UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

ISO 11608-3

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers

active, Most Current
Buy Now
Organization: ISO
Publication Date: 1 October 2012
Status: active
Page Count: 16
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

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 applicable to single and multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduser integrated in the NIS or assembled with the NIS at the time of use.

This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for use in NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potential containers, including syringes to be used with a NIS.

This part of ISO 11608 is not applicable to cartridges intended for dental use.

Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this part of ISO 11608.

NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).

Document History

February 18, 2020
Needle-based injection systems for medical use — Requirements and test methods — Part 3: NIS containers and integrated fluid paths
This document specifies requirements and test methods for design verification of containers and integrated fluid paths to be used with Needle-Based Injection Systems (NIS) that fulfil the...
ISO 11608-3
October 1, 2012
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
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...
December 15, 2000
Pen-Injectors for Medical Use - Part 3: Finished Cartridges - Requirements and Test Methods
This part of ISO 11608 specifies performance and test methods for multidose, single-chamber, pre-filled, finished cartridges used as primary containers in pen-injectors fulfilling the specifications...

References

Advertisement