INTERNATIONAL REGULATIONS FOR SAFETY OF LASER PRODUCTS AND OF LASER PROCESSING MACHINES - AN OVERVIEW -

Paper: # 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 -

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

The Jungle of Regulations International Regulations on Safety of Laser Safety Article 95 IEC EN 207 Type A-, B-, C- Standards 89/391/EEC EN 12100 98/37/EC CENELEC IEC 60825-1 ISO 13949-1 ISO 11553-1 EN 954-1 Safety of Machinery Harmonized Standards New Approach ISO Article 137 CEN 2006/42/EC IEC 60825-4 UNI Article 95 Article 137 2006/42/EC ISO 12100 safe laser processing machine Systematic Structure

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. SOCIAL PROVISIONS Article 137 Improvement in particular of the working environment to protect workers' health and safety Framework Directives Generic Directives - sector specific Individual Directives - concerned with specific aspects of health and safety

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)

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)

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: Artikel 137 Measures to encourage improvements in the safety and health of workers Directive on Physical Agents 1992 proposed / 1993 proposal withdrawn Directive on Chemical Agents 98/24/EC Directive on Biological Agents 2005/54/EC Noise Directive 2003/10/EC Vibration Directive 2002/44/EC EMF Directive 2004/40/EC Optical Radiation Directive 2006/25/EC Individual Directives Individual Directives ArbSchLärmVibrationsV 03/2007 National Provisions Physical Agents (PhysV)

International Standardization Bodies International Level European Level National Level (Italy)

Hierarchy of the European Standards System Basic safety standards Safety group standards (generic standards) Type A Standards Design principles and basic concepts for machines 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

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

Structuring of ISO/TC 172 Structuring of ISO/TC 172

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 IEC - List of technical committees and subcommittees Total number of TC/SCs 174 IEC Technical Committees 94 IEC Subcommittees 80 JWG 10 IEC/ISO Safety of lasers and laser equipment in an Industrial materials processing environment

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

Steps on the way to elaborate an International Standard Proposal of a Standard National Working Group TC/SC NWIP (New Work Item Proposal) WD (Working Draft) Consensus between Experts of WG Voting Yes/No DIS (Draft International Standard) Consensus FDIS (Final Draft International Standard) Objections / Comments Formal Voting Yes/No CD (Committee Draft) Comments Final Text of International Standard Consensus within TC/SC Publication of International Standard

Development of an International Standard - Stages - Reference: DIN

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.

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 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.

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 - complete shielding - contact control - safety PLC Protective measures taken by the user - Organization - Provision of additional safeguards - Personal protective equipment

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 Is the machine safe? no yes Risk analysis End Risk assessment Method of hazard analysis and Risk assessment : (examples) - What-if-method - Fault tree analysis - FMEA* - MOSAR* Risk reduction * Failure mode and effects analysis Method organized for systematic analysis of risks

Standards directly related to laser safety - Examples - Responsibility of IEC Responsibility of ISO IEC 60825 P1 P2 P4 P... IEC 60601-2-22 Safety of laser products Equipment classification and requirements Safety of optical fibre communication systems (OFCS) Laser guards Medical electrical equipment Requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and laser equipment ISO 11553 processing P1 P2 Safety of machinery Laser processing machines General safety requirements Safety requirements for hand-held laser devices Responsibility of CEN ISO 12254 National responsibilities DIN 56912 Screens for laser working places Safety requirements and testing Showlaser and Showlaser equipment Safety requirements and control

Standards indirectly related to laser safety - Examples - EN 61040 EN ISO 11146 P1 P2 EN ISO 13694 EN ISO 11145 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

Part No. Overview about the series of standards IEC 60825 Type Title and scope Designer of the Product Manufacturer of the Product User of the Product Manufacturer of safetyrelated parts Test method Hazard analysis 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 Technical Report Guidance for laser displays and shows no no yes no no yes 4 Standard Laser guards yes yes yes yes yes yes 5 Technical Report 6 Technical Specification 7 Technical Report 8 Technical Report 9 Technical Report 10 Technical Report Manufacturer's checklist for IEC 60825-1 (good for safety 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 yes yes no yes no no no no yes no no no no no yes no yes yes 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 Technical Report A user's guide no yes yes no no yes

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 Exposure limits (Time base) Non-coherent radiation (each artificial optical radiation except for laser radiation) 180nm 400nm Single-day exposition (8h = 30.000s) Annual exposition (value) 380nm 1mm Single-day exposition (value) LED pulsed LED analog to BGV B2 Coherent radiation (Laser radiation) Single-day exposition Exceptions: λ = vis: 0,25s No MPE alteration λ 400nm: >100s λ 1050nm: >10s Labeling of the area W 09 W 10 International Standards National Regulations ELIA (BG) IEC 62471 BGV B9 BGI 5006 IEC 60825-1 BGV B2 + DA 2007

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 User s 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.

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: d 63 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

Guarding around a laser processing machine Laser Foreseeable exposure limit (FEL) Maximum reasonably foreseeable exposure at the front surface of the laser protective guard 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 Laser processing machine Outside the laser protective guard Laser Class 1 (AEL) according to IEC 60825-4

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

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

Control of access Description of Locations Location Controlled Restricted Unrestricted and uncontrolled People Authorized and trained in laser safety Personnel untrained in laser safety but not the public All, including the public Reference: ISO 11553-1 Corresponding measures for control of access must be provided

Embedded laser products - laser processing machines - Emission warning light Interlock Fiber connector Safe fiber - temperature - breakage Safety shutter Laser guards/ walls Controlled area Safety position switch with guard locking (magnetic lock) Safety door Power supply Power supply Interlock Restricted area stop Operating mode 2 Safety 1 PLC Control panel

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*: Technical measures Administrative measures *Laser units with restricted access 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

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 EN ISO 13849 SRP/CS as E/E/PES Hydraulics Pneumatics Mechanics IEC/EN 62061 SRP/CS as E/E/PES SRECS IEC/EN 61511 Electrical safety aspects IEC/EN 60204 IEC/EN 61508 SRP/CS as E/E/PES

Standards Controls and their safety functions 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 systems - Part 2: Validation Sensor acquisition of information - command - detect Programmable Logic Logic Control processing of information - control - evaluate Actuator performing of action - actuate - switch off Control Categories? B, 1, 2, 3, 4 Laser Class 1: Design of safety related devices - fail-safe - single-fault condition Safety function 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 the loss of the safety function

Iterative procedure for the design of safety related parts of controls (SRP/CS) Steps Start Identify the required safety functions, performed by SRP/CS Procedure of risk reduction ISO 12100-1 Protective measure depends on a control Define the safety function requirements for each safety function Determine the required Performance Level PL r Design and technical realization of the safety functions: Identification of safety related parts, performing the safety function Determine and evaluate the Performance Level PL for the above mentioned SRP/CS with regard to: category MTTF d DC CCF if applicable: Software Verification of PL For a certain safety function: PL PL r yes Validation: Have all demands been achieved? yes Have all safety functions been analyzed? yes End no no no Procedure of risk reduction ISO 12100-1

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)

Hazard identification and risk evaluation Risk graph for the determination of the required performance level (PL r ) DIN EN ISO 13849-1 1 Legend S1 S2 F1 F2 F1 F2 P1 P2 P1 P2 P1 P2 P1 P2 PL r 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 PL r Required performance level a b c d e L H 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

Architecture of HLG control - HLG-Block diagram - Control parts of the laser device Channel 1 B1 A1 G1 Q1 Line 1 K1 SV1 Channel 2 B2 A2 G2 Q2 B3 B4 A3 further input-units (diverse functional principle) A4 G3 Line 2 G4 K1 signal check - plausibility - simultaneity K1 Feedback Switch-off test Terms: B1/B2 Sensor A1/A2 Amplifier G1/G2 Limit switch K1 PLC Q1/Q2 Safety relay SV1 Safety shutter

Control categories defined in EN 954-1 Cat. Summary of requirements System behavior 1) Principle for achieving 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. 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, 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.

Control categories defined in EN 954-1 Cat. Summary of requirements System behavior 1) Principle for achieving safety 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. 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 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. 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.

Personal protective eyewear Laser protection glasses DIN EN 207 Laser adjustment glasses DIN EN 208 Protection level L1 - L10 Protection level R1 - R5

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

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.

Thank you very much for your attention