ASTM D4775/D4775M-09(2014) PDF

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 1: The values in SI units are the recommended values.

ASTM D4775/D4775M-09(2014) Referenced Document

ASTM D4267 Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers
ASTM D7298 Standard Test Method for Measurement of Comparative Legibility by Means of Polarizing Filter Instrumentation
ASTM D996 Standard Terminology of Packaging and Distribution Environments

2009 ASTM D4775/D4775M-09(2014) Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)
2009 ASTM D4775/D4775M-09 Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)
2004 ASTM D4775-04 Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)
1994 ASTM D4775-94(1999) Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)