ONORM EN ISO 21649 : 2010

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

Applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients.