01/560508 DC : DRAFT FEB 2001
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
07-23-2013
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Withdrawn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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