables and hoses with original spare parts.

Maintenance, Servicing and Troubleshooting

The prescribed adjustment, maintenance/servicing and inspection work is to be

conducted in accordance with the respective schedules.

Disconnect the FluidAqua Mobil from the power supply when performing any

maintenance, inspection or repair work. Protect the FAM from being inadvertently

switched back on.

Any screwed fittings which have been undone/removed are to be checked to see

that they have been properly resecured.

Always check the product to see that it functions properly when performing

maintenance and servicing work.

Modifications to the FluidAqua Mobil

Do not make any modifications (design modifications, extensions) to the FluidAqua

Mobil without the prior consent of the manufacturer.

Any modifications require written permission from HYDAC Filter Systems GmbH

Immediately replace any machine components which are not in perfect condition.

Only use original spare parts and consumables.

FAM 25/45/60/75/95 Safety Information and Instructions

HYDAC FILTER SYSTEMS GMBH en Page 12 / 140

BEWA FAM25-95 3402054c en 2010-02-09.doc 2010-02-09

Explanation of Symbols and Warnings, etc.

DANGER DANGER denotes situations which can lead to death if safety precautions are not observed.

WARNING WARNING denotes situations which can lead to death if safety precautions are not observed.

CAUTION CAUTION denotes situations which can lead to severe injuries if safety precautions are not observed.

CAUTION NOTICE denotes situations which can lead to property damage if safety precautions are not observed.

General Safety Precautions Maintenance work is to be carried out only by trained personnel.

The safe operation of this unit can only be ensured if it is used for the purpose it was intended. If there is any question about the use, please contact the manufacturer. The manufacturer will not accept responsibility for damages resulting from misuse of this equipment.

The following applies to all work performed using the unit: adherence to pertinent national regulations pertaining to accident prevention and safety at the workplace in addition to any applicable internal rules and regulations of the owner/operator, even though they are not specifically cited herein.

Leaks of dangerous materials must be properly collected and disposed of so as not to harm any persons or the environment. The corresponding statutory regulations are to be followed.

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To some extent the installation instructions for partly completed machinery also provide further information (Fig. 13), and are not just confined to installation.

Fig. 13: Example of installation instructions with user information

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4.StandardsinhydraulicsStandards 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 assessmentEN 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 4413EN 983 Safety requirements for fluid power systems and their components - PneumaticsEN IEC 60204 Electrical Equipment of MachinesEN 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 equipmentEN 14359 Hydraulic accumulators for hydraulic applications

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.

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5.Riskassessment-(fromriskanalysistoriskavoidance)

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 MethodSurvey 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).

Fig. 14: Flow chart of the risk assessment

Procedure for the design engineer in system designStart

End

Risk reduction necessary

Determine system limits

Hazard identification

Risk estimation

Risk evaluation

Is the machine adequately safe?

No

Yes

EN 1050 and EN ISO 14121

Ris

k as

sess

men

t

Ris

k an

alys

is

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6.SILorPL–Safety-relatedpartsforcontrolsystems

Functional SafetyA 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:

DIN EN ISO13849 DIN EN 61508

DIN EN61511

DIN EN62061

SRECS SIS

…

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 proportional to the failure rates.

MTTFd = 1/λd

Machinery industry

Process industry

SRP/CS as � Electrical/Electronic/Programmable Electronic

� Hydraulic � Pneumatic � Mechanical system

E/E/PES as � Electrical/Electronic/Programmable Electronic system

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Fig. 16: Wear characteristics of components

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

0λ

SRP/CS1SRP/CS2 SRP/CS3

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.

Premature failuresRemedy:

Burn-in, process optimisation

Wear failuresRemedy:

Sizing, preventive replacement

Random failures

Operating lifeTM or T10d

Failure rate

Time

Machine control system (CS)

Complete SRP/CS, fulfils safety function(s)

(as subsystem) (as subsystem) (as subsystem)

Non safety-related parts

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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.

Table 2: Typical reliability parameters of components

Fig. 18: Example based on categories B and 1

IEingang

IEingang

I LLogik

LLogikL O

AusgangO

AusgangO

* 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.

Tried and tested safety principles according to DIN EN ISO 13849-2:2003

Other relevant

standards

Typical values:MTTFd (years)B10d (cycles)

or Fault exclusion

Mechanical components Tables A.1 and A.2 – MTTFd = 150Hydraulic components Tables C.1 and C.2 EN 982 MTTFd = 150Pneumatic components Tables B.1 and B.2 EN 983 B10d = 20 000 000Relays and contactor relays with negligible load

Tables D.1 and D.2 EN 20205IEC61810IEC60947

B10d = 20 000 000

Relays and contactor relays with maximum load

Tables D.1 and D.2 EN 20205IEC61810IEC60947

B10d = 400 000

Emergency stop devices when used in areas exposed to low environmental contamination, e.g. in laboratories a)

Tables D.1 and D.2 IEC60947ISO 13850

Fault exclusion up to 100 000 cycles, provided

manufacturer's certification is available

Emergency stop devices when used in areas exposed to normal environmental contamination, e.g. on machinery a)

Tables D.1 and D.2 IEC60947ISO 13850

Fault exclusion up to 6 050 cycles

Enabling switches (3-stage) irrespective of the load a)

Tables D.1 and D.2 IEC 60947 Fault exclusion up to 100 000 cycles

a) if fault exclusion for positive opening is possible

Input Logic

Connection

Output

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

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

III LLL OOO

I2I2I2 O2O2O2L2L2L2

I1I1I1 L1L1L1 O1O1O1

OTEOTEOTETETETE

III LLL OOO

PL c PL d PL c

fluidic actuatorhazard-causing

movement

Light barrier

Electronic control logic

Fluidic control system

Category 2 [class 2] Category 3 Category 1

Drive elements

Components fulfilling safety function e.g.

valves

Viewing area of the safety-related part of the control system

Potentially relevant for compliance with tried and tested safety principles

Energy converter, energy transfer

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100 %

80 %

60 %

40 %

20 %

0 %0 5 10 15 20 25 30

MTTFd:

Fig. 21: SISTEMA user interface (calculation of parameters and input of parameters)

Table 3: Ranges for the reliability of control channels

Fig. 22: Reliability in years – MTTFd values

Designation of theMTTFd for each channel

Range of the MTTFd for each channel

low 3 years ≤ MTTFd < 10 years

medium 10 years ≤ MTTFd < 30 years

high 30 years ≤ MTTFd < 100 years

expe

cted

haz

ard-

caus

ing

failu

res not

accept-able

63% linelow

medium

high

3 years10 years

30 years

100 years

cap

Time [years]

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7.InternaldocumentationThe 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 machineryThis 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;

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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 machineryThis 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;

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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 M a c h i n e r y Partly completed machinery

What / where? In-house doc.

incl. in del.

In-house doc.

incl. in 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 essential health and safety requirements

X – X –

Documents for risk assessment: description of risk avoidance, risk reduction

X – X –

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 XWhere necess. copies of incorporation decl. & conformity decl. for bought-in prod.

X – – –

(Copy) Decl. of conformity X X – –Declaration of Incorporation – – – XList of measures to ensure conformity with the Directive

X – X –

Table 4: Overview of internal and external manufacturer's documentation

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Fig. 24: KAN Report No. 40_01 - The new Machinery Directive

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Fig. 25: Order Form for the booklet "The new EC Machinery Directive 2006"

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Index of Diagrams and Tables1) Fig. below Table of Contents: taken from Vortrag_Zenit_Teil2czichy.pdf Page 5

(Source: Siemens) (adapted) now from Maschinenschutz.ppt2) 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)19) Fig. 18 on Page 22: from rep2_08.pdf Page 222 (Source: DGUV, BGIA)20) Fig. 19 on Page 23: from rep2_08.pdf Page 64 (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)24) Fig. 22 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)

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