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BS EN 60601-2-22:2013

$142.49

Medical electrical equipment – Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

Published By Publication Date Number of Pages
BSI 2013 32
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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.

PDF Catalog

PDF Pages PDF Title
8 English
CONTENTS
9 INTRODUCTION
10 201.1 Scope, object and related standards
12 201.2 Normative references
201.3 Terms and definitions
14 201.4 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
16 201.8 Protection against electrical hazards from me equipment
17 201.9 Protection against mechanical hazards of me equipment and me systems
201.10 Protection against unwanted and excessive radiation hazards
18 201.11 Protection against excessive temperatures and other hazards
19 201.12 Accuracy of controls and instruments and protection against hazardous outputs
20 201.13 Hazardous situations and fault conditions
21 201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
22 201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
Annexes
Annex D (informative) Symbols on marking
Table D.1 – General symbols
25 Annex AA (informative) Particular guidance and rationale
27 Bibliography
BS EN 60601-2-22:2013
$142.49