BS EN ISO 20072:2010 Aerosol drug delivery device design verification. Requirements and test methods
BS EN ISO 20072 is an International Standard which applies 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. It applies to both refillable and disposable devices intended for personal use.
BS EN ISO 20072 is intended for device design verification and not for drug product quality assessment. The objective of BS EN ISO 20072 is to verify, by laboratory (in-vitro) testing, that the ADDD design consistently meets the manufacturer's design specification by satisfying a device functionality profile and system verification test both of which are determined from a risk assessment and evaluated in accordance with the instructions for use.
BS EN ISO 20072 excludes continuous or semi-continuous aerosolization devices covered in ISO 27427, aerosolization devices which do not emit active pharmaceutical ingredient (API), general purpose aerosolization devices (for use with ventilators) and atomizers.
BS EN ISO 20072 does not apply to manufacturers of single parts or components of the ADDDs [e.g. (spray) pumps, valves, containers, etc.].
Contents of BS EN ISO 20072:
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Requirements
5.1 General
5.2 Risk assessment requirements
5.3 Device functionality profile
5.4 System verification test
5.5 Uncertainty of measurements and conformance with specification
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) 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
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