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  • ISO
    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
    Edition: 2021
    $442.88
    / user per year

Content Description

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.



About ISO

ISO, the International Organization for Standardization, brings global experts together to agree on the best way of doing things – for anything from making a product to managing a process. As one of the oldest non-governmental international organizations, ISO has enabled trade and cooperation between people and companies all over the world since 1946. The International Standards published by ISO serve to make lives easier, safer and better.
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