BS EN ISO 8362-2:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Injection containers and accessories Closures for injection vials
Hardcopy , PDF
04-04-2024
English
31-10-2015
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/212
|
| DevelopmentNote |
Supersedes BS EN 28362-2. (09/2010) Supersedes 14/30301958 DC. (11/2015)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
This part of ISO8362 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO8362-1 and ISO8362-4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this part of ISO8362 are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
| Standards | Relationship |
| ISO 8362-2:2015 | Identical |
| EN ISO 8362-2:2015 | Identical |
| ISO 8871-1:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates |
| 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 |
| ISO 8362-4:2011 | Injection containers and accessories Part 4: Injection vials made of moulded glass |
| ISO 3302-1:2014 | Rubber — Tolerances for products — Part 1: Dimensional tolerances |
| 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 8362-1:2009 | Injection containers and accessories Part 1: Injection vials made of glass tubing |
| ISO 3302-2:2008 | Rubber Tolerances for products Part 2: Geometrical tolerances |
| ISO 8871-5:2016 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing |
| 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 |
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.