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ASTM D4774-11e1

(Specification)

Standard Specification for User Applied Drug Labels in Anesthesiology

Standard Specification for User Applied Drug Labels in Anesthesiology

ABSTRACT
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.
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.
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
"SUCCINYLcholine," "EPINEPHrine," and Beta Blockers,
"ESMOlol," "LABATolol," and "METOprolol"
NoteBold upper-case type is shown for first or first and second syllables of the drug name.FIG. 4 Optional Printing
FIG. 5 Drug Name and Dosage
FIG. 6 Alternative Label Showing Concentration in Percent and mg/mL

General Information

Status
Historical
Publication Date
31-Mar-2011
ICS
11.040.20 - Transfusion, infusion and injection equipment
Technical Committee
F02 - Primary Barrier Packaging
Drafting Committee
F02.50 - Package Design and Development
Current Stage
Ref Project

Relations

Replaces
ASTM D4774-11 - Standard Specification for User Applied Drug Labels in Anesthesiology
Effective Date
01-Apr-2011

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ASTM D4774-11e1 - Standard Specification for User Applied Drug Labels in Anesthesiology
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
´1
Designation:D4774 −11
Standard Specification for
1
User Applied Drug Labels in Anesthesiology
This standard is issued under the fixed designation D4774; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
ε NOTE—Figures 1-6 were corrected editorially in April 2012.
1. Scope D996 Terminology of Packaging and Distribution Environ-
ments
1.1 This specification covers the size, color, pattern, and
2.2 Other Standard:
type used on labels applied to unlabeled syringes filled by the
3
users or their agents to identify the drug content. This speci- Pantone Matching System
fication is not intended to cover labels applied by the drug
manufacturer. 3. Terminology
3.1 Definitions—General definitions for packaging and dis-
1.2 The values stated in SI units are to be regarded as the
recommended values. The use of inch-pound system values, tribution environments are found in Terminology D996.
not being exact equivalents, may result in nonconformance
with the standard. 4. Size and Background Color Requirements
1.3 This standard does not purport to address all of the 4.1 Label Size—Thelabelsshallhaveanominallengthof25
safety concerns, if any, associated with its use. It is the
to 35 mm and a width of 10 to 13 mm.
responsibility of the user of this standard to establish appro-
4.2 Label Background Color—Thecolorsandpatternsgiven
priate safety and health practices and determine the applica-
in Fig. 1 shall be used to distinguish these groups of drugs.The
bility of regulatory limitations prior to use.
background color shall not interfere with the ability of the user
to write information on the label.
2. Referenced Documents
4.2.1 Antagonists—To denote an antagonist, 1-mm wide
2
2.1 ASTM Standards:
diagonal stripes of the agonist color alternating with a 1-mm
wide white stripe shall be used. The stripes shall run from the
1
This specification is under the jurisdiction of ASTM Committee F02 on lower left to the upper right at an angle of approximately 45°
Flexible Barrier Packaging and is the direct responsibility of Subcommittee F02.50
to the long axis of the label. The name of an antagonist drug
on Package Design and Development.
shall appear in the center of the label and the striping shall be
Current edition approved April 1, 2011. Published May 2011. Originally
omitted behind and below the name (see Fig. 2).
approved in 1988. Last previous edition approved in 2006 as D4774 – 06. DOI:
10.1520/D4774-11E01.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Available from Pantone, Inc., 509 Commerce Boulevard, Carlstadt, NJ
the ASTM website. 07072–3098.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
´1
D4774−11
FIG. 1Standard Background Colors for User Applied Syringe Drug Labels
FIG. 2 Label for an Antagonist Drug
5. Significance and Use colorsisintendedonlyasanaidinidentificationofdruggroups
and does not absolve the user from the duty to read the label to
5.1 The objective of this specification is to facilitate iden-
correctly identify the drug prior to use.
tification of drugs
...

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