DIN EN ISO 8871-2:2014-08
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003 + AMD.1:2005)
Hardcopy , PDF
02-09-2020
German
01-01-2014
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National foreword
National Annex NA (informative) - Bibliography
Foreword to EN ISO 8871-2:2003
Foreword to EN ISO 8871-2:2004/A1:2014
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
This standard is included in DIN Handbook 231.
| DevelopmentNote |
Supersedes DIN ISO 8871 (11/2004)
|
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Supersedes |
| Standards | Relationship |
| ISO 8871-2:2003 | Identical |
| BS EN ISO 8871-2 : 2004 | Identical |
| NEN EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
| NBN EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
| UNE-EN ISO 8871-2:2005 | 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 |
| ONORM EN ISO 8871-2 : 2014 | Identical |
| DIN HDBK 231 : 4ED 2012 | |
| 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 |
| DIN EN ISO 1183-1:2013-04 | PLASTICS - METHODS FOR DETERMINING THE DENSITY OF NON-CELLULAR PLASTICS - PART 1: IMMERSION METHOD, LIQUID PYKNOMETER METHOD AND TITRATION METHOD (ISO 1183-1:2012) |
| DIN ISO 48:2016-09 | Rubber, vulcanized or thermoplastic - Determination of hardness (hardness between 10 IRHD and 100 IRHD) (ISO 48:2010) |
| ISO 8536-6:2016 | Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles |
| DIN EN ISO 8871-1:2004-11 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLE IN AQUEOUS AUTOCLAVATES |
| 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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