ISO 8871-2-2020 pdf free.Elastomeric parts for parenterals andfor devices for pharmaceutical use — Identification and characterization.
This document specifies identification and characterization procedures applicable to elastomeric partsincluding coated stoppers used for drug containers and medical devices.
The physical and chemical test procedures specified in this document permit the determination ofthe typical characteristics of elastomeric parts including coatings and surface treatments and canserve as a basis for agreements between manufacturer and user regarding the product consistency insubsequent supplies. Depending upon the type of elastomer and its application, an appropriate set oftests is selected.
The following documents are referred to in the text in such a way that some or all of their contentconstitutes requirements of this document. For dated references,only the edition cited applies.Forundated references, the latest edition of the referenced document(including any amendments) applies.ISO 48-4，Rubber， vulcanized or thermoplastic – Determination of hardness — Part 4: Indentationhardness by durometer method (Shore hardness)
ISO 247-1:2018,Rubber — Determination of ash — Part 1:Combustion methodISO 2781:2018,Rubber, vulcanized or thermoplastic — Determination of density.ISO8871-1,Elastomeric parts for parenterals and for devices for pharmaceutical use—Part 1: Extractablesin aqueous autoclavates.
For the purposes of this document, the following terms and definitions apply.
Rubber is a complex material and it is not generally definable.The only property which all elastomericmaterials 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 stretchingforce, it snaps back to its original size and shape virtually unaltered.Similarly, one can squeeze it, twistit or distort it in any direction comparatively easily, and it will virtually spring back again to its originalshape unchanged.
Owing to its three-dimensional network, achieved by chemical cross-linking of the elastomer duringvulcanization, rubber is practically insoluble in solvents such as tetrahydrofuran, although considerablereversible 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 producedfrom the same formulation and that they exhibit the same characteristics as the initially suppliedsamples.ISO 8871 pdf download.