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EN 60601-1-4:1996/A1:1999

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS

Amendment of

EN 60601-1-4:1996

Superseded date

01-10-2006

Superseded by

EN 60601-1:2006/A12:2014

Published date

09-12-1999

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INTRODUCTION
SECTION 1: GENERAL
1 Scope, object and relationship to other standards
    1.201 Scope
    1.202 Object
    1.203 Relationship to other standards
2 Terminology and definitions
    2.201 Defined terms
    2.202 Degrees of requirements and miscellaneous terms
6 Identification, marking and documents
    6.8 ACCOMPANYING DOCUMENTS
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS:
           ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
    52.201 Documentation
    52.202 RISK management plan
    52.203 DEVELOPMENT LIFE-CYCLE
    52.204 RISK management process
    52.205 Qualification of personnel
    52.206 Requirement specification
    52.207 Architecture
    52.208 Design and implementation
    52.209 VERIFICATION
    52.210 VALIDATION
    52.211 Modification
    52.212 Assessment
Table DFDD.1 - Suggested correlation of the documentation
requirement to the DEVELOPMENT LIFE-CYCLE PHASES
Figures
201 Content of RISK MANAGEMENT FILE and RISK
             MANAGEMENT SUMMARY
CCC.1 Risk chart
CCC.2 RISK management process
DDD.1 DEVELOPMENT LIFE-CYCLE model for PEMS
EEE.1 Examples of PEMS/PESS structures
Annexes
AAA Terminology - Index of defined terms
BBB Rationale
CCC RISK concepts
DDD DEVELOPMENT LIFE-CYCLE model
EEE Examples for PEMS/PESS structures
FFF Bibliography

Applicable to the safety of medical electrical equipment and medical electrical systems including programmable electronic subsystems (PEMS). Defines requirements for the design process of PEMS and is also the basis of requirements of Particular Standards, which includes serving as a guide to safety requirements for managing and reducing risk.

Committee
TC 62
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy

BS EN 60601-2-51:2003 Medical electrical equipment. Particular requirements for safety Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
BS EN 60601-2-30:2000 Medical electrical equipment. Particular requirements for safety Particular requirements for safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
UNE-EN 60645-6:2010 Electroacoustics - Audiometric equipment -- Part 6: Instruments for the measurement of otoacoustic emissions
S.R. CR 13694:1999 HEALTH INFORMATICS - SAFETY AND SECURITY RELATED SOFTWARE QUALITY STANDARDS FOR HEALTHCARE (SSQS)
ISO/IEEE 11073-00103:2015 Health informatics Personal health device communication Part 00103: Overview
CR 13694:1999 Health Informatics - Safety and Security Related Software Quality Standards for Healthcare (SSQS)
EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
EN 60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
EN 60645-5:2005 Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance
DIN EN 60601-2-30 : 2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT
BS EN 60601-2-38:1997 Medical electrical equipment. Particular requirements for safety Particular requirements for the safety of electrically operated hospital beds
BS EN 60645-6:2010 Electroacoustics. Audiometric equipment Instruments for the measurement of otoacoustic emissions
BS 5724-2.38(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
CEI EN 60645-1 : 2016 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AUDIOMETRY
CEI EN 62274 : 2005 MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS
PD CR 13694:1999 Health informatics. Safety and security related software quality standards for healthcare (SSQS)
I.S. EN 60645-6:2010 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS
DIN EN 1640:2010-02 Dentistry - Medical devices for dentistry - Equipment
BS EN 1640:2009 Dentistry. Medical devices for dentistry. Equipment
I.S. EN 1640:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
UNE-EN 62304:2007 Medical device software - Software life-cycle processes (IEC 62304:2006)
BS EN 60601-2-12:2006 Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators
03/317861 DC : DRAFT OCT 2003 EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
CEI EN 60601-2-12 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
I.S. EN 60601-1-1:2001 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
UNI EN 1640 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
08/30184608 DC : DRAFT SEP 2008 BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
I.S. EN ISO 11073-00103:2017 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
CEI EN 60645-6 : 2013 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS
BS ISO/IEEE 11073-00103 : 2015 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW
I.S. EN 62274:2005 MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS
EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
BS EN 62274:2005 Medical electrical equipment. Safety of radiotherapy record and verify systems
BS EN ISO 11073-00103:2017 Health informatics. Personal health device communication Overview
BS 5724-2.18(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ENDOSCOPIC EQUIPMENT
12/30258453 DC : 0 BS EN 62368-1 AMD - AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS
CEI EN 60601-1-1 : 2003 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
I.S. EN 60601-2-12:2006 MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
BS EN 12523:1999 External limb prostheses and external orthoses. Requirements and test methods
EN ISO 11073-00103:2017 Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)
EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment
CEI EN 60645-5 : 2006 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 5: INSTRUMENTS FOR THE MEASUREMENT OF AURAL ACOUSTIC IMPEDANCE/ADMITTANCE
IEEE 11073-00103-2012 Health informatics - Personal health device communication Part 00103: Overview
I.S. EN 60645-5:2005 ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 5: INSTRUMENTS FOR THE MEASUREMENT OF AURAL ACOUSTIC IMPEDANCE/ADMITTANCE
BS EN 62304 : 2006 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
I.S. EN 60601-2-38:1998 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
I.S. EN 60601-2-51:2003 MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS
EN 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems
EN 60601-2-38:1996/A1:2000 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS
EN 60601-2-30:2000 Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
EN 12523 : 1999 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
EN 60601-2-12:2006 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
EN 60645-6:2010 Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
ISO 9001:2015 Quality management systems — Requirements
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
ISO 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software

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