ISO 14708-1:2014
Current
Current
The latest, up-to-date edition.
Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
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Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English
Published date
11-08-2014
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ISO 14708-1:2014 specifies requirements that are generally applicable to active implantable medical devices.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an active implantable medical device to show compliance.
ISO 14708-1:2014 is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs).
ISO 14708-1:2014 is also applicable to some non-implantable parts and accessories of the active implantable medical devices.
| Committee |
ISO/TC 150/SC 6
|
| DevelopmentNote |
Supersedes ISO/DIS 14708-1. (08/2014)
|
| DocumentType |
Standard
|
| Pages |
57
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ANSI/AAMI/ISO 14708-1:2014 | Identical |
| NEN ISO 14708-1 : 2014 | Identical |
| AS ISO 14708.1:2015 | Identical |
| IS/ISO 14708 : Part 1 : 2019 | Identical |
| BIS IS/ISO 14708-1 : 2000 | Identical |
| GOST R ISO 14708-1 : 2012 | Identical |
| BS EN 60601-2-31 : 2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| ANSI/AAMI CI86:2017 | COCHLEAR IMPLANT SYSTEMS: REQUIREMENTS FOR SAFETY, FUNCTIONAL VERIFICATION, LABELING AND RELIABILITY REPORTING |
| CAN/CSA-ISO/TS 16775:17 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15) |
| S.R. CEN ISO/TS 16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014) |
| I.S. EN 60601-2-31:2008 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| CSA ISO/IEC TR 20017:14 (R2019) | Information technology - Radio frequency identification for item management - Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators (Adopted ISO/IEC TR 20017:2011, first edition, 2011-12-15) |
| AAMI ISO TIR 10974 : 2012 | ASSESSMENT OF THE SAFETY OF MAGNETIC RESONANCE IMAGING FOR PATIENTS WITH AN ACTIVE IMPLANTABLE MEDICAL DEVICE |
| AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| ISO/TR 21730:2007 | Health informatics Use of mobile wireless communication and computing technology in healthcare facilities Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices |
| AAMI ES60601-1 : 2005 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014) |
| AAMI ISO 27186 : 2010 | ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS |
| PD CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| 08/30191626 DC : DRAFT OCT 2008 | BS ISO 27186 - ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS |
| PD ISO/TR 21730:2007 | Health informatics. Use of mobile wireless communication and computing technology in healthcare facilities. Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices |
| 10/30195946 DC : DRAFT DEC 2010 | BS ISO 27185 - CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS |
| BS ISO 27186:2010 | Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements |
| CSA C22.2 No. 60601-2-31 : 2009 : R2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| ISO 14708-4:2008 | Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps |
| ISO 14708-3:2017 | Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators |
| CSA C22.2 No. 60601-2-31:2009 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| AAMI ES60601-1 : 2005 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| BIS IS/ISO 14708-3 : 2008 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS |
| 16/30339831 DC : 0 | PD ISO/TR 14283 - IMPLANTS FOR SURGERY - ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE |
| ASTM F 2401 : 2016 : REDLINE | Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices |
| ISO 14708-2:2012 | Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
| AAMI ISO 14708-5 : 2010 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
| I.S. EN 60601-1:2006&A1:2013&AC:2014&A12:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| ISO 14708-6:2010 | Implants for surgery Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) |
| ISO 27186:2010 | Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
| UNE-EN 60601-1:2008 | Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance |
| 08/30192448 DC : DRAFT DEC 2008 | BS ISO 14708-5 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 5: CIRCULATORY SUPPORT DEVICES |
| BS ISO 27185:2012 | Cardiac rhythm management devices. Symbols to be used with cardiac rhythm management device labels, and information to be supplied. General requirements |
| CSA C22.2 No. 60601-2-31 : 2009 : INC : AMD 1 : 2014 : | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| AAMI TIR41 : 2011 | ACTIVE IMPLANTABLE MEDICAL DEVICES - GUIDANCE FOR DESIGNATION OF LEFT VENTRICLE AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD CONNECTORS AND PULSE GENERATOR CONNECTOR CAVITIES FOR IMPLANTABLE PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS |
| AAMI ISO 14708-4 : 2008 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS |
| ISO/IEC TR 20017:2011 | Information technology Radio frequency identification for item management Electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators |
| AAMI ISO 27185 : 2012 | CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS |
| ANSI/AAMI/ISO TIR16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| ANSI/AAMI/ISO 14708-3:2017 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS |
| ISO 14708-5:2010 | Implants for surgery Active implantable medical devices Part 5: Circulatory support devices |
| ASTM F 3020 : 2016 | Performance Standard for Hand-Worn Metal Detectors Used in Safety and Security |
| ISO 27185:2012 | Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements |
| ISO/TS 10974:2012 | Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| IEC 60601-2-31:2008+AMD1:2011 CSV | Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
| BS EN 60601-1 : 2006 | MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| EN 60601-2-31:2008/A1:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| UNI CEN ISO/TS 16775 : 2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| PD ISO/TS 10974:2012 | Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| 07/30165025 DC : 0 | BS EN 60601-2-31 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| AAMI ISO 14708-4:2008(R2011) | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 4: IMPLANTABLE INFUSION PUMPS |
| ASTM F 3278 : 2017 | Standard Performance Specification for Hand-Held Metal Detectors Used in Safety and Security |
| I.S. EN 60601- 1:2006&A1:2013&A12:2014&A2:2021 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/A2:2020) |
| IEC 62127-1:2007+AMD1:2013 CSV | Ultrasonics - Hydrophones - Part 1: Measurement and characterizationof medical ultrasonic fields up to 40 MHz |
| 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 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN 45502-2-2 : 2008 COR 2009 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS) |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN 60068-2-64:2008 | ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| EN 50061 : 88 AMD 1 95 | SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS |
| IEC 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| 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 |
| ISO/TR 14283:2004 | Implants for surgery Fundamental principles |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| IEC 60068-2-47:2005 | Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ISO/TS 10974:2012 | Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| IEC 60068-2-14:2009 | Environmental testing - Part 2-14: Tests - Test N: Change of temperature |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| AAMI TIR42 : 2010 | EVALUATION OF PARTICULATES ASSOCIATED WITH VASCULAR MEDICAL DEVICES |
| EN 45502-2-2 : 2008 COR 2009 | ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS) |
| 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 |
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