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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.
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.
1.1 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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
ICS Number Code 55.180.40 (Complete, filled transport packages)
ASTM D4775 / D4775M-09(2014), Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages), ASTM International, West Conshohocken, PA, 2014, www.astm.orgBack to Top