This specific standard specifies the requirements for infusion pumps, infusion controllers, syringe pumps and portable infusion pumps defined in 2.101~2.110. These devices are used by medical staff and family patients according to prescriptions and doctor's orders. These particular requirements do not apply to the following equipment: ---- used exclusively for diagnostic or similar purposes (for example, angiography or other pumps permanently controlled or administered by the operator); ---- internal infusion; ---- Extracorporeal circulation of blood; ----implantable devices or single-use devices; ----devices designed for urodynamic diagnosis (use of a catheter to fill the bladder with water and measure its pressure-volume relationship); - ---Diagnostic equipment specially used for the detection of male impotence (in order to keep the penis erect, a preset pressure must be maintained, and the amount of fluid injected to maintain the pressure is measured: cavernous body).
GB 9706.27-2005 Referenced Document
GB 9706.1-1995 Medical electrical equipment--Part 1: General requirements for safety
YY 0505-2005 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
GB 9706.27-2005 history
2021GB 9706.224-2021 Medical electrical equipment—Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
2005GB 9706.27-2005 Medical electrical equipments.Part 2-24: Particular requirements for the safety of infusion pumps and controllers
GB 9706.27-2005 Medical electrical equipments.Part 2-24: Particular requirements for the safety of infusion pumps and controllers was changed to GB 9706.224-2021 Medical electrical equipment—Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers.