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IEC 80601-2-89-ed.1.0
Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children
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STANDARD published on 4.12.2025
The information about the standard:
Designation standards: IEC 80601-2-89-ed.1.0
Publication date standards: 4.12.2025
SKU: NS-1252517
The number of pages: 109
Approximate weight : 358 g (0.79 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 80601-2-89-ed.1.0 :
IEC 80601-2-89:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.219, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201). This document applies to both electrical and non-electrical(manual) MEDICAL BEDS with or without adjustable functions. This document applies to MEDICAL BEDS with an INTERNAL LENGTH of up to 180 cm suitable to a body length of 155 cm. If a MANUFACTURER wishes to make a bed that can be used by both a CHILD and an ADULT, e.g. INTERNAL LENGTH of 180 cm or more, then IEC 80601-2-52 and this document apply. This document does not apply to: • ADULT only beds covered by IEC 80601-2-52; • SPECIALITY MATTRESS covered by the ISO 20342 series; • incubators covered by IEC 60601-2-19; • devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table). 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 BEDS and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of MEDICAL BEDS or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1. LIEC 80601-2-89:2025 sapplique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des LITS MEDICAUX, designes ci-apres LITS MEDICAUX tels que definis en 201.3.219, destines aux ENFANTS tels que definis au 201.3.219, et aux ADULTES qui presentent une anatomie atypique (ADULTES qui ne relevent pas de la definition propre aux ADULTES au 201.3.201). Le present document sapplique aux LITS MEDICAUX electriques et non electriques (manuels) avec ou sans fonctions reglables. Le present document sapplique aux LITS MEDICAUX de LONGUEUR INTERNE maximale de 180 cm adaptes a une longueur du corps (taille) de 155 cm. Si un FABRICANT souhaite proposer un lit qui puisse etre utilise a la fois par un ENFANT et par un ADULTE, par exemple un lit dune LONGUEUR INTERNE de 180 cm ou plus, alors lIEC 80601 2 52 et le present document doivent sappliquent. Le present document ne sapplique pas aux: • LITS MEDICAUX destines uniquement aux ADULTES couverts par lIEC 80601-2-52; • MATELAS THERAPEUTIQUES couverts par la serie ISO 20342; • incubateurs couverts par lIEC 60601-2-19; • dispositifs pour lesquels lUTILISATION PREVUE est principalement lexamen ou le transport sous surveillance medicale (par exemple, brancard, table dexamen). Si un article ou un paragraphe est specifiquement destine a etre applicable uniquement a un LIT MEDICAL ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe lindiquent. Si cela nest pas le cas, larticle ou le paragraphe sapplique a la fois aux LITS MEDICAUX et aux SYSTEMES EM, selon le cas. Les DANGERS inherents a la fonction physiologique prevue des APPAREILS EM ou des SYSTEMES EM compris dans le domaine dapplication du present document ne sont pas couverts par des exigences specifiques dans le present document, en dehors de lIEC 60601-1:2005, lIEC 60601-1:2005/AMD1:2012 et lIEC 60601-1:2005/AMD2:2020, 7.2.13 et 8.4.1.
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