NEN EN ISO 8871-2 : 2004 AMD 1 2014

Current

Current The latest, up-to-date edition.

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

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Published date: 12-01-2013

Publisher: Netherlands Standards

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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)
Bibliography

Abstract - (Show below) - (Hide below)

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.

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Development Note	Supersedes NEN ISO 8871-2. (09/2004)
Document Type	Standard
ISBN
Pages
Published
Publisher	Netherlands Standards
Status	Current
Supersedes	NEN ISO 8871-2 : 2003

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
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
EN ISO 8871-2:2004/A1:2014	Identical
ISO 8871-2:2003	Identical
NBN EN ISO 8871-2 : 2004 AMD 1 2014	Identical
BS EN ISO 8871-2 : 2004	Identical
UNE-EN ISO 8871-2:2005	Identical
ONORM EN ISO 8871-2 : 2014	Identical

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