ISO 14708-1:2000
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Standard No.

ISO 14708-1:2000

Release Date

2000

Published By

International Organization for Standardization (ISO)

Status

Withdraw

Replace By

ISO 14708-1:2014

Latest

ISO 14708-1:2014

Scope

This part of ISO 14708 specifies requirements that are generally applicable to active implantable medical devices. NOTE For particular types of active implantable medical devices, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of ISO 14708. Special care is required in applying this part of ISO 14708 to active implantable medical devices where no particular standard exists. The tests that are specified in this part of ISO 14708 are type tests intended to be carried out on samples of a device to show compliance, and are not intended to be used for the routine testing of manufactured products. This part of ISO 14708 is applicable not only to active implantable medical devices that are electrically powered, but also to those powered by other energy sources (for example gas pressure or springs). This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the devices (see 3.3).

ISO 14708-1:2000 Referenced Document

• IEC 60068-2-47:1999 Environmental testing - Part 2-47: Test methods - Mounting of components, equipment and other articles for vibration, impact and similar dynamic tests
• IEC 60068-2-64:1993 Environmental testing; part 2: test methods; test Fh: vibration, broad-band random (digital control) and guidance
• IEC 60601-1-1:1992 Medical Electrical Equipment Part 1: General Requirements for Safety 1. Collateral Standard: Safety Requirements for Medical Electrical Systems; (CENELEC EN 60601-1-1: 1993) (Amendment 1-1995) (Edition 1.0)
• IEC 60601-1-2:1993 Medical electrical equipment; part 1: general requirements for safety; 2. collateral standard: electromagnetic compatibility; requirements and tests
• IEC 60601-1-4:1996 Appareils Electromedicaux - Partie 1-4: Regles Generales De Securite - Norme Collaterale: Systemes Electromedicaux Programmables (Edition 1.0; Amendment 1: 10-1999)
• IEC 60601-1:1988 Medical electrical equipment; part 1: general requirements for safety
• IEC 60601-2-27:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment
• IEC 61000-4-2:1995 Electromagnetic compatibility (EMC) - Part 4: Testing and measuring techniques - Section 2: Electrostatic discharge immunity test - Basic EMC publication
• ISO 11607:1997 Packaging for terminally sterilized medical devices
• ISO 14155:1996 Clinical investigation of medical devices
• ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
• ISO 8601:1988 Data elements and interchange formats — Information interchange — Representation of dates and times

ISO 14708-1:2000 history

• 2014 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
• 2000 ISO 14708-1:2000 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer