UNI EN ISO 20072 : 2013
Current
The latest, up-to-date edition.
AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS
05-09-2013
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).
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 20072:2013 | Identical |
| ISO 20072:2009 | Identical |
| IEC 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| IEC 61000-4-1:2006 | Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| IEC 60721-3-7:1995+AMD1:1996 CSV | Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO 16269-6:2014 | Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 15378:2017 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) |
| IEC 61000-4-2:2008 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
| IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 3951-2:2013 | Sampling procedures for inspection by variables — Part 2: General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics |
| IEC 60068-2-30:2005 | Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle) |
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