ASTM D4774-2011 Standard Specification for User Applied Drug Labels in Anesthesiology《麻醉学中使用者用药物标签的标准规范》.pdf

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1、Designation: D4774 11Standard 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 revision. A numbe

2、r 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 theusers or their agents

3、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 nonconformancewith the stand

4、ard.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 and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenc

5、ed 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 Terminology D996.4. Size and Background Color Requirements

6、4.1 Label SizeThe labels shall have a nominal length of25 to 35 mm and a width of 10 to 13 mm.4.2 Label Background ColorThe colors and patternsgiven in Fig. 1 shall be used to distinguish these groups ofdrugs. The background color shall not interfere with the abilityof the user to write information

7、on the label.4.2.1 Antagonists To 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 approximately 45to the long axis of the label. The name of an anta

8、gonist 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 D10 onPackaging and is the direct responsibility of Subcommittee D10.32 on Consumer,Pharmaceutical and Medical Pa

9、ckaging.Current edition approved April 1, 2011. Published May 2011. Originallyapproved in 1988. Last previous edition approved in 2006 as D4774 06. DOI:10.1520/D4774-11.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annua

10、l Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from Pantone, Inc., 509 Commerce Boulevard, Carlstadt, NJ070723098.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States

11、.ADrugs that do not fit into the above classes should be labeled with black printing on a white background. The examples shown are representative, not restrictive.BAll printing is to be in black boldtype, with the exception that “succinylcholine and “epinephrine shall be printed against the backgrou

12、nd color as reversed plate letterswithin a black bar running from edge to edge of the label.FIG. 1 Standard Background Colors for User Applied Syringe Drug LabelsD4774 1125. Significance and Use5.1 The objective of this specification is to facilitate iden-tification of drugs in syringes filled by th

13、e user. The use ofcolors is intended only as an aid in identification of drug groupsand does not absolve the user from the duty to read the label tocorrectly identify the drug prior to use.5.2 The user may alternatively use black and white labelsrather than these colored labels.6. Type and Color Req

14、uirements6.1 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”, METOPROLOL”,“LABATOLOL” which

15、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 (generic) name of the drug sha

16、ll 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 is typed in lower case (see Fi

17、g. 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 For induction agents and local a

18、nesthetics 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 ofdiagonal stripes to appear above the

19、 name for easy recognition(see Fig. 2).7. Keywords7.1 anesthesiology; drug labels; label requirementsFIG. 2 Label for an Antagonist DrugFIG. 3 Reversed Plate Printing Used to Identify(SUCCINYLcholine,(EPINEPHrine,( and Beta Blockers,(ESMOlol,(LABATolol,( and (METOprolol(D4774 113ASTM International t

20、akes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own

21、responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addr

22、essed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which 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

23、the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (

24、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 also be secured from the ASTM website (www.astm.org/COPYRIGHT/).NOTE 1Bold 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 114