NEN EN ISO 11608-1 : 2015
Current
The latest, up-to-date edition.
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS
01-12-2013
Contents
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviations
5 General requirements
6 Test conditions
6.1 Standard atmosphere
6.2 Cool atmosphere
6.3 Hot atmosphere
7 Preconditioning of pen-injectors
7.1 Preconditioning in dry heat atmosphere
7.2 Preconditioning in cold storage atmosphere
7.3 Preconditioning in cyclical atmosphere
7.4 Preconditioning by free fall
7.5 Preconditioning by vibration for
pen-injectors with electronic components
8 Reagent and apparatus
9 Determination f dose accuracy
9.1 Dose accuracy
9.2 Dose accuracy requirements
10 Freedom from defects
10.1 Defects after being subjected to cyclical
preconditioning
10.2 Freedom from defects after being subjected
to vibration
10.3 Freedom from defects after being subjected
to free fall
11 Determination of electromagnetic
compatibility
11.1 Electromagnetic compatibility (EMC)
11.2 Electrostatic discharge
11,3 Radiated radio frequency (RF) fields
12 Visual inspection
13 Functional inspection
13.1 Replaceable cartridge
13.2 Nonreplaceable cartridge
13.3 Accuracy
14 Test report
15 Information supplied by the manufacturer
15.1 General
15.2 Marking
15.3 Instructions for use
Annex A (informative) Two-sided tolerance limit
factors (k)
Bibliography
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