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英文版GB 18671-2009 一次性使用静脉输液针.doc 21页

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ICS 11. 040. 20 C 31 National Standard of the People's Republic of China GB 18671—2009 Replace GB 18671—2002 一次性使用静脉输液针 Intravenous needles for single use Issued on May 06, 2009 Implemented on March 01, 2010 Issued by General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China and Standardization Administration of the People's Republic of China GB 18671—2009 Foreword All the technical contents of this standard are mandatory. This standard will replace GB 18671—2002 "Intravenous needles for single use". The principal differences between this standard and GB 18671—2002 are as follows: —— The scope was extended to be applicable to gravity feed infusion sets, supporting intravenous needles for infusion sets and transfusion sets for use with pressure infusion equipments, and corresponding requirements were added; —— Intravenous needles for 0.36 mm needle tubing specifications and corresponding requirements were added; —— The product signs were modified to specification sings; —— The requirements specified for the connecting base was modified to be mandatory; —— The requirements for needle diameter for rapid evaluation of the free flow of needle tubing were provided in an informative appendix; and qualitative test methods for testing the piercing performance of needle tip were canceled; —— The acidity and alkalinity test was modified to titrimetry; —— For intravenous needles sterilized by ethylene oxide sterilization method, requirements for the amount of ethylene oxide residue were canceled, and the requirement that the pre-package shall be done with dialysis materials was added; —— The requirements for signs and package were modified; —— The delivery inspection was canceled. Appendixes A and B of this standard are normative appendixes, and appendixes C and D are informative appendixes. This standard was proposed by China Food and Drug Administration. This standard is under the jurisdiction of National Standardization Tech

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