Hivatkozási szám

MSZ EN 60601-2-39:2008

Dokumentumazonosító

146485

Cím

Gyógyászati villamos készülékek. 2-39. rész. Peritoneális dializálókészülékek alapvető biztonsági és működési követelményei (IEC 60601-2-39:2007)

Angol cím

Medical electrical equipment. Part 2-39. Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2007)

Alkalmazási terület

Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment. 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 standard can also be applied to PD EQUIPMENT used for compensation or alleviation of disease, injury or disability. These particular requirements do not apply to the DIALYSING SOLUTION, or the DIALYSING SOLUTION CIRCUIT. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for PD EQUIPMENT as defined in 201.3.208. 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 2 of this particular standard. The requirements of IEC 60601-1-3 and IEC 60601-1-8 do not apply to this standard. Túl hosszú scope

ICS

11.040.99 Egyéb orvostechnikai berendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2008-11-01

A visszavonás napja

2022-05-24

Forrás

idt EN 60601-2-39:2008; idt IEC 60601-2-39:2007

Előd

MSZ EN 60601-2-39:1999

Utód

MSZ EN IEC 60601-2-39:2020

Módosítás

MSZ EN 60601-2-39:2008/A11:2012

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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