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I.S. EN 60601-1-12:2015

Superseded

Superseded

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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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Superseded date

09-29-2020

US$88.62
Excluding Tax where applicable
Summarise this standard

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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
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
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZZA (informative) - Coverage of Essential
          Requirements of EU Directives
Annex ZZB (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, which are intended, as indicated in the instructions for use by their MANUFACTURER, for use in the EMS ENVIRONMENT (EMERGENCY MEDICAL SERVICES ENVIRONMENT).

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
116
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

Standards Relationship
EN 60601-1-12:2015 Identical
BS EN 60601-1-12:2015 Equivalent
UNE-EN 60601-1-12:2015 Equivalent

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US$88.62
Excluding Tax where applicable