Hivatkozási szám

MSZ EN IEC 60601-2-19:2021

Dokumentumazonosító

177850

Cím

Gyógyászati villamos készülékek. 2-19. rész: Csecsemőinkubátorok alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-19:2020)

Angol cím

Medical electrical equipment. Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2020)

Alkalmazási terület

Clause 1 of the general standard^1ˇ applies, except as follows: 201.1.1 * Scope Replacement: This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209, 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 safety requirements for INFANT INCUBATORS, 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: – INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20 [1]^2ˇ; – INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [2]; – devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35 [3]; – INFANT PHOTOTHERAPY EQUIPMENT; for information see IEC 60601-2-50 [4]. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED INCUBATOR 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 INCUBATORS as defined in 201.3.209, which minimize HAZARDS to PATIENT and OPERATOR, and to specify tests by which compliance with the requirements can be verified. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-2:2014 applies as modified in Clause 202. IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. 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 EN IEC 60601-2-19:2021; idt IEC 60601-2-19:2020

Előd

MSZ EN 60601-2-19:2009, MSZ EN 60601-2-19:2009/A11:2012, MSZ EN 60601-2-19:2009/A1:2017

Utód

Módosítás

MSZ EN IEC 60601-2-19:2021/A1:2024

Kiegészítő információk

SZK-közlemények

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