UNI EN ISO 11608-1 : 2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS
14-07-2022
01-01-2012
Foreword
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 (normative) - One- and two-sided
tolerance limit factors, k
Bibliography
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