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BSI - BS EN 16442

Controlled environment storage cabinet for processed thermolabile endoscopes

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Organization: BSI
Publication Date: 31 March 2015
Status: active
Page Count: 64
ICS Code (Hospital equipment): 11.140

Document History

BS EN 16442
March 31, 2015
Controlled environment storage cabinet for processed thermolabile endoscopes
A description is not available for this item.

References

This document references:
EN 1822-1 - High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
Published by CEN on April 1, 2019
This document applies to high efficiency particulate and ultra-low penetration air filters (EPA, HEPA and ULPA) used in the field of ventilation and air conditioning and for technical processes, e.g....
This document references:
EN ISO 11737-1 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
Published by CEN on January 1, 2018
This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw...
This document references:
EN ISO 14644-1 - Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
Published by CEN on December 1, 2015
This part of ISO 14644 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644-7....
This document references:
EN ISO 14644-3 - Cleanrooms and associated controlled environments - Part 3: Test methods
Published by CEN on October 1, 2019
This document provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions....
This document references:
EN ISO 14971 - Medical devices - Application of risk management to medical devices
Published by CEN on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
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