Standard Historical Last Updated: Dec 31, 2010 Track Document
ASTM D4775-04

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

Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages) D4775-04 ASTM|D4775-04|en-US Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages) Standard new BOS Vol. 15.10 Committee D10
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Abstract

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.

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.

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Details
Book of Standards Volume: 15.10
Developed by Subcommittee: D10.32
Pages: 2
DOI: 10.1520/D4775-04
ICS Code: 55.180.40