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I.S. EN 60601-1-8:2007/A2:2021

Current

Current

The latest, up-to-date edition.

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2006/A2:2020)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

02-08-2021

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
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT identification marking and documents
6 ALARM SYSTEMS
Annex A (informative) General guidance and rationale
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS
Annex C (normative) Symbols on marking
ANNEX D (informative) Guidance for auditory ALARM SIGNALS
ANNEX E (informative) Verbal ALARM SIGNALS
ANNEX F (normative) * Reserved melodies for ALARM SIGNALS
Bibliography

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

Committee
TC 62
DocumentType
Standard
ISBN
978-2-8322-8631-9
Pages
312
ProductNote
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
This standard is also refers to AAMI TIR 66,AAMI EC57-293
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
IEC 60601-1-8:2006/AMD2:2020 Identical
EN 60601-1-8:2007/A2:2021 Identical

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