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EN ISO 17664-2:2023 Standard

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  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

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EN ISO 11737-2:2020

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EN ISO 13408-6:2021

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EN ISO 13485:2016

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

EN ISO 13485:2016/A11:2021

Medical devices Regulation ((EU) 2017/745)

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

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