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