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BSI - 23/30449731 DC

Draft BS EN ISO 15883-2. Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices

pending
Organization: BSI
Publication Date: 5 May 2023
Status: pending
Page Count: 27
ICS Code (Sterilizing equipment): 11.080.10

Document History

23/30449731 DC
May 5, 2023
Draft BS EN ISO 15883-2. Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
A description is not available for this item.
BS EN ISO 15883-2
October 31, 2009
Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
A description is not available for this item.
BS EN ISO 15883-2
May 31, 2006
Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
A description is not available for this item.

References

This document references:
AAMI TIR34 - Water for the reprocessing of medical devices
Published by AAMI on January 1, 2014
General This TIR addresses how to determine the water quality needs for reprocessing various categories of medical devices at various stages of reprocessing and how to assess, generate, monitor, and...
This document references:
EN 10088-2 - Stainless steels - Part 2: Technical delivery conditions for sheet/plate and strip of corrosion resisting steels for general purposes
Published by CEN on October 1, 2014
This European Standard specifies the technical delivery conditions for hot or cold rolled sheet/plate and strip of standard grades and special grades of corrosion resisting stainless steels for...
This document references:
EN 868-8 - Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
Published by CEN on December 1, 2018
This document specifies test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point...
This document references:
17664-1 - Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
Published by ISO on July 1, 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...
This document references:
ISO TS 17665-3 - Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
Published by ISO on April 15, 2013
This part of ISO 17665 provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and...
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