ASTM D4775-2004 Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)《药物(不包括大批量的药房用药)用.pdf

1、Designation: D 4775 04Standard Specification forIdentification and Configuration of Prefilled Syringes andDelivery Systems for Drugs (Excluding Pharmacy BulkPackages)1This standard is issued under the fixed designation D 4775; the number immediately following the designation indicates the year ofori

2、ginal adoption or, in the case of revision, the year of last revision. A number 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 identification of:1.1.1 The dru

3、g contained in the prefilled syringe or deliverysystem.1.1.2 The concentration, volume, and total amount of thedrug, and whether it is to be diluted prior to administration.2. Referenced Documents2.1 ASTM Standards:2D 996 Terminology of Packaging and Distribution Environ-mentsD 4267 Specification fo

4、r Labels for Small-Volume (Lessthan 100 mL) Parenteral Drug Containers3. Terminology3.1 General definitions for packaging and distribution envi-ronments are found in Terminology D 996.3.2 Definitions of Terms Specific to This Standard:3.2.1 delivery systemas used in this specification,aclosed system

5、 consisting of a container of concentrated solu-tion or powder which facilitates the transfer of the contents intoa diluent prior to administration or use.3.2.2 pharmacy bulk packagedrug supplied in a stockcontainer to be held in the pharmacy and used for multipledispensing.3.2.3 syringean instrumen

6、t by means of which drugs insolution or other liquids are injected into or withdrawn fromany vessel or cavity.4. Significance and Use4.1 Difficulties have occurred in the correct identification ofsyringes containing significantly different medications oncethey have been removed from their cartons. T

7、he objective ofthis specification is to facilitate identification of the drug, itsconcentration, volume, and total amount.4.2 Difficulties have also occurred in distinguishing be-tween syringes containing drugs ready for intravenous injec-tion and similar syringes containing solutions which must bed

8、iluted before use. An objective of this specification is tominimize the chance for such errors.5. Label Requirements5.1 Label copy shall comply with Specification D 4267 andshall include the information required by regulation and by themanufacturer. In addition the requirements of the followingsecti

9、ons shall apply.5.2 In syringes of the type shown in Fig. 1, 10-point orlarger type is preferred for the drug name and the amount ofdrug per millilitre, or total amount as appropriate. This typeshall satisfy the test for legibility in 7.1, but at a distance of 500mm (19.7 in.). This information shal

10、l be legible with minimalrotation of the immediate drug container.5.3 In syringes of the type in Fig. 2, where the immediatedrug container is fitted into the syringe barrel, the drug name,concentration, and total volume shall appear as close to theextreme right hand end of the drug containerthat is,

11、 theopposite end to the needleas possible, in bold type, in heightat least equal to one ninth of the external circumference of thecontainer up to a maximum of 10 mm.5.3.1 The opaque background of these two lines of text shallnot exceed one third of the circumference of the container.There shall be g

12、ood contrast between the type used for the drugname, concentration, and total volume, and either the drugcontainer or an added opaque label background sufficient toconform with Section 7. The name of the drug on the containershall be legible through the barrel during preparation and usesufficient to

13、 conform with Section 7.1This specification is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee D10.32 on ConsumerPackages.Current edition approved April 1, 2004. Published May 2004. Originallyapproved in 1988. Last previous edition approved i

14、n 1994 as D 4775 94 (1999).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.FIG. 1 Label on Syringe Type Shown

15、1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.5.4 Distinctive labels or other means of distinguishingsyringes and containers filled with medications which can onlybe given safely by specific routes (such as anti-cancer drugs)shall

16、be employed.5.5 Syringes and containers of medications intended onlyfor regional anesthesia shall be clearly marked as such.6. Delivery Systems6.1 Delivery systems, for drugs which must be dilutedbefore administration, shall not resemble a normal syringe andshall be unsuitable for direct intravenous

17、 line injection (seeFig. 3). Such drugs shall preferably be supplied as a powder ina delivery system designed to facilitate the addition of thepowder to the container of parenteral solution. If supplied as aconcentrated solution, the immediate container shall not allowthe use of a standard syringe t

18、o transfer the concentratedsolution to a container of parenteral solution.6.2 The drug container shall be labelled “Dilute BeforeUse” or other appropriate warning, in at least 10-point boldtype in dark ink, whenever space permits, preferably within ared fluorescent box, such as Pantone 805 (see Fig.

19、 3).6.3 When copy space is not sufficient for 10-point type size,the warning shall be at least equal in size to the name andstrength designations of the drug. In addition to the label on thecontainer, “Dilute Before Use” or other appropriate warningshall be prominently displayed on the box and in ac

20、company-ing instructions.7. Legibility Test7.1 The copy for the proprietary name or established nameof the drug, and the amount of drug per unit and total volumeshall be legible in a light of 215 lx (20 fc) at a distance of 155cm (5 ft) (see 5.3) by a person with 20:20 unaided or correctedvision.8.

21、Keywords8.1 delivery systems; label requirements; legibility; prefilledsyringesASTM International takes 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 vali

22、dity 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 not revised, either reapproved or withdrawn. Your comm

23、ents 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 you may attend. If you feel that your comments have

24、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,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 through the ASTM website(www.astm.org).FIG. 2 Label on Syringe Type ShownFIG. 3 Label on Delivery System with SpikeD4775042