Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices - Critical and semi-critical medical devices
Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices - Critical and semi-critical medical devices
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Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices - Critical and semi-critical medical devices

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What is ISO 17664-1 about?  

ISO 17664-1 addresses the Processing of health care products that specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e., a medical device that enters normally sterile parts of the human body or medical device that encounters mucous membranes or non-intact skin) or medical devices that are intended to be sterilized. 

ISO 17664-1 specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, initial treatment at the point of use, preparation before cleaning, cleaning, disinfection, drying, inspection, and maintenance, packaging, sterilization, storage, and transportation. 

Who is ISO 17664-1 for? 

ISO 17664-1 is useful for: 

  • Manufacturers of medical device 
  • Healthcare facilities 
  • Research centres 

Why should you use ISO 17664-1? 

Cleaning is an important step in rendering a used medical device safe for subsequent use. ISO 17664-1 helps you to manufacture those medical devices that are intended to clean, disinfect, and sterilize by the processor to be ready for use. 

ISO 17664-1 helps you with detailed processing instructions to ensure that, when followed correctly, the risks of transmission of infectious agents are minimized. In addition, effective processing minimizes the risk of other adverse effects on medical devices. 

What’s changed since the last update? 

BS EN ISO 17664-1:2021 supersedes ISO 17664-1:2017, which has been withdrawn. BS EN ISO 17664-1:2021 has some technical changes with respect to ISO 17664-1:2017, these include: 

  • The title, introduction, and scope have been editorially revised to reflect the addition of a second part to the ISO 17664 series