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ISO 11040-4:2024

Current

Current

Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

03-06-2024

£190.00
Excluding VAT
Summarise this standard

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

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

This document is applicable to

sterilized subassembled syringes ready for filling.

Glass 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 stopper and plunger rod, are outside the scope of this document.

NOTE National or regional regulations such as Ph.Eur., USP, or JP can apply.

Committee
ISO/TC 76
DocumentType
Standard
Pages
53
PublisherName
International Organization for Standardization
Status
Current
Supersedes

Standards Relationship
IS 19329 : Part 4 : 2025 Identical
SS-ISO 11040-4:2025 Identical
NF ISO 11040-4:2024 Identical
DS/ISO 11040-4:2024 Identical

Frequently Asked Questions

ISO 11040-4 belongs to the topic area of prefilled syringes. It is an international standard published by International Organization for Standardization (ISO).

ISO 11040-4 is published by International Organization for Standardization (ISO). It is an international standard.

ISO 11040-4 is an international standard published by International Organization for Standardization (ISO), and is applied internationally rather than in a single country.

ISO 11040-4 is International Organization for Standardization (ISO)'s standard for prefilled syringes, while ISO 11070 covers intravascular introducers, dilators and guidewires (International). ISO 11040-4 specifies design, material or test requirements for components and systems used in prefilled syringes. ISO 11070 specifies requirements for introducer needles, catheters, guidewires and dilators used intravascularly.

ISO 11040-4 specifies design, material or test requirements for components and systems used in prefilled syringes. It is an international standard published by International Organization for Standardization (ISO).
£190.00
Excluding VAT