Standard Specification for User Applied Drug Labels in Anesthesiology

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.

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Historical
Publication Date
31-Dec-1999
Technical Committee
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ASTM D4774-94 - 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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: D 4774 – 94
Standard Specification for
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.
1. Scope tification of drugs in syringes filled by the user. The use of
colors is intended only as an aid in identification of drug groups
1.1 This specification covers the size, color and pattern, and
and does not absolve the user from the duty to read the label to
type used on labels applied to unlabeled syringes filled by the
correctly identify the drug prior to use.
users or their agents to identify the drug content. This speci-
5.2 The user may alternatively use black and white labels
fication is not intended to cover labels applied by the drug
rather than these colored labels. However if colors are used, the
manufacturer.
range of colors specified in this specification shall be utilized to
2. Referenced Documents
avoid confusion.
2.1 ASTM Standards:
6. Type and Color Requirements
D 996 Terminology of Packaging and Distribution Environ-
2 6.1 The type should be as large as possible (minimum
ments
10-point) using bold type. Upper and lower case letters are
2.2 Other Standard:
3 preferred for better legibility. All printing shall be in black with
Pantone Matching System
the exception of “SUCCINYLCHOLINE’’ and “EPINEPH-
3. Terminology RINE’’ which shall be printed against the background color as
bold reverse plate letters within a black bar running from edge
3.1 Definitions—General definitions for packaging and dis-
to edge on the upper half of the label, the rest of which shall
tribution environments are found in Terminology D 996.
display the colored background (see Fig. 2).
4. Size and Background Color Requirements
6.1.1 The established (generic) name of the drug shall be
used. The use of the proprietary (trade) name of the drug is
4.1 Label Size—The labels shall have a nominal length of
optional. The initial syllable, or initial two syllables, of the
25 to 35 mm and a width of 10 to 13 mm.
drug name may be emphasized by being printed in a bold upper
4.2 Label Background Color—The colors and patterns
case type a minimum of 2 points larger than the remainder of
given in Table 1 shall be used to distinguish these groups of
the drug name, which is typed in lower case (see Fig. 3).
drugs. The background color shall not interfere with the ability
6.1.2 Except for antagonists, the name of the drug should be
of the user to write information on the label.
printed on the upper half of the label to leave space below for
4.2.1 Antagonists— To denote an antagonist, 1-mm wide
entry of the dosage. In the bottom righthand corner either
diagonal stripes of the agonist color alternating with a 1-mm
“mg/mL”, “meg/mL” or “mcg/mL”, as appropriate (except for
wide white stripe shall be used. The stripes shall run from the
drug mixtures such as fentanyl/droperidol) shall be printed (see
lower left to the upper right at an angle of approximately 45°
Fig. 2 and Fig. 4).
to the long axis of the label. The name of an antagonist drug
6.1.3 For barbiturate induction agents the concentration of
shall appear in the center of the label and the striping shall be
the solution (as “%’’ or “mg/mL’’) and the date of preparation
omitted behind and below the name (see Fig. 1).
should appear on the label, as shown in Fig. 5 and Fig. 6.
5. Significance and Use
6.1.4 For antagonists the name of the drug should be printed
along the center line of the label to permit a sufficient width of
5.1 The objective of this specification is to facilitate iden-
diagonal stripes to appear above the name for easy recognition
1 (see Fig. 1).
This specification is under the jurisdicti
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