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ISO 8871-2:2003

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization
Available format(s)

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

Withdrawn date

05-16-2020

Published date

09-19-2003

ISO 8871-2:2003 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its application.

This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards.

DevelopmentNote
Supersedes ISO/DIS 8871-2 (09/2003) Together with ISO 8871-1 ISO 8871-3, ISO 8871-4 and ISO 8871-5, supersedes ISO 8871. (08/2005)
DocumentType
Standard
Pages
20
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy
Supersedes

ISO 8536-12:2007 Infusion equipment for medical use Part 12: Check valves
BS EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use Extractables in aqueous autoclavates
BS ISO 8536-12 : 2007 INFUSION EQUIPMENT FOR MEDICAL USE - PART 12: CHECK VALVES
DIN HDBK 231 : 4ED 2012
ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
EN ISO 8871-1 : 2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES
DIN ISO 8536-12:2013-04 Infusion equipment for medical use - Part 12: Check valves (ISO 8536-12:2007 + Amd. 1:2012)

ISO 11040-2:2011 Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges
ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
ISO 8362-2:2015 Injection containers and accessories — Part 2: Closures for injection vials
ISO 8536-2:2010 Infusion equipment for medical use — Part 2: Closures for infusion bottles
ISO 11040-5:2012 Prefilled syringes — Part 5: Plunger stoppers for injectables
ISO 8536-6:2016 Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
ISO 8362-5:2016 Injection containers and accessories Part 5: Freeze drying closures for injection vials
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
ISO 9924-1:2016 Rubber and rubber products — Determination of the composition of vulcanizates and uncured compounds by thermogravimetry — Part 1: Butadiene, ethylene-propylene copolymer and terpolymer, isobutene-isoprene, isoprene and styrene-butadiene rubbers
ISO 247:2006 Rubber Determination of ash
ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 2781:2008 Rubber, vulcanized or thermoplastic Determination of density

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