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ASTM D4774-94(2000)

(Specification)

Standard Specification for User Applied Drug Labels in Anesthesiology

Standard Specification for User Applied Drug Labels in Anesthesiology

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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
31-Dec-1999
ICS
11.040.20 - Transfusion, infusion and injection equipment
Technical Committee
D10 - Packaging
Current Stage
Ref Project

Relations

Replaces
ASTM D4774-94 - Standard Specification for User Applied Drug Labels in Anesthesiology
Effective Date
01-Jan-2000
Replaced By
ASTM D4774-06 - Standard Specification for User Applied Drug Labels in Anesthesiology
Effective Date
01-Dec-2006

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ASTM D4774-94(2000) - Standard Specification for User Applied Drug Labels in AnesthesiologyASTM D4774-94(2000) - Standard Specification for User Applied Drug Labels in Anesthesiology
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ASTM D4774-94(2000) - Standard Specification for User Applied Drug Labels in Anesthesiology
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: D 4774 – 94 (Reapproved 2000)
Standard Specification for
1
User Applied Drug Labels in Anesthesiology
This standard is issued under the fixed designation D 4774; 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 (e) 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, curare fluorescent red 805
2. Referenced Documents
mivacurium, vecuromum
2
2.1 ASTM Standards: pancuronium, atracurium
3a Relaxant neostigmine, fluorescent red 805
D 996 Terminology of Packaging and Distribution Environ-
C
antagonists endrophonium or warm red and
ments
pyridostigmine white diagonal
stripes
2.2 Other Standard:
4 Narcotics morphine, fentanyl, blue 297
3
Pantone Matching System
meperidine
4a Narcotic levallorphan, naloxone blue 297 and white
3. Terminology
antagonists diagonal stripes
5 Major tranquilizers droperidol, chlorpromazine salmon 156
3.1 Definitions—General definitions for packaging and dis-
5b Combinations of innovar, fentanyl-droperidol blue 297 and salmon
tribution environments are found in Terminology D 996.
narcotics and combination
major 156 longitudinal
tranquilizers stripes
4. Size and Background Color Requirements
B
6 Vasopressors epinephrine, ephedrine violet 256
4.1 Label Size—The labels shall have a nominal length of
phenylephrine
6a Hypotensive agents trimethaphan, violet 256 and white
25 to 35 mm and a width of 10 to 13 mm.
nitroprusside, diagonal stripes
4.2 Label Background Color—The colors and patterns
nitroglycerine,
given in Table 1 shall be used to distinguish these groups of
phentolamine
7 Local anesthetics bupivacaine, lidocaine gray 401
drugs. The background color shall not interfere with the ability
8 Anticholinergic atropine, glycopyrrolate green 367
of the user to write information on the label.
agents
4.2.1 Antagonists— To denote an antagonist, 1-mm wide
A
Drugs that do not fit into the above classes should be labeled with black
diagonal stripes of the agonist color alternating with a 1-mm
printing on a white background. The examples shown are representative, not
wide white stripe shall be used. The stripes shall run from the restrictive.
B
All printing is to be in black boldtype, with the exception that “succinyl-
lower left to the upper right at an angle of approximately 45°
choline’’ and “epinephrine’’ shall be printed against the background color as
to the long axis of the label. The name of an antagonist drug
reversed plate letters within a black bar running from edge to edge of the label.
C
Warm red may be used if the printing of 805 fluorescent red stripes presents
shall appear in the center of the label and the striping shall be
insurmountable difficulties.
omitted behind and below the name (see Fig. 1).
5. Significance and Use
1
This specification is under the jurisdiction of ASTM Committee D10 on
5.1 The objective of this specification is to facilitate iden-
Packaging and is the direct responsibility of Subcommittee D10.32 on Consumer
tification of drugs in syringes filled by the user. The use of
Packages.
Current edition approved Nov. 15, 1994. Published January 1995. Originally
published as D 4774 – 88. Last previous edition D 4774 – 93.
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., 55 Knickerbocker Rd., Moonachie, NJ 07074. 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 ----------------------
D 4774 – 94 (2000)
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 and Color Requirements
NOTE 1—Bold upper-case type
...

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