Needle-based Injection Systems For Medical Use - Part 1: Needle-based Injection Systems - Requirements And Test Methods
Japanese Standards Association
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Requirements
6 Reagent and apparatus
7 Determination of dose accuracy
8 Preparation and operation of NISs
9 Test matrix
10 Test descriptions
11 Inspection
12 Test report
13 Information supplied by the manufacturer
Annex A (informative) - Dose replicates, accuracy and
testing rationale
Annex B (informative) - One- and two-sided tolerance
limit factors, [k]
Annex JA (normative) - Requirements for cartridges
Bibliography
Annex JB (informative) - Comparison table between JIS
and corresponding International Standard
Gives requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers.
| Document Type | Standard |
| Status | Current |
| Publisher | Japanese Standards Association |
| Supersedes |
|
