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ISO 8362-5:2016

Current
Current

The latest, up-to-date edition.

Injection containers and accessories Part 5: Freeze drying closures for injection vials
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

French, English

Published date

02-15-2016

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

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)
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)
BS 7652-2:1995 Prefilled syringes Specification for plungers and discs for dental local anaesthetic cartridges
DIN ISO 11040-5 E : 2013 PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012)
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 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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