11/30193150 DC : 0

Superseded

View Superseded by

BS EN 60601-1:2006 AMD.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE

Available format(s)

Hardcopy , PDF

Superseded date

29-02-2012

Language(s)

English

Publisher

British Standards Institution

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

BS EN 60601-1:2006 AMD.1

Committee	CH/62/1
DocumentType	Draft
Pages	136
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN 60601-1 : 2006

IEC 80001-1:2010	Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
IEC 60245-1:2003+AMD1:2007 CSV	Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirements
ISO 7010:2011	Graphical symbols Safety colours and safety signs Registered safety signs
IEC TR 62354:2014	General testing procedures for medical electrical equipment
ISO 15001:2010	Anaesthetic and respiratory equipment Compatibility with oxygen
IEC 60825-1:2014	Safety of laser products - Part 1: Equipment classification and requirements
IEC 60601-2-22:2007+AMD1:2012 CSV	Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60851-5:2008+AMD1:2011 CSV	Winding wires - Test methods - Part 5: Electrical properties
IEC 60227-1:2007	Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements
ISO 11135-1:2007	Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
IEC 62304:2006+AMD1:2015 CSV	Medical device software - Software life cycle processes
IEC TR 60878:2015	Graphical symbols for electrical equipment in medical practice
IEC 61058-1:2016	Switches for appliances - Part 1: General requirements
IEC 60851-3:2009+AMD1:2013 CSV	Winding wires - Test methods - Part 3: Mechanical properties
ISO 80000-1:2009	Quantities and units — Part 1: General
ISO 13857:2008	Safety of machinery Safety distances to prevent hazard zones being reached by upper and lower limbs
IEC 62471:2006	Photobiological safety of lamps and lamp systems
IEC 62133 : 2.0EN+(REDLINE+VERSION)	SECONDARY CELLS AND BATTERIES CONTAINING ALKALINE OR OTHER NON-ACID ELECTROLYTES - SAFETY REQUIREMENTS FOR PORTABLE SEALED SECONDARY CELLS, AND FOR BATTERIES MADE FROM THEM, FOR USE IN PORTABLE APPLICATIONS
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 61010-1:2010+AMD1:2016 CSV	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 60695-1-10:2016	Fire hazard testing - Part 1-10: Guidance for assessing the fire hazard of electrotechnical products - General guidelines
IEC 60664-1:2007	Insulation coordination for equipment within low-voltage systems - Part 1: Principles, requirements and tests
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
IEC 60730-1:2013+AMD1:2015 CSV	Automatic electrical controls - Part 1: General requirements