ISO 11040-4 Fixtures for Testing Pre-filled Glass Syringes

ISO 11040-4  applies to

Tubing-glass barrels (single-chamber design) for injection preparations, and sterilized subassembled syringes ready for filling.

It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.

This ISO standard also specifies those components that are part of the sterilized subassembled syringe ready for filling.

Glass barrels and sterilized subassembled syringes ready for filling in accordance with ISO 11040-4  are intended for single use only.

FIXTURES

Fixtures are designed to accommodate all syringe sizes per this standard

Fixtures have a modular design to minimize the number of parts needed

*** Before conducting this ISO standard  , it is important to read the entire specification. Standards can be obtained from appropriate standard authorities.