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BS ISO 22413-2007 transfer sets for pharmaceutical preparations requirements and test methods

Standard Number:  BS ISO 22413-2007
Title:  transfer sets for pharmaceutical preparations requirements and test methods
Language:  English
Replaced by Standard:  BS ISO 22413-2010

Replacing Standard:  05/30135133 DC

Publication Date:  2007/3/30
Execute Date:  2007/3/30
Adopted International Standard:  ISO 7864:1993, ISO 8362, ISO 8536, ISO 15223, ISO 15747, ISO 15759, DIN 13097, EN 1707, ISO 594-1, ISO 594-2, ISO 7886-1, ISO 8871
Status:  withdrawn
Publisher:  British Standards
Price:  
Number of Pages:22  

Preface:Medical equipment, Drug containers, Drug administration, Drugs, Injection instruments, Cannulas, Parenteral infusion equipment, Fluids handling equipment (medical), Sterile equipment, Physical properties of materials, Test methods  
Description:ISO 22413:2006 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.  
Cross References:ISO 7864-1993; ISO 8362; ISO 8536; ISO 15223; ISO 15747; ISO 15759; DIN 13097; EN 1707; ISO 594-1; ISO 594-2; ISO 7886-1; ISO 8871  
Catalog:Foreword
Introduction
1 Scope
2 Normative references
3 Design and designation
3.1 Design
3.2 Designation for a transfer set with housing
3.3 Designation
4 Material
5 Physical requirements
5.1 Particulate contamination
5.2 Tensile strength
5.3 Tightness
5.4 Free flow
5.5 Piercing device
5.6 Penetration force
5.7 Fragmentation
5.8 Air inlet and air outlet
5.9 Protective caps
5.10 Transfer sets with a housing
6 Chemical requirements
7 Biological requirements
8 Testing of physical requirements
8.1 Particulate contamination
8.2 Tensile strength
8.3 Tightness of transfer set
8.4 Free flow
8.5 Piercing device
8.6 Penetration force
8.7 Testing on fragmentation
8.8 Effectiveness of air inlet and air outlet
with air filter
8.9 Efficiency of protective caps
9 Testing of chemical requirements
10 Testing of biological requirements
11 Packaging
12 Storage
13 Labelling
13.1 Unit container
13.2 Shelf or multi-unit container
Annex A (normative) Testing of fragmentation of
transfer sets with plastic piercing devices
Annex B (normative) Testing of fragmentation of transfer
sets with metal piercing devices
Bibliography  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  811KB
Tile in English:  transfer sets for pharmaceutical preparations requirements and test methods

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