Back

ISO 11040-6:2019

Prefilled syringes -- Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling

General information

Valid from 10.01.2019
ICS Groups
11.040.25 Syringes, needles and catheters
Directives or regulations
None

Standard history

Status
Date
Type
Name
10.01.2019
Main
ISO 11040-6:2019
29.03.2012
Main
ISO 11040-6:2012
This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only.
This document also specifies those components that are part of the sterilized subassembled syringe ready for filling.
Polymer 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 and rod, are not specified in this document.
Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.

Required fields are indicated with *

*
*
*
PDF
272.12 € incl tax
Paper
272.12 € incl tax
Standard monitoring
English (PDF 2 MB)

Related products

Main

EVS-EN ISO 80369-7:2021

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)
Newest version Valid from 01.06.2021
Main

EVS-EN ISO 10555-1:2023

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023)
Newest version Valid from 15.12.2023
Main

EVS-EN ISO 10555-1:2013

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013)
Withdrawn from 15.12.2023
Main

EVS-EN ISO 80369-20:2015

Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)
Withdrawn from 16.12.2024

Customers who bought this item also bought

Main

ISO 11040-8:2016

Prefilled syringes -- Part 8: Requirements and test methods for finished prefilled syringes
Newest version Valid from 04.11.2016
Main

ISO 11040-5:2012

Prefilled syringes -- Part 5: Plunger stoppers for injectables
Newest version Valid from 20.01.2012
Main + amendment

EVS-EN ISO 13485:2016+A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Newest version Valid from 16.09.2021
Main + amendment

EVS-EN ISO 14971:2019+A11:2021

Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Newest version Valid from 15.12.2021

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