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Elastomeric parts for parenterals and for devices for pharmaceutical use - Extractables in aqueous autoclavates

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Description

Elastomeric parts for parenterals and for devices for pharmaceutical use - Extractables in aqueous autoclavates1 Scope 1. 1 This part of ISO 8871 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use. It specifies a series of comparative test methods for chemical evaluation by the determination of extractables in aqueous autoclavates (see Clause 4) and describes the

Note: Safety and electromagnetic compatibility (EMC) requirements are outside the scope of BS EN 50600‑2‑3 and are covered by other standards and regulations

BS EN 50343 also provides EMC requirements

wood or concrete

16 of ISO 5053‑1:2015)

as well as the verification of electronic identity

equivalent alternatives are given

The imaging qualities of the focal spot are based on the two dimensional intensity distribution in the object plane

Aflatoxin B1 is the most hepatotoxic and hepatocarcinogenic of the aflatoxins and occurs as a contaminant in a variety of foods

Analysis of results

and checking of test equipment

added support for reverse connectivity

b)      Introduction of the hierarchy of overlapping lines

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