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BSI - BS EN ISO 11608-2

Needle-based injection systems for medical use - Requirements and test methods Part 2: Needles

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Organization: BSI
Publication Date: 30 April 2012
Status: active
Page Count: 28
ICS Code (Syringes, needles and catheters): 11.040.25

Document History

BS EN ISO 11608-2
July 31, 2022
Needle-based injection systems for medical use - Requirements and test methods Part 2: Double-ended pen needles
A description is not available for this item.
BS EN ISO 11608-2
April 30, 2012
Needle-based injection systems for medical use - Requirements and test methods Part 2: Needles
A description is not available for this item.
BS EN ISO 11608-2
March 15, 2001
Pen-Injectors for Medical Use - Part 2: Needles - Requirements and Test Methods
A description is not available for this item.

References

This document references:
BS EN ISO 11608-3 - Needle-based injection systems for medical use - Requirements and test methods Part 3: Containers and integrated fluid paths
Published by BSI on July 31, 2022
A description is not available for this item.
This document references:
ISO TR 19244 - Guidance on transition periods for standards developed by ISO/TC 84 - Devices for administration of medicinal products and catheters
Published by ISO on August 15, 2014
This Technical Report outlines the recommended transition plans for all the TC 84 standards: - Needle-based Injection systems [ISO 11608 (all parts)]; - Sharps Injury Protection (ISO 23908); - Sharps...
This document references:
ISO 13926-2 - Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use
Published by ISO on November 1, 2017
This document specifies the material, performance requirements and labelling and gives recommendations for shape and dimensions of plunger stoppers for pen-injectors for medical use. NOTE The...
This document references:
ISO 6009 - Hypodermic needles for single use - Colour coding for identification
Published by ISO on August 1, 2016
This lnternational Standard establishes a colour code for the identification of single-use hypodermic needles of designated metric sizein the range of 0,18 mm (34 Gauge) to 3,4 mm (10 Gauge) . It...
This document references:
ISO 11608-3 - Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
Published by ISO on October 1, 2012
This part of ISO 11608 specifies the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is...
This document references:
BS EN ISO 11608-3 - Needle-based injection systems for medical use - Requirements and test methods Part 3: Containers and integrated fluid paths
Published by BSI on July 31, 2022
A description is not available for this item.
This document is referenced by:
BS EN ISO 11608-1 - Needle-based injection systems for medical use - Requirements and test methods Part 1: Needle-based injection systems
Published by BSI on January 31, 2015
A description is not available for this item.
This document is referenced by:
BS EN ISO 11608-5 - Needle-based injection systems for medical use - Requirements and test methods Part 5: Automated functions
Published by BSI on March 31, 2023
A description is not available for this item.
This document is referenced by:
BS EN ISO 11608-4 - Needle-based injection systems for medical use — Requirements and test methods Part 4: Needle-based injection systems containing electronics
Published by BSI on July 31, 2022
A description is not available for this item.
This document is referenced by:
BS EN ISO 11608-1 - Needle-based injection systems for medical use - Requirements and test methods Part 1: Needle-based injection systems
Published by BSI on January 31, 2015
A description is not available for this item.
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