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ANSI/AAMI/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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2014

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of
ISO 14708-1:2014
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviations (optional)
5 General requirements for ACTIVE IMPLANTABLE
   MEDICAL DEVICES
6 Requirements for particular ACTIVE IMPLANTABLE
   MEDICAL DEVICES
7 General arrangement of the packaging
8 General MARKINGS for ACTIVE IMPLANTABLE
   MEDICAL DEVICES
9 MARKINGS on the SALES PACKAGING
10 Construction of the SALES PACKAGING
11 MARKINGS on the STERILE PACK
12 Construction of the NON-REUSABLE PACK
13 MARKINGS on the ACTIVE IMPLANTABLE MEDICAL DEVICE
14 Protection from unintentional biological effects being
   caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE
15 Protection from HARM to the patient or user caused by
   external physical features of the ACTIVE IMPLANTABLE
   MEDICAL DEVICE
16 Protection from HARM to the patient caused by electricity
17 Protection from HARM to the patient caused by heat
18 Protection from ionizing radiation released or emitted
   from the ACTIVE IMPLANTABLE MEDICAL DEVICE
19 Protection from unintended effects caused by the
   ACTIVE IMPLANTABLE MEDICAL DEVICE
20 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from
   damage caused by external
   defibrillators
21 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from
   changes caused by electrical fields applied directly
   to the patient
22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from
   changes caused by miscellaneous medical treatments
23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from
   mechanical forces
24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from
   damage caused by electrostatic discharge
25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from
   damage caused by atmospheric pressure changes
26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from
   damage caused by temperature changes
27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from
   electromagnetic non-ionizing radiation
28 Accompanying documentation
Annex A (informative) - General guidance and rationale
Annex B (informative) - Relationship between the fundamental
        principles in ISO/TR 14283:2004 and the clauses of this
        part of ISO 14708
Bibliography

Defines requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL DEVICES.

Committee
ISO/TC 150
DocumentType
Standard
ISBN
1-57020-565-5
Pages
65
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current

Standards Relationship
ISO 14708-1:2014 Identical

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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
EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
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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