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BSI - BS EN 17141

Cleanrooms and associated controlled environments — Biocontamination control

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Organization: BSI
Publication Date: 31 August 2020
Status: active
Page Count: 54
ICS Code (Cleanrooms and associated controlled environments): 13.040.35

Document History

BS EN 17141
August 31, 2020
Cleanrooms and associated controlled environments — Biocontamination control
A description is not available for this item.

References

This document references:
EN ISO 11139 - Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
Published by CEN on September 1, 2018
This document defines terms in the field of the sterilization of health care products including related equipment and processes.
This document references:
EN ISO 11290-1 - Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 1: Detection method
Published by CEN on June 1, 2017
This document specifies a horizontal method for — the detection of L. monocytogenes, and — the detection of Listeria spp. (including L. monocytogenes). This document is applicable to — products...
This document references:
EN ISO 11290-2 - Microbiology of the food chain - Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. - Part 2: Enumeration method
Published by CEN on June 1, 2017
This document specifies a horizontal method for — the enumeration of L. monocytogenes, and — the enumeration of Listeria spp. (including L. monocytogenes). This document is applicable to — products...
This document references:
EN ISO 13408-7 - Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
Published by CEN on August 1, 2015
This part of ISO 13408 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination...
This document references:
EN ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
Published by CEN on March 1, 2016
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that...
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