11/30193150 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
BS EN 60601-1:2006 AMD.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
Hardcopy , PDF
29-02-2012
English
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
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
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 G (normative) - Protection against HAZARDS of ignition of
flammable anaesthetic mixtures
Annex H (informative) - PEMS structure, PEMS DEVELOPMENT
LIFE-CYCLE and documentation
Annex J (informative) - Survey of insulation paths
Annex L (normative) - Insulated winding wires for use without
interleaved insulation
Annex M (normative) - Reduction of pollution degrees
Annex N (Informative) - Routine testing
Bibliography
INDEX OF ABBREVIATIONS AND ACRONYMS
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