BS EN ISO 17664:2017, Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices

BS EN ISO 17664:2017

Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Part 1: Devices that require cleaning followed by disinfection and/or sterilization

Status : Current   Published : January 2018

Format
PDF

Format
HARDCOPY



What is this standard about?

This document 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.

Who is this standard for?

The provisions of this document are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. Processing instructions are not defined in this document.

Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:

a) initial treatment at the point of use; b) preparation before cleaning; c) cleaning; d) disinfection; e) drying; f) inspection and maintenance; g) packaging; h) sterilization; i) storage; j) transportation.

This document excludes processing of the following: — non-critical medical devices not intended for direct patient contact; — textile devices used in patient draping systems or surgical clothing; — medical devices specified by the manufacturer for single-use only and supplied ready for use.




Standard NumberBS EN ISO 17664:2017
TitleProcessing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Part 1: Devices that require cleaning followed by disinfection and/or sterilization
StatusCurrent
Publication Date08 January 2018
Normative References(Required to achieve compliance to this standard)ISO 14971
Informative References(Provided for Information)ISO 17665, ISO 25424, ISO/TS 16775, ISO 15223?1, ISO 15883, AAMI/TIR 12, ISO 7000, ISO 10993?7, AAMI/TIR 30, ISO 20857, ISO 11135, ISO 11607?1, EN 16442, ISO 13485:2016, ISO 9000:2015, ISO/TS 11139:2006
ReplacesBS EN ISO 17664:2004
International RelationshipsISO 17664:2017,EN ISO 17664:2017
Draft Superseded By16/30280931 DC
DescriptorsSterile equipment, Health and safety requirements, Preparation, Sterilization (hygiene), Cleaning, Personnel, Storage, Re-usable, Hygiene, Medical equipment, Medical instruments, Consumer-supplier relations, Safety measures, Test methods, Inspection, Packaging, Instructions for use, Symbols, Training
ICS11.080.01
Title in FrenchTraitement de produits de soins de santé. Informations relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif
Title in GermanAufbereitung von Produkten für die Gesundheitsfürsorge. Vom Medizinprodukt-Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten
CommitteeCH/198
ISBN978 0 580 82544 6
PublisherBSI
FormatA4
DeliveryYes
Pages34
File Size890 KB
Price£214.00


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