BS EN ISO 8871-5:2016
Current
Current
The latest, up-to-date edition.
Elastomeric parts for parenterals and for devices for pharmaceutical use Functional requirements and testing
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
30-11-2016
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/212
|
| DevelopmentNote |
Supersedes 04/30086336 DC. (09/2014) Supersedes 15/30324254 DC. (12/2016)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This part of ISO8871 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 ISO8536-2 and in ISO8536-6.
| Standards | Relationship |
| EN ISO 8871-5:2016 | Identical |
| ISO 8871-5:2016 | 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.