90 medical device industry standards such as Hemodialysis and Related Therapeutic Water have been approved and approved. Among them, the compulsory medical device industry standard will be implemented from January 1, 2017, and the recommended medical device industry standard will be implemented from January 1, 2016. The standard number, name and applicable scope are shown in the annex.
Special announcement.
Attachment: YY 0572-2014 "hemodialysis and related treatment water" and other 90 medical device industry standard number, name and scope of application
Food and Drug Administration
March 2, 2015
I. Mandatory industry standards (14 in total)
(1) YY 0572-2014 "Hemodialysis and related treatment water"
This standard applies to hemodialysis, hemodiafiltration and on-line hemofiltration or on-line hemodiafiltration in the preparation of dialysis concentrates and dialysate and hemodialyzer re-treatment water. This standard specifies the minimum requirements for related water use. This standard does not cover the operation of water treatment equipment, nor does it involve the preparation of dialysate for treatment by mixing treated water with concentrate. These operations can only be performed by professional dialysis personnel. This standard does not apply to dialysate regeneration systems.
(2) YY 0598-2014 "Hemodialysis and related therapeutic concentrates"
This standard applies to hemodialysis and related therapeutic concentrates. This standard specifies the chemical composition and purity of the concentrate, microbial contamination, treatment, measurement and labeling of the concentrate, requirements for the container and various tests required for the quality inspection of the concentrate. This standard does not apply to the mixing process in which the concentrate and dialysis water are formulated into the final use concentration and the dialysate regeneration system.
(3) YY 0599-2014 "Excimer laser corneal refractive surgery machine for laser treatment equipment "
This standard applies to excimer laser corneal refractive surgery machine (hereinafter referred to as the treatment machine), the treatment machine uses 193nm excimer laser to remove corneal tissue to change the shape of the cornea to improve vision, mainly for refractive keratectomy (PRK), In situ keratomileusis (LASIK) and other corneal refractive correction and therapeutic keratectomy (PTK). This standard specifies the terms and definitions, structure and basic parameters, requirements, test methods, inspection rules, marking, packaging, transportation and storage of the treatment machine. This standard replaces YY 0599-2007 "Excimer Laser Corneal Refractor".
(4) YY 0603-2014 "Cardiac implants and artificial organs heart surgery hard shell blood reservoir / venous blood reservoir system (with or without filter) and venous blood pouch)
This standard applies to blood storage devices of multi-functional systems, which may have integral components such as blood gas exchangers (oxygenators), blood filters, bubblers, blood pumps, etc. This standard specifies the requirements for sterile, single-use extracorporeal circulation cardiac surgery hard-shell blood reservoirs, venous blood reservoir systems (with or without filters), and venous blood pouches (referred to as blood reservoirs). Test methods, signs, labels, instructions for use and packaging, transportation, storage. These devices are intended for use in blood transfusion during cardiopulmonary bypass surgery (CPB).
(5) YY 0605.9-2014 "Surgical implant metal materials - Part 9: Forging high nitrogen stainless steel"
This standard is applicable to stainless steel bars, steel wires, steel plates and steel strips used for surgical implants and meets the requirements of standard components. The mechanical properties of the samples taken from the finished samples may not comply with this standard. This standard specifies the chemical composition of stainless steel with a nitrogen content of 0.25% to 0.50% for surgical implants, microstructure under fully annealed condition, corrosion resistance, mechanical properties and corresponding test methods.
(6) YY 0831.2-2014 "Zero beam stereotactic radiotherapy system Part 2: Body multi-source gamma beam stereotactic radiotherapy system"
This standard applies to the body multi-source gamma beam stereotactic radiotherapy system (hereinafter referred to as the system), which uses multiple 60Co sealed radioactive sources (which can be either moving or stationary) to perform lesions on the body. Spotlight irradiation. This standard specifies the terms, definitions, requirements, and test methods for a multi-source gamma beam stereotactic radiotherapy system.
(7) YY 0832.2-2014 X-radiation radiotherapy stereotactic and planning system Part 2: Stereotactic and planning system for X-radiation radiotherapy
This standard applies to the body X-radiation radiotherapy stereotactic and planning system (hereinafter referred to as the system). The system is used in conjunction with a medical electron accelerator to perform stereotactic radiotherapy for a lesion in a body. This standard specifies the terms, requirements, and test methods for stereotactic and planning systems for X-radiation radiotherapy.
(8) YY 0945.2-2014 "Medical electrical equipment - Part 2: Particular requirements for external cardiac pacemakers with internal power supply"
This standard applies to external cardiac pacemakers and patient cables with internal power (if used). This standard specifies the safety specific requirements for external cardiac pacemakers and patient cables (if used) with internal power supply. This standard does not apply to devices that are directly or indirectly connected to the power supply network, nor to pacing electrodes or other devices used for ECG stimulation, such as devices that are stimulated externally through the chest or esophagus, providing resistance at high speed pacing. A device for tachycardia energy and a device that provides pacing system analysis.
(9) YY 0948-2014 "One-time use of arteriovenous intubation in cardiopulmonary circulation system"
This standard is applicable to the one-time use of arteriovenous intubation in cardiopulmonary circulation system for supporting cardiopulmonary bypass system. It is used when draining or perfusion blood during cardiopulmonary bypass. This standard specifies the classification and structure, requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage of sterile disposable arteriovenous cannula.
(10) YY 0950-2014 "Pneumatic Ballistic External Pressure Wave Treatment Equipment"
This standard is applicable to the use of the energy generated by compressed air to drive the bullet in the treatment handle, so that the bullet pulse impact treatment head, using the elastic collision of the two to generate pressure waves, transcutaneous conduction to the treatment of the pain site. This standard specifies the terms and definitions, composition, requirements, test methods, inspection rules, signs, instructions for use, packaging, transportation and storage of pneumatic ballistic extracorporeal pressure wave treatment equipment. This standard does not apply to pneumatic ballistic lithotripsy equipment.
(11) YY 0951-2014 "Interference Electrotherapy Equipment"
This standard is applicable to devices that simultaneously apply two or more (including two) intermediate frequencies (in the range of 1000 Hz to 100,000 Hz) of alternating current to the human body to form low-frequency modulated currents in the tissue for treatment. This standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, signs, instructions for use, packaging, transportation and storage of interference electrical therapy equipment.
(12) YY 0952-2014 "medical temperature control blanket"
This standard is applicable to the equipment that controls the temperature of the circulating fluid in the medical environment under the clinical use environment of the medical institution, and has the function of physically warming and/or cooling the human body in vitro to achieve the purpose of adjusting the temperature of the human body. This standard specifies the terms and definitions, classification and composition, requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage of medical temperature control blankets. This standard does not apply to thermal pad therapy devices, equipment used only for limbs and forehead cold/hot packs.
(13) YY 0953-2014 "medical carboxymethyl chitosan"
This standard applies to chitosan or chitin as raw material, deacetylated, carboxylated, purified and made of medical grade carboxymethyl chitosan for medical device products. This standard specifies the requirements, test methods, inspection rules, packaging, transportation, storage and other requirements for medical carboxymethyl chitosan raw materials.
(14) YY 0954-2014 Passive Surgical Implants - Type I Collagen Implants
This standard applies to injection-type collagen implants prepared from purified (non-crosslinked) type I collagen. This standard specifies the specific requirements and test methods for injection-type collagen implants, and provides expected performance, design properties, materials, design evaluation, test methods, clinical evaluation, post-marketing supervision, manufacturing, packaging, and provided by the manufacturer. The information and so on have been specified.
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