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ASTM D4774-11(2017)

(Specification)

Standard Specification for User Applied Drug Labels in Anesthesiology (Withdrawn 2022)

Standard Specification for User Applied Drug Labels in Anesthesiology (Withdrawn 2022)

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
5.1 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.  
5.2 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.
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"
FIG. 4 Optional 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
FIG. 6 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.
WITHDRAWN RATIONALE
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.
Formerly under the jurisdiction of Committee F02 on Primary Barrier Packaging, this specification was withdrawn in August 2022 because of limited use by industry.

General Information

Status
Withdrawn
Publication Date
14-Dec-2017
Withdrawal Date
15-Aug-2022
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

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ASTM D4774-11(2017) - Standard Specification for User Applied Drug Labels in Anesthesiology (Withdrawn 2022)ASTM D4774-11(2017) - Standard Specification for User Applied Drug Labels in Anesthesiology (Withdrawn 2022)
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ASTM D4774-11(2017) - Standard Specification for User Applied Drug Labels in Anesthesiology (Withdrawn 2022)
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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 −11 (Reapproved 2017)
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. Scope D996 Terminology of Packaging and Distribution Environ-
ments
1.1 This specification covers the size, color, pattern, and
type used on labels applied to unlabeled syringes filled by the
2.2 Other Standard:
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
1.2 The values stated in SI units are to be regarded as the
3.1 Definitions—General definitions for packaging and dis-
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-
priate safety, health, and environmental practices and deter-
4.2 Label Background Color—Thecolorsandpatternsgiven
mine the applicability of regulatory limitations prior to use.
in Fig. 1 shall be used to distinguish these groups of drugs.The
1.4 This international standard was developed in accor-
background color shall not interfere with the ability of the user
dance with internationally recognized principles on standard-
to write information on the label.
ization established in the Decision on Principles for the
4.2.1 Antagonists—To denote an antagonist, 1-mm wide
Development of International Standards, Guides and Recom-
diagonal stripes of the agonist color alternating with a 1-mm
mendations issued by the World Trade Organization Technical
wide white stripe shall be used. The stripes shall run from the
Barriers to Trade (TBT) Committee.
lower left to the upper right at an angle of approximately 45°
2. Referenced Documents
to the long axis of the label. The name of an antagonist drug
2
2.1 ASTM Standards: shall appear in the center of the label and the striping shall be
omitted behind and below the name (see Fig. 2).
1
This specification is under the jurisdiction of ASTM Committee F02 on
Primary Barrier Packaging and is the direct responsibility of Subcommittee F02.50
on Package Design and Development.
Current edition approved Dec. 15, 2017. Published January 2018. Originally
ɛ1
approved in 1988. Last previous edition approved in 2011 as D4774 – 11 . DOI:
10.1520/D4774-11R17.
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 ----------------------
D4774−11 (2017)
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 in syringes filled by the user. The use of
2

---------------------- Page: 2 ----------------------
D4774−11 (2017)
FIG. 3 Reversed Plate Printing Used to Identify
(SUCCINYLcholine,((EPINEPHrine,( and Beta Blockers,
(ESMOlol,((LABATolol,( and (METOprolol(
NOTE—Bold upper-case type is shown for first or first and second syllables of the drug name.
FIG. 4Optional Printing
FIG. 5 Drug Name and Dosage
FIG. 6 Alternative Label Showing Concentration in Percent and mg/mL
5.2 The user may alternatively use black and white labels 6.1.2 Except for antagonists, the name of the drug and
rather than these colored labels. concentration (for example, “mg/mL,” “meq/mL,” or “mcg/
mL”; see Fig. 3 and Fig. 5) should be printed on the upper half
6. Type and Color Requirements
ofthelabeltoleavespacebelowforentryofthedate,time,and
6.1 The type should be as large as possible (minimum
initials of user).
10-point) using bold type. Upper and lower case letters are
6.1.3 For
...

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SCOPE
1.1 This practice provides guidelines for biological assessment of tissue responses to nonabsorbable for medical device implants. It assesses the effects of the material that is implanted intramuscularly or intraosseously. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, or mutagenicity of the material since other standards address these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or skeletal muscle tissue in excess of 30 days. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials are well recognized with a well-characterized long-term response and can include metals and any one of the metal alloys in Specification F67, F75, F90, F136, F138, or F562, high purity dense aluminum oxide as described in Specification F603, ultra high molecular weight polyethylene as stated in Specification F648, or USP polyethylene negative control.  
1.2 The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other systems of measurement are included in this 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.

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ASTM
ASTM C1157/C1157M-23(Specification)
Standard Performance Specification for Hydraulic Cement

SCOPE
1.1 This performance specification covers hydraulic cements for both general and special applications. There are no restrictions on the composition of the cement or its constituents (see Note 1).
Note 1: There are two related hydraulic cement standards, Specification C150/C150M for portland cement and Specifications C595/C595M for blended cements, both of which contain prescriptive and performance requirements  
1.2 This performance specification classifies cements based on specific requirements for general use, high early strength, resistance to attack by sulfates, and heat of hydration. Optional requirements are provided for the property of low reactivity with alkali-silica-reactive aggregates and for air-entraining cements.  
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. Values in SI units [or inch-pound units] shall be obtained by measurement in SI units [or inch-pound units] or by appropriate conversion, using the Rules for Conversion and Rounding given in IEEE/ASTM SI 10, of measurements made in other units [or SI units]. Values are stated in only SI units when inch-pound units are not used in practice.  
1.4 The text of this performance specification refers to notes and footnotes that provide explanatory material. These notes and footnotes (excluding those in tables and figures) are not requirements of the standard.  
1.5 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.  
1.6 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.

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  • Technical specification
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