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Description of ASTM-D4774 2011ASTM D4774 - 11e1Standard Specification for User Applied Drug Labels in AnesthesiologyActive Standard ASTM D4774 | Developed by Subcommittee: D10.32 Book of Standards Volume: 15.10 ASTM D4774Abstract This specification covers the size, color and 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. The size and background color requirements of drug labels are presented in details. The type and color requirements of printing for drug labels are presented in details. This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date. Significance and Use The objective of this specification is to facilitate identification of drugs in syringes filled by the user. The use of colors is intended only as an aid in identification of drug groups and does not absolve the user from the duty to read the label to correctly identify the drug prior to use. The user may alternatively use black and white labels rather than these colored labels. 1. 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. 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 and health practices and determine the applicability of regulatory limitations prior to use. 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
Note Bold upper-case type is shown for first or first and second syllables of the drug name. FIG. 4 Optional PrintingFIG. 5 Drug Name and Dosage FIG. 6 Alternative Label Showing Concentration in Percent and mg/mL
ASTM Standards D996 Terminology of Packaging and Distribution Environments Other Standard Pantone Matching System Available from Pantone, Inc., 509 Commerce Boulevard, Carlstadt, NJ 07072-3098.Keywords anesthesiology; drug labels; label requirements; Anesthesia equipment--specifications; Drug containers/labels ICS Code ICS Number Code 11.040.20 (Transfusion, Infusion) DOI: 10.1520/D4774-11E01 ASTM International is a member of CrossRef. ASTM D4774This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM 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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