I.S. EN 60601-1-8:2007
Superseded
View Superseded by
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
Hardcopy , PDF
English
01-01-2007
04-09-2020
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.
National Foreword
FOREWORD
INTRODUCTION TO THE AMENDMENT
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
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) - Coverage of Essential Requirements
of EU Directives
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
| DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
170
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 60601-1-8:2006 | Identical |
| BS EN 60601-1-8 : 2007 | Identical |
| EN 60601-1-8:2007 | Equivalent |
| DIN EN 60601-1-8 : 2014 AMD 11 2018 | Identical |
| NF EN 60601-1-8 : 2007 AMD 11 2018 | Identical |
| UNE-EN 60601-1-8:2008 | Identical |
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