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Prefilled syringes — Part 5: Plunger stoppers for injectables

Available format(s)

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

Language(s)

English, French

Published date

01-20-2012

Publisher

International Organization for Standardization

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Committee	ISO/TC 76
DevelopmentNote	Supersedes ISO/DIS 11040-5. (01/2012)
DocumentType	Standard
Pages	5
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 11040-5:2001

Standards	Relationship
DIN ISO 11040-5:2013-12	Identical
NF ISO 11040-5:2019	Identical
NEN ISO 11040-5 : 2012	Identical
BS ISO 11040-5:2012	Identical
DIN ISO 11040-5 E : 2013	Identical

BS ISO 11040-6:2012	Prefilled syringes Plastic barrels for injectables
UNI EN ISO 8871-2 : 2014	ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
17/30357741 DC : 0	BS ISO 11040-6 - PREFILLED SYRINGES - PART 6: PLASTIC BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
DIN ISO 11040-4 E : 2017	PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
10/30208782 DC : DRAFT DEC 2010	BS EN ISO 11608-3 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS
BS ISO 11040-4:2015	Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling
ISO 11040-8:2016	Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
BS EN ISO 8871-1:2004	Elastomeric parts for parenterals and for devices for pharmaceutical use Extractables in aqueous autoclavates
13/30273499 DC : 0	BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
ISO 11040-6:2012	Prefilled syringes Part 6: Plastic barrels for injectables
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)
15/30304642 DC : 0	BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES
ISO 11040-4:2015	Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
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
BS EN 30-1-2:2012	Domestic cooking appliances burning gas. Safety Appliances having forced-convection ovens and/or grills
EN 30-1-2:2012	Domestic cooking appliances burning gas - Safety - Part 1-2: Appliances having forced-convection ovens and/or grills
EN ISO 8871-1 : 2004	ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES
DIN ISO 11040-4:2007-10	PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
BS EN ISO 8871-2 : 2004	ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
DIN ISO 11040-4:2017-07	PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)

ISO 8871-1:2003	Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
ISO 11040-4:2015	Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
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 9997:1999	Dental cartridge syringes
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 8362-5:2016	Injection containers and accessories Part 5: Freeze drying closures for injection vials
ISO 9001:2015	Quality management systems — Requirements
ISO 3302-2:2008	Rubber Tolerances for products Part 2: Geometrical tolerances
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