ASTM D4774-2006 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: D 4774 06Standard Specification forUser Applied Drug Labels in Anesthesiology1This standard is issued under the fixed designation D 4774; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A num

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

3、gents to identify the drug content. This speci-fication is not intended to cover labels applied by the drugmanufacturer.2. Referenced Documents2.1 ASTM Standards:2D 996 Terminology of Packaging and Distribution Environ-ments2.2 Other Standard:Pantone Matching System33. Terminology3.1 DefinitionsGene

4、ral definitions for packaging and dis-tribution environments are found in Terminology D 996.4. Size and Background Color Requirements4.1 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 Table 1 shall b

5、e used to distinguish these groups ofdrugs. The background color shall not interfere with the abilityof the user to write information 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 str

6、ipes 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 antagonist drugshall appear in the center of the label and the striping shall beomitted behind and below the name (see Fig. 1).5. Significance and Use5.1 The objective of

7、 this specification is to facilitate iden-tification of drugs in syringes filled by the user. The use of1This specification is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee D10.32 on Consumer,Pharmaceutical and Medical Packaging.Current edi

8、tion approved Dec. 1, 2006. Published January 2007. Originallyapproved in 1988. Last previous edition approved in 2000 as D 4774 94 (2000).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume

9、 information, refer to the standards Document Summary page onthe ASTM website.3Available from Pantone, Inc., 509 Commerce Boulevard, Carlstadt, NJ070723098.TABLE 1 Standard Background Colors for User Applied SyringeDrug LabelsADrug Class ExamplesPantone Color,All Uncoated1 Induction agents thiopenta

10、l, methohexitalthiamylal, etomidateketamineyellow2 Tranquilizers diazepam, midazolam orange 1513 Muscle relaxants succinylcholine,Brocuronium,mivacurium, vecuromumpancuronium, atracurium,cisatracuriumfluorescent red 8053a Relaxantantagonistsneostigmine,endrophoniumpyridostigminefluorescent red 805or

11、 warm redCandwhite diagonalstripes4 Narcotics morphine, fentanyl,alfentanyl, sufentanyl,meperidineblue 2974a Narcoticantagonistslevallorphan, naloxone blue 297 and whitediagonal stripes5 Major tranquilizers droperidol, chlorpromazine salmon 1565b Combinations ofnarcotics andmajortranquilizersblue 29

12、7 and salmon156 longitudinalstripes6 Vasopressors epinephrine,Bephedrinephenylephrineviolet 2566a Hypotensive agents trimethaphan,nitroprusside,nitroglycerine,phentolamineviolet 256 and whitediagonal stripes7 Local anesthetics bupivacaine, lidocaine gray 4018 Anticholinergicagentsatropine, glycopyrr

13、olate green 367ADrugs that do not fit into the above classes should be labeled with blackprinting on a white background. The examples shown are representative, notrestrictive.BAll printing is to be in black boldtype, with the exception that “succinyl-choline and “epinephrine shall be printed against

14、 the background color asreversed plate letters within a black bar running from edge to edge of the label.CWarm red may be used if the printing of 805 fluorescent red stripes presentsinsurmountable difficulties.FIG. 1 Label for an Antagonist Drug1Copyright ASTM International, 100 Barr Harbor Drive, P

15、O Box C700, West Conshohocken, PA 19428-2959, United States.colors 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

16、these colored labels. However if colors are used, therange of colors specified in this specification shall be utilized toavoid confusion.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 l

17、egibility.All printing shall be in black withthe exception of “SUCCINYLCHOLINE and “EPINEPH-RINE which shall be printed against the background color asbold reverse plate letters within a black bar running from edgeto edge on the upper half of the label, the rest of which shalldisplay the colored bac

18、kground (see Fig. 2).6.1.1 The established (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

19、 than the remainder ofthe drug name, which is typed in lower case (see Fig. 3).6.1.2 Except for antagonists, the name of the drug should beprinted on the upper half of the label to leave space below forentry of the dosage. The appropriate unit of measurement shallbe printed in the bottom right hand

20、corner (example: “mg/mL,”“meq/mL,” or “mcg/mL”; see Fig. 2 and Fig. 4).6.1.3 For induction agents the concentration of the solution(as “% or “mg/mL) and the date of preparation shouldappear on the label, as shown in Fig. 5 and Fig. 6.6.1.4 For antagonists the name of the drug should be printedalong

21、the center line of the label to permit a sufficient width ofdiagonal stripes to appear above the name for easy recognition(see Fig. 1).7. Keywords7.1 anesthesiology; drug labels; label requirements; pre-filled syringesASTM International takes no position respecting the validity of any patent rights

22、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 responsibility.This standard is subject to revision at any tim

23、e 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 addressed to ASTM International Headquarters. Your comments will r

24、eceive 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 the address shown below.This standard is copyrighted by ASTM I

25、nternational, 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 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or th

26、rough the ASTM website(www.astm.org).FIG. 2 Reverse Plate Printing Used to Identify Succinylcholineand EpinephrineNOTE 1Bold upper-case type is shown for first or first and secondsyllables of the drug name.FIG. 3 Optional PrintingFIG. 4 Drug Name and DosageFIG. 5 Alternative Barbiturate Label Showing Concentration inPercentFIG. 6 Alternative Barbiturate Label with Concentration inMilligrams per MillilitreD4774062