UNI EN ISO 20072 : 2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Requirements
6 Test methods
7 Test report
8 Information supplied by the manufacturer
Annex A (informative) - Rationale for requirements
Annex B (informative) - Further guidance and
        clarification of the device functionality
        profile
Annex C (informative) - Rationale for test methods
Annex D (informative) - Two-sided tolerance limit
        factors (k)
Annex E (informative) - Alternative acceptance
        criteria for the device functionality
        profile evaluation
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on Medical Devices
Bibliography

Pertains to the design, labelling, instructions for use and testing requirements for hand-held single- and multi-use aerosol drug delivery devices (ADDDs) intended to deliver a metered or premetered aerosolized medication to or by means of the human respiratory tract (including nasal, oral, tracheal, bronchial and alveolar sites).