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Overview ISO 8871-4:2006 - "Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods" defines the biological safety requirements and…
Overview ISO 8871-5:2016 - "Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing" defines functional requirements and test methods fo…
Overview ISO 8871-3:2003 specifies laboratory methods to determine the number of visible and subvisible particles released from elastomeric parts used with parenterals and pharmaceutical devices. The…
Overview ISO 8871-5:2025 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing defines functional requirements and test methods for…
Overview ISO 8871-1:2003 - “Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates” defines chemical evaluation procedures for elastom…
Overview ISO 8871-2:2020 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - sets out identification and characterization proced…
1 Scope This part of ISO 8871 specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i.e. it offers the ex…
1 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 bot…
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…