BS EN ISO 8362-2:2015
Withdrawn
Injection containers and accessories Closures for injection vials
Hardcopy , PDF
English
10-31-2015
04-04-2024
| 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Withdrawn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 |
| I.S. EN ISO 8362-2:2015 | Equivalent |
| UNE-EN ISO 8362-2:2015 | Equivalent |
| 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 |
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