ISO 11040-6:2019 PDF

Scope: This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only. This document also specifies those components that are part of the sterilized subassembled syringe ready for filling. Polymer barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only. Components to complete the subassembled syringe, such as plunger and rod, are not specified in this document. Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.

ISO 11040-6:2019 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
ISO 7886-1 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use*， 2019-08-01 Update
ISO 80369-1 Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications*， 2021-04-30 Update
ISO 8871-1 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
ISO 9626 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods

2019 ISO 11040-6:2019 Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
2012 ISO 11040-6:2012 Prefilled syringes - Part 6: Plastic barrels for injectables