I.S. EN 60601-1-12:2015/A1:2020
Current
The latest, up-to-date edition.
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
21-09-2020
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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
ME EQUIPMENT and ME SYSTEMS
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
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, which are intended, as indicated in the instructions for use by their MANUFACTURER, for use in the EMS ENVIRONMENT (EMERGENCY MEDICAL SERVICES ENVIRONMENT), as defined in 3.1.
| Committee |
SC 62A
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-1654-5
|
| Pages |
136
|
| ProductNote |
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS TO :EN 1789:2007,EN 13718-1
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IEC 60601-1-12:2014/AMD1:2020 | Identical |
| EN 60601-1-12:2015/A1:2020 | Identical |
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