I.S. EN 60601-1-8:2007/A11:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
10-08-2021
English - French
28-03-2017
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.
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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
Index of defined terms used in this collateral standard
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 |
CLC/TC 62
|
| DocumentType |
Standard
|
| ISBN |
978-2-83220-442-9
|
| Pages |
246
|
| ProductNote |
THIS STANDARD ALSO REFERS TO IEC 60417, CEI 60417, CEI 60601-1:2005, CEI 60601-1:2005Amendement 1:2012, AAMI EC57-293. The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 60601-1-8:2006/AMD1:2012 | Identical |
| EN 60601-1-8:2007/A11:2017 | Identical |
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