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DIN EN ISO 3826-1

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

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Organization: DIN
Publication Date: 1 September 2013
Status: inactive
Page Count: 32
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

This part of ISO 3826 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.

This part of ISO 3826 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 part of ISO 3826 apply to the plastics container as prepared ready for use.

This part of ISO 3826 is not applicable to plastics containers with and integrated filter.

Document History

DIN EN ISO 3826-1/A1
July 1, 2022
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/DAM 1:2022); German and English version EN ISO 3826-1:2019/prA1:2022
A description is not available for this item.
DIN EN ISO 3826-1
January 1, 2020
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)
A description is not available for this item.
DIN EN ISO 3826-1
April 1, 2018
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO/DIS 3826-1:2018); German and English version prEN ISO 3826-1:2018
A description is not available for this item.
DIN EN ISO 3826-1
September 1, 2013
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
This part of ISO 3826 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral...
DIN EN ISO 3826-1
April 1, 2004
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2003)
A description is not available for this item.

References

This document references:
DIN EN ISO 1135-4 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
Published by DIN on June 1, 2016
This part of ISO 1135 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as...
This document references:
EN 15986 - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Published by CEN on March 1, 2011
This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive...
This document references:
DIN EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Published by DIN on May 1, 2021
A description is not available for this item.
This document references:
DIN EN ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Published by DIN on October 1, 2014
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This...
This document references:
DIN EN ISO 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Published by DIN on September 1, 2018
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
This document references:
DIN EN ISO 10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
Published by DIN on August 1, 2021
A description is not available for this item.
This document references:
DIN EN ISO 1135-4 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
Published by DIN on June 1, 2016
This part of ISO 1135 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as...
This document is referenced by:
DIN EN ISO 3826-4 - Plastics collapsible containers for human blood and blood components - Part 4: Apheresis blood bag systems with integrated features (ISO 3826-4:2015)
Published by DIN on December 1, 2015
This part of ISO 3826 specifies requirements including performance requirements for aphaeresis blood bag systems with integrated features. Aphaeresis blood bag systems need not contain all of the...
This document is referenced by:
DIN EN ISO 1135-5 - Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
Published by DIN on June 1, 2016
This part of ISO 1135 specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International...
This document is referenced by:
DIN EN ISO 8536-14 - Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)
Published by DIN on April 1, 2018
This part of ISO 8536 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized...
This document is referenced by:
VDI 5701 - Biomaterials in medicine - Classification, requirements, and applications
Published by DIN on May 1, 2018
Die Richtlinie bezieht sich auf Biomaterialien und deren Verwendung für die Herstellung von Medizinprodukten (z.B. Implantaten) am lebenden Organismus, insbesondere bei Mensch und Tier....
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