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ISO - DIS 11608-3

Needle-based injection systems for medical use — Requirements and test methods — Part 3: NIS containers and integrated fluid paths

pending
Organization: ISO
Publication Date: 18 February 2020
Status: pending
Page Count: 32
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

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 requirements of ISO 11608-1 (and other subparts as appropriate). It is applicable to single and multi-dose containers (either filled by the manufacturer [primary container closure] or by the end-user [reservoir]) and fluid paths that are integrated with the NIS at the point of manufacture.

NOTE Prefilled syringes (ISO 11040-8) are included in the scope when used with a NIS; see also scope of ISO 11608-1:20xx.

Products excluded from scope are:

- sterile hypodermic needles for single use;

- sterile hypodermic syringes for single use;

- 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.

Document History

DIS 11608-3
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...
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

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