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  • ASTM
    D4774-11(2017) Standard Specification for User Applied Drug Labels in Anesthesiology
    Edition: 2017
    $91.10
    Unlimited Users per year

Description of ASTM-D4774 2017

ASTM D4774-11-Reapproved2017

Withdrawn Standard: Standard Specification for User Applied Drug Labels in Anesthesiology (Withdrawn 2022)




ASTM D4774

Scope

1.1 This specification covers the size, color, pattern, and type used on labels applied to unlabeled syringes filled by the users or their agents to identify the drug content. This specification is not intended to cover labels applied by the drug manufacturer.

FIG. 1 Standard Background Colors for User Applied Syringe Drug Labels

FIG. 2 Label for an Antagonist Drug

FIG. 3 Reversed Plate Printing Used to Identify "SUCCINYLcholine," "EPINEPHrine," and Beta Blockers, "ESMOlol," "LABATolol," and "METOprolol"

FIG. 4 Optional Printing

Note—Bold upper-case type is shown for first or first and second syllables of the drug name.

FIG. 5 Drug Name and Dosage

FIG. 6 Alternative Label Showing Concentration in Percent and mg/mL

1.2 The values stated in SI units are to be regarded as the recommended values. The use of inch-pound system values, not being exact equivalents, may result in nonconformance with the standard.

1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


Keywords

anesthesiology; drug labels; label requirements;


ICS Code

ICS Number Code 11.040.20 (Transfusion, Infusion)


DOI: 10.1520/D4774-11R17

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ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.

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