PRICES include / exclude VAT
Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.080 Sterilization and disinfection>11.080.01 Sterilization and disinfection in general>BS EN ISO 17664-1:2021 - TC Tracked Changes. 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
Sponsored link
immediate downloadReleased: 2021-09-28
BS EN ISO 17664-1:2021 - TC Tracked Changes. 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

BS EN ISO 17664-1:2021 - TC

Tracked Changes. 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

Format
Availability
Price and currency
English Secure PDF
Immediate download
370.08 USD
English Hardcopy
In stock
370.08 USD
Standard number:BS EN ISO 17664-1:2021 - TC
Pages:82
Released:2021-09-28
ISBN:978 0 539 19096 0
Status:Tracked Changes
DESCRIPTION

BS EN ISO 17664-1:2021 - TC


This standard BS EN ISO 17664-1:2021 - TC Tracked Changes. Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices is classified in these ICS categories:
  • 11.080.01 Sterilization and disinfection in general

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.