ASTM D4774-2011(2017) Standard Specification for User Applied Drug Labels in Anesthesiology《麻醉学中用户使用药物标签的标准规范》.pdf

1、Designation: D4774 11 (Reapproved 2017)Standard Specification forUser Applied Drug Labels in Anesthesiology1This standard is issued under the fixed designation D4774; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last

2、 revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers the size, color, pattern, andtype used on labels applied to unlabeled syringes filled by theuser

3、s or their agents to identify the drug content. This speci-fication is not intended to cover labels applied by the drugmanufacturer.1.2 The values stated in SI units are to be regarded as therecommended values. The use of inch-pound system values,not being exact equivalents, may result in nonconform

4、ancewith the standard.1.3 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory li

5、mitations prior to use.1.4 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organizati

6、on TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2D996 Terminology of Packaging and Distribution Environ-ments2.2 Other Standard:Pantone Matching System33. Terminology3.1 DefinitionsGeneral definitions for packaging and dis-tribution environments are found in T

7、erminology D996.4. Size and Background Color Requirements4.1 Label SizeThe labels shall have a nominal length of 25to 35 mm and a width of 10 to 13 mm.4.2 Label Background ColorThe colors and patterns givenin Fig. 1 shall be used to distinguish these groups of drugs. Thebackground color shall not in

8、terfere with the ability of the userto write information on the label.4.2.1 AntagonistsTo denote an antagonist, 1-mm widediagonal stripes of the agonist color alternating with a 1-mmwide white stripe shall be used. The stripes shall run from thelower left to the upper right at an angle of approximat

9、ely 45to the long axis of the label. The name of an antagonist drugshall appear in the center of the label and the striping shall beomitted behind and below the name (see Fig. 2).1This specification is under the jurisdiction of ASTM Committee F02 onPrimary Barrier Packaging and is the direct respons

10、ibility of Subcommittee F02.50on Package Design and Development.Current edition approved Dec. 15, 2017. Published January 2018. Originallyapproved in 1988. Last previous edition approved in 2011 as D4774 111. DOI:10.1520/D4774-11R17.2For referenced ASTM standards, visit the ASTM website, www.astm.or

11、g, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from Pantone, Inc., 509 Commerce Boulevard, Carlstadt, NJ070723098.Copyright ASTM International, 100 Barr Harbor Driv

12、e, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations iss

13、ued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.15. Significance and Use5.1 The objective of this specification is to facilitate iden-tification of drugs in syringes filled by the user. The use ofcolors is intended only as an aid in identification of drug groupsand do

14、es not absolve the user from the duty to read the label tocorrectly identify the drug prior to use.FIG. 1 Standard Background Colors for User Applied Syringe Drug LabelsFIG. 2 Label for an Antagonist DrugD4774 11 (2017)25.2 The user may alternatively use black and white labelsrather than these color

15、ed labels.6. Type and Color Requirements6.1 The type should be as large as possible (minimum10-point) using bold type. Upper and lower case letters arepreferred for better legibility.All printing shall be in black boldwith the exception of “SUCCINYLCHOLINE, “EPINEPH-RINE and Beta Blockers “ESMOLOL”,

16、 METOPROLOL”,“LABATOLOL” which shall be printed against the backgroundcolor as bold reverse plate letters within a black bar (copper barfor Beta Blockers) running from edge to edge on the upper halfof the label, the rest of which shall display the coloredbackground (see Fig. 3).6.1.1 The established

17、 (generic) name of the drug shall beused. The use of the proprietary (trade) name of the drug isoptional. The initial syllable, or initial two syllables, of thedrug name may be emphasized by being printed in a bold uppercase type a minimum of 2 points larger than the remainder ofthe drug name, which

18、 is typed in lower case (see Fig. 4).6.1.2 Except for antagonists, the name of the drug andconcentration (for example, “mg/mL,” “meq/mL,” or “mcg/mL”; see Fig. 3 and Fig. 5) should be printed on the upper halfof the label to leave space below for entry of the date, time, andinitials of user).6.1.3 F

19、or induction agents and local anesthetics the concen-tration of the solution (as “% or “mg/mL) and the date ofpreparation should appear on the label, as shown in Fig. 6.6.1.4 For antagonists the name of the drug should be printedalong the center line of the label to permit a sufficient width ofdiago

20、nal stripes to appear above the name for easy recognition(see Fig. 2).7. Keywords7.1 anesthesiology; drug labels; label requirementsASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard

21、 are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif n

22、ot revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which

23、 you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,Uni

24、ted States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may

25、also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 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 PrintingFIG. 5 Drug Name and DosageFIG. 6 Alternative Label Showing Concentration in Percent and mg/mLD4774 11 (2017)3