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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Available format(s):

Superseded date: 01-10-2006

Language(s):

Published date: 09-12-1999

Publisher: European Committee for Standards - Electrical

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Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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.

General Product Information - (Show below) - (Hide below)

Committee	TC 62
Document Type	Standard
ISBN
Pages
Published
Publisher	European Committee for Standards - Electrical
Status	Superseded
Superseded By	EN 60601-1:2006/A12:2014

National Adoptions - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
IEC 60601-1-4:1996+AMD1:1999 CSV	Identical
NF EN 60601-1-4 : 1999 AMD 1 2005	Identical
NBN EN 60601 1-4 : 1997 AMD 1 2000	Identical
NEN EN IEC 60601-1-4 : 1996 AMD 1 2000	Identical
I.S. EN 60601-1-4:1998	Identical
PN EN 60601-1-4 : 2006	Identical
SN EN 60601-1-4 : 1996 AMD 1 1999	Identical
VDE 0750-1-4 : 2001	Identical
CEI EN 60601-1-4/A1:2000	Identical
UNE-EN 60601-1-4:1997	Identical
BS 5724-1.4(1997) : 1997	Identical
BS EN 60601-1-4:1997	Identical
DIN EN 60601-1-4 : 2001-04	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

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

Standards Referencing This Book - (Show below) - (Hide below)

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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