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3 00000-30 Pu INTERNATIONAL REGULATIONS FOR SAFETY OF LASER PRODUCTS AND OF LASER PROCESSING MACHINES - AN OVERVIEW - Associazione Industriali Vicenza, 18.03.10 Dipl.-Ing. Thomas Püster - Safety engineer - Paper: #

INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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Page 1: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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INTERNATIONAL REGULATIONS FOR SAFETY OF LASER PRODUCTS AND OF LASER PROCESSING MACHINES

- AN OVERVIEW -

Associazione Industriali Vicenza, 18.03.10

Dipl.-Ing. Thomas Püster- Safety engineer -

Paper: #

Page 2: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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International Regulations for Safety of Laser Products and for

Safety of Laser Processing Machines - An Overview -

� Introduction

� EU-Legislation - Articles- Directives

� International Standards- ISO, CEN, UNI- IEC, CENELEC, CEI

�Cooperation between international standardizing bod ies IEC and ISO using the example of laser safety

� Approach to safety of laser processing machines- standards directly related to laser safety- standards related to safety of machinery

� Conclusions

Contents

Page 3: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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International Regulations on Safety of Laser Safety

The Jungle of Regulations

Article 95

EN 12100

98/37/EC

Article 137

New Approach

ISOIEC

TypeA-, B-, C-Standards

UNICENELEC

CEN

HarmonizedStandards

2006/42/EC

89/391/EEC

IEC 60825-1

ISO 11553-1

ISO 13949-1

EN 954-1

EN 207Safety of Machinery

IEC 60825-4

safe laser

processing machine

• Article 95

• Article 137

• 2006/42/EC

• ISO 12100

Systematic Structure

Page 4: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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European Legislation- Technology and Safety -

European Directives(according to Amsterdam Treaty, 1999)

APPROXIMATION OF LAWS

Article 95Measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States; establishment and functioning of the internal market.

SOCIAL PROVISIONS

Article 137Improvement in particular of the workingenvironment to protect workers' healthand safety

� Framework Directives

� Generic Directives- sector specific

� Individual Directives- concerned with specific

aspects of health and safety

Page 5: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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European Directives

Framework Directive

2001/104/EC, (7th December 2001)on medical devices

2006/95/EC, (12th December 2006)on electrical equipment designed for use within certain voltage limits (low voltage)

2006/42/EC, (17th May 2006)on safety of machinery

2004/108/EC, (15th December 2004)on electromagnetic compatibility and repealing Directive 89/336/EEC

Single Directive

89/686/EEC, (21st December 1989)on personal protective equipment

93/465/EEC, (22nd July 1993)concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives

Under Article 95Measures for the approximation of the provisions

Page 6: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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European Directives

89/391/EEC, (12th June 1989)on the introduction of measures to encourage improvements in the safety and health of workers at work

Framework Directive

Under Article 137Safety and health of workers at work

Single Directive

2003/10/EC, (6th February 2003)on the minimum health and safety requirements regarding the exposure of workers to the risksarising from physical agents (noise)

2004/40/EC, (29th April 2004)on the minimum health and safety requirements regarding the exposure of workers to the risksarising from physical agents (electromagnetic fields)

2006/25/EC, (5th April 2006)on the minimum health and safety requirements regarding the exposure of workers to risksarising from physical agents (artificial optical radiation)

98/24/EC, (7th April 1998)on the protection of the health and safety of workers from the risks related to chemical agents at work (chemical agents)

Page 7: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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European Regulations related to Health and Safety at Work

88/642/EEC: Protection of workers from the risks related to exposure to chemical, physical and biological agents 89/391/EEC: Measures to encourage improvements in the safety and health of

workers

Directive on Physical Agents1992 proposed /

1993 proposal withdrawn

Directive onChemical Agents

98/24/EC

Directive onBiological Agents

2005/54/EC

„Noise“Directive

2003/10/EC

„Vibration“Directive

2002/44/EC

„EMF“Directive

2004/40/EC

„OpticalRadiation“Directive

2006/25/EC

ArbSchLärmVibrationsV03/2007

IndividualDirectives

IndividualDirectives

National ProvisionsPhysical Agents (PhysV)

Artikel 137

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International Standardization Bodies

European Level

National Level (Italy)

International Level

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Hierarchy of the European Standards System

Basic safety standards

Safety group standards(generic standards)

Subject or productsafety standards

TypeA Standards

Design principles and basic concepts for machines

Typ C StandardsSpecific safety requirements for

special machines or machine types

TypeB Standards

B1 StandardsGeneral safety aspects

B2 StandardsReference to specialprotective devices

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Standards related to Laser Safety(Examples of Type A, B und C-Standards)

EC-DirectiveMachinery

Type A-Standards(Basic standards)

Type C-Standards(Product Standard)

Basic requirements on safety and health

Directive 89/392/EEC (consolidated by 98/37/EC, 2006/42/EC)

Basic safety requirements

ISO 12100 P1, P2 “Safety of machinery - Basic concept s, general principlesfor design“

Type B-Standards(Generic standards)

Type B1 Safety aspectsISO 13857 “Safety of machinery - Safety distances to p revent hazard zones

being reached by upper and lower limbs “

ISO 13849-1 „Safety of machinery - Safety-related par ts of control systems -Part 1: General principles for design“

Type B2 Safety related devices

ISO 13850 “Safety of machinery - Emergency stop - Prin ciples for design“

ISO 14119 „Safety of machinery - Interlocking device s associated withguards - Principles for design and selection”

Detailed safety requirements for a particular machi ne or type of machines

ISO 11553-2 „Safety of machinery - Laser processing m achines - Part 2: Safety requirements for hand-held laser processing devices”

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Structuring of ISO/TC 172

Structuring of ISO/TC 172

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Structuring of IEC/TC 76

IEC - List of technical committees and subcommittees

Total number of TC/SCs 174

IEC Technical Committees 94

IEC Subcommittees 80

WG 1Optical radiation

safety

WG 3Laser radiationmeasurement

WG 4Safety of

medical laser equipment

WG 5Safety of

fiber optics communications

systems

WG 7High

power lasers

WG 8Development

and Maintenance

of basic standards

WG 9Non coherent

sources

JWG 10IEC/ISO

Safety of lasersand

laser equipmentin an

Industrialmaterials

processingenvironment

IEC/TC 76

Optical radiation safety and laser equipment

Page 13: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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Cooperation of ISO and IECwith regard to laser safety

ISOTC 172SC 9WG 3

“Safety”

IECTC 76WG 10“Safety”

JWG

Joint Working

Group

Joint Working Group of ISO and IEC

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Steps on the way to elaborate an International Standard

VotingYes/No

Proposal of a Standard

NationalWorking Group

NWIP(New Work Item

Proposal)

WD(Working Draft)

Consensus between Experts of WG

CD(Committee Draft)

Consensus within TC/SC

Comments

TC/SC

VotingYes/No

Proposal of a Standard

NationalWorking Group

NWIP(New Work Item

Proposal)

WD(Working Draft)

Consensus betweenExperts of WG

CD(Committee Draft)

Consensus withinTC/SC

Comments

TC/SC

Objections /

DIS(Draft International

Standard)

Consensus

FDIS(Final Draft

International Standard)

Final Text of International

Standard

Publication of International

Standard

Formal VotingYes/No

Objections / Comments

DIS(Draft International

Standard)

Consensus

FDIS(Final Draft

International Standard)

Final Text ofInternational

Standard

Publication ofInternational

Standard

Formal VotingYes/No

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Development of an International Standard- Stages -

Reference: DIN

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Machinery Directive2006/42/EC

1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

1.5. RISKS DUE TO OTHER HAZARDS

1.5.12 Laser radiation

Where laser equipment is used, the following should be taken into account:

� laser equipment on machinery must be designed and constructed in such a way as to prevent any accidental radiation,

� laser equipment on machinery must be protected in such a way that effective radiation, radiation produced by reflection or diffusion and secondary radiation do not damage health,

� optical equipment for the observation or adjustment of laser equipment on machinery must be such that no health risk is created by laser radiation.

ANNEX IEssential health and safety requirements relating t o the design and constructionof machinery

The essential health and safety requirements laid down in this Annex are mandatory;

Page 17: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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Changes of new Machinery Directive 2006/42/EC (extract)

� Changes are especially prevalent with the conformity assessment procedure of Annex IV Machines (exemptfrom Type Examination). For the manufacturer the new directive opens up the option of self-certification with-out the participation of a test center, if they have a quality assurance procedure in accordance with Annex X.

� The basic safety and health requirements (Annex I) will in future require a risk assessment by the manufacturer.

� In the old Machinery Directive there are different procedures for proving the safety of machinery, exchangeable equipment, safety components, chains/ropes/belts for lifting purposes, Cardan shafts and load-carrying equipment. In the future the same machine regulations will also apply for these products. They will have to be distributedin the future with CE conformity assessment, declaration of conformity and the required user information.

� The requirements for "part-machines" (also referred to as "incomplete machines") have been re-formulated in the new version of the Machinery Directive. Until now a manufacturer declaration was sufficient, but in thefuture the manufacturer will also have to supply a declaration of incorporation, which must specify whichrequirements of the directive apply to the part-machine and have been complied with. Installation instructionsmust be provided with the machine’s documentation.

� The delimitation of the Low Voltage Directive is no longer regulated as risk-related, but rather product-related.

� Clearer delimitation of the Machinery Directive for the Low Voltage Directive.

� Instead of a "hazard analysis" a risk assessment and "risk evaluation" are required.

� Internal production controls for series machines (Annex VIII).

� The validity of EC Type Examination certifications must be checked by the test center every 5 years.Manufacturers and test centers are obligated to retain the relevant technical documents for 15 years.

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3-Step Procedure given in ISO 12100-1

Safety requirements3-Step Procedure given in ISO 12100-1

Step 1: Inherently safe design measures

Step 2: Safeguarding andcomplimentaryprotective measures

Step 3: Information for use- at the machine- in the instruction handbook

Protective measures taken by the designer

Protective measures taken by the user

- Organization- Provision of additional safeguards- Personal protective equipment

- complete shielding- contact control- safety PLC

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Risk Assessment

DIN EN 1050 Safety of machinery – Principles of hazard analysis

Method of hazard analysis and Risk assessment :(examples)- What-if-method- Fault tree analysis - FMEA*- MOSAR*

* Failure mode and effects analysisMethod organized for systematic analysis of risks

DIN EN ISO 14121-1:2007 Safety of machinery - Risk assessment - Part 1: Principles

Acc

ordi

ng to

DIN

EN

ISO

121

00-1

Determination of machine limits

Hazardidentification

yes

no

EndIs the

machinesafe ?

Risk analysis

Risk reduction

Iterative process to achieve safety

Start

Risk evaluation

Risk estimation

Risk assessment

Page 20: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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Standards directly related to laser safety - Examples -

Responsibility of IEC

IEC 60825 Safety of laser productsP1 Equipment classification

and requirements

P2 Safety of optical fibrecommunication systems (OFCS)

P4 Laser guards

P...

IEC 60601-2-22 Medical electrical equipment

Requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and laser equipment

Responsibility of ISOISO 11553 Safety of machinery

Laser processing machines

P1 General safety requirementsP2 Safety requirements for

hand-held laser processing

devices

National responsibilitiesDIN 56912 Showlaser and Show-

laser equipmentSafety requirements and control

Responsibility of CENISO 12254 Screens for laser

working placesSafety requirements andtesting

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Standards indirectly related to laser safety - Examples -

EN 61040 Power and energy measuring detectors, Instruments, and equipment for laser radiation

- standards of equipment- standards for measuring and interpretation

EN ISO 11146 Lasers and laser-related equipment, Test methods for laser beamwidths divergence angles and beam propagation ratios

P1 Stigmatic and simple astigmatic beamsP2 General astigmatic beams

EN ISO 13694 Optics and optical instruments - Lasers and laser-related equipment, Test methods for laser beam power (energy) density distribution

EN ISO 11145 Optics and photonics - Lasers and laser-related equipment,Vocabulary and symbols

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Overview about the series of standards IEC 60825

PartNo.

Type Title and scope Designer of the

Product

Manufacturer of the

Product

User of the

Product

Manufacturer of safety-

related parts

Testmethod

Hazardanalysis

1 Standard Equipment classification and requirements Yes yes yes yes yes yes

2 Standard Safety of optical fiber communication systems

yes yes yes yes yes yes

3 TechnicalReport

Guidance for laser displays and shows no no yes no no yes

4 Standard Laser guards yes yes yes yes yes yes

5 TechnicalReport

Manufacturer's checklist for IEC 60825-1 (good for safety report)

yes yes no yes no no

6 TechnicalSpecification

7 TechnicalReport

8 TechnicalReport

Guidelines for the safe use of laser beams on humans

no no yes no no no

9 TechnicalReport

Compilation of maximum permissible exposure to incoherent optical radiation

no no yes no yes yes

10 TechnicalReport

Application guidelines and explanatory notes to IEC 60825-1

yes yes no no yes no

12 Standard Safety of free space optical communication systems used for transmission of information

yes yes yes no yes yes

14 TechnicalReport

A user's guide no yes yes no no yes

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New regulations with regard to artificial optical radiation

19. Single Directive 2006/25/EG on the minimum health and safety requirements regarding the exposureof workers to risks asing from physical agents (artificial optical radiation)

National implementation until 27.04.2010

Electromagnetic Radiation: 100 nm – 1 mm

Non-coherent radiation(each artificial optical radiation

except for laser radiation)

Coherent radiation(Laser radiation)

International Standards

National RegulationsELIA (BG)

BGV B9BGI 5006

IEC 62471

BGV B2+ DA 2007

IEC 60825-1

Labeling of the area W 09 W 10

Exposure limits(Time base)

180nm – 400nmSingle-day exposition (8h = 30.000s)Annual exposition (value)380nm – 1mmSingle-day exposition (value)

Single-day exposition Exceptions:λ = vis: 0,25s No MPE alterationλ ≥ 400nm: >100sλ ≥1050nm: >10s

pulsed LEDanalog to BGV B2

LED

Page 24: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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Safety of Laser Products

IEC 60825-1:Safety of laser products - Part 1: Equipment classific ation and requirements

Main parts:- laser classification scheme- instructions to classify a laser product - engineering specifications - labelling of laser products���� User ´́́́s guide in TR 60825-14

Last substantial changes regarding the laser classi fication concept took place in 2001 (A2)From January 2004 for new laser products: classes 1 , 1M, 2, 2M, 3R, 3B and 4.

Classification into class 1 according to IEC 60825- 1 is based on strict requirements: - Prevention of human access (above AEL class 1),- Provision for foreseeable fault conditions,- Coping of single-fault conditions.

Class 1 laser products must be inherently safe and th e user does not need to know that a laser product is integral part of the machine;- laser guards: ���� in fault conditions (exposure of the guard) the las er radiation must be

automatically isolated,- human access (walk in access): ���� the access is automatically detected followed by an

instantaneous isolation of laser radiation.

Page 25: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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Technical standards for screens/guardsat laser work places

Laser guardsEN 60825-4: 2009

Screens for laser working placesEN 12254: 2008

� Laser radiationmax. 100 W mean powermax. 30 J single pulse energy

� intermittent/permanentpassive laser screens

- continuous surveillance -� for protection against laser radiation

only (unintended exposure) not against secondary radiation

� Testing of laser resistance:d63 of laser beam >2 mm (>0,5 mm)

Test-duration: EN 60825-1

� Laser radiationno power-/ energy limitation

� intermittent/permanentaktive and passive laser guards and screens (applies to all elements of alaser guard)- also unattended automatic mode -

� Testing of laser resistance:determinaton of protective exposure limit (PEL)EN 60825-4, Clause 3.4:Requirements on testing

Page 26: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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Guarding around a laser processing machine

according to IEC 60825-4

Foreseeable exposure limit

(FEL)Maximum reasonably foreseeable

exposure at the front surface of the laser protective guard

Protective exposure limit(PEL)

Protective properties of thelaser protective guard to prevent exceeding

of AEL class 1at the rear surface

Laser protective guard

Process area

Laser

Laser processing machine

Outside the laser protective guardLaser Class 1 (AEL)

Page 27: INTERNATIONAL REGULATIONS FOR SAFETY OF LASER … · international regulations for safety of laser products and of laser processing machines - an overview - ... b1 standards general

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Risk analysis to design passive laser protective guards

Question: when will a failure be recognized? (radiation hits the guard)

Laser-protective guard must safely protect over this time

Ref.: IEC 60825-4

Recommended application

automated production

short-cycle operation with intermittent inspection

processing under continuous surveillance

Inspection interval

30.000 s

100 s

10 s

Test class

T1

T2

T3

Classification of the laser protective guards with given protection level (PEL)

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Safety of Laser Processing Machines

ISO 11553-1:Safety of machinery - Laser processing machines - Part 1 : General safety requirements

Predominantly, an inherently safe machine is requir ed (accessible radiation should not exceed MPE)

Unauthorized access to danger zones shall be preven ted by engineering measures.

Applicable for functionally complete systemsMain parts:- hazard analysis- risk assessment- engineering specifications- safety measures (for laser radiation and further st andards)- information provided to the user

The standard also permits administrative control me asures and personal protective equipment to reduce risks by laser radia tion.

The machinery directive and the harmonized standard s on safety of machinery require that no hazardous laser radiation is emitted from t he machine;- laser guards: ���� inspection intervals by operators can be used, to t erminate the time

of the laser resistance of passive laser guards in f ault conditions - human access (walk in access): ���� the access can be restricted by administrative mean s

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Control of access

People All, including the public

Personnel untrained in laser safety but not the public

Authorized and trained in laser safety

Location Unrestricted and uncontrolled

RestrictedControlled

Description of Locations

Reference: ISO 11553-1

Corresponding measures for control of access must b e provided

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Embedded laser products- laser processing machines -

Safety positionswitch withguard locking(magnetic lock)

Interlock

InterlockFiber connector

Safe fiber- temperature- breakage

Laser guards/walls

Control panel

Safetyshutter

SafetyPLC

Restrictedarea

Controlled area

Operatingmode

Safety door

Emission warning light

Powersupply

Powersupply

stop

12

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Protective measures for use of laser units

Safe according DIN EN ISO 12100

DIN EN ISO 11553-1

„safe as class 1“

Technical measures

Safe accordingDIN EN 60825-1

laser class 1

Administrative measures

Safety must be achieved by following measures*:

Technical measures

The laser installation/unit must be inherently safe with regard totechnic and design

Type of safety measures for enclosed laser units

*Laser units with restricted access

Safety must be achieved by following measures*:

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Areas of applications of different standards related to functional safety

Construction and risk assessmentEN ISO 12100

Functional and safety requirementson a safety-related control system

Electrical safety aspectsIEC/EN 60204

Design and implementation of safety-relevant electrical control system

EN ISO 13849SRP/CS as

���� E/E/PES ���� Hydraulics���� Pneumatics ���� Mechanics

IEC/EN 62061SRP/CS as���� E/E/PES

SRECS

Machinery

IEC/EN 61508SRP/CS as���� E/E/PES

IEC/EN 61511

Processindustry

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Controls and their safety functions

SensorSensor ActuatorActuator

acquisition of information- command- detect

processing of information- control- evaluate

performing of action- actuate- switch off

Safety function

? B, 1, 2, 3, 4

EN 954-1 Safety-related parts of control systems -EN ISO 13849-1 Part 1: General principles for design

EN ISO 13849-2 Safety-related parts of control syste ms -Part 2: Validation

Standards

Control Categories

Cat. 3: a single fault in each of these parts must not cause a loss of the safety function

Cat. 4: an accumulation of faults must not cause theloss of the safety function

Laser Class 1:Design of safety related devices- fail-safe- single-fault condition

Programmable Logic Control

Programmable Logic Control

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Iterative procedure for the design of safety related parts of controls (SRP/CS)

Identify the required safety functions, performed by SRP/CS

Define the safety function requirementsfor each safety function

Determine the requiredPerformance Level PLr

Design and technical realization of the safety functions:Identification of safety related parts,

performing the safety function

Determine and evaluate the Performance Level PLfor the above mentioned SRP/CS with regard to:

• category• MTTFd• DC• CCF• if applicable: Software

Procedure of risk reductionISO 12100-1 Protective measure depends on a control

Start

Verification of PLFor a certain safety function:

PL ≥ PLr

Validation:Have all demands

been achieved?

Have all safety functions been analyzed?

yes

yes

yes

no

no

no

End

Procedure of risk reductionISO 12100-1

Steps

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Safety functions of controls

- Emergency Stop (acc. IEC 60204-1 and ISO 13850)

- Prevention of unexpected start-up (acc. ISO 14118)

- Start/Stop-Control: controlled start(acc. IEC 60204-1)

- Operation control device with automatic reset facility(acc. IEC 60204-1, EN 574)

- Enabling switch, e.g. 3-step (in danger area) (acc. IEC 60204-1, EN 1088)

Typical safety functions of a laser processing machi ne

Safety related parts of controls (SRP/CS) requirements on SRP/CS as result of risk evaluation(leads typically to cat. 3 acc. EN 954-1 or ISO 13849-1)

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Hazard identification and risk evaluationRisk graph for the determination of the required

performance level (PLr)

1

S1

S2

F1

F2

F1

F2

P1P2P1P2P1P2P1P2

a

b

c

d

e

L

H

DIN EN ISO 13849-1

Legend

1 Point at which the evaluation of the contribution to the risk minimization begins

L Low contribution to risk minimization H High contribution to risk minimizationPLr Required performance level

PLr Risk parameters

S Severity of potential injuryS1 Slight (normally reversible injury)S2 Serious (normally irreversible injury or death)F Frequency and/or exposure time to hazardF1 Seldom to not very frequent and/or exposure time to hazard is shortF2 Frequent to continuous and/or exposure time to hazard is longP Possibility of preventing the hazard or limiting the harmP1 Possible under certain conditionsP2 Scarcely possible

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SV1

Control partsof the laser device

Architecture of HLG control- HLG-Block diagram -

Terms:B1/B2 SensorA1/A2 AmplifierG1/G2 Limit switchK1 PLCQ1/Q2 Safety relaySV1 Safety shutter

K1

A1B1

A2B2

G1

G2

A3B3

A4B4

G3

G4

K1

Feedback

Switch-off testfurther input-units (diverse functional principle)

Channel 1

Channel 2

Line 1

Line 2

Q1

Q2

Control partsof the laser device

K1 signal check- plausibility- simultaneity

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Control categories defined in EN 954-1

Cat. Summary of requirements System behavior 1) Principle forachieving safety

B The safety-related parts of control systems and/ or their protective devices and their components shall be designed, constructed, selected and combined in accordance with the applicable standards in such a way that they can withstand the expected influences and effects.

The occurrence of a fault can cause the loss of the safety function.

Predominantly characterized by the selection of components.

1 The requirements of B shall be satisfied. Approved components and approved safety principles must be applied.

The occurrence of a fault can cause the loss of the safety function, but the probability that one will occur is lower than in B.

Predominantly characterized by the selection of components.

2 The requirements of B and the use of approved safety principles shall be ensured. The safety function shall be checked at appropriate intervals by the machine control system.

The occurrence of a fault can cause the loss of the safety function between the test intervals. The loss of the safety function is detected by the test.

Predominantly characterized by the structure.

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Control categories defined in EN 954-1

Cat. Summary of requirements System behavior 1) Principle forachieving safety

3 The requirements of B and the use of approvedsafety principles shall be ensured. Safety-

related parts shall be designed so that:�An single fault in each of these parts does not cause the loss of the safety function.�The single faults are detected whenever this is reasonably possibly.

If a single fault occurs, the safety function is always maintained.Some but not all faults are detected. An accumulation of undetected faults can lead to loss of the safety function.

Predominantly characterized by the structure.

4 The requirements of B and the use of provensafety principles shall be ensured. Safety-related parts shall be designed so that: •A single fault in each of these parts does not cause the loss of the safety function.•The single fault is detected with or before the next request to the safety function, or if this is not possible, an accumulation of faults may not cause the loss of the safety function.

If faults occur the safety function is always maintained.

The faults are detected in time to prevent a loss of the safety function.

Predominantly characterized by the structure.

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Personal protective eyewear

Laser protectionglassesDIN EN 207

Protection level

L1 - L10

Laser adjustmentglassesDIN EN 208

Protection level

R1 - R5

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Laser-eye protection / Testing

Requirements on testing acc. to cat.II:- one-time type examination test (by independend testing laboratory)- monitoring of manufacturing process by independend testing

laboratory is not stipulated (only by manufacturer himself)

European Directive 89/686/EEC; (93/95/EEC); (96/58/ EC) onthe approximation of the laws of the Member States relating to personal protective equipment(PPE-Directive)

PPE and also eye-protection is categorized into 3 different risk levels for assessment :- cat.I: simple risk- cat.II: intermediate risk- cat.III: complex riskLaser protection glasses are assigned to cat.II

Have to be marked with CE-mark

In comparison: Reqirements of DIN GS tests*- EU-type examination test, - Re-examination tests periodically, - Impartial sampling out of the manufacturing process, - Testing of testing sets and quality assurance at the manufacturing plant.*all tests carried out by independend testing laboratory voluntarily by the manufacturer

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Conclusions

The international and national regulations, provisi ons and technical standards with regard to safety of laser products and safety of laser proces sing machines are very complex .

���� The systematic approach of the European legislation to structure all directives and harmonized standards helps to compile relevant requirements and informat ion .

The appreciation of European standards to internati onal standards also improves the situation.

� Manufacturers of ready-to-use laser processing mach ines must comply with a number of standards on machine safety also relevant for laser safety (t o declare conformity).���� Especially requirements of the control of the laser radiation have to be met in order to prevent

human access to laser radiation above the maximum p ermissible exposure (MPE)- Standards on functional safety, safety controls an d safety related parts of controls (SRP/CS)

� Generally, regulations are based on both scientific knowledge and basic values of a community.���� Therefore, regulations are subject to continuous de velopment and changes

� Existing standards dealing with laser safety provid e substantial information on how to designa safe laser product or laser processing machine. ���� Standards must cope with new developments and applic ations

- such as LED, SLD, HLD or high-power laser remote welding, - this applies also to personal protective equipment (PPE) against laser radiation and especially to protective clothing, for which re quirements should be defined and test methods should be developed.

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Thank you very much for your attention