Sterilizace zařízení

Oblast zaměření: Sterilizace zařízení
Komise : CEN/TC 204 (Sterilization of medical devices)
Původce: CEN
K připomínkám do: 26.05.2019
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This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell based health care products.

This document does not specify requirements for restricted access barrier systems (RABS).

This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.

This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.

This International Standard does not define biosafety containment requirements.

Oblast zaměření: Sterilizace zařízení
Komise : CEN/TC 102 (Sterilizers and associated equipment for processing of medical devices)
Původce: CEN
K připomínkám do: 11.06.2019
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This document specifies requirements for electrically heated shell boilers manufactured from stainless steel specifically dedicated for generating steam for sterilizers and disinfectors.

This document covers only boilers that are heated by immersion heaters and which have a maximum allowable pressure (PS) of not greater than 6 bar, a maximum volume (V) of 1 000 litres and a product of PS ∙ V not greater than 3 000 bar ∙ l.