UNI EN ISO 8871-2 : 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
30-05-2022
01-01-2014
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
Defines 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 |
U42.01
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 8871-2:2014-08 | Identical |
| ONORM EN ISO 8871-2 : 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 |
| NEN EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
| ISO 8871-2:2003 | Identical |
| BS EN ISO 8871-2 : 2004 | 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.