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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 14-515
Standard
ISO 17664 Second edition 2017-10
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
U.S. Identical Adoption
ANSI AAMI ISO 17664:2017
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
Scope/Abstract
ISO 17664:2017 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.

This includes information for processing prior to use or reuse of the medical device. The provisions of ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect patient contact.

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.
Relevant FDA Guidance and/or Supportive Publications
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, Issued March 2015.

AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

AAMI TIR30:2011/(R)2016 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.

ANSI/AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness.

ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
FDA Technical Contacts
 Steven Turtil
  FDA/OMPT/CDRH/ODE/DOD/PSDB/
  301-796-6305
  steven.turtil@fda.hhs.gov
 Shanil Haugen
  FDA/OMPT/CDRH/ODE/DRGUD/ULDB/
  301-796-0301
  shanil.haugen@fda.hhs.gov
 Clarence Murray
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-0270
  Clarence.Murray@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Sterility
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