04/30106146 DC : DRAFT MARCH 2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
11-30-2006
11-23-2012
FOREWORD
INTRODUCTION
1. Scope, object and related standards
1.1 Scope
1.2 Object
1.3 Particular standards
1.4 Collateral standards
2. Normative references
3. Terminology and definitions
4. General requirements
4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS
4.2 RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS
4.3 ESSENTIAL PERFORMANCE
4.4 EXPECTED SERVICE LIFE
4.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS
4.6 ME EQUIPMENT or ME SYSTEMS parts that contact the PATIENT
4.7 NORMAL CONDITION and SINGLE FAULT CONDITION for
ME EQUIPMENT
4.8 Components of ME EQUIPMENT
4.9 Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in
ME EQUIPMENT
4.10 Power supply
4.11 Power input
5. General requirements for testing ME EQUIPMENT
5.1 TYPE TESTS
5.2 Number of samples
5.3 Ambient temperature, humidity, atmospheric pressure
5.4 Other conditions
5.5 Supply voltages, type of current, nature of supply,
frequency
5.6 Repairs and modifications
5.7 Humidity preconditioning treatment
5.8 Sequence of tests
5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS
6. Classification of ME EQUIPMENT and ME SYSTEMS
6.1 General
6.2 Protection against electric shock
6.3 Protection against harmful ingress of water or
particulate matter
6.4 Method(s) of sterilization
6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT
6.6 Mode of operation
7, ME EQUIPMENT identification, marking and documents
7.1 General
7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
7.4 Marking of controls and instruments
7.5 Safety signs
7.6 Symbols
7.7 Colours of the insulation of conductors
7.8 Indicator lights and controls
7.9 ACCOMPANYING DOCUMENTS
8. Protection against electrical HAZARDS from ME EQUIPMENT
8.1 Fundamental rule of protection against electric shock
8.2 Requirements related to power sources
8.3 Classification of APPLIED PARTS
8.4 Limitation of voltage, current or energy
8.5 Separation of parts
8.6 Protective earthing, functional earthing and
potential equalization of ME EQUIPMENT
8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
8.8 Insulation
8.9 CREEPAGE DISTANCES and AIR CLEARANCES
8.10 Components and wiring
8.11 MAINS PARTS, components and layout
9. Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS
9.1 MECHANICAL HAZARDS of ME EQUIPMENT
9.2 HAZARDS associated with moving parts
9.3 HAZARD associated with surfaces, corners and edges
9.4 Instability HAZARDS
9.5 Expelled parts HAZARD
9.6 Noise, vibration and acoustic energy (including
infra- and ultrasound)
9.7 Pressure vessels and parts subject to pneumatic
and hydraulic pressure
9.8 HAZARDS associated with support systems
10. Protection against unwanted and excessive radiation HAZARDS
10.1 X-Radiation
10.2 Alpha, beta, gamma, neutron radiation and other
particle radiation
10.3 Microwave radiation
10.4 Lasers and laser light emitting diodes
10.5 Other visual electromagnetic radiation
10.6 Infrared radiation
10.7 Ultraviolet radiation
11. Protection against excessive temperatures and other HAZARDS
11.1 Excessive temperatures in ME EQUIPMENT
11.2 Fire prevention
11.3 Constructional requirements for fire ENCLOSURES OF
ME EQUIPMENT
11.4 ME EQUIPMENT and ME SYSTEMS intended for use with
flammable anaesthetics
11.5 ME EQUIPMENT and ME SYSTEMS intended for use in
conjunction with flammable agents
11.6 Overflow, spillage, leakage, ingress of water,
cleaning, disinfection, sterilization and
compatibility with substances used with the ME
EQUIPMENT
11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS
11.8 Interruption of the power supply/SUPPLY
MAINS to ME EQUIPMENT
12. Accuracy of controls and instruments and protection
against hazardous outputs
12.1 Accuracy of controls and instruments
12.2 USABILITY
12.3 Alarm systems
12.4 Protection against hazardous output
13. Hazardous situations and fault conditions
13.1 Specific hazardous situations
13.2 SINGLE FAULT CONDITIONS
14. PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
14.1 General
14.2 Documentation
14.3 RISK MANAGEMENT plan
14.4 PEMS DEVELOPMENT LIFE-CYCLE
14.5 Problem resolution
14.6 RISK MANAGEMENT PROCESS
14.7 Requirement Specification
14.8 Architecture
14.9 Design and implementation
14.10 VERIFICATION
14.11 PEMS VALIDATION
14.12 Modification
14.13 Connection of PEMS by NETWORK/DATA COUPLING to
other equipment
15. Construction of ME EQUIPMENT
15.1 Arrangements of controls and indicators of ME EQUIPMENT
15.2 Serviceability
15.3 Mechanical strength
15.4 ME EQUIPMENT components and general assembly
15.5 MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and
transformers providing separation in accordance
with 8.5
16. ME SYSTEMS
16.1 General requirements for the ME SYSTEMS
16.2 ACCOMPANYING DOCUMENTS of an ME SYSTEM
16.3 Power supply
16.4 ENCLOSURES
16.5 SEPARATION DEVICES
16.6 LEAKAGE CURRENTS
16.7 Protection against MECHANICAL HAZARDS
16.8 Interruption of the power supply to parts of an ME SYSTEM
16.9 ME SYSTEM connections and wiring
17. Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
ANNEXES
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 structures, 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
Index of defined terms
Index of abbreviations and acronyms
Editing notes for the second CDV
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