ISO 8536-9:2015
Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment

Standard No.

ISO 8536-9:2015

Release Date

2015

Published By

International Organization for Standardization (ISO)

Latest

ISO 8536-9:2015

Scope

This part of ISO 8536 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by this part of ISO 8536: a) syringe pump lines (SPL); c) lines with integrated injection cannula (LIC). b) connecting lines (CL); In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

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 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 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

ISO 8536-9:2015 history

• 2015 ISO 8536-9:2015 Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment
• 2013 ISO 8536-9:2004 Infusion equipment for medical usePart 9:Fluid lines for use with pressure infusion equipment