Need help?

EN ISO 17664:2017 Standard

wave
Save  

  Keywords:

#use #medical #intended #information #processing

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  Description:

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

  Purpose

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.

  Publication

Wednesday 25th of March 2020

  Related Standards

EN 14139:2010

Medical devices Directive (93/42/EEC)

Ophthalmic optics - Specifications for ready-to-wear spectacles

EN 60601-2-30:2000

Medical devices Directive (93/42/EEC)

Medical electrical equipment -- Part 2-30: Particular requirements for the safety, including essential performance, of automatic c...

EN 60601-2-45:2001

Medical devices Directive (93/42/EEC)

Medical electrical equipment -- Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic...

EN 60601-2-44:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipmen...

EN 60601-2-43:2010

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment fo...

EN 60601-2-41:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaire...

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 17664:2017 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0