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JSA - JIS T 3226-1

Needle-based injection systems for medical use-Part 1: Needle-based injection systems- Requirements and test methods

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Organization: JSA
Publication Date: 1 October 2015
Status: active
Page Count: 51
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

This Standard specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this Standard include single- and multi-dose syringebased and cartridge-based systems, filled either by the manufacturer or by the end-user.

Additional guidance for NISs equipped with electronic or electromechanical components and NISs equipped with automated functions is given in ISO 11608-4 and ISO 11608-5 respectively.

Needle-free injectors, and requirements relating to methods or equipment associated with end-user filling of containers, are outside the scope of this Standard.

NOTE 1 JIS T 3226-1:2011 may be applied until 30 September, 2018

NOTE 2 The International Standard corresponding to this Standard and the symbol of degree of correspondence are as follows.

ISO 11608-1: 2012 Needle-based injection systems for medical use-Requirements and test methods-Part 1: Needle-based injection systems (MOD)

In addition, symbols which denote the degree of correspondence in the contents between the relevant International Standard and JIS are IDT (identical), MOD (modified), and NEQ (not equivalent) according to ISO/lEC Guide 21-1.

Document History

JIS T 3226-1
October 1, 2015
Needle-based injection systems for medical use-Part 1: Needle-based injection systems- Requirements and test methods
This Standard specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered...
July 29, 2011
Pen-injectors for medical use- Part 1 : Pen-injectors for medical use - Requirements and test methods
This Standard specifies pen-shaped injectors (hereafter referred to as "pen-injectors") intended to be used with needles and with replaceable or non -replaceable prefilled cartridges. This Standard...
July 1, 2006
Pen-injectors for medical use - Part 1: Pen-injectors for medical use - Requirements and test methods
A description is not available for this item.
March 25, 2005
Pen-injectors for medical use - Part 1: Pen-injectors for medical use - Requirements and test methods
A description is not available for this item.

References

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