Hivatkozási szám

MSZ EN IEC 60601-2-21:2021

Dokumentumazonosító

177851

Cím

Gyógyászati villamos készülékek. 2-21. rész: Csecsemőmelegítő hősugárzók alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-21:2020)

Angol cím

Medical electrical equipment. Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2020)

Alkalmazási terület

Clause 1 of the general standard1 applies, except as follows: 201.1.1 * Scope Replacement: This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT 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 ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT 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 the general standard. NOTE See also 4.2 of the general standard. This particular standard specifies the safety requirements for INFANT RADIANT WARMERS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device. This particular standard does not apply to: - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; - INFANT INCUBATORS; for information, see IEC 60601-2-19; - INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20; - INFANT PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for INFANT RADIANT WARMERS as defined in 201.3.204, which minimize HAZARDS to PATIENT and OPERATOR, and to specify tests by which compliance with the requirements can be verified. Túl hosszú scope

ICS

11.040.10 Altató-, érzéstelenítő-, lélegeztető- és újraélesztőberendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2021-12-01

Forrás

idt IEC 60601-2-21:2020; idt EN IEC 60601-2-21:2021

Előd

MSZ EN 60601-2-21:2009, MSZ EN 60601-2-21:2009/A11:2012, MSZ EN 60601-2-21:2009/A1:2017

Utód

Módosítás

SZK-közlemények

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