GSO ISO 17664:2014
ISO 17664:2004
								
									
									Gulf Standard
								
								
								
									 
									
									Historical
								
								
									·
									Approved on
									25 December 2014
								
							
							Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of resterilizable medical devices
GSO ISO 17664:2014 Files
													English
													
														18 Pages
													
												
												
													
														
														Historical
													
													
														Reference Language
													
												
			                                
													45.59 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.
									
								
							
						
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