Hivatkozási szám

MSZ EN 60601-2-50:2009

Dokumentumazonosító

147994

Cím

Gyógyászati villamos készülékek. 2-50. rész: Csecsemő-fényterápiás készülékek alapvető biztonsági és lényeges teljesítőképességi követelményei (IEC 60601-2-50:2009)

Angol cím

Medical electrical equipment. Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (IEC 60601-2-50:2009)

Alkalmazási terület

Clause 1 of the general standard1) applies, except as follows: 201.1.1 * Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203 of this standard, 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 standard are not covered by specific requirements in this standard 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 PHOTOTHERAPY EQUIPMENT, 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 80601-2-35; – INFANT INCUBATORS; for information see IEC 60601-2-19; – INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20; – INFANT RADIANT WARMERS; for information see IEC 60601-2-21. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for INFANT PHOTOTHERAPY EQUIPMENT (as defined in 201.3.203), which reduce the safety HAZARDS to PATIENTS and OPERATORS as much as possible and to specify tests for demonstrating compliance with these requirements. Túl hosszú

ICS

11.040.60 Terápiás berendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2009-08-01

A visszavonás napja

2024-07-16

Forrás

idt EN 60601-2-50:2009; idt IEC 60601-2-50:2009

Előd

MSZ EN 60601-2-50:2002

Utód

MSZ EN IEC 60601-2-50:2021

Módosítás

MSZ EN 60601-2-50:2009/A11:2012, MSZ EN 60601-2-50:2009/A1:2017

Kiegészítő információk

SZK-közlemények

Kapcsolódó európai jogszabály

93/42/EGK A TANÁCS 93/42/EGK IRÁNYELVE (1993. június 14.) az orvostechnikai eszközökről (MDV93)

A szabvány

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