I.S. EN ISO 20072:2013
Current
AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
Hardcopy , PDF
English
01-01-2013
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 93/42/EEC on Medical Devices
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 pre-metered aerosolized medication to or by means of the human respiratory tract (including nasal, oral, tracheal, bronchial and alveolar sites).
| DocumentType |
Standard
|
| Pages |
57
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 20072:2013 | Identical |
| ISO 20072:2009 | Identical |
| UNE-EN ISO 20072:2013 | Equivalent |
| BS EN ISO 20072:2013 | Equivalent |
| DIN EN ISO 20072:2013-10 | Equivalent |
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