BS EN ISO 8871-2 : 2004
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
08-06-2020
English
01-01-2014
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Foreword
Introduction
1 Scope
2 Normative references
3 Tests
4 Preparation of samples for testing
5 Reagents and materials
Annex A (informative) - Identification of
elastomeric material by pyrolysis IR
Annex B (informative) - Determination of
compression set
Annex C (informative) - Swelling behaviour in oils
Annex D (informative) - Development of a fingerprint
by gas chromatography
Annex E (informative) - Analysis of volatile
components by headspace gas chromatography
Annex F (informative) - Determination of residual moisture
Annex G (informative) - Determination of a fingerprint by
thermal gravimetry (TG)
Annex H (informative) - Determination of a fingerprint by
surface infrared spectroscopy (ATR, attenuated total
reflection)
Bibliography
Provides 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.
| Committee |
CH/212
|
| DevelopmentNote |
Together with BS EN ISO 8871-1 and BS EN ISO 8871-3 it supersedes BS EN ISO 8871. (09/2004) 2004 Edition Re-Issued in July 2014 & incorporates AMD 1 2014. (07/2014)
|
| DocumentType |
Standard
|
| Pages |
34
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 8871-2 : 2014 | Identical |
| NEN EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
| ISO 8871-2:2003 | Identical |
| NBN EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
| UNE-EN ISO 8871-2:2005 | Identical |
| DIN EN ISO 8871-2:2014-08 | Identical |
| NS EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
| SN EN ISO 8871-2 : 2005 AMD 1 2014 | Identical |
| I.S. EN ISO 8871-2:2004 | Identical |
| NF EN ISO 8871-2 : 2005 AMD 1 2014 | Identical |
| UNI EN ISO 8871-2 : 2014 | Identical |
| 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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