BS EN ISO 8871‑2:2020 pdf download.Elastomeric parts for parenterals and for devices for pharmaceutical use.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 48‑4, Rubber, vulcanized or thermoplastic — Determination of hardness — Part 4: Indentation hardness by durometer method (Shore hardness)
ISO 247‑1:2018, Rubber — Determination of ash — Part 1: Combustion method
ISO 2781:2018, Rubber, vulcanized or thermoplastic — Determination of density
ISO 8871‑1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
4 Tests
4.1 General Rubber is a complex material and it is not generally definable. The only property which all elastomeric materials have in common is a special type of resilience or elasticity. When a strip of rubber is stretched, it will extend by up to many times its original length without breaking. On release of the stretching force, it snaps back to its original size and shape virtually unaltered. Similarly, one can squeeze it, twist it or distort it in any direction comparatively easily, and it will virtually spring back again to its original shape unchanged. Owing to its three‑dimensional network, achieved by chemical cross‑linking of the elastomer during vulcanization, rubber is practically insoluble in solvents such as tetrahydrofuran, although considerable reversible swelling may occur; this characteristic differentiates rubber from pseudo‑elastic materials, such as poly(vinyl chloride) and certain thermoplastic elastomers. In view of the complexity of rubber, a set of tests is needed for reliable identification. The manufacturer shall guarantee that all elastomeric parts of current supplies have been produced from the same formulation and that they exhibit the same characteristics as the initially supplied samples.
4.2 Hardness Hardness shall be determined in accordance with ISO 48‑4.
4.3 Density Density shall be determined in accordance with the procedure described in ISO 2781:2018, Clause 4, method A.
4.4 Ash
The inorganic residue after combustion shall be determined as described in ISO 247‑1:2018,
4.1, method A.BS EN ISO 8871‑2 pdf download.