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BS EN ISO 8871-2:2020:2024 Edition

BS EN ISO 8871-2:2020:2024 Edition

$142.49

Elastomeric parts for parenterals and for devices for pharmaceutical use – Identification and characterization

Published By Publication Date Number of Pages
BSI 2024 32
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This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.

The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Tests
4.1 General
4.2 Hardness
4.3 Density
11 4.4 Ash
4.5 Infrared spectrum
4.5.1 Material
4.5.2 Coating
4.6 Compression set
4.7 Swelling
4.8 Development of a fingerprint by gas chromatography
12 4.9 Detection of volatile substances by gas chromatography
4.10 Determination of residual moisture
4.11 Determination of fingerprint by thermogravimetric analysis (TGA)
4.12 Determination of extractables in aqueous autoclavates
5 Preparation of samples for testing
5.1 Treatment before testing
5.2 Number of samples needed for the tests
13 6 Reagents and materials
14 Annex A (informative) Identification of elastomeric material by pyrolysis IR
16 Annex B (informative) Determination of compression set
18 Annex C (informative) Swelling behaviour in oils
20 Annex D (informative) Development of a fingerprint by gas chromatography
22 Annex E (informative) Analysis of volatile components by headspace gas chromatography
24 Annex F (informative) Determination of residual moisture
25 Annex G (informative) Determination of a fingerprint by thermal gravimetry (TG)
28 Annex H (informative) Determination of the elastomer identity and verification of the presence of a coating by surface infrared spectroscopy [attenuated total reflection (ATR)]
31 Bibliography

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BS EN ISO 8871-2:2020
$142.49