ISO-17664 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices

ISO-17664 - 2ND EDITION - CURRENT
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ISO 17664:2017 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.

This includes information for processing prior to use or reuse of the medical device. The provisions of ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect patient contact.

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

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Document Number

ISO 17664:2017

Revision Level

2ND EDITION

Status

Current

Publication Date

Oct. 1, 2017

Committee Number

ISO/TC 198