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I.S. EN IEC 60601-2-22:2020

Current
Current

The latest, up-to-date edition.

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)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

11-16-2020

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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 for ME EQUIPMENT
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

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.

Committee
TC 76
DocumentType
Standard
ISBN
978-2-8322-7586-3
Pages
76
ProductNote
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
IEC 60601-2-22:2019 Identical
EN IEC 60601-2-22:2020 Identical

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