Hivatkozási szám

MSZ EN 60601-2-31:2009

Dokumentumazonosító

147086

Cím

Gyógyászati villamos készülékek. 2-31. rész: Belső tápforrású, külső szívritmus-szabályozók alapvető biztonsági és működési követelményei (IEC 60601-2-31:2008)

Angol cím

Medical electrical equipment. Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power cource (IEC 60601-2-31:2008)

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 EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This standard applies to PATIENT CABLES as defined in 201.3. 109. 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 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 does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1 This standard does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This standard 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. 103. 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. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in e general 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 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words: "Replacement" means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard. "Addition" means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard. "Amendment" means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard. Subclauses or figures which are additional to those of the general standard are numbered starting from 201.101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc. The term "this standard" is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.

ICS

11.040.01 Orvostechnikai berendezések általában

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2009-03-01

A visszavonás napja

2023-04-03

Forrás

idt EN 60601-2-31:2008; idt IEC 60601-2-31:2008

Előd

MSZ EN 60601-2-31:2002

Utód

MSZ EN IEC 60601-2-31:2020

Módosítás

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

Kiegészítő információk

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