This part of ISO 8536 provides users with information about sterilized single-use infusion devices with pressure infusion devices up to a maximum pressure of 200 kPa (2 bar). In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.
EN ISO 8536-8:2015 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 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for 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 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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 8536-4:2010 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ISO 8536-9:2015 Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment
EN ISO 8536-8:2015 history
2015EN ISO 8536-8:2015 Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)
2004EN ISO 8536-8:2004 Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus