kSIST FprEN ISO 11553-2:2026
(Main)Safety of machinery - Laser processing machines - Part 2: Safety requirements for hand-held or hand-operated laser processing machines (ISO/FDIS 11553-2:2026)
- Abstract
This document deals with all significant hazards, hazardous situations or hazardous events relevant to hand-held or hand-operated laser processing machines (HLMs), when they are used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer. HLM is the machine, as defined in ISO 11553-1:2020, 3.7, in which laser radiation is generated, where the laser provides sufficient energy/power to cause a phase transition in a part of the workpiece and where the laser output or workpiece to be processed is guided manually or hand-held during the laser material processing.
This document defines general design requirements of HLM. HLM includes the laser device, beam-guiding device (e.g. mirror, fibre, lenses), beam-shaping device (e.g. telescope, focusing), and controls. The laser assembly as an integral part of the HLM or only the laser processing head is hand-held or hand-operated during the laser material processing.
This document does not apply
to laser processing machines which are remotely controlled by a manual controller (hand-operated controller), such as joy sticks, keyboard, etc., without touching a workpiece or a part mechanically connected with the laser material processing head by using the hand(s) of the operator (user)
to laser processing machines without a drive system which may not belong to machinery. And the laser processing apparatus without moving parts, which may not be considered as machinery in “Type C standard”.
to medical or cosmetic applications for the treatment of living human or animal tissue;
to weapon applications, (e.g. such as with regard to military applications, direct close combat.)
NOTE “hand-operated laser processing machine” is synonymous with “hand-guided laser processing machine” in this document. Hand-operated laser processing machines often use manual force reduction means such as wheels, supports, etc., for manual positioning of the laser processing heads or the workpieces.
It is applicable to HLMs using laser radiation to process materials.
The purpose of this document is to draw attention to the hazards related to HLMs and to prevent personal injury. Depending on the application and the location/operating conditions of HLMs, a number of different significant hazards can arise. This document describes both the areas of hazards analysis and risk assessment as well as protective measures.
Requirements dealing with noise as a hazard are covered by ISO 11553-3:2013.
This document does not apply to laser products or equipment manufactured solely or expressly for applications which are excluded from the Scope of ISO 11553-1:2020. This document is not applicable for HLMs which have been manufactured before the date of publication of this standard.
HLMs include the following types:
HLMs which are designed as all-in-one laser assembly including the beam delivery/forming(shaping) system and optional features such as gas nozzles, material (e.g. powder, wire) feed system;
HLMs where the relevant devices are connected by a beam guidance system (e.g. optical fibre) and power/control cables to an external laser assembly device and which includes only the beam delivery/forming(shaping) system and optional features such as gas nozzles, material (e.g. powder, wire) feed system;
laser processing machines where the workpiece is manually moved under/relative to the laser beam (see informative Annex A).
The intended use of HLMs covers both:
movement of elements or workpieces by hand to be processed under/relatively to stationary laser beams as shielded , and
movement of the laser processing head (beam shaping device) by hand to move laser beam(s) over or relative to elements or workpieces to be processed.
Laser processing machines, where la
- Status
- Not Published
- Public Enquiry End Date
- 30-Mar-2025
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 5020 - Formal vote (FV) (Adopted Project)
- Start Date
- 11-Jun-2026
- Due Date
- 30-Jul-2026
- Completion Date
- 08-Jul-2026
kSIST FprEN ISO 11553-2:2026 is a European standard published by CEN that specifies safety requirements for hand-held or hand-operated laser processing machines (HLMs). It covers hazard identification, risk reduction, verification, user information and labelling for industrial laser processing equipment used by manufacturers, integrators and trained operators.
What does kSIST FprEN ISO 11553-2:2026 specify?
kSIST FprEN ISO 11553-2:2026 specifies general design and safety requirements for HLMs and their components and assemblies. It focuses on laser radiation hazards, but it also addresses mechanical, electrical, thermal, ergonomic, control-system, warning and environmental hazards that arise during intended use and reasonably foreseeable misuse.
The scope includes machines in which laser radiation is generated and the laser output or the workpiece is guided manually or hand-held during laser processing. The document notes that “hand-operated laser processing machine” is synonymous with “hand-guided laser processing machine”, and it is aimed at industrial use by trained and authorized personnel indoors and outdoors.
The scope excludes remotely controlled machines that are not hand-held or hand-operated at the workpiece, medical or cosmetic applications on living tissue, weapon applications, and equipment outside the scope of ISO/IEC 11553-1:2020. Noise as a hazard is handled by ISO/IEC 11553-3:2013.
The document is organized into the following main parts:
- Clause 1 Scope
- Clause 2 Normative references
- Clause 3 Terms and definitions
- Clause 4 Risk assessment
- Clause 5 Safety requirements and risk reduction measures
- Clause 6 Verification of safety requirements and measures
- Clause 7 Information for user
- Clause 8 Labelling
| Annex | What it covers |
|---|---|
| Annex A | Representative types of HLMs and example machine layouts |
| Annex B | List of significant hazards for HLMs |
| Annex C | Possible hazards related to HLMs, including special environments |
| Annex D | Examples of technical safety measures for HLMs |
| Annex E | Recommendations for selecting PPE for HLMs |
| Annex F | Design recommendations for laser fume extraction systems on process nozzles |
| Annex G | Parameter information the manufacturer should provide to the user, with worked examples |
| Annex ZA | Relationship with Directive 2006/42/EC |
What are the key requirements of kSIST FprEN ISO 11553-2:2026?
kSIST FprEN ISO 11553-2:2026 is built around risk assessment, then layered risk reduction by design, safeguarding and user information. In practice, a manufacturer has to show that hazards were identified, reduced where possible in the machine itself, and then covered by instructions, training and PPE where residual risk remains.
Risk assessment and machine limits
Clause 4 requires an ISO 12100-style risk assessment: define the machine limits, identify hazards, estimate the risks and evaluate whether further reduction is needed. That matters because the standard expects the analysis to cover the whole life of the HLM, including assembly, installation, commissioning, use, maintenance, decommissioning and disposal.
The risk assessment must also consider substantial modifications and reasonably foreseeable misuse. For a designer or buyer, that means the safety concept has to remain valid not only for normal production, but also for foreseeable faults, maintenance tasks and alternative operating conditions.
Mechanical, electrical and environmental safety
Clause 5.2 requires the machine and its parts to have adequate mechanical strength for normal use, foreseeable faults and misuse. It also requires guarding of moving or rotating parts such as wire feeders, with fixed or movable guards designed in line with ISO 14120, ISO 13857 and ISO 14119 where interlocking is needed.
Clause 5.3 addresses electrical safety. kSIST FprEN ISO 11553-2:2026 points to IEC 60204-1 for machine electrical equipment, and it sets minimum ingress protection levels for indoor and outdoor use. For outdoor work it also calls for an RCD in accordance with IEC 60364, with construction-site installations following IEC 60364-7-704.
Clause 5.12 covers the operating environment, including lightning, moisture, pollution, snow, rain, water, wind and extreme temperatures. In practice, this means the manufacturer must check whether the HLM can really be used where it is intended, especially for outdoor cleaning or site work.
Laser radiation, thermal effects and secondary radiation
Clause 5.6 is the core laser-safety section. kSIST FprEN ISO 11553-2:2026 requires laser classification in accordance with IEC 60825-1 and design measures to prevent hazardous laser emission from the HLM, the beam delivery system, the fibre cable, connectors, misalignment and unintended start-up. Where a hand-held laser processing head (HLH) is used, the housing, beam path control and contact or distance control to the workpiece are part of the safety strategy.
The standard also addresses scanning laser radiation, movable interlocking guards and protective enclosures. In practice, this means the laser beam must be isolated or disabled quickly when a fault, loss of contact or unsafe movement occurs.
Clauses 5.4 and 5.5 deal with thermal hazards and incoherent radiation. The standard gives priority to technical measures integrated into the HLH; if that is not possible, the manufacturer has to specify administrative controls and suitable PPE such as heat-protective or UV-protective gloves, clothing and eyewear. That matters because laser processing can produce hot surfaces, molten splatter, bright visible radiation, UV, visible and NIR secondary radiation.
Control systems, third persons and warnings
Clause 5.9 requires safety-related control devices to be designed and validated as safety-related parts of control systems (SRP/CS), with reference to ISO 13849-1 and IEC 62061. It also covers common control devices, EMC, emergency stop, initial start-up procedures, beam isolation and temporary protective measures. For the user, this is the part that determines how reliably the machine stops, isolates or restrains the beam when something goes wrong.
Clause 5.10 adds requirements for hazards to and from third persons, including authorization control and training. Clause 5.11 requires visible laser-ready indication and optical and/or acoustic indication of laser emissions above Class 2 AEL, with the indicators visible even when the operator wears eye protection.
Verification, user information and labelling
Clause 6 requires the manufacturer to verify and validate the design, structure and function of the ready-to-use HLM. Table 1 links safety measures to verification methods such as visual inspection, functional testing, measurements, observation during operation and review of safety-related hardware and software documentation. Clause 6 also ties laser classification, control-system validation and recurring tests to the relevant standards.
Clauses 7 and 8 require clear user information and labelling. The user information has to cover safe use, residual risks, conversions between applications, workplace measures, training, authorization, PPE and emergency actions. Labels must identify the manufacturer, manufacturing date, type or series and relevant warnings, using the visual rules of ISO 3864 and IEC 60825-1.
What terms does kSIST FprEN ISO 11553-2:2026 define?
- Hand-held or hand-operated laser processing machine (HLM) - The machine where laser radiation is generated and the laser beam or workpiece is guided manually during processing.
- Hand-held or hand-guided laser head (HLH) - The component that is held or guided by hand and contains the laser output or aperture.
- Laser hazard area - The area where eye or skin exposure can exceed the applicable maximum permissible exposure (MPE), including accidental misdirection.
- Nominal ocular hazard distance (NOHD) - The distance from the output aperture beyond which eye exposure stays below the corneal MPE.
- Nominal ocular hazard area (NOHA) - The area within which eye exposure can exceed the corneal MPE.
- Nominal hazard zone (NHZ) - The space in which direct, reflected or scattered radiation may exceed the applicable MPE.
- Supply unit - The devices that provide the process energies and operating material supply needed for the HLM, such as cooling, power and gas supply.
Who uses kSIST FprEN ISO 11553-2:2026?
kSIST FprEN ISO 11553-2:2026 is used by machine manufacturers, system integrators, safety engineers, and quality managers who design or assess hand-held laser processing equipment. Buyers and technical specifiers use it to check whether a supplier has covered the main laser, electrical, guarding, control and PPE-related risks.
It is relevant for industrial laser processing applications such as welding, cutting, cleaning and material processing, including work outdoors and special locations such as facades or monuments. It is also useful for training, maintenance planning, service work and acceptance checks for ready-to-use HLMs.
What changed in kSIST FprEN ISO 11553-2:2026 from the previous edition?
kSIST FprEN ISO 11553-2:2026 replaces SIST EN ISO 11553-2:2009.
Which standards are used with kSIST FprEN ISO 11553-2:2026?
| Standard | What it contributes |
|---|---|
| ISO 3864 | Safety sign and marking design principles |
| ISO 6385:2016 | Ergonomics principles for work systems |
| ISO 11145:2018 | Laser vocabulary and symbols |
| ISO/IEC 11553-1:2020 | General safety requirements for laser processing machines |
| ISO/IEC 11553-3:2013 | Noise reduction and noise measurement methods |
| ISO 12100:2010 | Risk assessment and risk reduction principles |
| ISO 13732-1:2006 | Assessment of contact with hot surfaces |
| ISO 13849-1:2023 | Safety-related parts of control systems |
| ISO 13850:2015 | Emergency stop design principles |
| ISO 13857:2019 | Safety distances to prevent reaching hazard zones |
| ISO 14118:2017 | Prevention of unexpected start-up |
| ISO 14119:2024 | Interlocking devices associated with guards |
| ISO 14120:2015 | Fixed and movable guards |
| ISO 20607:2019 | Instruction handbook drafting principles |
| ISO 26800:2011 | General ergonomics principles |
| IEC 60204-1:2016 | Electrical equipment of machines |
| IEC 60364 (series) | Low-voltage electrical installations |
| IEC 60364-7-704:2017 | Special requirements for construction and demolition site installations |
| IEC 60529:1989+AMD1:1999, CSV | IP Code degrees of protection |
| IEC 60825-1:2014 | Laser product classification and requirements |
| IEC 60825-4:2020 | Laser guards |
| IEC 61000-6-2:2016 | EMC immunity for industrial environments |
| IEC 61000-6-3:2020 | EMC emission for residential environments |
| IEC 61000-6-4:2018 | EMC emission for industrial environments |
| IEC 61000-6-7:2014 | EMC immunity for safety-related functional safety equipment |
| IEC 62061:2021 | Functional safety of safety-related control systems |
| EN 379:2003+A1:2009 | Automatic welding filters |
What does the kSIST FprEN ISO 11553-2:2026 document contain?
kSIST FprEN ISO 11553-2:2026 contains the full hazard-and-controls structure for HLMs, starting with the machine definitions and moving into risk assessment, protective measures, verification, user instructions and labelling. Annex B gives the main hazard list, while Annex C extends that thinking to confined spaces, working at heights, offshore use and other special conditions.
The annexes are practical rather than decorative. Annex D shows example technical safety measures, Annex E supports PPE selection, Annex F gives guidance for fume extraction at the process nozzle, and Annex G lists the laser parameters the manufacturer should pass to the user, with worked examples for hazard-distance calculations.
Table 1 in Clause 6 is especially useful for audits and design verification because it ties each safety topic to suitable validation methods and related standards. Annex ZA maps the European standard to the essential requirements of Directive 2006/42/EC.
Relations
- Effective Date
- 23-Feb-2022
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Frequently Asked Questions
kSIST FprEN ISO 11553-2:2026 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Safety of machinery - Laser processing machines - Part 2: Safety requirements for hand-held or hand-operated laser processing machines (ISO/FDIS 11553-2:2026)". This standard covers: This document deals with all significant hazards, hazardous situations or hazardous events relevant to hand-held or hand-operated laser processing machines (HLMs), when they are used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer. HLM is the machine, as defined in ISO 11553-1:2020, 3.7, in which laser radiation is generated, where the laser provides sufficient energy/power to cause a phase transition in a part of the workpiece and where the laser output or workpiece to be processed is guided manually or hand-held during the laser material processing. This document defines general design requirements of HLM. HLM includes the laser device, beam-guiding device (e.g. mirror, fibre, lenses), beam-shaping device (e.g. telescope, focusing), and controls. The laser assembly as an integral part of the HLM or only the laser processing head is hand-held or hand-operated during the laser material processing. This document does not apply to laser processing machines which are remotely controlled by a manual controller (hand-operated controller), such as joy sticks, keyboard, etc., without touching a workpiece or a part mechanically connected with the laser material processing head by using the hand(s) of the operator (user) to laser processing machines without a drive system which may not belong to machinery. And the laser processing apparatus without moving parts, which may not be considered as machinery in “Type C standard”. to medical or cosmetic applications for the treatment of living human or animal tissue; to weapon applications, (e.g. such as with regard to military applications, direct close combat.) NOTE “hand-operated laser processing machine” is synonymous with “hand-guided laser processing machine” in this document. Hand-operated laser processing machines often use manual force reduction means such as wheels, supports, etc., for manual positioning of the laser processing heads or the workpieces. It is applicable to HLMs using laser radiation to process materials. The purpose of this document is to draw attention to the hazards related to HLMs and to prevent personal injury. Depending on the application and the location/operating conditions of HLMs, a number of different significant hazards can arise. This document describes both the areas of hazards analysis and risk assessment as well as protective measures. Requirements dealing with noise as a hazard are covered by ISO 11553-3:2013. This document does not apply to laser products or equipment manufactured solely or expressly for applications which are excluded from the Scope of ISO 11553-1:2020. This document is not applicable for HLMs which have been manufactured before the date of publication of this standard. HLMs include the following types: HLMs which are designed as all-in-one laser assembly including the beam delivery/forming(shaping) system and optional features such as gas nozzles, material (e.g. powder, wire) feed system; HLMs where the relevant devices are connected by a beam guidance system (e.g. optical fibre) and power/control cables to an external laser assembly device and which includes only the beam delivery/forming(shaping) system and optional features such as gas nozzles, material (e.g. powder, wire) feed system; laser processing machines where the workpiece is manually moved under/relative to the laser beam (see informative Annex A). The intended use of HLMs covers both: movement of elements or workpieces by hand to be processed under/relatively to stationary laser beams as shielded , and movement of the laser processing head (beam shaping device) by hand to move laser beam(s) over or relative to elements or workpieces to be processed. Laser processing machines, where la
This document deals with all significant hazards, hazardous situations or hazardous events relevant to hand-held or hand-operated laser processing machines (HLMs), when they are used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer. HLM is the machine, as defined in ISO 11553-1:2020, 3.7, in which laser radiation is generated, where the laser provides sufficient energy/power to cause a phase transition in a part of the workpiece and where the laser output or workpiece to be processed is guided manually or hand-held during the laser material processing. This document defines general design requirements of HLM. HLM includes the laser device, beam-guiding device (e.g. mirror, fibre, lenses), beam-shaping device (e.g. telescope, focusing), and controls. The laser assembly as an integral part of the HLM or only the laser processing head is hand-held or hand-operated during the laser material processing. This document does not apply to laser processing machines which are remotely controlled by a manual controller (hand-operated controller), such as joy sticks, keyboard, etc., without touching a workpiece or a part mechanically connected with the laser material processing head by using the hand(s) of the operator (user) to laser processing machines without a drive system which may not belong to machinery. And the laser processing apparatus without moving parts, which may not be considered as machinery in “Type C standard”. to medical or cosmetic applications for the treatment of living human or animal tissue; to weapon applications, (e.g. such as with regard to military applications, direct close combat.) NOTE “hand-operated laser processing machine” is synonymous with “hand-guided laser processing machine” in this document. Hand-operated laser processing machines often use manual force reduction means such as wheels, supports, etc., for manual positioning of the laser processing heads or the workpieces. It is applicable to HLMs using laser radiation to process materials. The purpose of this document is to draw attention to the hazards related to HLMs and to prevent personal injury. Depending on the application and the location/operating conditions of HLMs, a number of different significant hazards can arise. This document describes both the areas of hazards analysis and risk assessment as well as protective measures. Requirements dealing with noise as a hazard are covered by ISO 11553-3:2013. This document does not apply to laser products or equipment manufactured solely or expressly for applications which are excluded from the Scope of ISO 11553-1:2020. This document is not applicable for HLMs which have been manufactured before the date of publication of this standard. HLMs include the following types: HLMs which are designed as all-in-one laser assembly including the beam delivery/forming(shaping) system and optional features such as gas nozzles, material (e.g. powder, wire) feed system; HLMs where the relevant devices are connected by a beam guidance system (e.g. optical fibre) and power/control cables to an external laser assembly device and which includes only the beam delivery/forming(shaping) system and optional features such as gas nozzles, material (e.g. powder, wire) feed system; laser processing machines where the workpiece is manually moved under/relative to the laser beam (see informative Annex A). The intended use of HLMs covers both: movement of elements or workpieces by hand to be processed under/relatively to stationary laser beams as shielded , and movement of the laser processing head (beam shaping device) by hand to move laser beam(s) over or relative to elements or workpieces to be processed. Laser processing machines, where la
kSIST FprEN ISO 11553-2:2026 is classified under the following ICS (International Classification for Standards) categories: 13.110 - Safety of machinery; 31.260 - Optoelectronics. Laser equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
kSIST FprEN ISO 11553-2:2026 has the following relationships with other standards: It is inter standard links to SIST EN ISO 11553-2:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
kSIST FprEN ISO 11553-2:2026 is associated with the following European legislation: EU Directives/Regulations: 2006/42/EC, 2023/1230; Standardization Mandates: M/396, M/605. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
kSIST FprEN ISO 11553-2:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 11553-2:2025
01-marec-2025
Nadomešča:
SIST EN ISO 11553-2:2009
Varnost strojev - Laserski obdelovalni stroji - 2. del: Varnostne zahteve za ročne
ali ročno upravljane laserske obdelovalne naprave (ISO/DIS 11553-2:2025)
Safety of machinery - Laser processing machines - Part 2: Safety requirements for hand-
held or hand-operated laser processing machines (ISO/DIS 11553-2:2025)
Sicherheit von Maschinen - Laserbearbeitungsmaschinen - Teil 2:
Sicherheitsanforderungen an handgeführte Laserbearbeitungsgeräte (ISO 11553-2:20xx)
Sécurité des machines - Machines à laser - Partie 2: Exigences de sécurité pour
machines de traitement laser portatives ou à commande manuelle (ISO/DIS 11553-
2:2025)
Ta slovenski standard je istoveten z: prEN ISO 11553-2
ICS:
13.110 Varnost strojev Safety of machinery
31.260 Optoelektronika, laserska Optoelectronics. Laser
oprema equipment
oSIST prEN ISO 11553-2:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 11553-2:2025
oSIST prEN ISO 11553-2:2025
DRAFT
International
Standard
ISO/DIS 11553-2
ISO/TC 172/SC 9
Safety of machinery — Laser
Secretariat: DIN
processing machines —
Voting begins on:
Part 2: 2025-01-14
Safety requirements for hand-held
Voting terminates on:
2025-04-08
or hand-operated laser processing
machines
Sécurité des machines — Machines à laser —
Partie 2: Exigences de sécurité pour machines de traitement laser
portatives ou à commande manuelle
ICS: 31.260; 13.110
THIS DOCUMENT IS A DRAFT CIRCULATED
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Member bodies are requested to consult relevant national interests in IEC/TC AND MAY NOT BE REFERRED TO AS AN
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ISO/DIS 11553-2:2025(en)
oSIST prEN ISO 11553-2:2025
DRAFT
ISO/DIS 11553-2:2025(en)
International
Standard
ISO/DIS 11553-2
ISO/TC 172/SC 9
Safety of machinery — Laser
Secretariat: DIN
processing machines —
Voting begins on:
Part 2:
Safety requirements for hand-held
Voting terminates on:
or hand-operated laser processing
machines
Sécurité des machines — Machines à laser —
Partie 2: Exigences de sécurité pour machines de traitement laser
portatives ou à commande manuelle
ICS: 31.260; 13.110
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
Member bodies are requested to consult relevant national interests in IEC/TC AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
76 before casting their ballot to the e-Balloting application.
PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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© ISO 2025
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Published in Switzerland Reference number
ISO/DIS 11553-2:2025(en)
ii
oSIST prEN ISO 11553-2:2025
ISO/DIS 11553-2:2025(en)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 3
4 Risk assessment . 7
4.1 General .7
4.1.1 Types of HLM and special hazards .8
4.1.2 Special hazards with regard to types of HLM .8
4.2 Determination of limits of HLM .9
4.3 Hazards identification .10
4.4 Risk estimation .10
4.5 Risk evaluation .10
4.6 Hazards (significant) .10
4.6.1 Mechanical Hazards .11
4.6.2 Electrical Hazards .11
4.6.3 Thermal Hazards .11
4.6.4 Hazards by incoherent radiation . 12
4.6.5 Hazards by laser radiation . 12
4.6.6 Hazards associated with materials and substances . 15
4.6.7 Hazards by disregarding ergonomic principles .17
4.6.8 Hazards due to malfunction of the control system .18
4.6.9 Hazards due to third parties (persons) . 20
4.6.10 Hazards caused by lack or inadequacy of visual or acoustic warning means . 22
4.6.11 Hazards associated with the environment . 23
5 Safety requirements and risk reduction measures .25
5.1 General . 25
5.2 Requirements related to Mechanical Hazards . 26
5.3 Requirements related to Electrical Hazards . 26
5.4 Requirements related to Thermal Hazards . 26
5.5 Requirements related to incoherent radiation .27
5.6 Requirements related to Hazards by laser radiation .27
5.6.1 General .27
5.6.2 Laser Classification . 29
5.6.3 Design to avoid hazardous laser emission out of HLM or components respectively . 29
5.6.4 Use of a movable and interlocking guard with or without guard locking . 29
5.6.5 Design to avoid laser emission for HLMs connected to an external laser assembly. 30
5.6.6 Design to avoid laser emission by beam delivery system. 30
5.6.7 Design to avoid laser emission by damage of fibre optical cable .31
5.6.8 Design to avoid laser emission by damage or malfunction of fibre connectors .31
5.6.9 Design to avoid laser hazards by misalignment of beam path .31
5.6.10 Design to avoid laser hazards by not properly working active beam guiding and
shaping elements .31
5.6.11 Design to avoid laser emission by not properly designed HLH housing .31
5.6.12 Design to avoid laser hazards by not properly working handing system (HLH)
, where elements of the HLH (e.g., optical elements, nozzles) can be changed to
enable different applications .32
5.6.13 Safety devices for scanning laser radiation (cleaning) .32
5.6.14 Design to avoid hazards by laser radiation caused by the handheld laser
processing head .32
5.6.15 Design to avoid hazards by laser radiation in cases where HLH elements can be
changed .32
iii
oSIST prEN ISO 11553-2:2025
ISO/DIS 11553-2:2025(en)
5.6.16 Control for the contact or the intended distance between HLH aperture (nozzle)
and workpiece .32
5.6.17 Design to avoid an unintended release/start-up of laser radiation (in cases
when the HLH is positioned on a grounded table or workpiece (welding) . 33
5.6.18 Protective enclosure (workplace) . 33
5.7 Requirements related to Hazards related to materials and substances . 33
5.7.1 Protection against hazards generated by materials and substances . 33
5.8 Requirements related to Ergonomic hazards . 34
5.8.1 Design according to ergonomic principles . 34
5.8.2 Design of machinery to facilitate its handling . 35
5.8.3 Ergonomics in design of portable hand-held and/or hand guided machinery . 35
5.9 Requirements related to malfunction of control system. 36
5.9.1 General . 36
5.9.2 Common control devices used in HLMs . 36
5.9.3 Performance requirements . . 38
5.9.4 Electromagnetic compatibility requirements . 39
5.9.5 Emergency stop control . 39
5.9.6 Procedure plan for the initial start-up . . 40
5.9.7 Laser assembly is used for several HLMs . 40
5.9.8 Provisions and controls for isolation of the laser beam .41
5.9.9 Selection of temporary protective measures .41
5.10 Requirements related to Hazards from/to third persons .42
5.10.1 Authorizing control device .42
5.10.2 Requirement of training .42
5.11 Requirements related to hazards caused by lack or inadequacy of visual or acoustic
warning means .42
5.12 Requirements related Hazards associated with the environment .42
5.12.1 Lightning .42
5.12.2 Moisture .43
5.12.3 Pollution .43
5.12.4 Snow, rain, water, wind and extreme temperatures .43
6 Verification of safety requirements and measures .45
6.1 General .45
6.2 Methods for verification and validation .45
6.3 Required verification and validation . 48
6.4 Verification and Validation of protective devices . 48
6.5 Control category classification . 49
6.6 Laser classification . 49
7 Information for user.50
7.1 General . 50
7.2 Instruction handbook / Manual . 50
7.2.1 General . 50
7.2.2 Assembly and installation .51
7.2.3 Commissioning and operating .51
7.2.4 Use .52
7.2.5 Maintenance/Servicing . 54
7.2.6 Decommissioning . 54
7.2.7 Disposal . 55
7.2.8 System information . 55
7.2.9 Information how to act in emergency cases . 55
8 Labelling .56
8.1 Information to be indicated in labels . 56
8.2 Labels styles . . 56
Annex A (informative) Representative types of hand-held or hand-operated laser processing
machines (HLMs) .57
Annex B (informative) List of significant hazards .60
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Annex C (informative) Possible hazards related to hand-held or hand operated laser processing
machines (HLMs) .63
Annex D (informative) Examples for the design of technical safety measures for hand-held or
hand-operated laser processing machines (HLMs) .65
Annex E (informative) Recommendations for the selection of personal protective equipment
for use with hand-held or hand-operated laser processing, machines (HLMs) .69
Annex F (informative) Design recommendations for laser fume extraction systems on process
nozzles .72
Annex G (informative) Parameter information for user by manufacturer related to laser
radiation with hand-held or hand-operated laser processing, machines (HLMs) .75
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of Directive 2006/42/EC Aimed to be Covered .78
Bibliography .80
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO [had/had not] received notice of
(a) patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 9, Laser and electro-optical systems in collaboration with IEC/TC 76, Optical radiation safety and laser
equipment.
This second edition cancels and replaces the first edition (ISO/IEC 11553-2:2007), which has been technically
revised with the following main changes:
a) Several terms and definitions were modified or newly added;
b) the covered hazards as well as the requirements concerning the hazards were added in more detail;
c) Table 1 was newly added in Clause 6, and the previous Annex A was deleted;
d) Several subclause headings were modified and several technical requirements were amended;
e) Some of the lists were renumbered;
f) Previous Annex B was modified and was renumbered as the new Annex A;
g) New Annex B, Annex C and Annex D were added.
h) Annex E was modified;
i) new Annex F and Annex G were added.
A list of all parts in the ISO 11553 series can be found on the ISO website/IEC website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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Introduction
This document is a type-C standard as stated in ISO 12100:2010.
This document is of relevance particularly for the following stakeholder groups representing the market
players with regard to machinery safety:
a) hand-held or hand-operated laser processing machines (HLMs) manufacturers (small, medium and
large enterprises); including manufacturers of sub/part machines such as devices or devices assembly
related to laser radiation, as well as system integrators (small, medium, and large enterprises);
NOTE Devices or device assemblies are including but not limited to: guiding; shaping, delivery, protective,
locking, control, enabling, limiting, impeding, switching, exhaust, stop, loading/feeding, scanning and warning
devices.
b) health and safety bodies (regulators, accident prevention organizations, market surveillance, etc.).
Others can be affected by the level of machinery safety achieved with the means of the document by the
above-mentioned stakeholder groups:
c) machine users/employers (small, medium and large enterprises);
d) machine users/employees (e.g., trade unions, organizations for people with special needs);
e) service providers, e.g., for maintenance (small, medium and large enterprise);
f) consumers (in case of machinery intended for use by consumers).
g) bystanders
The above-mentioned stakeholder groups have been given the possibility to participate at the drafting
process of this document.
The machinery concerned and the extent to which hazards, hazardous situations or hazardous events are
covered are indicated in the Scope of this document.
When requirements of this type-C standard are different from those which are stated in type-A or type-B
standards, the requirements of this type-C standard take precedence over the requirements of the other
standards for machines that have been designed and built according to the requirements of this type-C
standard.
The purpose of this document is to prevent injures to persons:
h) by listing potential hazards generated by hand-held or hand-operated laser processing machines;
i) by describing the risk assessment procedure for all relevant hazards;
j) by specifying safety measures and verification procedures necessary for reducing the risk caused by
specific hazardous conditions;
k) by providing references to pertinent standards;
l) by specifying the information which is to be supplied to the user so that they can establish proper
procedures and precautions at the workplace.
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DRAFT International Standard ISO/DIS 11553-2:2025(en)
Safety of machinery — Laser processing machines —
Part 2:
Safety requirements for hand-held or hand-operated laser
processing machines
1 Scope
This document specifies the requirements for hand-held or hand-operated laser processing machines (HLM)
and their components as well as assemblies. HLM is the machine in which laser radiation is generated, where
the laser provides sufficient energy/power to cause a phase transition in a part of the workpiece and where
the laser output or workpiece to be processed is guided manually or hand-held during the laser process.
HLM includes the laser device, beam-guiding device (e.g., mirror, fibre, lenses), beam-shaping device (e.g.,
telescope, focusing), and controls. The laser assembly as an integral part of the HLM or only the laser
processing head is hand-held or hand-operated during the laser process.
This document does not apply:
— to laser processing machines which are remotely controlled by a manual controller (hand-operated
controller), such as joy sticks, keyboard, etc., without touching a workpiece or a part mechanically
connected with the laser processing head by using the hand(s) of the operator (user).
— to laser processing machines without a drive system which may not belong to machinery. And the laser
processing apparatus without moving parts, which may not be considered as machinery in “Type C
standard”.
NOTE “hand-operated laser processing machine” is synonymous with “hand-guided laser processing machine”
in this document. Hand-operated laser processing machines often use manual force reduction means such as wheels,
supports, etc., for manual positioning of the laser processing heads or the workpieces.
It is applicable to HLMs using laser radiation to process materials.
The purpose of this document is to draw attention to the hazards related to HLMs and to prevent personal
injury. Depending on the application and the location/operating conditions of HLMs, a number of different
significant hazards can arise. This document describes both the areas of hazards analysis and risk
assessment as well as protective measures.
Requirements dealing with noise as a hazard are covered by ISO 11553-3.
This document deals with the specific hazards resulting from laser radiation arising in HLMs, when they are
used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer.
This document does not apply to laser products or equipment manufactured solely or expressly for
applications which are excluded from the scope of ISO 11553-1:2020. This document is not applicable for
HLMs which have been manufactured before the date of publication of this standard.
HLMs include the following types:
a) HLMs which are designed as all in-one laser assembly including the beam delivery/forming(shaping)
system and optional features such as gas nozzles, material (e.g., powder, wire) feed system;
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ISO/DIS 11553-2:2025(en)
b) HLMs where the relevant devices are connected by a beam guidance system (e.g., optical fibre) and
power/control cables to an external laser assembly device and which includes only the beam delivery/
forming(shaping) system and optional features such as gas nozzles, material (e.g., powder, wire) feed system;
c) laser processing machines where the workpiece is manually moved under/relative to the laser beam
(see informative Annex A).
The intended use of HLMs covers both:
d) movement of the laser processing head (beam shaping device) by hand to move laser beam(s) over or
relative to elements or workpieces to be processed, and
e) movement of elements or workpieces by hand to be processed under/relatively to stationary laser
beams as shielded.
Laser processing machines, where laser processing is performed with hand-held or hand-operated
workpieces outside the fixed (neither hand-held nor hand-operated by the operator or user) laser processing
machines are out of the scope of this document. Such a fixed laser processing machine is to be covered by
ISO 11553-1.
HLMs are intended for the industrial use and can be only operated by trained and authorized personnel in
indoor and/or outdoor environments/locations (e.g., cleaning of facades, statues).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 3864 (all parts), Graphical symbols — Safety colours and safety signs — Part 1: Design principles for safety
signs and safety markings
ISO 6385:2016, Ergonomics principles in the design of work systems
ISO 11145:2018, Optics and photonics — Lasers and laser-related equipment — Vocabulary and symbols
ISO/IEC 11553-1:2020, Safety of machinery — Laser processing machines — Part 1: General safety requirements
ISO/IEC 11553-3:2013, Safety of machinery — Laser processing machines - Part 3: Noise reduction and noise
measurement methods for laser processing machines and hand-held processing devices and associated auxiliary
equipment (accuracy grade 2)
ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk reduction
ISO 13732-1:2006, Ergonomics of the thermal environment — Methods for the assessment of human responses
to contact with surfaces — Part 1: Hot surfaces
ISO 13849-1:2023, Safety of machinery — Safety-related parts of control systems — Part 1: General principles
for design
ISO 13850:2015, Safety of machinery — Emergency stop function — Principles for design
ISO 13857:2019, Safety of machinery — Safety distances to prevent hazard zones being reached by upper and
lower limbs
ISO 14118:2017, Safety of machinery — Prevention of unexpected start-up
ISO 14119:2024, Safety of machinery — Interlocking devices associated with guards — Principles for design and
selection
ISO 14120:2015, Safety of machinery — Guards — General requirements for the design and construction of fixed
and movable guards
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ISO/DIS 11553-2:2025(en)
ISO 20607:2019, Safety of machinery — Instruction handbook — General drafting principles
ISO 26800:2011, Ergonomics — General approach, principles and concepts
IEC 60204-1:2016, Safety of machinery — Electrical equipment of machines — Part 1: General requirements
IEC 60364 (series), Low-voltage electrical installations
IEC 60364-7-704:2017, Low-voltage electrical installations - Part 7-704: Requirements for special installations
or locations - Construction and demolition site installations
IEC 60529:1989+AMD1:1999, CSV, Degrees of protection provided by enclosures (IP Code)
IEC 60825-1:2014, Safety of laser products — Part 1: Equipment classification and requirements
IEC 60825-4:2020, Safety of laser products — Part 4: Laser guards
IEC 61000-6-2:2016, Electromagnetic compatibility (EMC) - Part 6-2: Generic standards - Immunity standard
for industrial environments
IEC 61000-6-3:2020, Electromagnetic compatibility (EMC) - Part 6-3: Generic standards - Emission standard for
equipment in residential environments
IEC 61000-6-4:2018, Electromagnetic compatibility (EMC) - Part 6-4: Generic standards - Emission standard
for industrial environments
IEC 61000-6-7:2014, Electromagnetic compatibility (EMC) - Part 6-7: Generic standards - Immunity requirements
for equipment intended to perform functions in a safety-related system (functional safety) in industrial locations
IEC 62061:2021, Safety of machinery — Functional safety of safety-related control systems
EN 379:2003+A1:2009, Personal eye-protection - Automatic welding filters
3 Terms and definitions
For the purposes of this document, the terms and definitions given in in ISO 11145, ISO 11553-1, ISO 12100,
IEC 60825-1, IEC 60825-4 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
confined space
working area surrounded on all sides, or for the most part, by solid walls where they, on account of their
confinement or containment of materials, preparation or equipment, augment or can augment particular
hazards that considerably exceed the hazard potential normally prevailing at workplaces
3.2
disposal unit
equipment that captures and removes effluents and/or chemical pollutants (e.g., fumes, gases) and/or by
products during laser material processing passing these on for filtration
EXAMPLE Capture devices, pipes, filtration systems, ventilation systems.
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3.3
hazard area
danger zone
any space within and/or around machinery in which a person can be exposed to a hazard
Note 1 to entry: There may be several hazard areas (danger zones) on the same workplace depending on the types of
hazards and relevant safety control measures against the hazards.
Note 2 to entry: For “laser hazard area”, see 3.6.
Note 3 to entry: Hazard area (danger zone) is not synonymous to “laser hazard area” and “nominal ocular hazard area
(NOHA)”.
[SOURCE: ISO 12100:2010, 3.11, modified, Note 1 to entry, Note 2 to entry and Note 3 to entry added]
3.4
hand-held or hand operated laser processing machine
HLM
machine in which laser radiation is generated, together with essential additional facilities (e.g., cooling,
power and gas supply) that are necessary to operate the laser, where the laser provides sufficient energy/
power to melt, evaporate or cause a phase transition in a part of the workpiece and where the laser beam or
workpiece to be processed is guided manually or hand-held during the laser process
Note 1 to entry: The HLM is synonymous with “laser unit”, see, 3.10.
Note 2 to entry: Generally, HLM can be divided in two representative types (Type 1 and Type 2) (see Annex A):
— Type 1: Machine equipped with a fixed laser assembly, where the workpiece is manually guided or manually
positioned relative to the laser processing head (beam shaping device),
— Type 2: Machines equipped with a hand-held or hand-guided laser head (HLH) where the laser processing head is
connected to a remotely located (i.e. external) laser device via a beam delivery system (e.g. fibre optical cable) or
where the laser source is integral part of the hand-held device.
3.5
hand-held or hand-guided laser head (HLH)
component, which is hand-held or hand guided and contains the laser output/aperture
Note 1 to entry: The HLH can be equipped via an optical fibre with an external laser source or contain the laser system
itself, which can be positioned or guided on the work piece surface or in a certain distance to the workpiece. Usually
HLM comprises a housing/enclosure with optical elements for beam guidance and shaping, the operating elements,
controls and indication elements (e.g., warning LED).
Note 2 to entry: The HLH can further comprise nozzle, feeder (gas/wire/powder), feed drive support, sensors/controls
for contact or distance to workpiece, capturing device for fume and gas emissions.
Note 3 to entry: Depending on the equipment, the HLH can also be connected with feeding devices for wire, gas,
cooling water, etc.
3.6
laser hazard area
area in which the laser radiation exposure of the eye and/or the skin exceeds the respective maximum
permissible exposure values (MPEs), including the possibility of accidental misdirection of the laser beam
Note 1 to entry: To avoid ambiguities, information whether the laser hazard area is based on the eye or the skin MPEs
should be added.
Note 2 to entry: See 3.11 for nominal ocular hazard area.
[SOURCE: IEC 60825-1:2014, 3.47, modified, Note 2 to entry added]
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3.7
laser system
laser in combination with an appropriate laser energy source with or without additional incorporated
components
[SOURCE: IEC 60825-1:2014, 3.51]
Note 1 to entry: See Figure 1.
3.8
laser assembly
laser system together with specific, normally optical, mechanical and/or electrical system components for
beam handling and forming
[SOURCE: ISO 11145:2018, 3.19.7, modified, “laser device” replaced by “laser system”, included “normally”
and changed “beam guiding and beam shaping” to “beam handling and forming”]
Note 1 to entry: See Figure 1.
3.9
laser device
laser where the radiation is generated, together with essential additional facilities (e.g., cooling, power and
gas supply) that are necessary to operate the laser
[SOURCE: ISO 11145:2018, 3.19.6, modified]
Note 1 to entry: See Figure 1.
3.10
laser unit
one or more laser assemblies together with handling units, measurement systems and control systems
...