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Norm

ISO 17664-1:2021

Issue date: 2021 07 06

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

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...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 23 Pages
Language:
English

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.

ISO 17664-1:2021
2021 07 06
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Norm
ISO 17664:2017
2017 10 25
Processing of health care products — Information to be provided by the medical device manufacturer f...
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ISO 17664:2004
2004 02 25
Sterilization of medical devices — Information to be provided by the manufacturer for the processing...
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