We have collected information about Aerosol Drug Delivery Device Design Verification for you. Follow the links to find out details on Aerosol Drug Delivery Device Design Verification.
https://www.iso.org/standard/41989.html
ISO 20072:2009 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).Category: p
https://www.iso.org/obp/ui/#!iso:std:41989:en
This International Standard applies to hand-held aerosol drug delivery devices (ADDD) intended to administer medication to humans. To avoid unnecessarily restricting innovation, given the broad variation in device designs, this International Standard addresses the more general design/labelling requirements rather than specific physical and prescriptive design requirements.
https://www.cambridge-design.com/design-verification-testing
Often standards specific to the product type will help inform this decision. For example BS EN ISO 20072:2013 “Aerosol drug delivery device design verification” provides detailed guidance on the confidence levels required – which inform the sample size planning. Other relevant pages: Requirements capture > Risk management >
https://webstore.ansi.org/Standards/ISO/ISO200722009
ISO 20072:2009 Aerosol drug delivery device design verification - Requirements and test methods. ISO 20072:2009 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 ...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4685506/
Dec 01, 2015 · The consistency of in vitro dose delivery over the inhaler in-use life of 30 days was assessed through life-simulated in-use testing. Delivered dose (defined as the total recovered from all stages ex-device) and fine particle mass ([FPM]; fraction of material with aerodynamic particle size of 0.94–4.46 μm) were assessed separately.Author: Andrew C. Grant, Richard Walker, Melanie Hamilton, Karl Garrill
http://shop.bsigroup.com/ProductDetail/?pid=000000000030279778
Purchase your copy of BS EN ISO 20072:2013 as a PDF download or hard copy directly from the official BSI Shop. All BSI British Standards available online in electronic and print formats. BS EN ISO 20072:2013 - Aerosol drug delivery device design verification.
https://standards.globalspec.com/std/1191741/ISO%2020072
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).
https://www.sis.se/api/document/preview/911429/
Aerosol drug delivery device design verification — Requirements and test methods 1 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 …
https://www.techstreet.com/standards/bs-en-iso-20072-2013?product_id=1851880
BS EN ISO 20072:2013 Aerosol drug delivery device design verification. Requirements and test methods . standard by British Standard / European Standard / International Organization for Standardization, 02/28/2013. View all product details
https://global.ihs.com/doc_detail.cfm?item_s_key=00497376
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).
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