International Standards and Conformity Assessment for all electrical, electronic and related technologies

 

Project

Reference prEN 60601-2-22:2007/FprA1
Title Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Project Number 23464
Abstract/Scope Applies to the basic safety and essential performance of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a class 3B or class 4 laser product as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as laser equipment. Throughout this International Standard, light emitting diodes (LED) are included whenever the word 'laser' is used. This standard can also be applied to surgical, cosmetic, therapeutic and diagnostic laser equipment used for compensation or alleviation of disease, injury or disability. This third edition cancels and replaces the second edition of IEC 60601-2-22, published in 1995. This edition constitutes a technical revision. This third edition takes account of the recently published new editions of the General Standard IEC 60601-1 and Group safety publication IEC 60825-1. Additionally, it addresses technical and safety issues which have arisen in the time following the previous second edition.
Status
Approval stage

Status

Current Stage code 5098
Current Stage code date 2012-11-29
Current Stage code deadline  
Deadline date for vote  

Legal

Directive(s) MDD (93/42/EEC)
Mandate(s)  
Order Voucher  

Details

IEC Technical Body IEC/TC 76
Reference Document IEC 60601-2-22:2007/A1:2012 (EQV)
ICS 11.040.01 - Medical equipment in general
31.260 - Optoelectronics. Laser equipment
Keywords Medical equipment; Laser; Surgical; Diagnostic; Therapeutic
Note D141/070: prEN 60601-2-22:2007 together with prEN 60601-2-22:2007/FprA1:2011 positively assessed
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
5098 2012-11-29    
5099 2012-11-16 2013-01-16  
5060 2011-09-12 2011-10-03 export to doc file  EN
5020 2011-04-08 2011-09-09  
1090 2011-04-05 2011-04-08  

Implementation Dates

date of Ratification (DOR) (1) 2012-11-16
date of Availability (DAV) (2)  
date of Announcement (DOA) (3) 2013-02-16
date of Publication (DOP) (4) 2013-08-16
date of Withdrawal (DOW) (5) 2015-11-16

Relations

Supersedes  
Superseded by  
Normative reference (6)  

(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved


(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat


(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level


(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement


(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn


(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.