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EN ISO 17664:2017 Standard

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  Keywords:

#use #medical #intended #information #processing

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  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 455-1:2000

Medical devices Directive (93/42/EEC)

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

EN ISO 10535:2006

Medical devices Directive (93/42/EEC)

Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)

EN ISO 10079-2:2009

Medical devices Directive (93/42/EEC)

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)

EN ISO 10079-3:2009

Medical devices Directive (93/42/EEC)

Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)

EN ISO 10524-1:2006

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (I...

EN ISO 10524-2:2006

Medical devices Directive (93/42/EEC)

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

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