ISO 8536-11:2015
Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment

Standard No.

ISO 8536-11:2015

Release Date

2015

Published By

International Organization for Standardization (ISO)

Latest

ISO 8536-11:2015

Scope

This part of ISO 8536 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

ISO 8536-11:2015 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 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 8536-11:2015 history

• 2015 ISO 8536-11:2015 Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment
• 2004 ISO 8536-11:2004 Infusion equipment for medical use - Part 11: Infusion filters for use with pressure infusion equipment