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EN 62471 and EN 60825: photobiological and laser safety

Two IEC families decide how a product that emits light is assessed for eye and skin safety. IEC 62471 (EN 62471:2008 in Europe) covers incoherent sources, LEDs included, and sorts them into four risk groups. IEC 60825-1 (EN 60825-1:2014 with A11:2021) covers laser products and sorts them into eight classes. This page checks both against the IEC catalogue, the Low Voltage Directive list as consolidated on April 30, 2026, Directive 2006/25/EC, 21 CFR 1040.10 and FDA Laser Notice No. 56, and lists what changed since 2019: Laser Notice No. 50 is gone, IEC 62471-7 introduced an application-based method for luminaires, and the IEC versions of several 60825 parts are newer than the EN versions cited under the LVD. It also links the ANSI Z136 user standards and the IEC catalogue entries behind every edition quoted.

The split: incoherent sources versus laser products

Section titled “The split: incoherent sources versus laser products”
CharacteristicIEC 62471IEC 60825-1
Scope (IEC catalogue abstract)All electrically powered incoherent broadband sources, including LEDs but excluding lasersLaser products emitting laser radiation
Wavelength range200 nm to 3000 nm180 nm to 1 mm
Current IEC editionEdition 1.0, July 26, 2006 (prepared as CIE S 009:2002), stability date 2026Edition 3.0, May 15, 2014, with ISH1 and ISH2 of December 2017, stability date 2027
EN cited under the LVDEN 62471:2008 (row 559)EN 60825-1:2014 and A11:2021 (row 337)
OutcomeExempt, RG1, RG2, RG3Class 1, 1M, 1C, 2, 2M, 3R, 3B, 4
CommitteeIEC TC 76 (part 7: TC 34 Lighting)IEC TC 76

Two boundary rules matter in practice. First, LEDs belong to IEC 62471, not to IEC 60825-1. The exceptions are inside the 60825 series: IEC 60825-2:2021 applies to optical fibre communication systems whatever the source (lasers, LEDs or optical amplifiers), while IEC 60825-12:2022 states that LEDs used in free space optical links are outside its scope. Second, a laser can be used as a lamp. Clause 4.4 of IEC 60825-1:2014 allows the emission of a laser product designed to function as a conventional lamp to be classified under the IEC 62471 series if it stays below a radiance criterion, and IEC 62471-7:2023 says it can be applied to such products when the conditions of 4.4 are met.

IEC 62471 sets eight exposure limits in clause 4.3, and the risk group of a source is driven by the worst of them.

ClauseHazardBand
4.3.1Actinic UV, skin and eye200 nm to 400 nm
4.3.2Near-UV (UV-A), eye315 nm to 400 nm
4.3.3Retinal blue light300 nm to 700 nm
4.3.4Retinal blue light, small source300 nm to 700 nm
4.3.5Retinal thermal380 nm to 1400 nm
4.3.6Retinal thermal, weak visual stimulus780 nm to 1400 nm
4.3.7Infrared radiation, eye780 nm to 3000 nm
4.3.8Thermal, skin380 nm to 3000 nm

The clause numbers are those of IEC 62471:2006; the bands are those of the matching clauses of IEC 62471-7:2023.

Clause 6 of IEC 62471:2006 defines the groups for continuous wave lamps (6.1) and has a separate subclause for pulsed lamps (6.2). The time bases below come from an LED manufacturer's application note that tabulates the standard, so treat them as a secondary reading and take the limit values from the standard itself.

GroupMeaningBlue-light time base and radiance limitRetinal thermal time base and limit
ExemptNo photobiological hazard10 000 s, 100 W/(m²·sr)10 s, 28 000/α W/(m²·sr)
RG1 (low risk)No hazard due to normal behavioural limitations on exposure100 s, 10 000 W/(m²·sr)10 s, 28 000/α W/(m²·sr)
RG2 (moderate risk)No hazard due to the aversion response to very bright sources or to thermal discomfort0.25 s, 4 × 10⁶ W/(m²·sr)0.25 s, 71 000/α W/(m²·sr)
RG3 (high risk)Hazardous even for momentary or brief exposureAbove RG2Above RG2

The higher the group, the shorter the time base. The distance matters as much as the limit: values are compared at 200 mm, except for lamps intended for general lighting service, which are reported at the distance where they produce 500 lx, and never closer than 200 mm. Using 200 mm on a general lighting product, or 500 lx on a product that is not one, gives a classification the standard did not ask for.

The parts of the 62471 series and their status

Section titled “The parts of the 62471 series and their status”
DocumentDateWhat it does
IEC 62471:2006July 26, 2006Exposure limits, measurement technique and the risk-group scheme for lamps and lamp systems, including luminaires
IEC TR 62471-2:2009August 6, 2009, withdrawn May 21, 2021Guidance on manufacturing requirements: safety measures and labelling of products
IEC TR 62471-3:2015January 20, 2015Guidelines for the safe use of intense pulsed light (IPL) equipment on humans in professional premises
IEC 62471-5:2015June 9, 2015Risk groups, measurement conditions and manufacturing requirements for image projectors (theatre, data and home-use projectors)
IEC 62471-6:2022October 11, 2022Ultraviolet lamp products, including UV LED products, where more than half of the power emitted between 180 nm and 3000 nm is in 180 nm to 400 nm
IEC 62471-7:2023February 16, 2023, COR1 June 2023, COR2 September 2024, ISH1 July 11, 2025Light sources and luminaires that emit mainly in 380 nm to 780 nm, used for illumination or signalling

IEC 62471-7 does not simply re-run the 2006 method. Its introduction describes a new assessment procedure with revised time bases and emission limits that depend on the application and on whether the luminaire is viewed intentionally or not, and it leads to a pass or fail result for a given product in a given application. It treats light sources with pulse width modulation as continuous emitters and is meant to be referenced by product standards such as the EN 60598 luminaire series.

IEC 60825-1 applies to laser products from 180 nm to 1 mm. Its scope excludes lasers sold to other manufacturers as components of a system for subsequent sale, and repair parts, because the end product is itself subject to the standard; a laser system that still works when removed from the end product is in scope. Edition 3.0 (2014) introduced Class 1C, removed measurement condition 2 (the "eye loupe" condition), added the 4.4 lamp-replacement option and updated the AEL values of Classes 1, 1M, 2, 2M and 3R for pulsed sources to follow revised ICNIRP guidelines.

ClassWhat it means (Annex C.2 description, summarised)
1Safe under reasonably foreseeable conditions of use
1MAs Class 1, but may be hazardous when viewed with optical instruments
1CLaser radiation applied in contact with the target tissue; the clause 6.12 safeguard limits emission when there is no contact, so stray radiation stays within Class 1
2Visible (400 nm to 700 nm), protection afforded by aversion responses
2MAs Class 2, but may be hazardous when viewed with optical instruments
3RExceeds Class 1 or 2 limits by a limited margin, with reduced requirements
3BDirect viewing hazardous; diffuse reflections normally not
4Direct viewing, skin exposure and diffuse reflections can be hazardous; may present a fire risk

Engineering requirements: IEC 60825-1 against 21 CFR 1040.10

Section titled “Engineering requirements: IEC 60825-1 against 21 CFR 1040.10”

Clause 6 runs from 6.1 to 6.16. The table puts the main features next to their US counterparts, because the classes they apply to are not the same.

FeatureIEC 60825-1:2014 clauseClasses (IEC)21 CFR 1040.10Classes (US)
Protective housing6.2All(f)(1)All
Interlocked access panels6.3Any class whose removable panel exposes higher-class radiation(f)(2)Any class, as specified
Remote interlock connector6.43B and 4 (not handheld battery-powered 3B)(f)(3)IIIb and IV
Key control6.63B and 4(f)(4)IIIb and IV
Emission warning or indicator6.73R only outside 400 nm to 700 nm, 3B, 4(f)(5)II, IIIa, IIIb, IV
Beam stop or attenuator6.83B and 4(f)(6)II, III, IV
Scanning safeguard6.11Scanned products(f)(9)Scanned products
Class 1C safeguard6.121CNo equivalent class

The R in 3R stands for reduced requirements: a visible 3R product needs no key switch, remote interlock connector or beam stop under IEC 60825-1, but the same product in the US is Class IIIa and needs an emission indicator and a beam attenuator under 1040.10(f).

The Nominal Ocular Hazard Distance (NOHD), defined in clause 3.65, is not an engineering control. It belongs to clause 8.1, information for the user, which asks for the applicable MPE and NOHD of Class 3B and Class 4 products where appropriate. Operator training is not in clause 6 either. In the EU it is an employer duty under article 6 of Directive 2006/25/EC, which requires information and training on the exposure limit values, the results of the risk assessment, safe working practices and the proper use of personal protective equipment. Article 4 of the same Directive requires the employer assessment to follow IEC standards for laser radiation and CIE and CEN recommendations for non-coherent radiation, with exposure limits in Annex I (non-coherent) and Annex II (laser).

Classification rules sit in clause 4.3. Interpretation sheet 1 (December 2017) clarifies how 4.3 treats multiple wavelengths, extended sources, multiple apparent sources and groups of pulses, which is where scanned or pulsed emitters such as LIDAR are decided. The same clause considers reasonably foreseeable single-fault conditions; Laser Notice No. 56 uses it to read clause 6.3 as requiring redundancy or safe failure for interlocks guarding Class IIIb or IV radiation. A product whose laser current is set by firmware has to keep its class when that control fails, which is why output limiting usually sits in hardware (clause 6.16 covers a power limiting circuit).

The IEC 60825:2026 SER pack, published July 10, 2026, lists the parts in force: IEC 60825-1:2014, 60825-2:2021, TR 60825-3:2022, 60825-4:2022, TR 60825-5:2019, TR 60825-8:2022, 60825-12:2022, TS 60825-13:2026, TR 60825-14:2022, TR 60825-17:2015, TS 60825-19:2024 and TS 60825-20:2025.

PartIEC editionEN reference cited under the LVD
60825-1 Classification and requirementsEdition 3.0, 2014EN 60825-1:2014 + A11:2021
60825-2 Optical fibre communication systemsEdition 4.0, March 16, 2021 (replaces 2004 + A1:2006 + A2:2010)EN 60825-2:2004 + A1:2007 + A2:2010
60825-4 Laser guardsEdition 3.0, July 22, 2022EN 60825-4:2006 + A1:2008 + A2:2011
60825-12 Free space optical communicationEdition 3.0, December 20, 2022 (corrigenda July 2024 and January 2026)EN 60825-12:2004
TR 60825-8 Safe use of lasers on humansEdition 3.0, September 14, 2022: classes 1C, 3B and 4 in interventional useTechnical report, not cited

For laser processing machines under the Machinery Directive, the cited references include EN ISO 11553-1:2020 with A11:2020, EN 12254:2010 (screens for laser working places) and EN 12198-1/-2/-3 (radiation emitted by machinery), in Decision (EU) 2023/1586. Directive 2006/42/EC is repealed from January 20, 2027, when Regulation (EU) 2023/1230 applies; see the machinery guide.

United States: 21 CFR 1040 and Laser Notice No. 56

Section titled “United States: 21 CFR 1040 and Laser Notice No. 56”

21 CFR 1040.10 applies to laser products manufactured or assembled after August 1, 1976, and classifies them as Class I, IIa, II, IIIa, IIIb or IV. 1040.11 adds requirements for medical, for surveying, levelling and alignment, and for demonstration laser products. Labels follow fixed wording: for example a Class IIIb product carries warning logotype B with "LASER RADIATION, AVOID DIRECT EXPOSURE TO BEAM" and "CLASS IIIb LASER PRODUCT".

DateEvent
June 2007Laser Notice No. 50: FDA does not intend to enforce comparable parts of 1040.10 for products conforming to IEC 60825-1 Ed. 1.2 or Ed. 2
May 8, 2019Laser Notice No. 56 for IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1
June 7, 2023FDA announces it intends to withdraw Laser Notice No. 50 by the end of 2024
December 31, 2024Laser Notice No. 50 withdrawn

Laser Notice No. 56 lists the comparable 1040.10 paragraphs (definitions, classification, accessible emission limits, tests, housing, interlocks, remote interlock, key control, emission indicator, beam attenuator, controls, viewing optics, scanning safeguard, labelling, user information, and 1040.11(a) medical lasers). It leaves untouched certification (1010.2), identification (1010.3), variances, applicability, removable laser systems, purchasing and servicing information, modification of a certified product, and 1040.11(b) and (c). The certification label carries a statement such as "Complies with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 60825-1 Ed. 3., as described in Laser Notice No. 56, dated May 8, 2019.", and product reports under 21 CFR Part 1002 are still required. Laser Notice No. 56 also lists IEC clauses it does not accept, including 4.4 (lamp replacement, handled by Laser Notice No. 57 for laser illuminated projectors) and the definition of a laser product in 3.48, because 1040.10(b)(21) treats a laser intended as a component as a laser product.

ANSI Z136 is a separate layer for users. The series, maintained by the Laser Institute of America as secretariat, runs from Z136.1 (safe use of lasers) to Z136.9 (manufacturing environments), with parts for optical fibre communication (Z136.2), health care (Z136.3), measurements (Z136.4), educational institutions (Z136.5), outdoors (Z136.6), protective equipment (Z136.7) and research (Z136.8).

LED luminaires. EN 62471:2008 is the cited reference; IEC 62471-7:2023 is the newer, application-based method. Ecodesign rules for light sources come from Regulation (EU) 2019/2020, a Regulation, not a Directive (see the ecodesign guide).

Laser light sources. A laser-based light module sold to luminaire makers is a component outside IEC 60825-1, but ISH2 says the luminaire is in scope, including 4.4. The radiance criterion is measured at 200 mm, averaged over 5 mrad, under single-fault conditions; the Class 1 label then becomes mandatory next to the IEC 62471 risk-group label.

Projectors. Projectors are assessed under IEC 62471-5:2015, and a laser-illuminated projector can use it through clause 4.4 of IEC 60825-1; in the US, Laser Notice No. 56 sends laser illuminated projectors to Laser Notice No. 57.

AR glasses. IEC 63145-22-20:2024 measures image quality of AR eyewear displays. It is a TC 110 display standard, not a photobiological method.

UV-C and IPL. UV lamp products fall under IEC 62471-6:2022; IPL use on humans is covered by IEC TR 62471-3:2015.

Common claimWhat the text says
EN 60825-1 covers LEDs used in fibre-optic linksIEC 60825-1 covers laser products; LEDs in optical fibre systems are in IEC 60825-2, and IEC 60825-12:2022 excludes LEDs
IEC 62471 has seven hazard mechanismsClause 4.3 sets eight exposure limits, with separate blue-light limits for small sources (4.3.4)
EN 62471-2 gives manufacturing and labelling rulesIt was IEC TR 62471-2:2009, a technical report, withdrawn May 21, 2021
IEC 62471-6 covers special UV sources and 62471-7 covers flash lamps62471-6 covers UV lamp products; 62471-7 covers visible light sources and luminaires; IPL is TR 62471-3
IEC 60825-8 deals with medical laser products and 60825-12 with LEDsTR 60825-8:2022 is guidance for the safe use of lasers on humans; 60825-12 covers free space optical communication and excludes LEDs
FDA accepts IEC classification through Laser Notice No. 50Withdrawn December 31, 2024; Laser Notice No. 56 (May 8, 2019) is the current route
EN 60825-1 clause 4.3 is a dedicated single-fault clause, and a cyber attack counts as a foreseeable faultClause 4.3 is the classification rules, which consider reasonably foreseeable single faults; neither IEC 60825-1 nor Laser Notice No. 56 says anything about cyber attacks
IEC TR 63145-22-20 is the photobiological method for headsetsIEC 63145-22-20:2024 is an International Standard on AR display image quality
An RG2 marking is mandatory under EN 62471IEC 62471:2006 classifies; labelling guidance was in the withdrawn TR 62471-2, and IEC 62471-6 sets labelling for UV lamp products and IEC 62471-5 sets manufacturing requirements for projectors
The ecodesign "Directive" 2019/2020It is Commission Regulation (EU) 2019/2020
Operator training and the NOHD are product engineering controlsNOHD is user information under 8.1; training is an employer duty under article 6 of Directive 2006/25/EC
Class 3R needs a key switch and a beam stopUnder IEC 60825-1 key control (6.6), remote interlock (6.4) and beam stop (6.8) apply to 3B and 4; the US Class IIIa rules differ
  • IEC 62471 (incoherent, LEDs included) and IEC 60825-1 (lasers) are split by source type, with clause 4.4 as the bridge for lasers used as lamps.
  • The LVD list still cites EN 62471:2008 and EN 60825-1:2014 + A11:2021; the newer IEC parts (62471-5/-6/-7, 60825-2:2021, -4:2022, -12:2022) are not cited.
  • IEC 62471 has eight exposure limits and four risk groups with shrinking time bases; distance (200 mm or 500 lx) is part of the result.
  • In the US, Laser Notice No. 56 is the only IEC route left since December 31, 2024, and Class 3R and Class IIIa engineering requirements do not match.

Sources & references

  1. IEC 62471:2006 Photobiological safety of lamps and lamp systems (edition 1.0, July 26, 2006, prepared as CIE S 009:2002), IEC webstore.iec.ch/en/publication/7076
  2. IEC 60825-1:2014 Safety of laser products, Part 1: Equipment classification and requirements (edition 3.0, includes ISH1 and ISH2 of December 2017), IEC webstore.iec.ch/en/publication/3587
  3. IEC 60825-1:2014 preview: table of contents and interpretation sheets ISH1 and ISH2 (secondary host of the IEC preview), iTeh Standards (IEC preview) cdn.standards.iteh.ai/samples/19924/180b76346cc34b12b33d6261e3dcf367/IEC-60825-1-2014.pdf
  4. IEC 62471:2006 preview: table of contents, clauses 4.3.1 to 4.3.8 and 6 (secondary host of the IEC preview), iTeh Standards (IEC preview) cdn.standards.iteh.ai/samples/15358/5d30e63eeba94e6ab50031932b0d23a1/IEC-62471-2006.pdf
  5. IEC 62471-7:2023 Light sources and luminaires primarily emitting visible radiation (with COR1, COR2 and ISH1:2025), IEC webstore.iec.ch/en/publication/68810
  6. IEC 62471-6:2022 Ultraviolet lamp products, IEC webstore.iec.ch/en/publication/59543
  7. IEC 62471-5:2015 Image projectors, IEC webstore.iec.ch/en/publication/22639
  8. IEC TR 62471-2:2009 Guidance on manufacturing requirements (withdrawn May 21, 2021), IEC webstore.iec.ch/en/publication/7074
  9. IEC TR 62471-3:2015 Guidelines for the safe use of intense pulsed light source equipment on humans, IEC webstore.iec.ch/en/publication/7075
  10. IEC 60825:2026 SER, list of current parts of the IEC 60825 series (July 10, 2026), IEC webstore.iec.ch/en/publication/62424
  11. IEC 60825-2:2021 Safety of optical fibre communication systems (edition 4.0), IEC webstore.iec.ch/en/publication/29858
  12. IEC 60825-4:2022 Laser guards (edition 3.0), IEC webstore.iec.ch/en/publication/30245
  13. IEC 60825-12:2022 Free space optical communication systems (edition 3.0, corrected version January 2026), IEC webstore.iec.ch/en/publication/65386
  14. IEC TR 60825-8:2022 Guidelines for the safe use of lasers on humans, IEC webstore.iec.ch/en/publication/63122
  15. IEC 63145-22-20:2024 Eyewear display, AR type, image quality, IEC webstore.iec.ch/en/publication/65444
  16. Commission Implementing Decision (EU) 2023/2723, LVD harmonised standards, consolidated version of April 30, 2026, European Commission (EUR-Lex) eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02023D2723-20260430
  17. Commission Implementing Decision (EU) 2023/1586, Machinery Directive harmonised standards, European Commission (EUR-Lex) eur-lex.europa.eu/eli/dec_impl/2023/1586/oj
  18. Directive 2006/25/EC on exposure of workers to artificial optical radiation, European Parliament and Council (EUR-Lex) eur-lex.europa.eu/eli/dir/2006/25/oj
  19. 21 CFR 1040.10 Laser products, US eCFR www.ecfr.gov/current/title-21/chapter-I/subchapter-J/part-1040/section-1040.10
  20. 21 CFR 1040.11 Specific purpose laser products, US eCFR www.ecfr.gov/current/title-21/chapter-I/subchapter-J/part-1040/section-1040.11
  21. Laser Products, Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56), May 8, 2019, US Food and Drug Administration www.fda.gov/media/110120/download
  22. Federal Register notice of availability of Laser Notice No. 56, May 8, 2019, Federal Register www.federalregister.gov/documents/2019/05/08/2019-09381/laser-products-conformance-with-iec-60825-1-ed-3-and-iec-60601-2-22-ed-31-laser-notice-no-56
  23. FDA bulletin: Laser Notice No. 50 withdrawn on December 31, 2024 (January 8, 2025), US Food and Drug Administration content.govdelivery.com/accounts/USFDA/bulletins/3cb2a72
  24. List of Z136 standards, Laser Institute of America (ASC Z136 secretariat) z136.lia.org/about/list-of-standards
  25. Details on photobiological safety of LED light sources, application note AN002 (secondary source for IEC 62471 time bases), ams OSRAM look.ams-osram.com/m/1d720a7b18ab3fce/original/Details-on-photobiological-safety-of-LED-light-sources.pdf

Frequently asked questions

What is the difference between EN 62471 and EN 60825-1?
IEC 62471:2006 (EN 62471:2008) covers all electrically powered incoherent broadband sources of optical radiation, including LEDs but excluding lasers, from 200 nm to 3000 nm, and sorts them into four risk groups. IEC 60825-1:2014 (EN 60825-1:2014 with A11:2021) covers laser products from 180 nm to 1 mm and sorts them into eight classes. LEDs are not in IEC 60825-1: an LED inside an optical fibre communication system is handled by IEC 60825-2, and IEC 60825-12:2022 excludes LEDs from free space optical links. A product with both an LED and a laser is assessed under both.
What do the four IEC 62471 risk groups mean?
Exempt: no photobiological hazard. Risk Group 1 (low risk): no hazard due to normal behavioural limitations on exposure. Risk Group 2 (moderate risk): no hazard due to the aversion response to very bright sources or to thermal discomfort. Risk Group 3 (high risk): hazardous even for momentary or brief exposure. For the retinal blue-light hazard the time bases behind these groups are 10 000 s, 100 s and 0.25 s. The limit values sit in clause 6 of IEC 62471:2006 and must be read in the standard.
How many hazards does IEC 62471 assess?
Eight exposure limits, clauses 4.3.1 to 4.3.8 of IEC 62471:2006: actinic UV for skin and eye, near-UV for the eye, retinal blue light, retinal blue light for small sources, retinal thermal, retinal thermal with a weak visual stimulus, infrared for the eye, and thermal for the skin. Pages that list seven usually merge the two blue-light limits.
Is EN 62471-7 or EN 62471-5 a harmonised standard under the LVD?
No. In Implementing Decision (EU) 2023/2723, as consolidated on April 30, 2026, the photobiological reference is EN 62471:2008 (row 559). The laser references are EN 60825-1:2014 with A11:2021, EN 60825-2:2004 with A1 and A2, EN 60825-4:2006 with A1 and A2, and EN 60825-12:2004 (rows 337 to 340). The newer IEC editions (60825-2:2021, 60825-4:2022, 60825-12:2022) and the parts 62471-5, 62471-6 and 62471-7 are not on that list, so they give no presumption of conformity under the LVD.
Is FDA Laser Notice No. 50 still usable for US labelling?
No. FDA withdrew Laser Notice No. 50 on December 31, 2024. The route today is Laser Notice No. 56 (May 8, 2019): for clauses of IEC 60825-1 Ed. 3 that FDA lists as comparable, it does not intend to enforce the matching parts of 21 CFR 1040.10 and 1040.11. Certification (21 CFR 1010.2), identification (1010.3) and product reports (Part 1002) still apply, and the certification label carries the Laser Notice No. 56 statement worded by FDA.
Can a laser be used as a light source and still avoid laser classification?
Partly. Clause 4.4 of IEC 60825-1:2014 lets emission from laser products designed to function as conventional lamps be classified under the IEC 62471 series when it stays below a radiance criterion. Interpretation sheet 2 (December 2017) sets the method: radiance averaged over 5 mrad at 200 mm from the closest point of human access, single faults included. The rest of IEC 60825-1 still applies, and the Class 1 label then becomes mandatory next to the risk-group label.
Where does single-fault safety sit in IEC 60825-1?
In the classification rules of clause 4.3, which consider reasonably foreseeable single-fault conditions. FDA Laser Notice No. 56 relies on that sub-clause to read IEC 60825-1 clause 6.3 as requiring redundancy or safe failure for interlocks protecting against Class IIIb or IV radiation. For a laser whose output is set by firmware, the classification therefore has to hold when that control fails.