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YY 0053-2016 English PDF (YY 0053-2008, YY 0053-1991)

YY 0053-2016_English: PDF (YY0053-2016)
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YY 0053-2016English115 Add to Cart 0--9 seconds. Auto-delivery Hemodialysis and relevant therapies - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Valid YY 0053-2016
YY 0053-2008English160 Add to Cart 0--9 seconds. Auto-delivery Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Obsolete YY 0053-2008
YY 0053-1991English519 Add to Cart 4 days [Need to translate] Hollow fiber dialyzer Obsolete YY 0053-1991


BASIC DATA
Standard ID YY 0053-2016 (YY0053-2016)
Description (Translated English) Hemodialysis and relevant therapies. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C45
Classification of International Standard 11.040.30
Word Count Estimation 18,195
Date of Issue 3/23/2016
Date of Implementation 2018-01-01
Older Standard (superseded by this standard) YY 0053-2008
Quoted Standard GB/T 1962.2; GB/T 14233.1-2008; GB/T 16886.1; �л����񹲺͹�ҩ�� 2010���
Adopted Standard ISO 8637-2010, MOD
Drafting Organization Weihai high blood purification Products Co., Ltd., the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center
Administrative Organization National Standardization Technical Committee for Extracorporeal Circulation Equipment (SAC/TC 158)
Regulation (derived from) Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Proposing organization State Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

BASIC DATA
Standard ID YY 0053-2008 (YY0053-2008)
Description (Translated English) Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C45
Classification of International Standard 11.040.30
Word Count Estimation 15,196
Date of Issue 2008-04-25
Date of Implementation 2009-12-01
Older Standard (superseded by this standard) YY 0053-1991
Quoted Standard GB/T 1962.2-2001; GB/T 2828.1; GB/T 14233.1; GB/T 14437-1997; GB/T 16886.1-2001; GB/T 16886.4-2003; GB/T 16886.5-2003; GB/T 16886.7-2001; GB/T 16886.10-2005; GB/T 16886.11-1997; YY 0267-2008; YY 0466-2003
Adopted Standard ISO 8637-2004, MOD
Drafting Organization Guangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center
Administrative Organization National Technical Committee of Standardization for medical pump device
Regulation (derived from) SFDA [2008] No. 192
Proposing organization State Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the use of the body's blood dialyzers, hemodialysis filtration device, hemofiltration, and hemoconcentrators technical requirements. Covered in this article of the "device" refers specifically to these products. This standard does not apply to: extracorporeal blood lines, plasma separator, blood perfusion apparatus, vascular access device, blood pump, extracorporeal blood tubing pressure monitor, air monitors, preparation, dialysate supply and monitoring system, used for hemodialysis, hemofiltration or hemodiafiltration system, further processing steps and equipment.

BASIC DATA
Standard ID YY 0053-1991 (YY0053-1991)
Description (Translated English) Hollow fiber dialyzer
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C45
Classification of International Standard 11.04
Word Count Estimation 13,189
Date of Issue 1991/10/12
Date of Implementation 1992/7/1
Drafting Organization Shanghai Medical Devices Research Institute
Administrative Organization State Administration of Medicine Guangzhou medical equipment standardization technology sub - centralized units
Proposing organization State Administration of Medicine
Issuing agency(ies) State Administration of Medicine


YY 0053-2016 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.30 C 45 Replacing YY 0053-2008 Hemodialysis and Relevant Therapies - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators (ISO 8637.2010, MOD) ISSUED ON. MARCH 23, 2016 IMPLEMENTED ON. JANUARY 01, 2018 Issued by. China Food and Drug Administration Table of Contents Foreword ... 3 1 Scope ... 4 2 Normative References ... 4 3 Requirements ... 5 4 Test Methods ... 9 5 Marking ... 19 Appendix A (Informative) Technical Differences and Causes between this Standard and ISO 8637.2010 ... 23 Bibliography ... 24 Hemodialysis and Relevant Therapies - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators 1 Scope This Standard specifies the technical requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcenrators used for human body; the “instruments” involved in this document indicate the above-mentioned products. This Standard is not applicable to. --- Extracorporeal circulation blood line; --- Plasma separator; --- Blood perfusion device; --- Vascular access device; -- Blood pump; --- Pressure monitor of the extracorporeal circulation blood line; --- Air monitor; --- System for preparing, supplying and monitoring dialysate; --- System for performing hemodialysis, hemofiltration or hemodiafiltration treatment; --- Retreatment steps and equipment. NOTE. The requirements for extracorporeal circulation blood line of haemodialysers, haemodiafilters and haemofilters are specified in YY 0267-2016. 2 Normative References The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the The screening coefficients of albumin, inulin and myoglobin or β2-microglobulin shall conform to the provisions of the manufacturer. The test conditions shall be subject to the information given by the manufacturer. 3.5.3 Ultrafiltration rate The ultrafiltration rate shall conform to the provisions of the manufacturer. The test shall cover the range of transmembrane pressure and blood flow rate specified by the manufacturer. 3.5.4 Blood chamber volume The blood chamber volume shall conform to the provisions of the manufacturer; the test conditions shall cover the range of transmembrane pressure specified by the manufacturer. If the blood chamber is not compliant, it is confirmed that the volume under any particular transmembrane pressure is acceptable. 3.5.5 Blood chamber pressure drop The blood chamber pressure drop shall conform to the provisions of the manufacturer. 3.6 Chemical properties 3.6.1 Reducing substances (easy oxides) The volume difference of potassium permanganate solution [c(KMnO4=0.002mol/L)] consumed by 20mL test solution and the same batch of blank solution shall not exceed 2.0mL. 3.6.2 Metal ions 3.6.2.1 When using the atomic absorption spectrophotometer (AAS) or equivalent method to test, the total content of the antimony, chromium, copper, lead and tin in the test solution shall not exceed 1µg/mL. The cadmium content shall not exceed 0.1µg/mL. 3.6.2.2 Colorimetric analysis method. the color of the test solution shall not exceed the standard control solution with mass concentration of ρ(Pb2+) = 1µg/mL. 3.6.3 pH value The pH value difference between test solution and the same batch of blank solution shall not exceed 1.5. 3.6.4 Evaporation residue The part of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators that is in direct or indirect contact with the patient’s blood shall be biologically evaluated according to the provisions of GB/T 16886.1. 4.3 Sterility 4.3.1 It shall be performed according to the PRC pharmacopoeia, and shall conform to the provisions of 3.2. NOTE. such method is not suitable for exit-factory inspection. 4.3.2 Refer to the relevant standards for the suitable sterilization methods. 4.4 Non-pyrogen Appropriate test methods shall be selected to evaluate the pyrogenicity of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. The test shall be performed as per the PRC pharmacopoeia, and shall conform to the provisions of 3.3. 4.5 Mechanical properties 4.5.1 Mechanical adhesion 4.5.1.1 General Test shall be performed as per 4.5.1.2~4.5.1.3, and shall meet the requirements of 3.4.1. 4.5.1.2 Positive pressure test Fill the instrument with degassed distilled water; place at 37°C±1°C; all interfaces shall be closed except the interface connecting to the pressure test device. Exert a positive pressure of 1.5 times of the pressure specified by the manufacturer, and close the test device. After 10min, record the pressure value and visually examine whether the product has leakage. 4.5.1.3 Negative pressure test Fill the instrument with degassed distilled water; place at 37°C±1°C; all interfaces shall be closed except the interface connecting to the pressure test device. Exert a negative pressure of 1.5 times of the pressure specified by the manufacturer; unless the negative pressure exceeds 93.3kPa (700mmHg) or is not specified; at this time, 93.3kPa (700mmHg) negative pressure shall be exerted; close the test device. The obtainable maximum negative pressure value shall be exerted in the high-altitude area; after 10min, record the pressure value and visually examine whether the product has leakage. 10 – measure the pressure value on the outlet side of dialysate pDO. Figure 4 – Schematic Diagram of an Open-Loop Device for Determining the Clearance Rate of Haemodialysers and haemodiafilters 4.6.2.4 Calculation formula of screening coefficient Where. S – screening coefficient; cBI – solution concentration on the blood inlet of haemodiafilters, haemofilters and haemoconcentrators; cBO - solution concentration on the blood outlet of haemodiafilters, haemofilters and haemoconcentrators; cF – solution concentration on the filtrate end of haemodiafilters, haemofilters and haemoconcentrators. In Formula (2), cBI, cBO and cF are in the same concentration unit. 4.6.3 Ultrafiltration rate 4.6.3.1 Test solution The test solution of haemodialysers, haemodiafilters and haemofilters shall be anticoagulated bovine blood or human blood with protein concentration of 60g/L±5g/L, and the hematocrit of 32%±3%. Or the fresh anticoagulated bovine plasma with protein concentration of 60g/L±5g/L; while the test solution of haemoconcentrators can use the anticoagulated bovine blood or human blood with protein concentration of 50g/L±5g/L, and hematocrit of 25%±3%. No solution shall be used to perfuse the dialysate space or filtrate chamber. 4.6.3.2 Test procedures Assemble the test circuit as per Figure 5. Adjust the flow rate of blood and filtrate to be stable (including temperature, flow rate and pressure). Measure the size of the ultrafiltration rate, so that cover the range given by the manufacturer. Measure the ultrafiltration rate value as per the transmembrane pressure sequence from small to large. Take a set of samples to form a circulation system through connecting with a glass flask; add 500mL of laboratory water and keep it at 37°C±1°C; apply a peristatic pump to a section of silicone rubber tube as short as possible to make the water cycle for 4h with the flow of 200mL/min. Take 50mL of circulating fluid, dilute to 1000mL for later- use. Take the same volume of laboratory water, prepare a blank control solution without the sample. 4.7.2 Reducing substances (easy oxides) It shall be performed as per the Method II in 5.2.2 of GB/T 14233.1-2008; it shall conform to the provisions of 3.6.1. 4.7.3 Metal ions 4.7.3.1 The atomic absorption spectrophotometry is an arbitration method; it shall be performed as per the provisions of 5.9.1 in GB/T 14233.1-2008; it shall conform to the provisions of 3.6.2.1. 4.7.3.2 Colorimetric analysis method. it shall be performed as per the Method I in 5.6.1 of GB/T 14233.1-2008; it shall conform to the provisions of 3.6.2.2. 4.7.4 pH value It shall be performed as per the Method I in 5.4.1 in GB/T 14233.1-2008; it shall conform to the provisions of 3.6.3. 4.7.5 Evaporation residue It shall be performed as per the provisions of GB/T 14233.1-2008; it shall conform to the provisions of 3.6.4. 4.7.6 UV absorbance It shall be performed within the wavelength range of 250nm~320nm specified in GB/T 14233.1-2008; it shall conform to the provisions of 3.6.5. 4.7.7 Ethylene oxide residue If applicable, inspect as per the analysis method of ethylene oxide residue in GB/T 14233.1; it shall conform to the provisions of 3.6.6. 4.7.8 Valid period After an accelerated or real-time shelf life (equivalent to the valid period), the product is tested for sterility, non-pyrogen and medical adhesion; it shall conform to the f) Sterilization method; g) Valid period; h) Instructions for single use or multiple use; i) There shall be a text description of “please read the instruction manual before use’; j) If applicable, instructions for the requirements of the ultrafiltration control unit shall be available. NOTE. In summary, the symbols in YY/T 0466.1 can also be used. 5.3 Markings on the outer package The outer package shall have at least the following information. a) Name and address of the manufacturer; b) Product name, the description of product catalog and quantity on the outer package; c) Product specification and model or manufacturer instrument identification code; d) Production batch number; e) Sterility and non-pyrogen declaration; f) Warning and instructions regarding treatment and storage; g) Valid period. NOTE. In summary, the symbols in YY/T 0466.1 can also be used. 5.4 Instruction manual The instruction manual shall provide at least the following information. a) Name and address of the manufacturer; b) Product name; c) User guide. 1) A description of the supporting equipment in the user guide (if applicable) provided by the manufacturer; 2) The connection position of the extracorporeal circulation blood line and the ......


YY 0053-2008 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.30 C 45 Replacing YY 0053-1991 Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637.2004, MOD) ISSUED ON. APRIL 25, 2008 IMPLEMENTED ON. DECEMBER 1, 2009 Issued by. China Food and Drug Administration Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative references ... 4  3 Requirements ... 6  4 Test methods ... 9  5 Marks ... 17  Appendix A ... 22  Appendix B ... 23  Foreword All technical contents of this Standard are mandatory. This Standard modifies and adopts ISO 8637.2004 “Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators”. This Standard replaces YY 0053-1991 “Hollow-fiber dialyzer”. Differences between this Standard and YY 0053-1991. - Add haemodiafilters, haemofilters, and haemoconcentrators according to the application scope of international standards, so as to broaden the application scope of this Standard; - Add project indicators for multiple use of haemodialysers according to relevant content of international standards, so as to make this Standard not to be limited to the range of single use; - Add biological evaluation to conduct inspection by use of prevailing domestic methods and projects according to the content of the relevant international standards and national regulations, so as to suit Chinese national conditions; - In use performance, modify the decline rate of creatinine and urea TO the clearance-rate of creatinine, urea, vitamin B12 and phosphate; add inspection items for screening factors of haemodiafilters, haemofilters and haemoconcentrators; specify the screening factors for albumin, myoglobin and inulin; - Provide multiple test plans in test methods for the user. Appendix A and Appendix B of this Standard are informative. This Standard was proposed by State Food and Drug Administration. This Standard shall be under the jurisdiction of National Technical Committee of Standardization for Medical Cardiopulmonary Bypass Equipment. The drafting organization of this Standard. Guangdong Medical Devices Quality Surveillance and Test Institute of State Food and Drug Administration. Main drafters of this Standard. He Xiaofan, Wu Jingbiao and Zhou Ying. Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators 1 Scope This Standard specifies the technical requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, which are used in human body. “Devices” in this Standard refer to these products. This Standard is not applicable to. - Extracorporeal blood line; - Plasma separator; - Blood perfusion apparatus; - Vascular access device; - Blood pump; - Pressure monitor of extracorporeal blood line; - Air monitor; - Dialysate preparation, supply and monitoring system; - System used for hemodialysis, hemofiltration or hemodiafiltration; - Further processing steps and equipment. Note. Requirements for extracorporeal blood lines of haemodialysers, haemodiafilters and haemofilters shall comply with provisions in YY 0267. 2 Normative references The following standards contain the provisions which, through reference in this Standard, constitute the provisions of this Standard. For dated references, subsequent amendments (excluding corrections) or revisions do not apply to this Standard. However, the parties who enter into agreement based on this Standard are encouraged to investigate whether the latest versions of these documents are applicable. For undated reference documents, the latest versions apply to this Standard. GB/T 1962.2-2001 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2. Lock fittings (GB/T 1962.2-2001, ISO 594-2.1998, IDT) GB/T 2828.1 Sampling procedures for inspection by attributes - Part 1. Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (GB/T 2828.1-2003, ISO 2859-1.1999, IDT) GB/T 14233.1 Test methods for infusion transfusion injection equipment for medical use - Part 1. Chemical analysis methods GB/T 14437-1997 Single sampling procedures and tables by attributes (suitable for large amount) GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing within a risk management process (idt ISO 10993- 1.1997) GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4. Selection of tests for interactions with blood (ISO 10993-4.2002, IDT) GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. Test for in vitro cytotoxicity (ISO 10993-5.1999, IDT) GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals (idt ISO 10993-5.1995) GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. Tests for irritation and delayed-type hypersensitivity (ISO 10993-10.2002, IDT) GB/T 16886.11-1997 Biological evaluation of medical devices - Part 11. Tests for systemic toxicity (idt ISO 10993-11.1993) YY 0267-2008 Cardiovascular implants and artificial organs - Extracorporeal blood circuit for blood purification devices YY 0466-2003 Medical devices - Symbols to be used with medical device labels labelling and information to be supplied (YY 0466-2003, ISO 15223.2000, IDT) The Pharmacopoeia of the People's Republic of China solution, collected air, and equipment pollution caused by impurities, algae and bacteria. 4.2 Biological evaluation Conduct biological evaluation on the part which is directly or indirectly in contact with patient’s blood of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators according to provisions in GB/T 16886.1, GB/T 16886.4, GB/T 16886.5, GB/T 16886.10 and GB/T 16886.11. 4.2.1 Residual ethylene oxide Conduct inspection according to the analysis method of residual ethylene oxide in GB/T 14233.1; it shall be ≤ 10 mg/kg. 4.3 Sterility 4.3.1 Conduct according to the provisions in Pharmacopoeia of People's Republic of China and provisions in 3.2. Note. This method is not suitable for exit-factory inspection. 4.3.2 Appropriate sterilization methods are shown in Appendix B. 4.4 Pyrogen free Evaluate the pyrogenicity of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators by appropriate test methods. Inspect according to the provisions in Pharmacopoeia of People's Republic of China and provisions in 3.3. 4.5 Mechanical performance 4.5.1 Structure adhesion 4.5.1.1 General principles Conduct according to the following test methods and requirements in 3.4.1. 4.5.1.2 Positive pressure test Fill the device with degassed distilled water. Place it at 37°C ± 1°C. Except the interfaces with pressure test equipment, all the interfaces shall be closed. Apply a positive pressure which is 1.5 times stipulated pressure by the manufacturer to the product, and close the test equipment. After 10 min, record the pressure value and visually check whether the product has leakage. 4.5.1.3 Negative pressure test Figure 5 Device schematic diagram of ultrafiltration rate or screening factor measurement of coil-type or hollow fiber haemodialysers, haemodiafilters, haemofilters and haemoconcentrators 4.6.4 Blood chamber capability For hollow-fiber dialyzer, calculate chamber volume according to dialyzer size and the number of fiber bundles. If there are significant changes in the size of the known film after contacting with the solution, it shall use the following test methods. As another choice, use a solution that is easy to be extracted but does not go through the film to fill the blood chamber. Measure solution volume fulfilled in the blood chamber. Measure under the given scope of transmembrane pressure. If there is no change in blood chamber volume, it shall be acceptable to inspect under one single pressure. 4.6.5 Pressure drop 4.6.5.1 Pressure drop of blood chamber 4.6.5.1.1 General principles Conduct inspection according to the following test methods and requirements in 3.5.5.1. 4.6.5.1.2 Test solution Use anticoagulated bovine plasma of which the protein concentration is 60 g/L ± 5 g/L as test solution or solution of similar viscosity to fill the blood chamber. Use general dialysate to fill dialysate chamber or filtrate chamber. 4.6.5.1.3 Test steps Adjust blood flow rate, read pressure value of blood chamber entrance, and calculate pressure drop. Repeat the inspection according to the scope of blood flow rate provided by the manufacturer. For flat-plate dialyzer, adjust dialysate flow rate. And it is necessary to detect pressure and blood flow rate. 4.6.5.2 Pressure drop of dialysate compartment 4.6.5.2.1 Test solution Use general dialysate as test solution to fill the dialysate compartment. Use bovine plasma to fill th... ......

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