ISO 8536-4:2010
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed

Standard No.
ISO 8536-4:2010
Release Date
2010
Published By
International Organization for Standardization (ISO)
Status
Replace By
ISO 8536-4:2010/Amd 1:2013
Latest
ISO 8536-4:2019
Scope
This part of ISO 8536 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

ISO 8536-4:2010 Referenced Document

  • ISO 14644-1 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (includes Redline Version)*2015-02-01 Update
  • ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
  • ISO 3696 Water for analytical laboratory use; Specification and test methods
  • ISO 594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
  • ISO 594-2 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
  • ISO 7864 Sterile hypodermic needles for single use - Requirements and test methods*2016-08-01 Update

ISO 8536-4:2010 history

  • 2019 ISO 8536-4:2019 Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
  • 2013 ISO 8536-4:2010/Amd 1:2013 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed; Amendment 1
  • 2010 ISO 8536-4:2010 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
  • 2007 ISO 8536-4:2007 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
  • 2004 ISO 8536-4:2004 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
  • 1998 ISO 8536-4:1998 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
  • 1987 ISO 8536-4:1987 Infusion equipment for medical use; Part 4 : Infusion sets for single use
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed



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