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Normas DIN – AENOR
DIN EN ISO 17664:2016-06

DIN EN ISO 17664:2016-06

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO/DIS 17664:2016); German and English version prEN ISO 17664:2016 / Note: Date of issue 2016-05-06

Traitement de produits de soins de santé - Informations devant être fournies par le fabricant de l'appareil pour le traitement des dispositifs médicaux (ISO/DIS 17664:2016); Version allemande et anglaise prEN ISO 17664:2016 / Attention: Date de parution 2016-05-06

Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten (ISO/DIS 17664:2016); Deutsche und Englische Fassung prEN ISO 17664:2016 / Achtung: Erscheinungsdatum 2016-05-06

Fecha Anulación:
2018-04 /Withdrawn
Equivalencias internacionales:

ISO/DIS 17664 (2016-04)

prEN ISO 17664 (2016-04)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 17664:2018-04

Resumen:
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. This standard excludes: a) Noncritical medical devices not intended for direct patient contact; b) Textile devices used in patient draping systems or surgical clothing; c) Processing of medical devices specified by the manufacturer for single-use only and supplied sterile.
Keywords:
Capability of sterilization, Care of the sick, CE marking, Characterisations, Cleaning, Consumer-supplier relations, Data of the manufacturer, Decontaminations, Definitions, Disinfection, Enterprises, Health protection, Hygiene, Information, Information supplied by the manufacturer, Instructions, Medical devices, Medical equipment, Medical products, Packages, Product information, Reprocessing, Reuse, Risk analysis, Sequence of operations, Specification, Specification (approval), Sterilization (birth control), Sterilization (hygiene), Sterilized goods, Sterilizers, Surveillance (approval), Treatment, Validation, Verification
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