Abstract
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.
Amendments
Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.
Amendment 1
Edition 2020
Life cycle
-
Previously
WithdrawnISO 11040-4:2007
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Now
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00
Preliminary
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10
Proposal
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20
Preparatory
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30
Committee
-
40
Enquiry
-
50
Approval
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60
Publication
-
90
Review
-
95
Withdrawal
Amendments
Provide additional content; Available for purchase; Not included in the text of the existing standard.PublishedISO 11040-4:2015/Amd 1:2020
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00
-
Revised by
Under developmentISO 11040-4
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