NF EN ISO 13408-6

NF EN ISO 13408-6

September 2011
Standard Cancelled

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

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Main informations

Collections

National standards and national normative documents

Publication date

September 2011

Number of pages

31 p.

Reference

NF EN ISO 13408-6

ICS Codes

11.080.01   Sterilization and disinfection in general

Print number

1 - 18/08/2011

International kinship

ISO 13408-6:2005

European kinship

EN ISO 13408-6:2011
Replaced standards (1)
NF EN 13824
March 2005
Standard Cancelled
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Standard replaced by (1)
NF EN ISO 13408-6
May 2021
Standard Current
Aseptic processing of health care products - Part 6 : isolator systems

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 document does not define biosafety containment requirements.

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