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WITHDRAWN ASTM D4775/D4775M-09 1.10.2009 preview

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ASTM D4775/D4775M-09

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



STANDARD published on 1.10.2009


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The information about the standard:

Designation standards: ASTM D4775/D4775M-09
Note: WITHDRAWN
Publication date standards: 1.10.2009
SKU: NS-28524
The number of pages: 2
Approximate weight : 6 g (0.01 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM D4775/D4775M-09 :

Keywords:

delivery systems, label requirements, legibility, prefilled syringes, Drug applications, Drug containers/labels, Identification--drugs, Intravenous injection, Labels/labeling--specifications, Legibility, Medical materials/applications--specifications, Medications, Prefilled syringes, Syringes, Configuration control, Delivery systems (drugs), ICS Number Code 55.180.40 (Complete, filled transport packages)

Additional information

 
1. 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.
 
2. Referenced Documents

D4267-07

Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers

D7298-06(2017)

Standard Test Method for Measurement of Comparative Legibility by Means of Polarizing Filter Instrumentation

D996-23

Standard Terminology of Packaging and Distribution Environments

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