I.S. EN 60601-1-2:2015/A1:2021
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014/A1:2020)
Hardcopy , PDF
English
07-04-2021
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CONTENTS
FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT and ME SYSTEMS identification, marking and documents
6 Documentation of the tests
7 ELECTROMAGNETIC EMISSIONS requirements for ME EQUIPMENT and ME SYSTEMS
8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS
9 * Test report
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) Guidance in classification according to CISPR 11
Annex D (informative) Guidance in the application of IEC 60601-1-2 to particular standards
Annex E (informative) Determination of IMMUNITY TEST LEVELS for SPECIAL ENVIRONMENTS
Annex F (informative) RISK MANAGEMENT for BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to ELECTROMAGNETIC DISTURBANCES
Annex G (informative) Guidance: Test plan
Annex H (informative) PATIENT-coupled cables EMISSIONS
Annex I (informative) Identification of IMMUNITY pass/fail criteria
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 |
TC 62
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-8630-2
|
| Pages |
248
|
| ProductNote |
This standard is also refers as IEC/TR 60788, IEC/TR 61000-1-1, ISO 17025, ANSI C63.7 The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IEC 60601-1-2:2014/AMD1:2020 | Identical |
| EN 60601-1-2:2015/A1:2021 | Identical |
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