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IEC 80601-2-52:2026

Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds for adults

Edition date: 2026-05-05
In Force
Available languages: English, French
Summary: IEC 80601-2-52:2026 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS as defined in 201.3.214, intended for ADULTS as defined in 201.3.222. Included in the scope are both electrical and non-electrical (manual) MEDICAL BEDS with or without adjustable functions.
This document is applicable to either a BED-LIFT or a detachable MATTRESS SUPPORT PLATFORM or both. The combination of BED-LIFT or a detachable MATTRESS SUPPORT PLATFORM with a compatible non-MEDICAL BED as specified by the MANUFACTURER is also considered a MEDICAL BED.
This document does not apply to:
- MEDICAL BEDS for CHILDREN and ADULTS with atypical anatomies (ADULTS ranging outside the definition for ADULTS in 202.3.222) covered by IEC 80601-2-89;
- SPECIALITY MATTRESS covered by ISO 20342 series;
- devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table);
- all requirements for MEDICAL BEDS with special functionality.
If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.

L'IEC 80601-2-52:2026 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des LITS MEDICAUX tels qu'ils sont définis au 201.3.214, destinés aux ADULTES tels qu'ils sont définis au 201.3.222. Le domaine d'application inclut les LITS MEDICAUX électriques et non électriques (manuels) avec ou sans fonctions réglables.
Le présent document s'applique à un SOULEVE-LIT ou à un SOMMIER amovible, ou au deux. La combinaison d'un SOULEVE-LIT ou d'un SOMMIER amovible avec un LIT non MEDICAL compatible SPECIFIE PAR LE FABRICANT est également considérée comme un LIT MEDICAL.
Le présent document ne s'applique pas:
- aux LITS MEDICAUX destinés aux ENFANTS et aux ADULTES qui présentent une anatomie atypique (ADULTES qui ne relèvent pas de la définition propre aux ADULTES au 201.3.222) couverts par l'IEC 80601-2-89;
- aux MATELAS THERAPEUTIQUES couverts par la série ISO 20342;
- aux dispositifs pour lesquels l'UTILISATION PREVUE est principalement l'examen ou le transport sous surveillance médicale (par exemple, brancard, table d'examen);
- à l'ensemble des exigences relatives aux LITS MEDICAUX avec une fonctionnalité spéciale.
Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement à un LIT MEDICAL ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois au LIT MEDICAL et aux SYSTEMES EM, selon le cas.
Les DANGERS inhérents à la fonction physiologique prévue du LIT MEDICAL ou des SYSTEMES EM compris dans le domaine d'application du présent document ne sont pas couverts par des exigences spécifiques dans le présent document, en dehors du 7.2.13 et du 8.4.1 de l'IEC 60601-1:2005, l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601-1:2005/AMD2:2020.
ICS: 11.140-Hospital equipment
CTN: TC 62/SC 62D - 1365

Otras Relaciones

Acuerdo de Frankfurt FprEN IEC 80601-2-52:2025

Reemplazo Normas

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