CSA Group Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling ISO 11040-4:2015

Description
ISO 11040-4:2015 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. ISO 11040-4:2015 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 11040-4:2015 are intended for single use only. Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040‑4:2015.
  • Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling - ISO 11040-4:2015 - CSA Group
    CSA Group
Description
ISO 11040-4:2015 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. ISO 11040-4:2015 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 11040-4:2015 are intended for single use only. Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040‑4:2015.

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Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling - ISO 11040-4:2015 - CSA Group
CSA Group
Toronto, Ontario, Canada
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
ISO 11040-4:2015
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling ISO 11040-4:2015
ISO 11040-4:2015 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. ISO 11040-4:2015 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 11040-4:2015 are intended for single use only. Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040‑4:2015.

ISO 11040-4:2015 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.

ISO 11040-4:2015 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 11040-4:2015 are intended for single use only.

Components to complete the subassembled syringe, such as plunger and rod, are not specified in ISO 11040‑4:2015.

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Technical Specifications

  CSA Group
Product Category Standards and Technical Documents
Product Number ISO 11040-4:2015
Product Name Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
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