Norm

ASTM D4774 - 11(2017) en

Standard Specification for User Applied Drug Labels in Anesthesiology

45,11 54,58 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 3
Gepubliceerd op 15-12-2017
Taal Engels

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

Standard Background Colors for User Applied Syringe
 Drug LabelsStandard Background Colors for User Applied Syringe
 Drug Labels

FIG. 2 Label for an Antagonist Drug

 Label for an Antagonist Drug Label for an Antagonist Drug

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

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

FIG. 4 Optional Printing

Optional PrintingOptional 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

 Drug Name and Dosage Drug Name and Dosage

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

 Alternative Label Showing Concentration in Percent
 and mg/mL 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.

Details

ICS-code 11.040.20
Nederlandse titel Standard Specification for User Applied Drug Labels in Anesthesiology
Engelse titel Standard Specification for User Applied Drug Labels in Anesthesiology

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