ONORM EN ISO 21649 : 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS
07-26-2023
01-12-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Requirements
5.1 General requirements
5.2 Noise requirements
5.3 Dose specification requirements
5.4 Uncertainty of measurements and conformance with
specifications
5.5 Performance profile requirements
5.6 Test requirements
6 Test methods
6.1 General
6.2 Test procedures
6.3 Test conditions
6.4 Test evaluations
7 Test report
8 Information supplied by the manufacturer
8.1 General
8.2 Marking
8.3 Instructions for use
Annex A (informative) Two-sided tolerance limit factors (k)
Annex B (informative) Examples of accuracy limit calculations
and random settings
Annex C (informative) Correspondence between ISO/IEC
standards and EN standards
Annex ZA (informative) Relationship between this
International Standard and the Essential
Requirements of EU Directive 93/42/EEC
Bibliography
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