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Overview ISO 8871-3:2003/Amd 1:2018 is an essential international standard concerning elastomeric parts used in parenteral and pharmaceutical devices. This document is an amendment to Part 3 of ISO 8…
Overview EN ISO 8871-5:2025 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing - is the CEN-adopted version of ISO 8871-5:2025. I…
Overview EN ISO 8871-2:2020 - "Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization" (ISO 8871-2:2020) specifies procedures for the i…
Overview SIST EN ISO 8871-3:2004/A1:2019 is a European amendment to the international standard ISO 8871-3:2003/Amd 1:2018. It focuses on elastomeric parts used in parenteral and pharmaceutical device…
Overview EN ISO 8871-3:2004/A1:2019 is a European amendment to the international standard ISO 8871-3:2003/Amd 1:2018. It focuses on elastomeric parts used in parenteral and pharmaceutical devices, sp…
Overview EN ISO 8871-4:2006 - "Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods" (ISO 8871-4:2006) specifies biological safe…
Overview EN ISO 8871-1:2004 (ISO 8871-1:2003) specifies chemical test methods to classify and evaluate elastomeric parts for parenterals and pharmaceutical devices by determining extractables in aque…
Overview SIST EN ISO 8871-3:2004 is a critical international standard developed by CEN and ISO that specifies methods for evaluating elastomeric parts used in parenteral and pharmaceutical devices. S…
Overview EN ISO 8871-3:2004 is a critical international standard developed by CEN and ISO that specifies methods for evaluating elastomeric parts used in parenteral and pharmaceutical devices. Specif…
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…
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…
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…
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…
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 8871-5:2025 - 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 8871-3:2003 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 8871-5:2016 - "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 8871-4:2006 - "Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods" defines the biological safety requirements and…