What is ISO 17664-2 about?

ISO 17664-2 is one of the series of documents for processing of health care products that 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).
ISO 17664-2 includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, ISO 17664-2 specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable preparation before processing, cleaning, disinfection, drying, inspection and maintenance, packaging, storage and transportation.
ISO 17664-2 excludes processing of critical and semi-critical medical devices, medical devices intended to be sterilized, textile medical devices used in patient draping systems or surgical clothing, and 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.

Who is ISO 17664-2 for?

ISO 17664-2 on the processing of health care products is useful for-

Manufacturers of the medical device
Medical laboratories
Healthcare facilities
Research facilities

Why should you use ISO 17664-2?

ISO 17664-2 guidelines will help you with non-critical medical devices that are intended to be cleaned and/or disinfected by the processor to be made ready for use or reuse. This includes medical devices that are intended for reuse and require processing to take them from their state after clinical use to the state of being ready for their next use and single-use medical devices that require processing before use and are intended to be used in a clean and/or disinfected state.
The developments described in ISO 17664-2 ensures that manufacturers of medical devices provide adequate instruction that supports the end-users to undertake safe and effective processing of medical devices, utilizing the available equipment and processes and medical devices that are to be processed have will ensure that the design of the medical devices facilitates achievement of effective processing.

BS ISO 17664-2:2021

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

Current

Published:

28 Feb 2021