ISO 3826-4:2015
Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features

Standard No.

ISO 3826-4:2015

Release Date

2015

Published By

International Organization for Standardization (ISO)

Latest

ISO 3826-4:2015

Scope

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 integrated features identified in this part of ISO 3826. The integrated features refer to: — needle stick protection device; — leucocyte filter; — sterile barrier filter; — pre-collection sampling device; — red blood cell storage bag; — plasma storage bag; — platelet storage bag; — polymorphonucleic (e.g. stem) cell storage bag; — post-collection sampling devices; and — connections for storage solutions, anticoagulant, and replacement fluid. This part of ISO 3826 specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. This part of ISO 3826 can be used on automated or semi-automated blood collection systems. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 3826.

ISO 3826-4:2015 Referenced Document

• EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
• ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
• ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
• ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
• ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
• ISO 1135-4:2012 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
• ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
• ISO 15747 Plastic containers for intravenous injections*， 2018-08-31 Update
• ISO 3696:1987 Water for analytical laboratory use; Specification and test methods
• ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components.Part 1: Conventional containers
• ISO 3826-2:2008 Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets
• ISO 3826-3:2006 Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features
• ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
• ISO 8536-4:2010 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed

ISO 3826-4:2015 history

• 2015 ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features