Norm

ISO/DIS 17664:2016 en

Sterilisatie van medische hulpmiddelen - Informatie te verstrekken door de fabrikant voor de terugwinning van opnieuw te steriliseren medische hulpmiddelen

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Over deze norm

Status Ontwerp
Aantal pagina's 28
Gepubliceerd op 01-05-2016
Taal Engels
This International Standard 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 this standard are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. Processing instructions are not defined in this standard. Rather, this International Standard specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities where applicable: a) Pre-treatment at the point of use before processing; b) Preparation before cleaning; c) Cleaning; d) Disinfection; e) Drying; f) Inspection, maintenance and functionality testing; g) Packaging; h) Sterilization; i) Storage; j) Transportation.

Details

ICS-code 11.080.01
Nederlandse titel Sterilisatie van medische hulpmiddelen - Informatie te verstrekken door de fabrikant voor de terugwinning van opnieuw te steriliseren medische hulpmiddelen
Engelse titel Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
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