INTERNATIONAL REGULATIONS FOR SAFETY OF
LASER PRODUCTS AND OF LASER PROCESSING MACHINES
AN OVERVIEW
-Associazione Industriali
Vicenza, 18.03.10
Dipl.-Ing. Thomas Püster
International Regulations for
Safety of Laser Products and for
Safety of Laser Processing Machines
An Overview
Introduction
EU-Legislation
- Articles - DirectivesInternational 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
International Regulations
on Safety of Laser Safety
The Jungle of Regulations
Article 95 EN 12100 98/37/EC Article 137 New Approach ISO IEC Type A-, B-, C-Standards UNI CENELEC CEN Harmonized Standards 2006/42/EC 89/391/EEC IEC 60825-1 ISO 11553-1 ISO 13949-1 EN 954-1 EN 207 Safety of Machinery IEC 60825-4 safe laser processing machine • Article 95 • Article 137 • 2006/42/EC • ISO 12100 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
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 95
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 137
Safety 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 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)
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)
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 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 ArbSchLärmVibrationsV 03/2007 Individual Directives Individual Directives National Provisions Physical Agents (PhysV)
International Standardization Bodies
European Level
National Level (Italy)
International Level
Hierarchy of the European Standards
System
Basic safety standards
Safety group standards
(generic standards)
Subject or product
safety standards
Type
A Standards
Design principles and basic concepts for machinesTyp C Standards
Specific safety requirements for special machines or machine typesType
B Standards
B1 StandardsGeneral safety aspects
B2 Standards Reference to special
Standards related to Laser Safety
(Examples of Type A, B und C-Standards)
EC-Directive Machinery 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 concepts, general principles for design“
Type B-Standards (Generic standards)
Type B1 Safety aspects
ISO 13857 “Safety of machinery - Safety distances to prevent hazard zones being reached by upper and lower limbs“
ISO 138491 „Safety of machinery Safetyrelated 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”
Detailed safety requirements for a particular machine or type of machines ISO 11553-2 „Safety of machinery - Laser processing machines - Part 2:
Structuring of ISO/TC 172
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 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/TC 76
Cooperation of ISO and IEC
with regard to laser safety
ISO
TC 172
SC 9
WG 3
“Safety”
IEC
TC 76
WG 10
“Safety”
JWG
Joint
Working
Group
Steps on the way to elaborate an
International Standard
Voting Yes/No Proposal of a Standard National Working Group NWIP (New Work ItemProposal) WD (Working Draft) Consensus between Experts of WG CD (Committee Draft) Consensus within TC/SC Comments TC/SC Voting Yes/No Proposal of a Standard National Working Group NWIP (New Work Item
Proposal) WD (Working Draft) Consensus between Experts of WG CD (Committee Draft) Consensus within TC/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 Voting Yes/No Objections / Comments DIS (Draft International Standard) Consensus FDIS (Final Draft International Standard) Final Text of International Standard Publication of International Standard Formal Voting Yes/No
Development of an International Standard
Stages
Machinery Directive
2006/42/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 I
Essential health and safety requirements relating to the design and construction of machinery
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 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 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
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 designer
Protective measures taken by the user
- Organization
- Provision of additional safeguards - Personal protective equipment
- complete shielding - contact control - safety PLC
Risk Assessment
DIN EN 1050
Safety of machinery – Principles of hazard analysisMethod 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
DIN EN ISO 14121-1:2007 Safety of machinery - Risk assessment - Part 1: Principles
A c c o rd in g t o D IN E N I S O 1 2 1 0 0 -1 Determination of machine limits Hazard identification yes no End Is the machine safe ? Risk analysis Risk reduction
Iterative process to achieve safety Start
Risk evaluation Risk estimation
Risk assessment
Standards directly related to laser safety
Examples
-Responsibility of IEC
IEC 60825 Safety of laser products
P1 Equipment classification and requirements
P2 Safety of optical fibre
communication 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 ISO
ISO 11553 Safety of machinery
Laser processing machines P1 General safety requirements P2 Safety requirements for
hand-held laser processing
devices
National responsibilities
DIN 56912 Showlaser and Show-laser equipment
Safety requirements and control
Responsibility of CEN
ISO 12254 Screens for laser working places
Safety requirements and testing
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 beam widths divergence angles and beam propagation ratios
P1 Stigmatic and simple astigmatic beams
P2 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,
Overview about the series of standards
IEC 60825
Part No.
Type Title and scope Designer of the Product Manufacturer of the Product User of the Product Manufacturer of safety-related 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
Manufacturer's checklist for IEC 60825-1 (good for safety report)
yes yes no yes no no
6 Technical Specification 7 Technical Report 8 Technical Report
Guidelines for the safe use of laser beams on humans
no no yes no no no
9 Technical Report
Compilation of maximum permissible exposure to incoherent optical radiation
no no yes no yes yes
10 Technical Report
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 Technical Report
New regulations with regard to
artificial optical radiation
19. Single Directive 2006/25/EG on the minimum health and safety requirements regarding the exposure of 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 Regulations ELIA (BG) BGV B9 BGI 5006 IEC 62471 BGV B2 + DA 2007 IEC 60825-1
Labeling of the area W 09 W 10
Exposure limits (Time base)
180nm – 400nm
Single-day exposition (8h = 30.000s)
Annual exposition (value)
380nm – 1mm
Single-day exposition (value)
Single-day exposition Exceptions: λ= vis: 0,25s No MPE alteration λ ≥ 400nm: >100s λ ≥1050nm: >10s pulsed LED analog to BGV B2 LED
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
Laser guards EN 60825-4: 2009 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 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
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 the laser protective guard
to prevent exceeding of AEL class 1 at the rear surface
Laser protective guard
Process area Laser
Laser processing machine
Outside the laser protective guard Laser Class 1 (AEL)
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
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 required (accessible radiation should not exceed MPE)
Unauthorized access to danger zones shall be prevented by engineering measures.
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
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
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
Restricted
Controlled
Description of Locations
Reference: ISO 11553-1
Embedded laser products
laser processing machines
-Safety position switch with guard locking (magnetic lock) Interlock Interlock Fiber connector Safe fiber - temperature - breakage Laser guards/ walls Control panel Safety shutter Safety PLC Restricted area Controlled area Operating mode Safety door Emission warning light Power supply Power supply stop 1 2
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 according DIN EN 60825-1 laser class 1Administrative measures
Safety must be achieved by following measures*:Technical measures
The laser installation/unit must be inherently safe with regard to technic and design
Type of safety measures for enclosed laser units
*Laser units with restricted access
Safety must be achieved by following measures*:
Areas of applications of different standards
related to functional safety
Construction and risk assessment
EN ISO 12100
Functional and safety requirements on a safety-related control system
Electrical safety aspects
IEC/EN 60204
Design and implementation of safety-relevant electrical control system
EN ISO 13849
SRP/CS as E/E/PES Hydraulics Pneumatics MechanicsIEC/EN 62061
SRP/CS as E/E/PES SRECSMachinery
IEC/EN 61508
SRP/CS as E/E/PESIEC/EN 61511
Process
industry
Controls and their safety functions
Sensor
Sensor
Actuator
Actuator
acquisition of information - command - detect processing of information - control - evaluate performing of action - actuate - switch off
Safety function
? B, 1, 2, 3, 4EN 954-1 Safetyrelated parts of control systems -EN ISO 13849-1 Part 1: General principles for design
EN ISO 13849-2 Safetyrelated parts of control systems -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 the loss of the safety function
Laser Class 1:
Design of safety related devices - fail-safe - single-fault condition
Programmable
Logic Control
Programmable
Logic Control
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 requirements for each safety function
Determine the required Performance 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 PL for the above mentioned SRP/CS with regard to:
• category • MTTFd • DC • CCF • if applicable: Software Procedure of risk reduction ISO 12100-1 Protective measure depends on a control Start Verification of PL For 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 reduction ISO 12100-1 Steps
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 machine
Safety related parts of controls (SRP/CS)
requirements on SRP/CS as result of risk evaluation
Hazard identification and risk evaluation
Risk graph for the determination of the required
performance level (PL
r)
1 S1 S2 F1 F2 F1 F2 P1 P2 P1 P2 P1 P2 P1 P2 a b c d e L HDIN EN ISO 13849-1
Legend1 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
PLr 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
SV1
Control parts of the laser device
Architecture of HLG control
HLGBlock diagram
-Terms: B1/B2 Sensor A1/A2 Amplifier G1/G2 Limit switch K1 PLC Q1/Q2 Safety relay SV1 Safety shutter K1 A1 B1 A2 B2 G1 G2 A3 B3 A4 B4 G3 G4 K1 Feedback Switch-off test further input-units(diverse functional principle) Channel 1 Channel 2 Line 1 Line 2 Q1 Q2 Control parts of the laser device
K1 signal check - plausibility - simultaneity
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.
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.
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.
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 proven safety 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.
Personal protective eyewear
Laser protection
glasses
DIN EN 207
Protection level
L1 - L10
Laser adjustment
glasses
DIN EN 208
Protection level
R1 - R5
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) 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
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.
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.