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Description of ASTM-D4775 2009ASTM D4775 / D4775M - 09Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)Active Standard ASTM D4775 / D4775M | Developed by Subcommittee: D10.32 Book of Standards Volume: 15.10 ASTM D4775 / D4775MAbstract
This specification covers the identification of: drug contained in the prefilled syringe or delivery sysetm and the concentration, volume, and total amount of the drug, and whether it is to be diluted prior to administration. The label copy shall comply with the specified requirements. Delivery systems shall not resemble a normal syringe and shall be unsuitable for direct intravenous line injection. The copy for the proprietary name or established name of the drug shall be legible in accordance with the legibility test. This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date. 1. Scope
1.1 This specification covers the identification of: 1.1.1 The drug contained in the prefilled syringe or delivery system. 1.1.2 The concentration, volume, and total amount of the drug, and whether it is to be diluted prior to administration. 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. Note 1The values in SI units are the recommended values. ASTM Standards D996 Terminology of Packaging and Distribution Environments D4267 Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers D7298 Test Method for Measurement of Comparative Legibility by Means of Polarizing Filter Instrumentation Keywords delivery systems; label requirements; legibility; prefilled syringes; Drug applications; Drug containers/labels; Identification--drugs; Intravenous injection; Labels/labeling--specifications; Legibility; Medical materials/applications--specifications; Medications; Prefilled syringes; Syringes; Configuration control; Delivery systems (drugs); ICS Code ICS Number Code 55.180.40 (Complete, filled transport packages) DOI: 10.1520/D4775_D4775M-09 ASTM International is a member of CrossRef. ASTM D4775 / D4775MThis book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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