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BSI - 21/30387349 DC

Draft BS EN ISO 13408-1 Aseptic processing of health care products. Part 1: General requirements

pending
Organization: BSI
Publication Date: 17 December 2021
Status: pending
Page Count: 85
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

21/30387349 DC
December 17, 2021
Draft BS EN ISO 13408-1 Aseptic processing of health care products. Part 1: General requirements
A description is not available for this item.
BS EN ISO 13408-1
August 31, 2015
Aseptic processing of health care products Part 1: General requirements
A description is not available for this item.
BS EN ISO 13408-1
October 30, 2011
Aseptic processing of health care products Part 1: General requirements
A description is not available for this item.
BS EN ISO 13408-1
October 30, 2011
Aseptic processing of health care products Part 1: General requirements
A description is not available for this item.

References

This document references:
EN 556-2 - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Published by CEN on September 1, 2015
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive(s) for medical devices (see...
This document references:
11737-3 - Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
Published by ISO on June 1, 2023
Inclusions This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins...
This document references:
ISO 18362 - Manufacture of cell-based health care products - Control of microbial risks during processing
Published by ISO on February 1, 2016
This International Standard specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of...
This document references:
ISO/IEC GUIDE 63 - Guide to the development and inclusion of aspects of safety in International Standards for medical devices
Published by ISO on August 1, 2019
This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk...
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