ISO 8362-1:2009
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Injection containers and accessories Part 1: Injection vials made of glass tubing
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
26-06-2019
Superseded by
Published date
07-12-2009
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ISO 8362-1:2009 specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers shall be made and the performance requirements of those containers.
ISO 8362-1:2009 applies to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.
| DevelopmentNote |
DRAFT ISO/DIS 8362-1 is also available for this standard. (08/2017)
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| DocumentType |
Standard
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| Pages |
5
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| PublisherName |
International Organization for Standardization
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 8362-1:2016-06 | Identical |
| NF EN ISO 8362-1 : 2010 AMD 1 2016 | Identical |
| NS EN ISO 8362-1 : 2009 AMD 1 2015 | Identical |
| NEN EN ISO 8362-1 : 2010 AMD 1 2016 | Identical |
| PN EN ISO 8362-1 : 2010 AMD 1 2016 | Identical |
| BS EN ISO 8362-1 : 2009 | Identical |
| UNI EN ISO 8362-1 : 2010 | Identical |
| SN EN ISO 8362-1 : 2010 AMD 1 2016 | Identical |
| NBN EN ISO 8362-1 : 2010 AMD 1 2016 | Identical |
| I.S. EN ISO 8362-1:2009 | Identical |
| SN EN ISO 8362-1:2010 | Identical |
| ONORM EN ISO 8362-1 : 2016 | Identical |
| NS ISO 8362-1 : 1ED 1993 | Identical |
| SNV NF EN 28362-1 : 1993 | Identical |
| I.S. EN 28362-1:1994 | Identical |
| EN 28362-1 : 1993 | Corresponds |
| BS EN 28362-1:1993 | Identical |
| UNE-EN 28362-1:1994 | Identical |
| UNE-EN ISO 8362-1:2010 | Identical |
| DIN ISO 8362-1:1990-12 | Identical |
| 15/30315528 DC : 0 | BS ISO 4802-2 - GLASSWARE - HYDROLYTIC RESISTANCE OF THE INTERIOR SURFACES OF GLASS CONTAINERS - PART 2: DETERMINATION BY FLAME SPECTROMETRY AND CLASSIFICATION |
| 09/30178946 DC : 0 | BS ISO 4802-1 - GLASSWARE - HYDROLYTIC RESISTANCE OF THE INTERIOR SURFACES OF GLASS CONTAINERS - PART 1: DETERMINATION BY TITRATION METHOD AND CLASSIFICATION |
| 09/30178949 DC : 0 | BS ISO 4802-2 - GLASSWARE - HYDROLYTIC RESISTANCE OF THE INTERIOR SURFACES OF GLASS CONTAINERS - PART 2: DETERMINATION BY FLAME SPECTROMETRY AND CLASSIFICATION |
| BS ISO 4802-1:2016 | Glassware. Hydrolytic resistance of the interior surfaces of glass containers Determination by titration method and classification |
| ISO 4802-1:2016 | Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification |
| I.S. EN ISO 8871-5:2016 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016) |
| ISO 8871-5:2016 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing |
| DIN ISO 10985:2009-12 | Caps made of aluminium-plastics combinations for infusion bottles and injection vials - Requirements and test methods (ISO 10985:2009) |
| BS EN ISO 8362-7:2010 | Injection containers and accessories Injection caps made of aluminium-plastics combinations without overlapping plastics part |
| 15/30324254 DC : 0 | BS EN ISO 8871-5 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING |
| UNE-EN ISO 8362-7:2011 | Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006) |
| BS EN ISO 7864:2016 | Sterile hypodermic needles for single use. Requirements and test methods |
| DIN ISO 8362-7:2007-06 | INJECTION CONTAINERS AND ACCESSORIES - PART 7: INJECTION CAPS MADE OF ALUMINIUM-PLASTICS COMBINATIONS WITHOUT OVERLAPPING PLASTICS PART |
| 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 |
| UNI EN ISO 8362-7 : 2011 | INJECTION CONTAINERS AND ACCESSORIES - PART 7: INJECTION CAPS MADE OF ALUMINIUM-PLASTICS COMBINATIONS WITHOUT OVERLAPPING PLASTICS PART |
| BS ISO 4802-2:2016 | Glassware. Hydrolytic resistance of the interior surfaces of glass containers Determination by flame spectrometry and classification |
| DIN EN ISO 8362-2:2016-02 | Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015) |
| EN ISO 8362-2:2015 | Injection containers and accessories - Part 2: Closures for injection vials (ISO 8362-2:2015) |
| 14/30296389 DC : 0 | BS EN ISO 7864 - STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS |
| BS EN ISO 8871-5:2016 | Elastomeric parts for parenterals and for devices for pharmaceutical use Functional requirements and testing |
| BS EN ISO 8362-2:2015 | Injection containers and accessories Closures for injection vials |
| NF EN ISO 8362-7 : 2011 | INJECTION CONTAINERS AND ACCESSORIES - PART 7: INJECTION CAPS MADE OF ALUMINIUM-PLASTICS COMBINATIONS WITHOUT OVERLAPPING PLASTICS PART |
| 04/30086336 DC : 0 | BS ISO 8871-5 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING |
| I.S. EN ISO 8362-7:2010 | INJECTION CONTAINERS AND ACCESSORIES - PART 7: INJECTION CAPS MADE OF ALUMINIUM-PLASTICS COMBINATIONS WITHOUT OVERLAPPING PLASTICS PART |
| ISO 4802-2:2016 | Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification |
| I.S. EN ISO 8362-2:2015 | INJECTION CONTAINERS AND ACCESSORIES - PART 2: CLOSURES FOR INJECTION VIALS (ISO 8362-2:2015) |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 8362-2:2015 | Injection containers and accessories — Part 2: Closures for injection vials |
| UNE-EN ISO 7864:2017 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| EN ISO 8871-5:2016 | Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016) |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| EN ISO 8362-7:2010 | Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006) |
| DIN EN ISO 8362-7:2011-03 | Injection containers and accessories - Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part (ISO 8362-7:2006) |
| 15/30315525 DC : 0 | BS ISO 4802-1 - GLASSWARE - HYDROLYTIC RESISTANCE OF THE INTERIOR SURFACES OF GLASS CONTAINERS - PART 1: DETERMINATION BY TITRATION METHOD AND CLASSIFICATION |
| UNE-EN ISO 8871-5:2017 | Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016) |
| DIN EN ISO 8871-5:2015-08 (Draft) | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016) |
| 09/30196282 DC : DRAFT AUG 2009 | BS ISO 8362-6 - INJECTION CONTAINERS AND ACCESSORIES - PART 6: CAPS MADE OF ALUMINIUM-PLASTICS COMBINATIONS FOR INJECTION VIALS |
| ISO 10985:2009 | Caps made of aluminium-plastics combinations for infusion bottles and injection vials — Requirements and test methods |
| DIN EN ISO 8871-5:2017-03 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016) |
| ISO 720:1985 | Glass Hydrolytic resistance of glass grains at 121 degrees C Method of test and classification |
| ISO 1101:2017 | Geometrical product specifications (GPS) — Geometrical tolerancing — Tolerances of form, orientation, location and run-out |
| ISO 4802-2:2016 | Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification |
| ISO 4802-1:2016 | Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification |
| ISO 719:1985 | Glass Hydrolytic resistance of glass grains at 98 degrees C Method of test and classification |
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