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
04-07-2021
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
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