Need help?

EN ISO 17664-1:2021 Standard

wave
Save  

  Keywords:

#document #medical #use #instructions #intended

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Thursday 11th of June 2026

  Description:

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 (ISO 17664-1:2021)

  Purpose

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized. This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) initial treatment at the point of use; b) preparation before cleaning; c) cleaning; d) disinfection; e) drying; f) inspection and maintenance; g) packaging; h) sterilization; i) storage; j) transportation. This document excludes processing of the following: — non-critical medical devices unless they are intended to be sterilized; — textile devices used in patient draping systems or surgical clothing; — medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a medical device.

  Publication

Wednesday 5th of January 2022

  Related Standards

EN 285:2015+A1:2021

Medical devices Regulation ((EU) 2017/745)

Sterilization - Steam sterilizers - Large sterilizers

EN ISO 13485:2016

Medical devices Regulation ((EU) 2017/745)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN IEC 60601-2-83:2020

Medical devices Regulation ((EU) 2017/745)

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light the...

EN ISO 15223-1:2021

Medical devices Regulation ((EU) 2017/745)

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223...

EN ISO 14971:2019/A11:2021

Medical devices Regulation ((EU) 2017/745)

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

EN ISO 14971:2019

Medical devices Regulation ((EU) 2017/745)

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0