I.S. EN 60601-1-2:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
Hardcopy , PDF
English
01-01-2015
12-04-2021
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
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
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Annex ZZ (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.
| 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 |
208
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 60601-1-2:2016 | Identical |
| EN 60601-1-2:2015 | Identical |
| BS EN 60601-1-2:2015 | Identical |
| DIN EN 60601-1-2 : 2006-10 | Identical |
| UNE-EN 60601-1-2:2008 | Identical |
| UNE-EN 60601-1-2:2015 | Equivalent |
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