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01/560508 DC : DRAFT FEB 2001

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

BS ISO 13408-2 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: FILTRATION
Withdrawn date

07-23-2013

Published date

11-23-2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Pre-selection of filters and filter assemblies
   based on filter manufacturer's data
6 Fluid-specific selection criteria based
   on filter user's data
7 Filtration process
   7.1 Process parameters
   7.2 Validation of fluid-specific microbial retention
       by filters
       7.2.1 Bacterial challenge test
       7.2.2 Challenge fluid and challenge microorganisms
8 Filtration system design
9 Routine process
10 Process documentation
11 Maintenance and change control
12 Operator training
Annex A Basic information and quality certificates for
        filter cartridges

Committee
CH/67
DocumentType
Draft
PublisherName
British Standards Institution
Status
Withdrawn

ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration

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