The ASTM D4775/D4775M specification specifies requirements for the identification of pre-filled syringes and delivery systems. The specification covers the concentration, volume, total amount of the drug and whether dilute identification is required. Labels should clearly identify the drug's proper or generic name and meet the requirements for legibility testing. The specification emphasizes that delivery systems, unlike regular syringes, are not suitable for direct intravenous injection. The standard also states that the units of the label can be used in SI units or inch-pound units, which need to be applied independently and avoid mixed use. These requirements are designed to ensure accurate communication of drug information.
| Status | Abolish |
|---|---|
| CCS | ICS |
| Release Date | Implementation Date |