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EN ISO 17664:2017

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

Publication date:   Feb 14, 2018

General information

99.60 Withdrawal effective   Sep 1, 2021

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 17664:2004

NOW

WITHDRAWN
EN ISO 17664:2017
99.60 Withdrawal effective
Sep 1, 2021

REVISED BY

PUBLISHED
EN ISO 17664-1:2021