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DIN EN ISO 8871-5:2015-08 (Draft)

DIN EN ISO 8871-5:2015-08 (Draft)

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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)

Available format(s)

Hardcopy , PDF

Superseded date

03-07-2021

Language(s)

German

Published date

01-01-2015

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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Superseded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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Hardcopy - German
PDF - German
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