This part of ISO 8536 applies to sterilized, single-use pressure infusion transfer lines for use with pressure infusion devices up to a maximum of 200 kPa (2 bar). This part of ISO 8536 covers: a) syringe pump lines (SPL); b) connecting lines (CL); c) Lines with integrated injection cannula (LIC). In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.
EN ISO 8536-9:2015 Referenced Document
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 15 Rolling bearings - Radial bearings - Boundary dimensions, general plan*， 2017-07-01 Update
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
ISO 8536-10:2015 Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment
ISO 8536-11:2015 Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment
ISO 8536-4:2010 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ISO 8536-8:2015 Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus
EN ISO 8536-9:2015 history
2015EN ISO 8536-9:2015 Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment
2004EN ISO 8536-9:2004 Infusion equipment for medical use - Part 9: Fluid lines for use with pressure infusion equipment