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ASTM D4774-06

(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.
SCOPE
1.1 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.

General Information

Status
Historical
Publication Date
30-Nov-2006
ICS
11.040.20 - Transfusion, infusion and injection equipment
Technical Committee
D10 - Packaging
Current Stage
Ref Project

Relations

Replaces
ASTM D4774-94(2000) - Standard Specification for User Applied Drug Labels in Anesthesiology
Effective Date
01-Dec-2006
Replaced By
ASTM D4774-11 - Standard Specification for User Applied Drug Labels in Anesthesiology
Effective Date
01-Apr-2011

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ASTM D4774-06 - Standard Specification for User Applied Drug Labels in AnesthesiologyASTM D4774-06 - Standard Specification for User Applied Drug Labels in Anesthesiology
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ASTM D4774-06 - 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
Designation: D4774 – 06
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.
TABLE 1 Standard Background Colors for User Applied Syringe
1. Scope
A
Drug Labels
1.1 This specification covers the size, color and pattern, and
Pantone Color,
Drug Class Examples
type used on labels applied to unlabeled syringes filled by the
All Uncoated
users or their agents to identify the drug content. This speci-
1 Induction agents thiopental, methohexital yellow
fication is not intended to cover labels applied by the drug
thiamylal, etomidate
manufacturer. ketamine
2 Tranquilizers diazepam, midazolam orange 151
B
3 Muscle relaxants succinylcholine, rocuronium, fluorescent red 805
2. Referenced Documents
mivacurium, vecuromum
2
2.1 ASTM Standards: pancuronium, atracurium,
cisatracurium
D996 Terminology of Packaging and Distribution Environ-
3a Relaxant neostigmine, fluorescent red 805
C
ments
antagonists endrophonium or warm red and
pyridostigmine white diagonal
2.2 Other Standard:
stripes
3
Pantone Matching System
4 Narcotics morphine, fentanyl, blue 297
alfentanyl, sufentanyl,
3. Terminology
meperidine
4a Narcotic levallorphan, naloxone blue 297 and white
3.1 Definitions—General definitions for packaging and dis-
antagonists diagonal stripes
tribution environments are found in Terminology D996.
5 Major tranquilizers droperidol, chlorpromazine salmon 156
5b Combinations of blue 297 and salmon
narcotics and
4. Size and Background Color Requirements
major 156 longitudinal
4.1 Label Size—The labels shall have a nominal length of
tranquilizers stripes
B
6 Vasopressors epinephrine, ephedrine violet 256
25 to 35 mm and a width of 10 to 13 mm.
phenylephrine
4.2 Label Background Color—The colors and patterns
6a Hypotensive agents trimethaphan, violet 256 and white
given in Table 1 shall be used to distinguish these groups of
nitroprusside, diagonal stripes
nitroglycerine,
drugs. The background color shall not interfere with the ability
phentolamine
of the user to write information on the label.
7 Local anesthetics bupivacaine, lidocaine gray 401
4.2.1 Antagonists— To denote an antagonist, 1-mm wide
8 Anticholinergic atropine, glycopyrrolate green 367
agents
diagonal stripes of the agonist color alternating with a 1-mm
A
wide white stripe shall be used. The stripes shall run from the Drugs that do not fit into the above classes should be labeled with black
printing on a white background. The examples shown are representative, not
lower left to the upper right at an angle of approximately 45°
restrictive.
B
to the long axis of the label. The name of an antagonist drug
All printing is to be in black boldtype, with the exception that “succinyl-
choline’’ and “epinephrine’’ shall be printed against the background color as
shall appear in the center of the label and the striping shall be
reversed plate letters within a black bar running from edge to edge of the label.
omitted behind and below the name (see Fig. 1).
C
Warm red may be used if the printing of 805 fluorescent red stripes presents
insurmountable difficulties.
1
This specification is under the jurisdiction of ASTM Committee D10 on
5. Significance and Use
Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer,
Pharmaceutical and Medical Packaging.
5.1 The objective of this specification is to facilitate iden-
Current edition approved Dec. 1, 2006. Published January 2007. Originally
tification of drugs in syringes filled by the user. The use of
approved in 1988. Last previous edition approved in 2000 as D4774 – 94 (2000).
DOI: 10.1520/D4774-06.
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
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3
Available from Pantone, Inc., 509 Commerce Boulevard, Carlstadt, NJ
07072–3098. FIG. 1 Label for an Antagonist Drug
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
D4774 – 06
colorsisintendedonlyasanaidinidentificationofdruggroups
and does not absolve the user from the duty to read the label to
correctly identify the drug prior to use.
5.2 The user may alternatively use black and white labels
ratherthanthesecoloredlabels.Howeverifcolorsareused,the
rangeofcolorsspecifiedinthisspecificationshallbeutilizedto
avoid confusion.
6. Type a
...

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