EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
This part of ISO 3826 specifies requirements, including required performance characteristics, for apheresis blood bag systems with integrated features. Apheresis blood bag systems need not include all of the integrated features identified in this part of ISO 3826. The integrated features refer to the following: puncture protection device; leukocyte filter; sterile barrier filters; Device for taking samples before taking blood; RBC storage bags; plasma storage bags; platelet storage bags; storage bags for polymorphonuclear cells (e.g. stem cells); Device for collecting samples after blood collection; Connections for storage, anticoagulant and exchange fluids. This part of ISO 3826 specifies additional requirements for blood bag systems for the collection of various quantities of blood components or cells by apheresis. This part of ISO 3826 can be applied to both automatic and semi-automatic 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.
EN 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 ISO IEC 27001-2013 cor2-2015 technical errata*， 2024-04-20 Update
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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 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 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis 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
EN ISO 3826-4:2015 history
2015EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)