ISO 11040-6:2019 Preview

Prefilled syringes -- Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling

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.


General information

  • Status :  Published
    Publication date : 2019-01
  • Edition : 2
    Number of pages : 53
  • :
    ISO/TC 76
    Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
  • 11.040.25
    Syringes, needles and catheters

Buy this standard

Format Language
PDF + ePub
Paper
  • CHF178

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information

Subscribe