GSO ISO 17664:2014

Gulf Standard   Current Edition
Approved on  25 December 2014

Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices

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

GSO ISO 17664:2014 Files

English 18 Pages
Current Edition Reference Language
37.33 BHD

GSO ISO 17664:2014 Scope

This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be re-sterilizable and medical devices intended to be sterilized by the processor. This standard specifies requirements for the information to be provided by the medical device manufacturer, so that the medical device can be processed safely and will continue to meet its performance specification. Requirements are specified for processing that consists of all or some of the following activities: — preparation at the point of use; — preparation, cleaning, disinfection; — drying; — inspection, maintenance and testing; — packaging; — sterilization; — storage. When providing instructions for these activities, medical device manufacturers are expected to be aware of the training and knowledge of procedures, and of the processing equipment available to the persons likely to be responsible for processing. It is likely that some processing procedures will be generic and well known and will use equipment and consumables conforming to recognized standards. In this case, a reference in the instructions is all that is required. For those medical devices where instructions for use are not required to accompany the medical device, other means of communicating the information can be used, e.g. user manuals, symbols or wall charts supplied separately. This standard excludes textile devices used in patient draping systems or surgical clothing. NOTE The principles of this standard may be applied when considering the information to be supplied with medical devices which only require disinfection prior to re-use.

Best Sellers From Health Sector

GSO 2528:2016
 
Gulf Technical Regulation
Cosmetic products – Technical Regulation of cosmetic and personal care products claims
BH GSO 2528:2017
GSO 2528:2016 
Bahraini Technical Regulation
Cosmetic products – Technical Regulation of cosmetic and personal care products claims
GSO 2302:2022
 
Gulf Standard
Cosmetic Products – Face Masks
GSO 2680:2021
 
Gulf Standard
Halal medical device – General requirements

Recently Published from Health Sector

GSO EN 455-2:2022
EN 455-2:2015 
Gulf Standard
Medical gloves for single use - Part 2: Requirements and testing for physical properties
GSO ASTM F1556:2022
ASTM F1556:94(2015) 
Gulf Standard
Standard Guide for Spinal Immobilization and Extrication (SPINE) Device Characteristics
GSO ISO 22570:2022
ISO 22570:2020 
Gulf Standard
Dentistry — Spoons and bone curettes
GSO ASTM F1949:2022
ASTM F1949:99(2013) 
Gulf Standard
Standard Specification for Medical Oxygen Delivery Systems for EMS Ground Vehicles