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  • BSI
    BS EN ISO 17664-1:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices - Critical and semi-critical medical devices
    Edition: 2021
    $418.55
    / user per year

Description of BS EN ISO 17664-1:2021 2021

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.

This includes information for processing prior to use or reuse of the medical device.

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:

  1. initial treatment at the point of use;

  2. preparation before cleaning;

  3. cleaning;

  4. disinfection;

  5. drying;

  6. inspection and maintenance;

  7. packaging;

  8. sterilization;

  9. storage;

  10. transportation.

This document excludes processing of the following:

  • non-critical medical devices unless they are intended to be sterilized;

  • 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.

NOTE

See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a medical device.



Standard NumberBS EN ISO 17664-1:2021
TitleProcessing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices - Critical and semi-critical medical devices
StatusDefinitive
Publication Date2021-09-01
ReplacesBS EN ISO 17664:2017
Identical National Standard OfEN ISO 17664-1, ISO 17664-1
DescriptorsTraining, Symbols, Instructions for use, Packaging, Inspection, Test methods, Safety measures, Consumer-supplier relations, Medical instruments, Medical equipment, Hygiene, Re-usable, Storage, Personnel, Cleaning, Sterilization (hygiene), Preparation, Health and safety requirements, Sterile equipment
ICS11.080.01 Sterilization and disinfection in general
CommitteeCH/198
ISBN978 0 539 15411 5
PublisherBSI
Pages36

The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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