EN 60601-1-4:1996/A1:1999
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
01-10-2006
09-12-1999
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Superseded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 |
| Standards | 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 |
| 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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