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SSH EN ISO 3826-1:2013

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)

Apr 23, 2014
95.99 Withdrawal of Standard   Jun 29, 2021

General information

95.99     Jun 29, 2021

DPS

DPS/KT 205

European Norm

11.040.20  

English  

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Scope

ISO 3826-1:2013 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile 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 may contain anticoagulant and/or preservative solutions, depending on the application envisaged.
ISO 3826-1:2013 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 ISO 3826-1:2013 apply to the plastics container as prepared ready for use.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 3826-1:2003

NOW

WITHDRAWN
SSH EN ISO 3826-1:2013
95.99 Withdrawal of Standard
Jun 29, 2021

REVISED BY

PUBLISHED
SSH EN ISO 3826-1:2019

Related project

Adopted from EN ISO 3826-1:2013