BS EN ISO 20072:2010 - Aerosol drug delivery device design verification. Requirements and test methods – BSI British Standards
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BS EN ISO 20072:2010

Aerosol drug delivery device design verification. Requirements and test methods

Status : Revised, Withdrawn   Published : December 2010 Replaced By : BS EN ISO 20072:2013

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BS EN ISO 20072:2010 Aerosol drug delivery device design verification. Requirements and test methods

BS EN ISO 20072 is an International Standard which 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. It applies to both refillable and disposable devices intended for personal use.

BS EN ISO 20072 is intended for device design verification and not for drug product quality assessment. The objective of BS EN ISO 20072 is to verify, by laboratory (in-vitro) testing, that the ADDD design consistently meets the manufacturer's design specification by satisfying a device functionality profile and system verification test both of which are determined from a risk assessment and evaluated in accordance with the instructions for use.

BS EN ISO 20072 excludes continuous or semi-continuous aerosolization devices covered in ISO 27427, aerosolization devices which do not emit active pharmaceutical ingredient (API), general purpose aerosolization devices (for use with ventilators) and atomizers.

BS EN ISO 20072 does not apply to manufacturers of single parts or components of the ADDDs [e.g. (spray) pumps, valves, containers, etc.].

Contents of BS EN ISO 20072:

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Requirements
5.1 General
5.2 Risk assessment requirements
5.3 Device functionality profile
5.4 System verification test
5.5 Uncertainty of measurements and conformance with specification
5.6 Test requirements
6 Test methods
6.1 General
6.2 Test procedures
6.3 Test conditions
6.4 Test evaluations
7 Test report
8 Information supplied by the manufacturer
8.1 General
8.2 Marking
8.3 Instructions for use
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

 




Standard NumberBS EN ISO 20072:2010
TitleAerosol drug delivery device design verification. Requirements and test methods
StatusRevised, Withdrawn
Publication Date31 December 2010
Withdrawn Date28 February 2013
Cross ReferencesISO 14971:2007, ISO 10993-1, ISO 11135-1, ISO 11137, ISO 15223-1, ISO 17665-1, IEC 60068-2-27, IEC 60068-2-30:2005, IEC 60068-2-32, IEC 60068-2-64, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60721-3-7, IEC 61000-4-2, IEC 61000-4-3, IEC 62304, IEC 62366, ISO 3951-2, ISO 15378, ISO 27427, ISO 16269-6:2005, ISO 13485, IEC 61000-4-1, CAN/CSA/Z264.1-02:2002, 93/42/EEC
Replaced ByBS EN ISO 20072:2013
International RelationshipsEN ISO 20072:2010,ISO 20072:2009
Draft Superseded By07/30145258 DC
DescriptorsMedical equipment, Aerosols, Drug administration, Nebulizers, Respiratory system, Inhalers, Drugs, Sprays, Drug containers, Design, Verification, Marking, Instructions for use, Testing
ICS11.040.10
Title in FrenchVérification de la conception d'un dispositif d'administration de médicament sous forme d'aérosol. Exigences et méthodes d'essai
Title in GermanAusführungsverifizierung von Inhalationsgeräten. Anforderungen und Prüfverfahren
CommitteeCH/84
ISBN978 0 580 56424 6
PublisherBSI
FormatA4
DeliveryNo
Pages54
File Size1.81 MB
Price£238.00


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