Hivatkozási szám

MSZ EN IEC 80601-2-77:2022

Dokumentumazonosító

178414

Cím

Gyógyászati villamos készülékek. 2-77. rész: Robotokkal támogatott sebészeti készülékek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 80601-2-77:2019)

Angol cím

Medical electrical equipment. Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (IEC 80601-2-77:2019)

Alkalmazási terület

Clause 1 of the general standard3 applies, except as follows: 201.1.1 Scope Replacement: This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS. 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. If RASE or RASS, or its ACCESSORIES fall within scope of another particular standard, then the particular standard applies in addition to this standard. EXAMPLES IEC 60601-2-2[3] for HF SURGICAL EQUIPMENT; IEC 60601-2-18[4] for ENDOSCOPIC EQUIPMENT; IEC 60601-2-22[5] for laser equipment; IEC 60601-2-37[6] for ultrasound equipment; IEC 60601-2-46[7] for operating tables, etc. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ROBOTICALLY ASSISTED SURGICAL EQUIPMENT and ROBOTICALLY ASSISTED SURGICAL SYSTEMS. 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 and IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013 apply as modified in Clauses 202 and 206 respectively. IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013[8], IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013[9], and IEC 60601-1-11:2015[10] do not apply. 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. 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 document 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 IEC 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 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, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc. Subclauses, figures or tables 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 document" 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

11.040.30 Sebészeti műszerek és anyagok

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2022-04-01

Forrás

idt EN IEC 80601-2-77:2021; idt IEC 80601-2-77:2019

Előd

Utód

Módosítás

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

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