DIN EN ISO 8871-2 2014-08 PDF

Full title and description

DIN EN ISO 8871-2:2014-08 — Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization. This German/adopted European edition reproduces EN ISO 8871-2:2004 with Amendment A1:2014 and specifies identification and characterization procedures for elastomeric parts (including coated stoppers and surface treatments) used in contact with parenteral pharmaceutical products.

Abstract

Specifies physical and chemical identification and characterization test procedures that permit determination of typical properties of elastomeric parts (and coatings) intended for parenteral containers and related devices. The tests are intended to support product consistency, characterization for regulatory submissions, and agreements between manufacturer and user on acceptance criteria; an appropriate subset of tests is selected depending on elastomer type and application. The content of the DIN/EN adoption corresponds to earlier ISO editions and has subsequently been consolidated in a later ISO revision.

General information

• Status: Withdrawn / replaced by a later ISO revision (see notes).
• Publication date: 2014-08-01 (DIN edition designation 2014-08).
• Publisher: Deutsches Institut für Normung (DIN) — adoption of EN ISO 8871-2.
• ICS / categories: 11.040.20 (Transfusion, infusion and injection equipment / elastomeric parts for parenteral use).
• Edition / version: DIN EN ISO 8871-2:2014-08 (based on EN ISO 8871-2:2004 + A1:2014).
• Number of pages: Approximately 31 pages (varies slightly by national publisher / format).

Scope

Defines identification and characterization test methods for elastomeric components intended for use with parenteral pharmaceutical products and medical devices. Methods cover physical and chemical analyses (including surface and coating characterization) to verify identity, detect changes between lots, and provide data for specification and supplier–user agreements. The standard is intended for empty elastomeric parts used in primary packaging and in medical devices where contact with parenteral preparations may occur.

Key topics and requirements

• Identification procedures for elastomer type and formulation (rubber class, major constituents).
• Physical tests (dimensions, resilience, compression set, hardness where applicable).
• C hemical characterization and screening for extractables/impurities relevant to parenteral use.
• Surface and coating description and testing (coated stoppers, surface treatments).
• Sampling and lot-to-lot consistency checks; criteria for acceptance and for agreement between supplier and user.
• Test selection guidance depending on elastomer type and intended application.

Typical use and users

Used by manufacturers of elastomeric closures and coated stoppers, pharmaceutical packaging suppliers, quality-control and analytical laboratories, regulatory affairs specialists preparing dossiers, and purchasers/specifiers who need to define acceptance criteria for elastomeric components for parenteral products.

Related standards

Part of the ISO 8871 series addressing elastomeric parts for parenteral use; related documents include ISO 8871-1 (extractables in aqueous autoclavates), ISO 8871-3 (released-particle count), ISO 8871-4 (biological requirements and test methods) and later Parts addressing functional testing and updates. The DIN/EN adoption here was later superseded by ISO 8871-2:2020 (new consolidated edition).

Keywords

elastomeric parts; parenteral; coated stoppers; identification; characterization; extractables; surface treatment; quality control; DIN EN ISO 8871-2; pharmaceutical packaging.

FAQ

Q: What is this standard?

A: A German/European adoption (DIN EN ISO 8871-2:2014-08) of the ISO standard that specifies identification and characterization methods for elastomeric parts used with parenteral pharmaceuticals.

Q: What does it cover?

A: Physical and chemical test procedures to identify elastomer type, characterize coatings and surfaces, and assess lot-to-lot consistency; guidance on selecting appropriate tests for different elastomer types and applications.

Q: Who typically uses it?

A: Elastomer and closure manufacturers, pharmaceutical packaging suppliers, QC/analytical labs, regulatory and quality professionals, and purchasers who need agreed acceptance criteria for parenteral packaging components.

Q: Is it current or superseded?

A: The DIN EN ISO 8871-2:2014-08 edition is withdrawn at national levels and has been superseded by a later ISO revision (ISO 8871-2:2020); users should refer to the 2020 edition or the currently applicable national adoption for up-to-date requirements.

Q: Is it part of a series?

A: Yes — it is Part 2 of the ISO 8871 series dealing with elastomeric parts for parenterals; other parts cover extractables (Part 1), particle release (Part 3), biological tests (Part 4), and functional testing/requirements (other parts and later revisions).

Q: What are the key keywords?

A: Elastomeric parts, parenteral, identification, characterization, coated stoppers, extractables, QC, ISO 8871-2, DIN EN ISO.