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  • BSI
    BS EN ISO 20072:2013 Aerosol drug delivery device design verification. Requirements and test methods
    Edition: 2013
    $526.05
    / user per year

Description of BS EN ISO 20072:2013 2013

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 pre-metered 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) 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.

This International Standard 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.

This International Standard does not apply to manufacturers of single parts or components of the ADDDs [e.g. (spray) pumps, valves, containers, etc.].

NOTE There might be times when a device falls under the scope of this International Standard and that of ISO 27427. The committee envisions that the intended use of the product and the risk assessment of the device will derive which International Standard the manufacturer chooses for design verification of the ADDD. This International Standard outlines the process by which ADDD design verification is to be performed in conjunction with a risk-based device functionality profile of the ADDD with either the medication, a placebo or a representative medication. ISO 27427 outlines the process by which the characterization of the aerodynamic aerosol performance of a nebulizing system for use with a non-specific class of active pharmaceutical ingredient(s) is made.



Standard NumberBS EN ISO 20072:2013
TitleAerosol drug delivery device design verification. Requirements and test methods
StatusDefinitive
Publication Date2013-02-28
ReplacesBS EN ISO 20072:2010
Identical National Standard OfEN ISO 20072:2013, ISO 20072:2009
DescriptorsRespiratory system, Medical equipment, Drug administration, Design, Instructions for use, Inhalers, Verification, Marking, Testing, Nebulizers, Drug containers, Drugs, Sprays, Aerosols
ICS11.040.10 Anaesthetic, respiratory and reanimation equipment, 11.140 Hospital equipment, 13.340.99 Other protective equipment, 31.260 Optoelectronics. Laser equipment
CommitteeCH/84
ISBN978 0 580 82254 4
PublisherBSI
Pages54

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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