ISO 8362-5:2016
Current
The latest, up-to-date edition.
Injection containers and accessories Part 5: Freeze drying closures for injection vials
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
French, English
15-02-2016
Important note : All end users must be registered with an Account prior to user licenses being assigned.
ISO 8362-5:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 83621 and ISO 83624, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this part of ISO 8362 are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.
| DevelopmentNote |
Supersede ISO/DIS 8362-5. (02/2016)
|
| DocumentType |
Standard
|
| Pages |
9
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 8362-5 : 2016 | Identical |
| NBN EN ISO 8362-5 : 2016 | Identical |
| NEN EN ISO 8362-5 : 2016 | Identical |
| NS EN ISO 8362-5 : 2016 | Identical |
| I.S. EN ISO 8362-5:2016 | Identical |
| PN EN ISO 8362-5 : 2016 | Identical |
| SN EN ISO 8362-5:2016 | Identical |
| UNI EN ISO 8362-5 : 2016 | Identical |
| UNE-EN ISO 8362-5:2016 | Identical |
| BS EN ISO 8362-5:2016 | Identical |
| EN ISO 8362-5:2016 | Identical |
| DIN EN ISO 8362-5:2016-07 | Identical |
| IS 1984 : Part 5 : 2024 | Identical |
| NEN ISO 8362-5 : 2008 | Identical |
| NF ISO 8362-5 : 2008 | Identical |
| DIN ISO 8362-5:2011-06 | Identical |
| ISO 11040-5:2012 | Prefilled syringes — Part 5: Plunger stoppers for injectables |
| 00/560909 DC : DRAFT MAR 2000 | BS ISO 8871-2 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION |
| BS ISO 11040-5:2012 | Prefilled syringes Plunger stoppers for injectables |
| UNI EN ISO 8871-2 : 2014 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION |
| BS EN ISO 7864:2016 | Sterile hypodermic needles for single use. Requirements and test methods |
| BS EN ISO 8871-1:2004 | Elastomeric parts for parenterals and for devices for pharmaceutical use Extractables in aqueous autoclavates |
| I.S. EN ISO 7864:2016 | STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014) |
| DIN ISO 11040-5:2013-12 | PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012) |
| DIN EN ISO 8871-2:2014-08 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003 + AMD.1:2005) |
| I.S. EN ISO 8871-2:2004 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003) |
| BS 7652-2:1995 | Prefilled syringes Specification for plungers and discs for dental local anaesthetic cartridges |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 8871-2:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization |
| ISO 8871-1:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates |
| UNE-EN ISO 7864:2017 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| EN ISO 8871-1:2004 | Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003) |
| BS EN ISO 8871-2 : 2004 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION |
| 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 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 3302-2:2008 | Rubber Tolerances for products Part 2: Geometrical tolerances |
| ISO 554:1976 | Standard atmospheres for conditioning and/or testing — Specifications |
| 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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