1Key Takeaways
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 14…
2Scope / Description
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).
5Citation Network
Standards that cite ISO 14708-1:2000
Referenced by ISO 14708-1:2000
IEC 60068-2-47:1999
IEC 60068-2-64:1993
IEC 60601-1-1:1992
IEC 60601-1-2:1993
IEC 60601-1-4:1996
IEC 60601-1:1988
IEC 60601-2-27:1994
IEC 61000-4-2:1995
6Frequently Asked Questions
What is ISO 14708-1:2000?
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 is an international standard developed by International Organization for Standardization (ISO). 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...
What does ISO 14708-1:2000 cover?
This standard covers: 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...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of ISO 14708-1:2000?
The current published version is ISO 14708-1:2000, published on 2000-11. Always check for amendments or pending revisions.
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