This part of ISO 1135 specifies requirements for single-use gravity transfusion medical transfusion devices to ensure that they are suitable for use with blood and blood component containers and intravenous puncture devices. Other objectives of this part of ISO 1135 are to provide guidance on specifications of the quality and performance of materials used in transfusion devices, to provide names for components of transfusion devices, and to ensure compatibility of the devices with a range of cell and blood plasma components . In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 1135.
EN ISO 1135-4:2015 Referenced Document
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
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ISO 3696:1987 Water for analytical laboratory use; Specification and test methods
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ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
ISO 7000:2014 Graphical symbols for use on equipment - Registered symbols
ISO 7864:1993 Sterile hypodermic needles for single use
EN ISO 1135-4:2015 history
2015EN ISO 1135-4:2015 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
2012EN ISO 1135-4:2012 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
2011EN ISO 1135-4:2011 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
2010EN ISO 1135-4:2010 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
2004EN ISO 1135-4:2004 Transfusion equipment for medical use - Part 4: Transfusion sets for single use