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ISO 11040-4:2024

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

General information

Valid from 03.06.2024
ICS Groups
11.040.25 Syringes, needles and catheters
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.06.2024
Main
ISO 11040-4:2024
02.04.2015
Main
ISO 11040-4:2015
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
—     tubing-glass barrels (single-chamber design) for injection preparations, and
—     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.

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Paper
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Standard monitoring
English (PDF 2 MB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English