I.S. EN 60601-1:2006&A1:2013&AC:2014&A12:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
Hardcopy , PDF
English - French, English
01-01-2006
11-09-2026
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 Terminology and definitions
4 General requirements
5 General requirements for testing ME EQUIPMENT
6 Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification, marking and documents
8 Protection against electrical HAZARDS from ME EQUIPMENT
9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT
and ME SYSTEMS
10 Protection against unwanted and excessive radiation
HAZARDS
11 Protection against excessive temperatures and other
HAZARDS
12 Accuracy of controls and instruments and protection
against hazardous outputs
13 HAZARDOUS SITUATIONS and fault conditions for
ME EQUIPMENT
14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
(PEMS)
15 Construction of ME EQUIPMENT
16 ME SYSTEMS
17 Electromagnetic compatibility of ME EQUIPMENT and ME
SYSTEMS
Annex A (informative) - General guidance and rationale
Annex B (informative) - Sequence of testing
Annex C (informative) - Guide to marking and labeling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex E (informative) - Examples of the connection of the
measuring device (MD) for measurement of the PATIENT
LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT
Annex F (informative) - Suitable measuring supply circuits
Annex G (normative) - Protection against HAZARDS of ignition
of flammable anaesthetic mixtures
Annex H (informative) - PEMS structure, PEMS DEVELOPMENT
LIFE-CYCLE and documentation
Annex I (informative) - ME SYSTEMS aspects
Annex J (informative) - Survey of insulation paths
Annex K (informative) - Simplified PATIENT LEAKAGE
CURRENT diagrams
Annex L (normative) - Insulated winding wires for use without
interleaved insulation
Annex M (normative) - Reduction of pollution degrees
Bibliography
INDEX OF ABBREVIATIONS AND ACRONYMS
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZA (informative) - Coverage of Essential Requirements
of EC Directives
Annex ZZB (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable
Medical Devices
Renumber the note as Note 1. Delete the fourth paragraph. Replace the fifth paragraph with: The IEC 60601 series does not apply to: – in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61]; – implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or – medical gas pipeline systems covered by ISO 7396-1 [68].
| Committee |
CLC/TC 62
|
| DevelopmentNote |
Supersedes I.S. EN 60601-1-1 & I.S. EN 60601-1-4. (10/2013) 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
|
| ISBN |
978-2-83220-227-2
|
| Pages |
1082
|
| ProductNote |
THIS STANDARD ALSO REFERS TO IEC 60065+A1,IEC 60065+A2, IEC 60227-1+A1, IEC 60227-1+A2, IEC 60529+A1, IEC 60601-1-3+A1, IEC 60601-1-8+A1, IEC 60695-11-10+A1, IEC 60851-6+A1, IEC 61058-1+A1, IEC 61058-1+A2, ISO 10994-4, ISO 10994-4+A1, The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. CSV Version of this standard is now available.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 60601-1:2005 | Identical |
| NBN EN 60601-1 : 2007 AMD 2/COR 15 | Identical |
| BS EN 60601-1 : 2006 | Identical |
| EN 60601-1:2006 | Equivalent |
| NF EN 60601-1 : 2007-01 | Identical |
| DIN EN 60601-1 : 2010-05 | Identical |
A newer version of this standard is available.
View Current Edition
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.