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STANDARD

Current

ÖNORM EN ISO 11608-2

Issue date: 2022 10 15

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022)

This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated doubleended needle according to ISO 11608-1. This document is not applicable to the following: - needles for dental use; - pre-attached syringe needles; - hypodermic needles; - needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular); - materials that form the medicinal product contact surfaces of the primary container closure. However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them.

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General information on ÖNORM EN ISO 11608-2

Format

Digital | 42 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 11608-2 from 2001 til today.

• ÖNORM EN ISO 11608-2

  2022 10 15 Standard ÖNORM EN ISO 11608-2, Edition: 2022 10 15

  Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ende...
• ÖNORM EN ISO 11608-2

  2012 12 01 Standard ÖNORM EN ISO 11608-2, Edition: 2012 12 01

  Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (IS...
• ÖNORM EN ISO 11608-2

  2001 03 01 Standard ÖNORM EN ISO 11608-2, Edition: 2001 03 01

  Pen-injectors for medical use - Part 2: Needles - Requirements and test methods (ISO 11608-2:2000)

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Frequently Asked Questions about ÖNORM EN ISO 11608-2

What is a "Single-User Licence"?

When you purchase a standard from the Austrian Standards webshop (e.g. ÖNORM, ISO), a single-user licence is included as standard. This entitles a single person to use the standard. A multi-user licence is required if several employees need access. It enables company-wide, legally compliant use and sharing of standards.

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How can I get involved in the further development of this standard?

Standardization thrives on expertise and participation. Anyone interested can play an active role in its further development – for example, by joining the relevant committee or a working group. In this way, you can help shape the content and contribute to advancing the state of the art.

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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 10993-1:2018	Titel Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)	Ausgabedatum 2018 08 17	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 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 11608-3:2022	Titel Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths (Corrected version 2023-01)	Ausgabedatum 2022 04 07	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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