1Key Takeaways
This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separat…
2Scope / Description
This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers can contain anticoagulant and/or preservative solutions, depending on the application envisaged. This document is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units. Unless otherwise specified, all tests specified in this document apply to the plastics container as prepared ready for use. This document is not applicable to plastics containers with an integrated filter.
6Frequently Asked Questions
What is EN ISO 3826-1:2019?
EN ISO 3826-1:2019 — Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019) is an international standard developed by European Committee for Standardization (CEN). This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional...
What does EN ISO 3826-1:2019 cover?
This standard covers: This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage,...
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.
What is the latest version of EN ISO 3826-1:2019?
The current published version is EN ISO 3826-1:2019, published on 2019-10-16. Always check for amendments or pending revisions.
How do I purchase EN ISO 3826-1:2019?
You can purchase EN ISO 3826-1:2019 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.