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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 Pster - Safety engineer - Pu 3 00000-30

International Regulations for Safety of Laser Products and for Safety of Laser Processing Machines
- An Overview Contents
Introduction EU-Legislation
- Articles - Directives

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

Cooperation between international standardizing bodies 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
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International Regulations on Safety of Laser Safety

The Jungle of Regulations
IEC 60825-1 Article 95 EN 12100 IEC EN 207 Type A-, B-, CStandards 98/37/EC ISO 13949-1 Article 137 ISO 11553-1 Harmonized Standards UNI IEC 60825-4 Safety of Machinery EN 954-1 New Approach ISO 2006/42/EC
Article 95 Article 137 2006/42/EC ISO 12100

CEN

ser safe la achine sing m proces

Systematic Structure

CENELEC 89/391/EEC

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European Legislation
- Technology and Safety European Directives
(according to Amsterdam Treaty, 1999)

APPROXIMATION OF LAWS Article 95

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

Framework Directives Generic Directives

- sector specific

SOCIAL PROVISIONS Article 137

Improvement in particular of the working environment to protect workers' health and safety

Individual Directives
- concerned with specific aspects of health and safety

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European Directives
Under Article 95 Measures for the approximation of the provisions
Framework Directive
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

Single Directive 89/686/EEC, (21st December 1989)

on personal protective equipment

2001/104/EC, (7th December 2001)

on medical devices

2004/108/EC, (15th December 2004)

on electromagnetic compatibility and repealing Directive 89/336/EEC

2006/42/EC, (17th May 2006)

on safety of machinery

2006/95/EC, (12th December 2006)

on electrical equipment designed for use within certain voltage limits (low voltage)
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European Directives
Under Article 137 Safety and health of workers at work
Framework Directive
89/391/EEC, (12th June 1989) on the introduction of measures to encourage improvements in the safety and health of workers at work Single Directive 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)

2003/10/EC, (6th February 2003)

on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (noise)

2004/40/EC, (29th April 2004)

on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields)

2006/25/EC, (5th April 2006)

on the minimum health and safety requirements regarding the exposure of workers to risks arising from physical agents (artificial optical radiation)
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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 Artikel 137 Directive on Physical Agents 1992 proposed / 1993 proposal withdrawn Noise Directive 2003/10/EC Vibration Directive 2002/44/EC EMF Directive 2004/40/EC Optical Radiation Directive 2006/25/EC Directive on Chemical Agents 98/24/EC Directive on Biological Agents 2005/54/EC

Individual Directives

Individual Directives

National Provisions Physical Agents (PhysV) ArbSchLrmVibrationsV 03/2007

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International Standardization Bodies

International Level

European Level

National Level (Italy)

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Hierarchy of the European Standards System

Basic safety standards

Type A Standards
Design principles and basic concepts for machines

Safety group standards (generic standards)

Type B Standards
B1 Standards General safety aspects B2 Standards Reference to special protective devices

Subject or product safety standards

Typ C Standards
Specific safety requirements for special machines or machine types

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Standards related to Laser Safety

(Examples of Type A, B und C-Standards)
EC-Directive Machinery Type A-Standards (Basic standards) Type B-Standards (Generic standards) 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 concepts, general principles for design Type B1 Safety aspects ISO 13857 Safety of machinery - Safety distances to prevent hazard zones being reached by upper and lower limbs ISO 13849-1 Safety of machinery - Safety-related parts of control systems Part 1: General principles for design Type B2 Safety related devices ISO 13850 Safety of machinery - Emergency stop - Principles for design ISO 14119 Safety of machinery - Interlocking devices associated with guards - Principles for design and selection Type C-Standards (Product Standard) Detailed safety requirements for a particular machine or type of machines ISO 11553-2 Safety of machinery - Laser processing machines - 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/TC 76
Optical radiation safety and laser equipment

WG 1
Optical radiation safety

WG 3
Laser radiation measurement

WG 4
Safety of medical laser equipment

WG 5
Safety of fiber optics communications systems

WG 7
High power lasers

WG 8
Development and Maintenance of basic standards

WG 9
Non coherent sources

JWG 10
IEC/ISO Safety of lasers and laser equipment in an Industrial materials processing environment

IEC - List of technical committees and subcommittees Total number of TC/SCs IEC Technical Committees IEC Subcommittees 174 94 80

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Cooperation of ISO and IEC with regard to laser safety

Joint Working Group of ISO and IEC

ISO TC 172 SC 9 WG 3 Safety

JWG

IEC TC 76 WG 10 Safety

Joint Working Group

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Steps on the way to elaborate an International Standard

Proposal of a Standard National Working Group

TC/SC DIS NWIP

(New Work Item Proposal) Voting Voting Yes/No Yes/No
(Draft International Standard)

Objections / Comments
Consensus

FDIS
(Final Draft International Standard)

WD
(Working Draft) Consensus between Experts of WG

Formal Voting Yes/No Final Text of International Standard Publication of International Standard
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CD
(Committee Draft)

Comments
Consensus within TC/SC

Development of an International Standard - Stages -

Reference: DIN
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Machinery Directive
2006/42/EC
ANNEX I
Essential health and safety requirements relating to the design and construction of machinery The essential health and safety requirements laid down in this Annex are mandatory; 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.

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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 (exempt from Type Examination). For the manufacturer the new directive opens up the option of self-certification without 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 distributed in 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 the future the manufacturer will also have to supply a declaration of incorporation, which must specify which requirements of the directive apply to the part-machine and have been complied with. Installation instructions must be provided with the machines 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 requirements
3-Step Procedure given in ISO 12100-1 Protective measures taken by the designer Step 1: Inherently safe design measures Step 2: Safeguarding and complimentary protective measures Step 3: Information for use - at the machine - in the instruction handbook Protective measures taken by the user - Organization - Provision of additional safeguards - Personal protective equipment
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- complete shielding - contact control - safety PLC

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

DIN EN 1050 Safety of machinery Principles of hazard analysis

Iterative process to achieve safety
Start Determination of machine limits According to DIN EN ISO 12100-1 Hazard identification Risk estimation Risk evaluation Risk analysis Risk assessment

Is the machine safe ? no Risk reduction

yes End

Method of hazard analysis and Risk assessment : (examples) - What-if-method - Fault tree analysis - FMEA* - MOSAR*
* Failure mode and effects analysis Method organized for systematic analysis of risks

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Standards directly related to laser safety - Examples Responsibility of IEC

IEC 60825
P1 P2 P4 P...

Responsibility of ISO
ISO 11553
P1 P2 processing devices

Safety of laser products

Equipment classification and requirements Safety of optical fibre communication systems (OFCS) Laser guards

Safety of machinery
Laser processing machines General safety requirements Safety requirements for hand-held laser

Responsibility of CEN
ISO 12254
Requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and laser equipment

IEC 60601-2-22 Medical electrical equipment

Screens for laser working places

Safety requirements and testing

National responsibilities
DIN 56912 Showlaser and Showlaser equipment
Safety requirements and control
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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 Lasers and laser-related equipment, Test methods for laser beam widths divergence angles and beam propagation ratios Stigmatic and simple astigmatic beams General astigmatic beams Optics and optical instruments - Lasers and laser-related equipment, Test methods for laser beam power (energy) density distribution Optics and photonics - Lasers and laser-related equipment, Vocabulary and symbols

EN ISO 11146 P1 P2 EN ISO 13694

EN ISO 11145

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Overview about the series of standards IEC 60825

Part No. 1 2 3 4 5 6 Type Title and scope Designer of the Product Yes yes no yes yes Manufacturer of the Product yes yes no yes yes User of the Product yes yes yes yes no Manufacturer of safetyrelated parts yes yes no yes yes Test method yes yes no yes no Hazard analysis yes yes yes yes no Standard Standard Technical Report Standard Technical Report Technical Specification Technical Report Technical Report Technical Report Technical Report Standard Technical Report Guidelines for the safe use of laser beams on humans Compilation of maximum permissible exposure to incoherent optical radiation Application guidelines and explanatory notes to IEC 60825-1 Safety of free space optical communication systems used for transmission of information A user's guide no no yes yes no no no yes yes yes yes yes no yes yes no no no no no no yes yes yes no no yes no yes yes Equipment classification and requirements Safety of optical fiber communication systems Guidance for laser displays and shows Laser guards Manufacturer's checklist for IEC 60825-1 (good for safety report)

8 9 10 12 14

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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 exposure
National implementation until 27.04.2010

of workers to risks asing from physical agents (artificial optical radiation)

Electromagnetic Radiation: 100 nm 1 mm Non-coherent radiation

(each artificial optical radiation except for laser radiation) LED

Coherent radiation
(Laser radiation)

Exposure limits (Time base)

180nm 400nm Single-day exposition (8h = 30.000s) Annual exposition (value) pulsed LED 380nm 1mm analog to BGV B2 Single-day exposition (value)
W 09

Single-day exposition Exceptions: = vis: 0,25s No MPE alteration 400nm: >100s 1050nm: >10s
W 10

Labeling of the area

International Standards National Regulations ELIA (BG)

IEC 62471 BGV B9 BGI 5006

IEC 60825-1 BGV B2 + DA 2007

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Safety of Laser Products

IEC 60825-1: Safety of laser products - Part 1: Equipment classification and requirements
Main parts: - laser classification scheme - instructions to classify a laser product - engineering specifications - labelling of laser products Users guide in TR 60825-14 Last substantial changes regarding the laser classification 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 the 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 laser radiation must be automatically isolated, - human access (walk in access): the access is automatically detected followed by an instantaneous isolation of laser radiation.
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Technical standards for screens/guards at laser work places

Screens for laser working places EN 12254: 2008 Laser radiation max. 100 W mean power max. 30 J single pulse energy intermittent/permanent passive 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 guards EN 60825-4: 2009 Laser radiation no power-/ energy limitation intermittent/permanent aktive and passive laser guards and screens (applies to all elements of a laser guard) - also unattended automatic mode Testing of laser resistance: determinaton of protective exposure limit (PEL) EN 60825-4, Clause 3.4: Requirements on testing

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Guarding around a laser processing machine

Foreseeable exposure limit (FEL) Maximum reasonably foreseeable exposure at the front surface of the laser protective guard Laser Protective exposure limit (PEL) Protective properties of the laser protective guard to prevent exceeding of AEL class 1 at the rear surface Laser protective guard Process area Outside the laser protective guard Laser Class 1 (AEL)

Laser processing machine

according to IEC 60825-4
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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
Classification of the laser protective guards with given protection level (PEL) Test class T1 T2 T3 Inspection interval 30.000 s 100 s 10 s Recommended application automated production short-cycle operation with intermittent inspection processing under continuous surveillance
Ref.: IEC 60825-4

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Safety of Laser Processing Machines

ISO 11553-1: Safety of machinery - Laser processing machines - Part 1: General safety requirements
Applicable for functionally complete systems Main parts: - hazard analysis - risk assessment - engineering specifications - safety measures (for laser radiation and further standards) - information provided to the user Predominantly, an inherently safe machine is required (accessible radiation should not exceed MPE) Unauthorized access to danger zones shall be prevented by engineering measures. The standard also permits administrative control measures and personal protective equipment to reduce risks by laser radiation. The machinery directive and the harmonized standards on safety of machinery require that no hazardous laser radiation is emitted from the machine; - laser guards: inspection intervals by operators can be used, to terminate the time of the laser resistance of passive laser guards in fault conditions - human access (walk in access): the access can be restricted by administrative means
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Control of access

Description of Locations
Location Controlled Restricted Unrestricted and uncontrolled All, including the public

People

Authorized Personnel untrained and trained in in laser safety but not laser the public safety

Reference: ISO 11553-1

Corresponding measures for control of access must be provided

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Embedded laser products - laser processing machines Interlock Fiber Emission connector warning light Safe fiber - temperature - breakage Safety shutter Laser guards/ walls Safety position switch with guard locking (magnetic lock)

Controlled area

Safety door

Power supply

Power supply Operating stop mode 2 Safety 1 PLC

Interlock

Restricted area

Control panel
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Protective measures for use of laser units

Type of safety measures for enclosed laser units

Safe according DIN EN ISO 12100 DIN EN ISO 11553-1 safe as class 1 Safety must be achieved by following measures*:

Safe according DIN EN 60825-1 laser class 1 Safety must be achieved by following measures*: The laser installation/unit must be inherently safe with regard to technic and design

Technical measures Administrative measures

*Laser units with restricted access

Technical measures

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Areas of applications of different standards related to functional safety Machinery

Construction and risk assessment EN ISO 12100
Functional and safety requirements on a safety-related control system Design and implementation of safety-relevant electrical control system

Process industry
IEC/EN 61511

EN ISO 13849
SRP/CS as E/E/PES Hydraulics Pneumatics Mechanics

IEC/EN 62061
SRP/CS as E/E/PES SRECS

Electrical safety aspects IEC/EN 60204

IEC/EN 61508
SRP/CS as E/E/PES
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Controls and their safety functions

Standards
EN 954-1 EN ISO 13849-1 EN ISO 13849-2 Safety-related parts of control systems Part 1: General principles for design Safety-related parts of control systems Part 2: Validation

Sensor Sensor
acquisition of information - command - detect

Programmable Programmable LogicControl Control Logic

processing of information - control - evaluate

Actuator Actuator
performing of action - actuate - switch off

Safety function

Control Categories
? B, 1, 2, 3, 4
Laser Class 1: Design of safety related devices - fail-safe - single-fault condition Cat. 3: Cat. 4: a single fault in each of these parts must not cause a loss of the safety function an accumulation of faults must not cause the loss of the safety function
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Iterative procedure for the design of safety related parts of controls (SRP/CS)
Start

Steps

Identify the required safety functions, performed by SRP/CS Define the safety function requirements for each safety function Determine the required Performance Level PLr Verification of PL For a certain safety function: PL PLr yes Design and technical realization of the safety functions: Identification of safety related parts, performing the safety function Validation: Have all demands been achieved? yes Determine and evaluate the Performance Level PL for the above mentioned SRP/CS with regard to: category MTTFd DC CCF if applicable: Software Have all safety functions been analyzed? yes End

Procedure of risk reduction ISO 12100-1

Protective measure depends on a control

no

no

no

Procedure of risk reduction ISO 12100-1

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Safety functions of controls

Typical safety functions of a laser processing machine
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)

- 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)

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Hazard identification and risk evaluation

Risk graph for the determination of the required performance level (PLr)
DIN EN ISO 13849-1
PLr F1 S1 F2 1 F1 S2 F2 P1 P2 P1 P2 P1 P2 P1 P2 a b c d e H L

Risk parameters
S Severity of potential injury S1 Slight (normally reversible injury) S2 Serious (normally irreversible injury or death) F Frequency and/or exposure time to hazard F1 Seldom to not very frequent and/or exposure time to hazard is short F2 Frequent to continuous and/or exposure time to hazard is long P Possibility of preventing the hazard or limiting the harm P1 Possible under certain conditions P2 Scarcely possible

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 minimization PLr Required performance level

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Architecture of HLG control

- HLG-Block diagram Control parts of the laser device Channel 1

B1

A1

G1
Line 1

Q1 K1 Q2 SV1

Channel 2

B2

A2

G2

B3

A3

G3
Line 2

further input-units (diverse functional principle)

K1

Feedback Switch-off test

B4

A4

G4

Terms:
B1/B2 A1/A2 G1/G2 K1 Q1/Q2 SV1 Sensor Amplifier Limit switch PLC Safety relay Safety shutter
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K1 signal check - plausibility - simultaneity

Control categories defined in EN 954-1

Cat. Summary of requirements 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 requirements of B shall be satisfied. Approved components and approved safety principles must be applied. System behavior 1) The occurrence of a fault can cause the loss of the safety function. Principle for achieving safety Predominantly characterized by the selection of components.

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. 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 selection of components. Predominantly characterized by the structure.

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.

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Control categories defined in EN 954-1

Cat. Summary of requirements 3 The requirements of B and the use of approved safety principles shall be ensured. Safetyrelated 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. System behavior 1) Principle for achieving safety If a single fault occurs, Predominantly the safety function is characterized always maintained. by the structure. Some but not all faults are detected. An accumulation of undetected faults can lead to 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.

The requirements of B and the use of proven safety principles shall be ensured. Safetyrelated 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.

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Personal protective eyewear

Laser protection glasses

DIN EN 207

Laser adjustment glasses

DIN EN 208

Protection level L1 - L10

Protection level R1 - R5
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Laser-eye protection / Testing

European Directive 89/686/EEC; (93/95/EEC); (96/58/EC) on the 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 risk Laser protection glasses are assigned to cat.II Have to be marked with CE-mark 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) 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, provisions and technical standards with regard to safety of laser products and safety of laser processing machines are very complex. The systematic approach of the European legislation to structure all directives and harmonized standards helps to compile relevant requirements and information. The appreciation of European standards to international standards also improves the situation. Manufacturers of ready-to-use laser processing machines must comply with a number of standards on machine safety also relevant for laser safety (to 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 permissible exposure (MPE) - Standards on functional safety, safety controls and 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 development and changes Existing standards dealing with laser safety provide substantial information on how to design a safe laser product or laser processing machine. Standards must cope with new developments and applications - 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 requirements should be defined and test methods should be developed.

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Thank you very much for your attention

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