Home » Compliance Management Blog- ESG, EHS, EHSQ » New Transfusion, Infusion, and Injection Equipment Standards for the 4th Quarter 2016

New Transfusion, Infusion, and Injection Equipment Standards for the 4th Quarter 2016

Kyle Bach

Document Center, Inc. is pleased to announce that the following Standards on Transfusion, Infusion, and Injection Equipment are now available;


  • BS EN 80369-5, 2016 Edition, Small-bore connectors for liquids and gases in healthcare applications. Connectors for limb cuff inflation applications
  • BS EN ISO 8536-13, 2016 Edition, Infusion equipment for medical use. Graduated flow regulators for single use with fluid contact
  • BS EN ISO 8871-5, 2016 Edition, Elastomeric parts for parenterals and for devices for pharmaceutical use. Functional requirements and testing
  • BS ISO 11418-1, 2016 Edition, Containers and accessories for pharmaceutical preparations. Drop-dispensing glass bottles
  • BS ISO 11418-2, 2016 Edition, Containers and accessories for pharmaceutical preparations. Screw-neck glass bottles for syrups
  • BS ISO 11418-3, 2016 Edition, Containers and accessories for pharmaceutical preparations. Screw-neck glass bottles (veral) for solid and liquid dosage forms
  • ISO 1135-3, 2nd Edition, Transfusion equipment for medical use – Part 3: Blood-taking sets for single use
  • ISO 8536-6, 3rd Edition, Infusion equipment for medical use – Part 6: Freeze drying closures for infusion bottles
  • ISO 8536-13, 1st Edition, Infusion equipment for medical use – Part 13: Graduated flow regulators for single use with fluid contact
  • ISO 8536-14, 1st Edition, Infusion equipment for medical use – Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
  • ISO 8871-5, 2nd Edition, Elastomeric parts for parenterals and for devices for pharmaceutical use – Part 5: Functional requirements and testing
  • ISO 11418-1, 3rd Edition, Containers and accessories for pharmaceutical preparations – Part 1: Drop-dispensing glass bottles
  • ISO 11418-2, 3rd Edition, Containers and accessories for pharmaceutical preparations – Part 2: Screw-neck glass bottles for syrups
  • ISO 11418-3, 3rd Edition, Containers and accessories for pharmaceutical preparations – Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
  • SS EN ISO 1135-5, 2016 Edition, Transfusion equipment for medical use – Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
  • SS EN ISO 8536-13, 2016 Edition, Infusion equipment for medical use – Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016)
  • SS EN ISO 9626, 2016 Edition, Stainless steel needle tubing for the manufactureof medical devices (ISO 9626:1991)