1Key Takeaways
This document specifies 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 this document permit the determination of the typical characteristics of elastomeric parts …
2Scope / Description
This document specifies 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 this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.
6Frequently Asked Questions
What is EVS-EN ISO 8871-2:2020?
EVS-EN ISO 8871-2:2020 — Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020) is an international standard developed by Estonian Centre for Standardisation. This document specifies 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 this document permit...
What does EVS-EN ISO 8871-2:2020 cover?
This standard covers: This document specifies 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 this document permit the determination of the typical characteristics...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
How do I purchase EVS-EN ISO 8871-2:2020?
You can purchase EVS-EN ISO 8871-2:2020 by visiting our contact page. Click "Get This Standard" to view pricing and send a purchase inquiry. Our team will respond with payment and delivery details.