EN ISO 20072:2013
Aerosol drug delivery device design verification - Requirements and test methods

Standard No.
EN ISO 20072:2013
Release Date
2013
Published By
European Committee for Standardization (CEN)
Latest
EN ISO 20072:2013
Replace
EN ISO 20072:2010
Scope
This International Standard 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). This International Standard applies to both refillable and disposable devices intended for personal use.This International Standard is intended for device design verification and not for drug product quality assessment. The objective of this International Standard is to verify, by laboratory (in-vitro) te

EN ISO 20072:2013 Referenced Document

  • IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
  • IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)
  • IEC 60068-2-32:1975 Basic environmental testing procedures. Part 2 : Tests. Test Ed: Free fall
  • IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broad-band random and guidance
  • IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
  • IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  • IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • IEC 60721-3-7:1995 Classification of environmental conditions - Part 3: Classification of groups of environmental parameters and their severities - Section 7: Portable and non-stationary use
  • IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measuring techniques - Electrostatic discharge immunity test
  • IEC 61000-4-3:2006 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
  • IEC 62304:2006 Medical device software - Software life cycle processes
  • IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
  • ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
  • 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

EN ISO 20072:2013 history

  • 2013 EN ISO 20072:2013 Aerosol drug delivery device design verification - Requirements and test methods
  • 2010 EN ISO 20072:2010 Aerosol drug delivery device design verification - Requirements and test methods



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