ISO 17664-1:2021 — Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
Summary
Specifies requirements for the information to be provided by medical device manufacturers to allow proper processing (cleaning, disinfection, sterilization) of reusable medical devices. Covers reprocessing instructions, validation of cleaning procedures, and chemical compatibility.
Standard Details
- Standard Number: ISO 17664-1:2021
- Type: ISO Standard
- Published by: ISO
- Official Link: https://www.iso.org/standard/81720.html
This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.
Document Details
Document IDISO 17664-1:2021
TypeISO Standard
AuthorityISO
Publication Date2021-07-01