Name: UNI EN ISO 20072 : 2013
Brand: UNI

AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS

Published date

05-09-2013

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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	UNI EN ISO 20072 : 2011

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)