UNLIMITED FREE
ACCESS
TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

CEN - EN ISO 17664-2

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

active, Most Current
Organization: CEN
Publication Date: 1 December 2023
Status: active
Page Count: 38
ICS Code (Sterilization and disinfection in general): 11.080.01
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.

Document History

EN ISO 17664-2
December 1, 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
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...

References

Advertisement