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BSI - BS EN ISO 3826-4

Plastics collapsible containers for human blood and blood components Part 4: Aphaeresis blood bag systems with integrated features

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Organization: BSI
Publication Date: 31 August 2015
Status: active
Page Count: 44
ICS Code (Transfusion, infusion and injection equipment): 11.040.20

Document History

BS EN ISO 3826-4
August 31, 2015
Plastics collapsible containers for human blood and blood components Part 4: Aphaeresis blood bag systems with integrated features
A description is not available for this item.

References

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:
NS-EN ISO 10993-4:2002/A1:2006 - Amendment A1 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2002/Amd 1:2006)
Published by SN on November 1, 2006
A description is not available for this item.
This document references:
EN ISO 10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
Published by CEN on May 1, 2017
This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact...
This document references:
EN ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Published by CEN on February 1, 2023
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: —...
This document references:
EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by CEN on December 1, 2020
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by CEN on December 1, 2020
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
EN ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Published by CEN on February 1, 2023
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: —...
This document references:
EN ISO 10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
Published by CEN on May 1, 2017
This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact...
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