IEC 60601-2-22:2007+AMD1:2012 CSV
Superseded
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Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Hardcopy , PDF
English - French
26-10-2012
03-05-2022
FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT
and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
HAZARDS
201.11 Protection against excessive temperatures and other
HAZARDS
201.12 Accuracy of controls and instruments and protection
against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and
ME SYSTEMS
Annexes
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
IEC 60601-2-22:2007+A1:2012 applies to the 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 publication IEC 60825-1. Additionally, it addresses technical and safety issues which have arisen in the time following the previous second edition.
This consolidated version consists of the third edition (2007) and its amendment 1 (2012). Therefore, no need to order amendment in addition to this publication.
| Committee |
TC 76
|
| DevelopmentNote |
Stability Date: 2017. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
53
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBR IEC 60601-2-22 : 2014 | Identical |
| NF EN 60601-2-22:2020 | Identical |
| DIN EN IEC 60601-2-22:2022-10 | Identical |
| OVE/ONORM EN 60601-2-22 : 2015 | Identical |
| GOST IEC 60601-2-22 : 2011 | Identical |
| NEN EN IEC 60601-2-22 : 2013 | Identical |
| PN EN 60601-2-22 : 2013 | Identical |
| AS IEC 60601.2.22:2014 | Identical |
| DIN EN 60601-2-22 : 2015 | Identical |
| IS 13450 : Part 2 : Sec 22 : 2019 | Identical |
| BS EN 60601-2-22:2013 | Identical |
| CEI EN 60601-2-22 : 2014 | Identical |
| EN 60601-2-22:2013 | Identical |
| NF EN 60601-2-22:2013 | Identical |
| NEN 10601-2-22 : 1996 | Identical |
| VDE 0750-2-22 : 2015 | Identical |
| GOST R IEC 60601-2-22 : 2008 | Identical |
| UNE-EN 60601-2-22:1997 | Identical |
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