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DIN ISO 11040-5:2013-12

Current
Current

The latest, up-to-date edition.

PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012)
Available format(s)

Hardcopy , PDF

Language(s)

English, German

Published date

12-01-2012

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
Introduction
1 Scope
2 Normative references
3 Classification
4 Shape and dimensions
5 Designation
6 Material
7 Requirements
8 Labelling
Bibliography

This standard is included in DIN Handbook 231.

Committee
TC 76
DevelopmentNote
Supersedes DIN 58358-5 (08/2002)
DocumentType
Standard
Pages
11
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current
Supersedes

Standards Relationship
ISO 11040-5:2012 Identical

DIN HDBK 231 : 4ED 2012
DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)

ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
ISO 2230:2002 Rubber products — Guidelines for storage
DIN ISO 48:2016-09 Rubber, vulcanized or thermoplastic - Determination of hardness (hardness between 10 IRHD and 100 IRHD) (ISO 48:2010)
DIN EN ISO 8871-1:2004-11 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLE IN AQUEOUS AUTOCLAVATES
DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
ISO 3302-1:2014 Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 9997:1999 Dental cartridge syringes
DIN EN ISO 15378:2016-03 PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017)
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 8362-5:2016 Injection containers and accessories Part 5: Freeze drying closures for injection vials
DIN EN ISO 8871-4:2006-09 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)
ISO 9001:2015 Quality management systems — Requirements
ISO 3302-2:2008 Rubber Tolerances for products Part 2: Geometrical tolerances
ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods
DIN ISO 8362-5:2011-06 INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS

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Hardcopy - English
PDF - English
Hardcopy - German
PDF - German
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