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ASTM D4775-04

Current Revision

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

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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.


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 April 1, 2004
Language en - English
Page Count 2
Revision Level 04
Supercedes
Committee D10.32
Publish Date Document Id Type View
April 1, 2004 D4775-04 Revision
Jan. 1, 1999 D4775-94R99 Reaffirmation