ISO 17664-2:2021

International Standard   Current Edition
· Approved on 25 February 2021 ·

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

Sterilization and disinfection in general
Including sterilization methods, air quality of surgery rooms, etc.

ISO 17664-2:2021 Files

English 26 Pages
Current Edition
56.75 OMR

ISO 17664-2:2021 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.

Best Sellers

GSO 150-2:2013
 
Gulf Standard
Expiration dates for food products - Part 2 : Voluntary expiration dates
OS GSO 150-2:2013
GSO 150-2:2013 
Omani Standard
Expiration dates for food products - Part 2 : Voluntary expiration dates
OS GSO 150-1:2013
GSO 150-1:2013 
Omani Standard
Expiration dates for food products -Part 1 : Mandatory expiration dates
GSO 150-1:2013
 
Gulf Technical Regulation
Expiration dates for food products -Part 1 : Mandatory expiration dates

Recently Published

ISO/IEC 39075:2024
 
International Standard
Information technology — Database languages — GQL
ISO 6435:2024
 
International Standard
Stainless steel bars for the reinforcement of concrete
ISO 20433:2024
 
International Standard
Leather — Tests for colour fastness — Colour fastness to crocking
ISO/IEC 23415:2024
 
International Standard
Information technology — Data Format Description Language (DFDL) v1.0 Specification