ASTM-D4775 › Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)
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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.
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 1: The values in SI units are the recommended values.
delivery systems; label requirements; legibility; prefilled syringes ;; ICS Number Code 55.180.40 (Complete, filled transport packages)
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2009 R14 EDITION
Dec. 1, 2014