JSA - JIS T 3226-1
Needle-based injection systems for medical use-Part 1: Needle-based injection systems- Requirements and test methods
|Publication Date:||1 October 2015|
|ICS Code (Transfusion, infusion and injection equipment):||11.040.20|
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.