ISO 11040-4:2007
Prefilled syringes - Part 4: Glass barrels for injectables

Standard No.
ISO 11040-4:2007
Release Date
2007
Published By
International Organization for Standardization (ISO)
Status
Replace By
ISO 11040-4:2015
Latest
ISO 11040-4:2015/Amd 1:2020
Scope
This part of ISO 11040 applies to tubing-glass barrels(single-chamber design)for injection preparations and specifies materisals,dimensions and preformance details. Glass barrles from tubing glass in accrodance with part of ISO 10040 are internded for single use only. In conjunction with the right sealing components,they offer a safe system for parenteral use.

ISO 11040-4:2007 Referenced Document

  • ISO 4802-1:1988 Glassware; hydrolytic resistance of the interior surfaces of glass containers; part 1: determination by titration method and classification
  • ISO 4802-2:1988 Glassware; hydrolytic resistance of the interior surfaces of glass containers; part 2: determination by flame spectrometry and classification
  • 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 720:1985 Glass; Hydrolytic resistance of glass grains at 121 degrees C; Method of test and classification

ISO 11040-4:2007 history

  • 2020 ISO 11040-4:2015/Amd 1:2020 Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling — Amendment 1
  • 2015 ISO 11040-4:2015 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
  • 2007 ISO 11040-4:2007 Prefilled syringes - Part 4: Glass barrels for injectables
  • 1996 ISO 11040-4:1996 Prefilled syringes - Part 4: Glass barrels for injectables
Prefilled syringes - Part 4: Glass barrels for injectables



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