I.S. EN 60601- 1:2006&A1:2013&A12:2014&A2:2021
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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: General requirements for basic safety and essential performance (IEC 60601-1:2005/A2:2020)
Hardcopy , PDF
English
27-10-2021
11-09-2026
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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 46
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
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 labelling 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
Bibliography
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 |
TC 62
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-8632-6
|
| Pages |
1148
|
| ProductNote |
This standard is also refer to :IEC 60878,ISO 31,ISO 7000-DB,ISO 10993 The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 60601-1:2005 | Identical |
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