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STANDARD

Current

ÖNORM EN ISO 11608-3

Issue date: 2024 01 01

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01)

There are 1 addition(s) to this standard

Document Number	Title	Link
Document Number ÖNORM EN ISO 11608-3/A1	Title Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths - Amendment 1 (ISO 11608-3:2022/Amd 1:2026)

This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1. It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture. This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022). This document is not applicable to the following products: - sterile hypodermic needles; - sterile hypodermic syringes; - sterile single-use syringes, with or without needle, for insulin; - containers that can be refilled multiple times; - containers intended for dental use; - catheters or infusion sets that are attached or assembled separately by the user.

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General information on ÖNORM EN ISO 11608-3

Format

Paper | 36 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 11608-3 from 2001 til today.

• ÖNORM EN ISO 11608-3

  2024 01 01 Standard ÖNORM EN ISO 11608-3, Edition: 2024 01 01

  Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers ...
• ÖNORM EN ISO 11608-3

  2022 10 15 Standard ÖNORM EN ISO 11608-3, Edition: 2022 10 15

  Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers ...
• ÖNORM EN ISO 11608-3

  2012 12 15 Standard ÖNORM EN ISO 11608-3, Edition: 2012 12 15

  Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished co...
• ÖNORM EN ISO 11608-3

  2001 03 01 Standard ÖNORM EN ISO 11608-3, Edition: 2001 03 01

  Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods (ISO 116...

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Frequently Asked Questions about ÖNORM EN ISO 11608-3

What is a "Single-User Licence"?

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 10555-1:2013	Titel Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements (Corrected version 2014-01)	Ausgabedatum 2013 06 06	Art Standard	Zur Produktseite
Dokumentnummer ISO 10555-5:2013	Titel Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters	Ausgabedatum 2013 06 06	Art Standard	Zur Produktseite
Dokumentnummer ISO 10993-11:2017	Titel Biological evaluation of medical devices — Part 11: Tests for systemic toxicity	Ausgabedatum 2017 09 14	Art Standard	Zur Produktseite
Dokumentnummer ISO 10993-17:2002	Titel Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances	Ausgabedatum 2002 11 27	Art Standard	Zur Produktseite
Dokumentnummer ISO 11040-4:2015	Titel Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling	Ausgabedatum 2015 04 02	Art Standard	Zur Produktseite
Dokumentnummer ISO 11040-5:2012	Titel Prefilled syringes — Part 5: Plunger stoppers for injectables	Ausgabedatum 2012 01 20	Art Standard	Zur Produktseite
Dokumentnummer ISO 11040-6:2019	Titel Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling	Ausgabedatum 2019 01 10	Art Standard	Zur Produktseite
Dokumentnummer ISO 11040-8:2016	Titel Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes	Ausgabedatum 2016 11 04	Art Standard	Zur Produktseite
Dokumentnummer ISO 11607-1:2019	Titel Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems	Ausgabedatum 2019 01 31	Art Standard	Zur Produktseite
Dokumentnummer ISO 11608-1:2022	Titel Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems	Ausgabedatum 2022 04 07	Art Standard	Zur Produktseite
Dokumentnummer ISO 13926-1:2018	Titel Pen systems — Part 1: Glass cylinders for pen-injectors for medical use	Ausgabedatum 2018 10 15	Art Standard	Zur Produktseite
Dokumentnummer ISO 13926-2:2017	Titel Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use	Ausgabedatum 2017 11 28	Art Standard	Zur Produktseite
Dokumentnummer ISO 13926-3:2019	Titel Pen systems — Part 3: Seals for pen-injectors for medical use	Ausgabedatum 2019 05 27	Art Standard	Zur Produktseite
Dokumentnummer ISO 21881:2019	Titel Sterile packaged ready for filling glass cartridges	Ausgabedatum 2019 10 18	Art Standard	Zur Produktseite
Dokumentnummer ISO 7864:2016	Titel Sterile hypodermic needles for single use — Requirements and test methods	Ausgabedatum 2016 08 02	Art Standard	Zur Produktseite
Dokumentnummer ISO 80369-7:2021	Titel Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications	Ausgabedatum 2021 05 04	Art Standard	Zur Produktseite
Dokumentnummer ISO 8872:2003	Titel Aluminium caps for transfusion, infusion and injection bottles — General requirements and test methods	Ausgabedatum 2003 03 14	Art Standard	Zur Produktseite
Dokumentnummer ISO 9626:2016	Titel Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods	Ausgabedatum 2016 08 02	Art Standard	Zur Produktseite

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