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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 3-170
Standard
ISO 14708-5 Second edition 2020-05
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
Scope/Abstract
This 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.
Extent of Recognition
Complete standard
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.
Transition Period
FDA recognition of ISO 14708-5 First edition 2010-02-01 [Rec# 3-92] will be superseded by recognition of ISO 14708-5 Second edition 2020-05 [Rec# 3-170]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-92] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 3-92] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.3545 Ventricular Bypass (Assist) Device Class 3 OKR
FDA Technical Contacts
 Jean E. Rinaldi
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2523
  jean.rinaldi@fda.hhs.gov
 Changfu Wu
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIB/
  301-796-6086
  changfu.wu@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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