• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 3-156
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
Scope/Abstract
ISO 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.
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.
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
-
-