ISO 8362-2:2015
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Injection containers and accessories — Part 2: Closures for injection vials
Amended by
Available format(s)
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
21-03-2024
Language(s)
English, French
Published date
30-09-2015
ISO 8362-2:2015 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362‑1 and ISO 8362‑4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in ISO 8362-2:2015 are intended for single use only.
| Committee |
ISO/TC 76
|
| DevelopmentNote |
Supersedes ISO/DIS 8362-2. (10/2015)
|
| DocumentType |
Standard
|
| Pages |
6
|
| PublisherName |
International Organization for Standardization
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 8362-2 : 2016 | Identical |
| DS EN ISO 8362-2 : 2015 | Identical |
| UNI EN ISO 8362-2:2022 | Identical |
| NF EN ISO 8362-2 : 2015 | Identical |
| NEN EN ISO 8362-2 : 2015 | Identical |
| NS EN ISO 8362-2 : 2010 | Identical |
| I.S. EN ISO 8362-2:2015 | Identical |
| PN EN ISO 8362-2 : 2016 | Identical |
| SN EN ISO 8362-2 : 2016 | Identical |
| UNI EN ISO 8362-2 : 2010 | Identical |
| UNE-EN ISO 8362-2:2015 | Identical |
| BS EN ISO 8362-2:2015 | Identical |
| EN ISO 8362-2:2015 | Identical |
| DIN EN ISO 8362-2:2016-02 | Identical |
| DIN ISO 8362-2:1989-12 | Identical |
| EN 28362-2 : 1993 | Identical |
| NS ISO 8362-2 : 1ED 1993 | Identical |
| IS 1984 : Part 4 : 2023 | Identical |
| I.S. EN 28362-2:1994 | Identical |
| PN EN 28362-2 : 2002 | Identical |
| NBN EN ISO 8362-2 : 2010 | Identical |
| NEN ISO 8362-2 : 2008 | Identical |
| UNE-EN 28362-2:1994 | Identical |
| UNI EN ISO 8871-2 : 2014 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION |
| 14/30296389 DC : 0 | BS EN ISO 7864 - STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS |
| 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 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) |
| BS 3970-2:1991 | Sterilizing and disinfecting equipment for medical products Specification for steam sterilizers for aqueous fluids in sealed rigid containers |
| 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) |
| EN ISO 8871-2:2004/A1:2014 | 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) |
| 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 |
| BS ISO 11418-5:2015 | Containers and accessories for pharmaceutical preparations Dropper assemblies |
| ISO 11418-5:2015 | Containers and accessories for pharmaceutical preparations Part 5: Dropper assemblies |
| 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 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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Hardcopy - English
PDF 1 User - English
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PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
PDF 1 User - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
PDF 1 User - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
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