EN IEC 60601-2-57:2026/A11:2026

Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use

The amendment to EN IEC 60601-2-57 contains the Annexes ZA (Normative references to international publications with their corresponding European publications) and ZZ (Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered). These two Annexes are necessary for the harmonization of the standard to the Regulation (EU) 2017/745.

Medizinische elektrische Geräte - Teil 2-57: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten mit Nicht-Laser-Lichtquellen für die Anwendung in der Therapie, Diagnose, Überwachung und für kosmetische/ästhetische Zwecke

Appareils électromédicaux - Partie 2-57: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à source de lumière non laser destinés à des usages thérapeutiques, de diagnostic, de surveillance, cosmétiques et esthétiques

Medicinska električna oprema - 2-57. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme z nelaserskim svetlobnim virom, namenjene za terapevtsko, diagnostično, nadzorovalno, kozmetično in estetsko uporabo - Dopolnilo AA

General Information

• Status: Not Published
• Publication Date: 22-Jan-2026
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 76 - Optical radiation safety and laser equipment
• Current Stage: 6055 - Ratification Completed (DOR) - Publishing
• Start Date: 17-Dec-2025
• Due Date: 13-May-2026
• Completion Date: 17-Dec-2025
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: SIST FprEN IEC 60601-2-57:2023/oprAA:2025 - Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use

Relations

• Amends: EN IEC 60601-2-57:2026 - Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
• Effective Date: 23-Jan-2024

Overview

EN IEC 60601-2-57:2026/A11:2026 is an amendment to the European adoption of IEC 60601-2-57, addressing basic safety and essential performance of non‑laser light source equipment used for therapeutic, diagnostic, monitoring, cosmetic and aesthetic purposes. The amendment adds the normative Annex ZA (mapping to corresponding European publications) and informative Annex ZZ (relationship to Regulation (EU) 2017/745, the Medical Device Regulation). These Annexes are required to harmonize the standard with EU regulatory requirements and to support a presumption of conformity when the standard is cited in the Official Journal of the EU.

Keywords: EN IEC 60601-2-57, non-laser light source equipment, medical electrical equipment, Regulation (EU) 2017/745, photobiological safety.

Key Topics

• Scope and intended use: Safety and essential performance requirements for non‑laser optical radiation medical devices (LEDs, IPL, phototherapy and similar sources) for clinical, cosmetic and monitoring applications.
• Optical emission and photobiological safety: References photobiological safety guidance (e.g., IEC 62471) and addresses risks associated with emitted optical radiation.
• Risk management and conformity: Aligns device risk reduction and manufacturer policies with the General Safety and Performance Requirements (GSPR) of MDR 2017/745.
• Labeling, instructions and warnings: Requirements for device labels, safety symbols, instructions for safe use, installation, maintenance and pre‑use checks to minimize exposure risks.
• Electrical and mechanical risks: Coverage includes electrical safety aspects related to cooling fluids and access to operational controls.
• Regulatory mapping: Annex ZA provides normative cross‑references to international standards adopted as European documents; Annex ZZ shows clause‑by‑clause correspondence to MDR Annex I GSPR to support conformity assessment.

Applications and Who Uses This Standard

• Manufacturers and designers of medical, cosmetic and aesthetic light‑based devices (LED therapy, IPL, phototherapy units).
• Regulatory and compliance teams preparing technical documentation and demonstrating conformity with MDR (EU) 2017/745.
• Quality, risk management and clinical evaluation specialists integrating safety, post‑market surveillance and clinical requirements.
• Notified bodies and test laboratories evaluating device safety, optical emission testing and labeling.
• Hospitals, clinics and biomedical engineers referencing safe operation, maintenance and user instructions.

Practical use: implement design controls, perform photobiological risk assessments, prepare instructions for use and labeling aligned with MDR GSPR, and ensure harmonized national adoption following Annex ZA/ZZ guidance.

Related Standards

• EN IEC 60601-1 (general medical electrical equipment safety)
• IEC 62471 / EN 62471 (Photobiological safety of lamps and lamp systems)
• IEC 60947-3 / EN IEC 60947-3 (low-voltage switchgear – referenced for electrical components)
• ISO 3864-2 (graphical symbols and safety labels)

Using EN IEC 60601-2-57 and its Annexes ZA/ZZ helps manufacturers and assessors demonstrate compliance with EU medical device requirements for non‑laser light source equipment, improving product safety and market access.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2025
Medicinska električna oprema - 2-57. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme z nelaserskim svetlobnim virom, namenjene za
terapevtsko, diagnostično, nadzorovalno, kozmetično in estetsko uporabo -
Dopolnilo AA
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and
essential performance of non-laser light source equipment intended for therapeutic,
diagnostic, monitoring, cosmetic and aesthetic use
Appareils électromédicaux - Partie 2-57: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à source de lumière non laser destinés à
des usages thérapeutiques, de diagnostic, de surveillance, cosmétiques et esthétiques
Ta slovenski standard je istoveten z: FprEN IEC 60601-2-57:2023/prAA:2025
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
11.040.60 Terapevtska oprema Therapy equipment
SIST FprEN IEC 60601-2- en
57:2023/oprAA:2025
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD DRAFT
FprEN IEC 60601-2-57:2023
NORME EUROPÉENNE
EUROPÄISCHE NORM
prAA
June 2025
ICS 11.040.50; 11.040.60 -
English Version
Medical electrical equipment - Part 2-57: Particular requirements
for the basic safety and essential performance of non-laser light
source equipment intended for therapeutic, diagnostic,
monitoring, cosmetic and aesthetic use
To be completed To be completed
This draft amendment prAA, if approved, will modify the European Standard FprEN IEC 60601-2-57:2023; it is submitted to CENELEC
members for enquiry.
Deadline for CENELEC: 2025-08-29.

It has been drawn up by CLC/TC 76.

If this draft becomes an amendment, CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment the status of a national standard without any alteration.

This draft amendment was established by CENELEC in three official versions (English, French, German).
A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to
the CEN-CENELEC Management Centre has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Project: 79321 Ref. No. FprEN IEC 60601-2-57:2023/prAA:2025 E

FprEN IEC 60601-2-57:2023/prAA:2025 (E)
Contents Page
1 European foreword . 3
2 Annex ZA (normative) Normative references to international publications with their corresponding
3 European publications . 4
4 Annex ZZ (informative) Relationship between this European standard and the General Safety and
5 Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 5
FprEN IEC 60601-2-57:2023/prAA:2025 (E)
6 European foreword
7 This document (FprEN IEC 60601-2-57:2023/prAA:2025) has been prepared by CLC/TC76 "Optical radiation
8 safety and laser equipment”".
9 This document is currently submitted to the Enquiry.
10 The following dates are proposed:
• latest date by which the existence of this (doa) dav + 6 months
document has to be announced at national
level
• latest date by which this document has to be (dop) dav + 12 months
implemented at national level by publication of
an identical national standard or by
endorsement
• latest date by which the national standards (dow) dav + 36 months
conflicting with this document have to be (to be confirmed or
withdrawn modified when voting)
11 This document has been prepared under a standardization request addressed to CENELEC by the European
12 Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
13 Member States.
14 For the relationship with EU Legislation, see informative Annex ZZ, which is an integral part of this document.
15 Collateral standards in the IEC 60601 family are numbered IEC 60601-1-xx. The IEC maintains a catalogue of
16 valid International Standards. Users of this document can consult this catalogue at "http://webstore.iec.ch" to
17 determine which collateral standards have been published.
FprEN IEC 60601-2-57:2023/prAA:2025 (E)
18 Annex ZA
19 (normative)
21 Normative references to international publications with their
22 corresponding European publications
23 The following documents are referred to in the text in such a way that some or all of their content constitutes
24 requirements of this document. For dated references, only the edition cited applies. For undated references, the
25 latest edition of the referenced document (including any amendments) applies.
26 NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
27 relevant EN/HD applies.
28 NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
29 www.cencenelec.eu.
30 The Annex ZA of EN 60601-1:2006/A12:2014 applies with the following additions:
Publication Year Title EN/HD Year
IEC 60947-3 - Low-voltage switchgear and control gear – EN IEC 60947-3 2021
Part 3: Switches, disconnectors, switch-
disconnectors and fuse-combination units

+ AC 2021-11
IEC 62471 - Photobiological safety of lamps and lamp EN 62471 2008
systems
ISO 3864-2 2016 Graphical symbols – Safety colours and - -
safety signs – Part 2: Design principles for
product safety labels
...