I.S. EN 60601-1-12:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT
Hardcopy , PDF
English
01-01-2015
29-09-2020
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.
FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 Classification of ME EQUIPMENT and ME SYSTEMS
6 ME EQUIPMENT identification, marking and documents
7 Protection against electrical HAZARDS from ME EQUIPMENT
8 Protection against excessive temperatures and other HAZARDS
9 Accuracy of controls and instruments and protection against
hazardous outputs
10 Construction of ME EQUIPMENT
11 Additional requirements for electromagnetic compatibility of
ME EQUIPMENT and ME 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 (informative) - Symbols on marking
Bibliography
Index of defined terms used in this collateral standard
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Annex ZZA (informative) - Coverage of Essential
Requirements of EU Directives
Annex ZZB (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, which are intended, as indicated in the instructions for use by their MANUFACTURER, for use in the EMS ENVIRONMENT (EMERGENCY MEDICAL SERVICES ENVIRONMENT).
| 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 |
116
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN 60601-1-12:2015 | Identical |
| BS EN 60601-1-12:2015 | Equivalent |
| UNE-EN 60601-1-12:2015 | Equivalent |
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