What is ISO 8871-2 about?
ISO 8871 discusses elastomeric parts for parenterals and for devices for pharmaceutical use. ISO 8871-2 layouts 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 ISO 8871-2 permits the determination of the typical characteristics of elastomeric parts including coatings and surface treatments. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.
Who is ISO 8871-2 for?
ISO 8871-2 on Elastomeric parts for pharmaceutical use is useful for:
Manufacturers of elastomeric parts for parenteral
Manufacturers of elastomeric parts devices for pharmaceutical use
Pharmacies and medical laboratories
Regulatory authorities
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