| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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056
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Date of Entry 06/07/2021
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|
FR Recognition Number
|
3-170
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| Standard | |
ISO 14708-5 Second edition 2020-05
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices |
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Scope/AbstractThis document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements.
NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products.
Included in the scope of this document are:
- ventricular assist devices (VAD), left or right heart support;
- total artificial hearts (TAH);
- biventricular assist devices (biVAD);
- percutaneous assist devices;
- paediatric assist 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.
Note: Electromagnetic immunity tests specified in this standard might not sufficiently represent your electromagnetic environment. Test conditions may vary based on your technology, intended use environment, and risk-based assessments. We encourage you to contact the review division prior to initiating your testing. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.3545 |
Ventricular Bypass (Assist) Device
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Class 3
|
OKR
|
|
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. |
