I.S. EN 60601-1:2006/A2:2021
Current
The latest, up-to-date edition.
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
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 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
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