Hivatkozási szám

MSZ EN IEC 60601-2-31:2020

Dokumentumazonosító

175992

Cím

Gyógyászati villamos készülékek. 2-31. rész: Belső tápforrású, külső szívritmus-szabályozók alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-31:2020)

Angol cím

Medical electrical equipment. Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source (IEC 60601-2-31:2020)

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 EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT 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 document does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for EXTERNAL PACEMAKERS as defined in 201.3.205. 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 does not apply. All other published collateral standards in the IEC 60601-1 series apply as published. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this particular standard as the general standard. Túl hosszú scope

ICS

11.040.01 Orvostechnikai berendezések általában

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2020-11-01

Forrás

idt EN IEC 60601-2-31:2020; idt IEC 60601-2-31:2020

Előd

MSZ EN 60601-2-31:2009, MSZ EN 60601-2-31:2008/A1:2012

Utód

Módosítás

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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