I.S. EN 60601-1-8:2007/A2:2021
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)
Hardcopy , PDF
English
02-08-2021
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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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