Logo

ASTM D4775/D4775M-09(2014)

Current Revision

Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages) (Withdrawn 2022)

$73.00

$73.00

$131.40


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


...

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.


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.


SDO ASTM: ASTM International
Document Number D4775
Publication Date Oct. 1, 2014
Language en - English
Page Count 2
Revision Level 09(2014)
Supercedes
Committee F02.50
Publish Date Document Id Type View
Oct. 1, 2014 D4775_D4775M-09R14 Revision
Oct. 1, 2009 D4775_D4775M-09 Revision