Name: UNI EN ISO 8871-2 : 2014
Brand: UNI

UNI EN ISO 8871-2 : 2014

Superseded

View Superseded by

ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION

Superseded date

30-05-2022

Published date

01-01-2014

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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Status	Superseded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	UNI EN ISO 8871-2:2021 UNI EN ISO 8871-2 : 2006
Supersedes	UNI EN ISO 8871-2 : 2006

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
EN ISO 8871-2:2004/A1:2014	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