DIN EN ISO 20072:2013-10
Current
Current
The latest, up-to-date edition.
AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
Available format(s)
Hardcopy , PDF
Language(s)
German, English
Published date
01-10-2013
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National foreword
National Annex NA (informative) - Bibliography
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 pre-metered aerosolized medication to or by means of the human respiratory tract (including nasal, oral, tracheal, bronchial and alveolar sites).
| Committee |
TC 84
|
| DocumentType |
Test Method
|
| Pages |
53
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 20072:2009 | Identical |
| EN ISO 20072:2013 | Identical |
| DIN EN ISO 15223-1:2015-08 (Draft) | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03) |
| 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 |
| DIN EN 60068-2-64 : 1995 | ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE |
| VDE 0750-1-2 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES REQUIREMENTS AND TESTS (IEC 60601-1-2:2014) |
| DIN EN 62366 : 2016 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
| 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 |
| VDE 0847-4-2 : 2009 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-2: TESTING AND MEASUREMENT TECHNIQUES - ELECTROSTATIC DISCHARGE IMMUNITY TEST |
| VDE 0750-101 : 2016 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| DIN EN ISO 11137-1:2015-11 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| 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 |
| DIN EN 60068-2-30:2006-06 | ENVIRONMENTAL TESTING - PART 2-30: TESTS - TEST DB: DAMP HEAT, CYCLIC (12 H + 12 H CYCLE) |
| 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 |
| DIN EN 60721-3-7:1995-09 | CLASSIFICATION OF ENVIRONMENTAL CONDITIONS - PART 3: CLASSIFICATION OF GROUPS OF ENVIRONMENTAL PARAMETERS AND THEIR SEVERITIES - SECTION 7: PORTABLE AND NON-STATIONARY USE |
| 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 |
| DIN EN 60068-2-27 : 1995 | ENVIRONMENTAL TESTING - PART 2-27: TESTS - TEST EA AND GUIDANCE: SHOCK |
| VDE 0750-241 : 2016 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014) |
| DIN EN ISO 17665-1:2006-11 | 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 17665-1:2006) |
| ISO 16269-6:2014 | Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals |
| VDE 0468-2-31 : 2009 | ENVIRONMENTAL TESTING - PART 2-31: TESTS - TEST EC: ROUGH HANDLING SHOCKS, PRIMARILY FOR EQUIPMENT-TYPE SPECIMENS |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| DIN EN ISO 11135-1:2007-08 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| 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 |
| DIN EN 61000-4-3 : 2011 | 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 |
| VDE 0468-2-27 : 2010 | ENVIRONMENTAL TESTING - PART 2-27: TESTS - TEST EA AND GUIDANCE: SHOCK |
| DIN EN 62304 : 2016 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| DIN EN 61000-4-2 : 2009 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-2: TESTING AND MEASUREMENT TECHNIQUES - ELECTROSTATIC DISCHARGE IMMUNITY TEST |
| VDE 0847-4-3 : 2011 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| VDE 0750-1 : 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
| VDE 0468-2-64 : 2009 | ENVIRONMENTAL TESTING - PART 2-64: TESTS - TEST FH: VIBRATION, BROADBAND RANDOM AND GUIDANCE |
| DIN EN 60068-2-31 : 2009 | ENVIRONMENTAL TESTING - PART 2-31: TESTS - TEST EC: ROUGH HANDLING SHOCKS, PRIMARILY FOR EQUIPMENT-TYPE SPECIMENS |
| 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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