Need help?

EN ISO 17664-2:2023 Standard

wave
Save  

  Keywords:

#document #medical #intended #devices #contact

  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 2: Non-critical medical devices (ISO 17664-2:2021)

  Purpose

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). 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) preparation before processing; b) cleaning; c) disinfection; d) drying; e) inspection and maintenance; f) packaging; g) storage; h) transportation.

  Publication

Friday 8th of March 2024

  Related Standards

EN ISO 11137-1:2015

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

EN 13795-2:2025

Medical devices Regulation ((EU) 2017/745)

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

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 17664-1:2021

Medical devices Regulation ((EU) 2017/745)

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical d...

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 IEC 60601-2-83:2020/A11:2021

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...

  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