ISO 14708-2:2012
Withdrawn
Withdrawn
View Superseded by
Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
Available format(s)
Hardcopy , PDF
Language(s)
English, Russian
Published date
08-06-2012
Withdrawn date
04-09-2025
Superseded by
US$96.00
Excluding Tax where applicable
ISO 14708-2:2012 specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias.
The tests that are specified in ISO 14708-2:2012 are type tests, and are to be carried out on samples of a device to show compliance.
ISO 14708-2:2012 is also applicable to some non-implantable parts and accessories of the devices.
| Committee |
ISO/TC 150/SC 6
|
| DevelopmentNote |
Supersedes ISO 5841-1. (10/2005) Supersedes CSA ISO 5841-1. (05/2007) DRAFT ISO/FDIS 14708-2 is also available for this standard. (03/2018)
|
| DocumentType |
Standard
|
| Pages |
68
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN ISO 14708-2 : 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 |
| ASTM F 3020 : 2016 | Performance Standard for Hand-Worn Metal Detectors Used in Safety and Security |
| ISO 14708-7:2013 | Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear implant systems |
| 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 |
| 13/30275206 DC : 0 | BS ISO 5841-2 - IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS |
| ISO 14117:2012 | Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices |
| 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) |
| NF EN 60601 2-31 : 2008 AMD 1 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-31: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| 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) |
| PD CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| 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 |
| 15/30290736 DC : 0 | BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
| ISO 5841-2:2014 | Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads |
| BS EN ISO 10993-4:2017 | Biological evaluation of medical devices Selection of tests for interactions with blood |
| 12/30264401 DC | BS ISO 5841-3. Implants for surgery. Cardiac pacemakers. Part 3. Low-profile connectors (IS-1) for implantable pacemakers |
| ASTM F 2401 : 2016 : REDLINE | Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices |
| BS ISO 14117:2012 | Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices |
| AAMI ISO 5841-2 : 2014 | IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS |
| 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 27185:2012 | Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements |
| BS ISO 5841-2:2014 | Implants for surgery. Cardiac pacemakers Reporting of clinical performance of populations of pulse generators or leads |
| 11/30243761 DC : 0 | BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS |
| 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 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 |
| 10/30208719 DC : 0 | |
| AAMI ISO 14117 : 2012 | ACTIVE IMPLANTABLE MEDICAL DEVICES - ELECTROMAGNETIC COMPATIBILITY - EMC TEST PROTOCOLS FOR IMPLANTABLE CARDIAC PACEMAKERS, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION DEVICES |
| 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 |
| EN ISO 10993-4:2017 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
| ISO 5841-3:2013 | Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers |
| 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 |
| 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 |
| 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 |
| 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 |
| ASTM F 3278 : 2017 | Standard Performance Specification for Hand-Held Metal Detectors Used in Safety and Security |
| I.S. EN ISO 10993-4:2017 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017) |
| UNE-EN ISO 10993-4:2018 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
| DIN VDE 0750-9 : 1992 | SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS |
| AAMI PC69 : 2007 | Active implantable medical devices— Electromagnetic compatibility— EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators American National Standard |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| 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 |
| ISO 14117:2012 | Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO/TR 14283:2004 | Implants for surgery — Fundamental principles |
| 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 14708-1:2014 | Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| IEC 61000-4-2:2008 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
| ISO 5841-3:2013 | Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers |
| IEC 60601-2-27:2011 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| ISO 5841-1:1989 | Cardiac pacemakers — Part 1: Implantable pacemakers |
| 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 |
| 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 |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| ISO 11318:2002 | Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements |
| 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) |
Summarise
US$96.00
Excluding Tax where applicable
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