CEI EN 60601-1-2 : 2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
01-04-2016
24-01-2019
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.
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-50 (08/2001) 3ED 2010 Edition is valid until 31-12-2018. (05/2016) Italian translation of 4ED 2016 Issued on 01/01/2018. (02/2018)
|
| DocumentType |
Standard
|
| Pages |
104
|
| ProductNote |
New child AMD 1 2021 is now added
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 60601-1-2:2014 | Identical |
| EN 60601-1-2:2015 | Identical |
| IEC 60601-1-2:2007 | Identical |
A newer version of this standard is available.
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