EN ISO 17664-2:2023

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)

Publication date:   Feb 19, 2024

General information

60.60 Standard published   Dec 20, 2023

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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Scope

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.
This document excludes processing of:
1) critical and semi-critical medical devices;
2) medical devices intended to be sterilized;
3) textile medical devices used in patient draping systems or surgical clothing;
4) medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.

Related legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

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Life cycle

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PUBLISHED
EN ISO 17664-2:2023
60.60 Standard published
Dec 20, 2023

Relations

Adopted from ISO 17664-2:2021 IDENTICAL