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来源

1. USP [2016]. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Setting. Rockville, MD: United States Pharmacopoeia, accessed USP [2016].

2. Michael R. Page, Closed-System Transfer Devices: Design Characteristics and Evolving Performance Standards, 19May2016; https://www.equashield.com/equashield-cstd-design-and-performance/; accessed 11Jan2021

3.NIOSH [2004]. NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. https://www.cdc.gov/niosh/topics/hazdrug/CSTD.html, accessed 06Jan2021

4.NIOSH [2015]. A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. http://www.cdc.gov/niosh/docket/review/docket288/pdfs/a-vapor-containment-performance-protocol-for-closed-system-transfer-devices.pdf, accessed 12Jan2021

5.FDA Manufacturer and User Facility Device Experience (MAUDE) Database, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm, accessed 12Oct2020

6.Cathy Zhao and Allison Radwick; 5 Challenges of Closed System Transfer Devices Parental Drug Association letter, Manufacturing Science 07Jan, 2020

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Aaron Chapman PhD

Program Manager, Commercial Technology Development

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