SR EN ISO 17664:2018

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)

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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General information

Status : Withdrawn
Approval date : 5/31/2018
Romanian version publish date : 12/20/2019
Withdrawal date : 10/29/2021
Number of pages : 30
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 17664:2004
Normative reference SR EN ISO 14971:2012
Replaced by SR EN ISO 17664-1:2021