EN ISO 8871-5:2016
Current
The latest, up-to-date edition.
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)
11-23-2016
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
ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.
| Committee |
CEN/TC 205
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| NBN EN ISO 8871-5 : 2014 | Identical |
| BS EN ISO 8871-5:2016 | Identical |
| NEN EN ISO 8871-5 : 2016 | Identical |
| I.S. EN ISO 8871-5:2016 | Identical |
| NS EN ISO 8871-5 : 2016 | Identical |
| ISO 8871-5:2016 | Identical |
| UNI EN ISO 8871-5 : 2017 | Identical |
| UNE-EN ISO 8871-5:2017 | Identical |
| SN EN ISO 8871-5 : 2017 | Identical |
| SS-EN ISO 8871-5:2016 | Identical |
| PN EN ISO 8871-5 : 2017 | Identical |
| NF EN ISO 8871-5 : 2017 | Identical |
| DIN EN ISO 8871-5:2015-08 (Draft) | Identical |
| DIN EN ISO 8871-5:2017-03 | Identical |
| ISO 8536-2:2010 | Infusion equipment for medical use — Part 2: Closures for infusion bottles |
| 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 |
| ISO 8362-1:2009 | Injection containers and accessories Part 1: Injection vials made of glass tubing |
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