This standard modification adopts ISO8536-4: 2004 "Medical Infusion Apparatus-Part 4: Disposable Infusion Set, Gravity Infusion Type". See the appendix for differences from the adopted international standards. Compared with GB8368-1998, the main technical modifications of this standard are: —The particulate pollution index and its test method are equivalent to the national standard; —Improved the requirements of the leak test; —Improved the requirements for pipeline length: —Increase the color limit of the flow regulator; —Improved the requirements for injection parts: —The pH test method was changed from the original acidimeter method to the titration method; -The requirements not specified in the corresponding international standards in GB8368-1998 are given in Appendix NA (Informative Appendix) "Design and Implementation Guide". The special infusion set specified in the GB18458 standard is not within the scope of products covered by this standard. Appendix A, Appendix B and Appendix C of this standard are normative appendixes, and Appendix NA and Appendix NB are informative appendices. This standard was proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Apparatus. This standard was drafted by Shandong Medical Device Product Quality Inspection Center. The main drafters of this standard: Wu Ping, Zhang Qiang, You Shaohua, Wang Yanwei, Qin Dongli. The previous versions of the standard replaced by this standard are: GB8368-1987, GB8368-1993, GB8368-1998. 1 Scope This standard specifies the requirements for single-use, gravity infusion type infusion sets to ensure compatibility with infusion containers and venous appliances. The second purpose of this standard is to provide guidelines for the performance and quality specifications of the materials used for infusion sets, and to give the infusion set assembly marks. 2 Normative references The clauses in the following documents become the clauses of this standard through quotation from this standard. For dated reference documents, all subsequent amendments (not including errata content) or revisions are not applicable to this standard. However, parties that have reached an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used . For the cited documents without date, the latest version is applicable to this standard. GB / T1962.1 6% taper (Luer) conical connector for syringes, injection needles and other medical devices Part 1: General requirements (GB / T 1962 1-2001, idt ISO594-1: 1986) GB / T 1962.2 6% taper (Luer) conical connector for syringes, injection needles and other medical devices Part 2: Locking cone head (GB / T1962.2-2001, idt ISO594-2: 1998) GB / T 6682-1992 Specification and test method of water for analytical laboratory (neq ISO3696: 1987) GB / T14233.1-1998 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1: Chemical analysis methods GB / T14233.2 Inspection methods for medical infusion, blood transfusion and injection equipment Part 2: Biological test methods GB 15811-2001 Sterile injection needle for single use (eqv ISO7864: 1993) YY0466 Medical device used for medical device labeling, marking and symbols for providing accommodation (YY 0466-2003, ISO15223: 2000, IDT ISO 14644-1: 1999 Clean room and related control environment-Part I: Air cleanliness classification
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Gravity infusion type disposable infusion set