DIN EN ISO 8871-5:2015-08 (Draft)
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)
Hardcopy , PDF
07-03-2021
German
01-01-2015
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National foreword
National Annex NA (informative) - Bibliography
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Preparation of elastomeric closures for testing
Annex A (normative) - Test for penetrability
Annex B (normative) - Test for fragmentation
Annex C (normative) - Test for self-sealing and dye
solution tightness
Annex D (normative) - Test for dye solution tightness
Bibliography
Defines requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
| DevelopmentNote |
Supersedes DIN ISO 8871-5. (10/2014)
|
| DocumentType |
Draft
|
| Pages |
31
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| ISO 8871-5:2016 | Identical |
| EN ISO 8871-5:2016 | Identical |
| DIN ISO 8536-6:2012-09 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES (ISO 8536-6:2016) |
| DIN EN ISO 8362-2:2016-02 | Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015) |
| DIN EN ISO 8362-5:2016-07 | INJECTION CONTAINERS AND ACCESSORIES - PART 5: FREEZE DRYING CLOSURES FOR INJECTION VIALS (ISO 8362-5:2016) |
| DIN EN ISO 7864:2015-01 (Draft) | STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO 7864:2016) |
| ISO 8536-2:2010 | Infusion equipment for medical use — Part 2: Closures for infusion bottles |
| DIN EN ISO 8536-2:2010-08 | Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010) |
| DIN ISO 8536-6:2012-09 | INFUSION EQUIPMENT FOR MEDICAL USE - PART 6: FREEZE DRYING CLOSURES FOR INFUSION BOTTLES (ISO 8536-6:2016) |
| DIN EN ISO 8362-4:2011-12 | Injection containers and accessories - Part 4: Injection vials made of moulded glass (ISO 8362-4:2011) |
| DIN EN ISO 8362-6:2011-07 | Injection containers and accessories - Part 6: Caps made of aluminium-plastics combinations for injection vials (ISO 8362-6:2010) |
| ISO 8362-4:2011 | Injection containers and accessories Part 4: Injection vials made of moulded glass |
| ISO 8536-6:2016 | Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles |
| ISO 8362-3:2001 | Injection containers and accessories Part 3: Aluminium caps for injection vials |
| ISO 8362-6:2010 | Injection containers and accessories Part 6: Caps made of aluminium-plastics combinations for injection vials |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| DIN EN ISO 8362-1:2016-06 | INJECTION CONTAINERS AND ACCESSORIES - PART 1: INJECTION VIALS MADE OF GLASS TUBING (ISO 8362-1:2009 + AMD 1:2015) |
| ISO 8362-1:2009 | Injection containers and accessories Part 1: Injection vials made of glass tubing |
| DIN EN ISO 8362-3:2003-10 | INJECTION CONTAINERS FOR INJECTABLES AND ACCESSORIES - PART 3: ALUMINIUM CAPS FOR INJECTION VIALS |
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