Standard

NS-EN 13824:2004

Feb 2005 Withdrawn

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Abstract

This document specifies requirements for the design and operation of aseptic processing facilities and the validation and routine control of aseptic processes for the preparation of sterile liquid medical devices. It is not applicable to those pharmaceutical products where the requirements of the relevant good manufacturing practices are applicable.NOTE Many of the principles included in this document can be applied to certain aseptically processed sterile solid medical devices.

Document information

Standard from SN
Published: 10 February 2005
Withdrawn: 1 September 2011
Edition: 2004-11
Version: 1
Document type: NAT
ISBN:

ICS 11.080.01
National Committee CEN/TC 204

Legal references

EU law: 90/385/EEC, 93/42/EEC

Product Relations

Replaced by: NS-EN ISO 13408-1:2011
Replaced by: NS-EN ISO 13408-6:2011
Replaced by: NS-EN ISO 13408-2:2011
Replaced by: NS-EN ISO 13408-5:2011
Replaced by: NS-EN ISO 13408-3:2011
Replaced by: NS-EN ISO 13408-4:2011
Adopted from: EN 13824:2004 , 0

NS-EN 13824:2004

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Abstract

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