ISO 8871-2:2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization
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16-05-2020
19-09-2003
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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)
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| DocumentType |
Standard
|
| Pages |
20
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| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 8871-2 : 2014 | Identical |
| GOST R ISO 8871-2 : 2010 | Identical |
| NF EN ISO 8871-2 : 2005 AMD 1 2014 | Identical |
| NBN EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
| NEN EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
| NEN ISO 8871-2 : 2003 | Identical |
| NS EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
| I.S. EN ISO 8871-2:2004 | Identical |
| PN EN ISO 8871-2 : 2005 AMD 1 2014 | Identical |
| SN EN ISO 8871-2 : 2005 AMD 1 2014 | Identical |
| UNI EN ISO 8871-2 : 2014 | Identical |
| NF EN ISO 8871-2:2005 | Identical |
| NEN-EN-ISO 8871-2:2004 en | Identical |
| PN-EN ISO 8871-2:2005 | Identical |
| SS-EN ISO 8871-2:2005 | Identical |
| UNE-EN ISO 8871-2:2005 | Identical |
| BS EN ISO 8871-2 : 2004 | Identical |
| DIN EN ISO 8871-2:2014-08 | Identical |
| 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 (ISO 8871-1:2003) |
| 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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