| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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050
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Date of Entry 09/17/2018
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FR Recognition Number
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3-156
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| Standard | |
ISO 14708-1 Second edition 2014-08-15
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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Identical AdoptionANSI AAMI 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 |
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Scope/AbstractISO 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. |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Relevant FDA Guidance and/or Supportive Publications*
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
