Hivatkozási szám

MSZ EN IEC 60601-2-22:2021

Dokumentumazonosító

177152

Cím

Gyógyászati villamos készülékek. 2-22. rész: Sebészeti, kozmetikai, terápiás és diagnosztikai lézerberendezések alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-22:2019)

Angol cím

Medical electrical equipment. Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (IEC 60601-2-22:2019)

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 laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as LASER PRODUCT of CLASS 1C where the ENCLOSED LASER is of CLASS 3B or 4, or CLASS 3B, or CLASS 4. MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS which incorporate lasers as sources of energy being transferred to the PATIENT or animal and where the lasers are specified as above, are referred to as “laser equipment” in this document. NOTE 1 LASER PRODUCTS for these applications classified as a Class 1, Class 1M, CLASS 2, Class 2M or CLASS 3R LASER PRODUCT, are covered by IEC 60825-1:2014 and by the general standard. 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 to ME EQUIPMENT and to ME SYSTEMS, as relevant. Hazards inherent in the intended physiological function of laser equipment within the scope of this document are not covered by specific requirements in this document except in 7.2.13, Physiological effects, of the general standard. NOTE 2 See also 4.2, RISK MANAGEMENT process, of the general standard. NOTE 3 If the laser equipment is CLASS 1C according to IEC 60825-1:2014 and is used as a laser appliance in a household, it is covered by IEC 60335-2-113:2016. 201.1.2 Object Replacement: The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for the safety of surgical, cosmetic, therapeutic and diagnostic laser equipment. 201.1.3 Collateral standards Addition: This document refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this document. 201.1.4 Particular standards Addition: For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this document as "the general standard". Collateral standards are referred to by their document number. The numbering of sections, clauses and subclauses of this document corresponds to that of the general standard or applicable collateral standard. 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 document. "Addition" means that the text of this document 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 document. 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 document" is used to make reference to the general standard, any applicable collateral standards and this document taken together. Where there is no corresponding section, clause or subclause in this document, the section, 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 document. Concerning laser radiation safety of laser equipment, IEC 60825-1:2014 applies, except for the relevant requirements that are specified, changed or amended in this document.

ICS

11.040.01 Orvostechnikai berendezések általában

11.040.50 Röntgenkészülékek

11.040.60 Terápiás berendezések

31.260 Optoelektronika. Lézerberendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2021-07-01

Forrás

idt EN IEC 60601-2-22:2020; idt IEC 60601-2-22:2019

Előd

MSZ EN 60601-2-22:2013

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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