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 ISO 17664-1:2021

Publication date:   Jul 6, 2021

General information

60.60 Standard published   Jul 6, 2021

ISO

ISO/TC 198 Sterilization of health care products

International Standard

11.080.01   Sterilization and disinfection in general

Buying

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 17664:2017

NOW

PUBLISHED
ISO 17664-1:2021
60.60 Standard published
Jul 6, 2021