YY/T 0636.3-2021 English PDF

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YY/T 0636.3-2021: Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
Status: Valid

YY/T 0636.3: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0636.3-2021	559	Add to Cart	5 days	Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source	Valid
YY 0636.3-2008	719	Add to Cart	4 days	Medical suction equipment. Part 3: Suction equipment powered from a vacuum or pressure source	Obsolete

Similar standards

YY/T 0636.1   YY 0671.1   YY 0600.1   YY/T 0486   YY/T 0339   YY/T 0636.2   

Basic data

Standard ID: YY/T 0636.3-2021 (YY/T0636.3-2021)
Description (Translated English): Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C46
Word Count Estimation: 30,333
Issuing agency(ies): State Drug Administration

YY/T 0636.3-2021: Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical suction equipment - Part 3.Suction equipment powered from a vacuum or possitive pressure gas source ICS 11.040.10 C46 People's Republic of China Pharmaceutical Industry Standards Replace YY 0636.3-2008 Medical suction equipment part 3. Suction equipment powered by vacuum or positive pressure source (ISO 10079-3.2014,MOD) Released on 2021-03-09 2023-05-01 implementation Issued by the State Drug Administration

Table of contents

Foreword Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 General requirements 4 4.1 Risk Management 4 4.2 Availability 5 4.3 Clinical investigation 5 4.4 Biophysics or model research 5 4.5 General Electric Safety 5 5 Cleaning, disinfection and sterilization 5 6 Design requirements 5 6.1 Collection container 5 6.2 Connection 6 6.3 Suction pipeline 6 6.4 Negative pressure indicator 6 6.5 Supply connection 7 7 Operation requirements 7 7.1 Easy to operate 7 7.2 Disassembly and reassembly 7 7.3 Mechanical shock 7 7.4 Stability 7 7.5 Guard 8 7.6 Noise 8 7.7 Air leakage 8 8 Physical requirements for suction equipment used in the field and/or transport 9 8.1 *Size 9 8.2 Quality 9 9 Performance requirements for negative pressure value and flow rate 9 9.1 High negative pressure/high flow equipment 9 9.2 Medium and negative pressure equipment 9 9.3 Low negative pressure/low flow equipment 9 9.4 Low negative pressure/high flow equipment 9 9.5 Adult thoracic drainage device 10 9.6 Intermittent negative pressure equipment 10 9.7 Fixed negative pressure regulator 10 9.8 Negative pressure regulator with variable settings 10 9.9 Equipment for pharyngeal suction 10 10 *Environmental tolerance of suction equipment used in the field and/or transport 10 10.1 Working conditions 10 10.2 Storage 10 11 Mark 11 11.1 Use of symbols 11 11.2 Equipment 11 11.3 Equipment or carrying case 11 12 Information provided by the manufacturer 12 Appendix A (informative appendix) Schematic diagram of suction equipment 13 Appendix B (Normative Appendix) Test Method 14 Appendix C (Informative Appendix) Basic Principles 23 Appendix D (informative appendix) Lumen size and its effect on flow 24 References 25

Foreword

The "Medical Suction Equipment" series of standards is divided into three parts. ---Part 1.Electric attraction equipment; ---Part 2.Manually driven suction equipment; ---Part 3.Suction equipment powered by vacuum or positive pressure source. This part is part 3. This section was drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces YY 0636.3-2008 "Medical Suction Equipment Part 3.Suction Equipment Powered by Vacuum or Positive Pressure Source". Compared with YY 0636.3-2008, the technical changes except for editorial changes are as follows. ---Modified the requirements of "Scope", moved "Figure 1 Schematic Diagram of Suction Equipment" to Appendix A, deleted equipment that is not applicable to this section, (see Chapter 1 and Appendix A, Chapter 1 of the.2008 edition); ---Modified the normative reference documents (see Chapter 2, Chapter 2 of the.2008 edition); ---Added protection terms and definitions (see Chapter 3); ---Added the "General Requirements" requirements and test methods (see Chapter 4); ---Added the "stability" requirement (see 7.4); ---Added the requirement of "pollution protection device" (see 7.5.1); ---Added the requirements and test methods for "intermittent negative pressure equipment" (see 9.6 and Appendix B.13); ---Added the "Use of Symbols" requirement (see 11.1); ---Added appendixes of "Basic Principles" and "Lumen Size and Its Influence on Flow" (see Appendix C and Appendix D) --- Amended the "cleaning, disinfection and sterilization" requirements (see Chapter 5, Chapter 4 of the.2008 edition); ---Modified the "collection container" requirements (see 6.1, 6.2.1, 6.2.2 and Appendix B.3, 5.1 in the.2008 edition); ---Modified the requirements and test methods of "pressure protection" (see 7.5.3, appendix B.6 and B.7, the.2008 edition of 6.5.1, 6.5.3, A.8 And A.9); ---Modified the requirements and test methods of "high negative pressure/high flow equipment" (see 9.1 and Appendix B.10,.2008 edition of 8.2 and A. 12); ---Modified the requirements and test methods of "medium negative pressure equipment" (see 9.2 and Appendix B.10, 8.3 and A.12 of the.2008 edition); ---Modified the requirements and test methods of "Equipment for Pharyngeal Suction" (see 9.9 and Appendix B.16,.2008 edition of 8.4, A.12 And A.13); ---Modified the requirements and test methods of "Adult Thoracic Drainage Device" (see 9.5 and Appendix B.12, 8.7 and A.15 of the.2008 edition); ---Modified the test equipment requirements of "Variable Setting Negative Pressure Regulator" (see Appendix B.15,.2008 edition of A.17); ---Modified the test requirements of "Environmental tolerance of suction equipment used in the field and/or transport" (see Chapter 10, Appendix B.17.2.2, B.17.2.3 and B.17.2.4, Chapter 11, A.18.2.2, A.18.2.3 and A.18.2.4 of the.2008 edition); ---Modified the "equipment" requirements (see 11.2, 12.1 of the.2008 edition); ---Modified the requirements of "equipment or carrying case" (see 11.3, 12.2 of the.2008 edition); ---Modified the requirements of "Information provided by the manufacturer" (see Chapter 12, Chapter 13 of the.2008 edition) --- Deleted the "terminal piece" requirement (see 5.3 of the.2008 edition) --- Deleted the "liquid spilling" requirement (see 6.2 and A.5 of the.2008 edition); --- Deleted the "filter components", "electrical protection" and "immersion" requirements (see the.2008 edition of 6.5.2, 6.5.4 and 6.9); --- Deleted the "Overview" part (see 8.1 in the.2008 edition); --- Deleted the "gas source" requirement (see Chapter 9 of the.2008 edition); This part uses the redrafting law to amend and adopt the international standard ISO 10079-3.2014 "Medical suction equipment Part 3.Vacuum or Suction equipment powered by a positive pressure source". Comparing this part with ISO 10079-3.2014, the main differences are as follows. ---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments. The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows. ● Replace ISO 3744 with GB/T 3767 which is equivalent to adopting international standards (see Appendix B.7); ● Replace IEC 61672-1 (see Appendix B.7) with GB/T 3785.1 which is equivalent to adopting international standards; ● Replace IEC 60601-1.2005 A1.2012 with GB 9706.1 which is modified to adopt international standards (see Chapter 4 and 6.5); ● Replace ISO 7000 with non-equivalent adopting international standard GB/T 16273.1 (see 11.1); ● Replace ISO 14155 (see 4.3) with YY/T 0297 which is equivalent to adopting international standards; ● Replace ISO 14971 with YY/T 0316 which is equivalent to the international standard (see 4.1.2); ● Replace ISO 15223-1 (see 11.21) with YY/T 0466.1 equivalent to the international standard; ● Replace ISO 5359 with YY/T 0799 which is modified to adopt international standards (see 6.5) ● Replace ISO 5356-1 (see 6.2.2) with YY/T 1040.1 which is equivalent to the international standard; ● Replace IEC 62366 with YY/T 1474 which is equivalent to adopting international standards (see 4.2); ● Replace IEC 60601-1-6 (see 4.2) with YY/T 9706.106 modified to adopt international standards. Compared with ISO 10079-3.2014, this part has made the following editorial changes. --- Deleted the foreword of ISO 10079-3.2014, and added the foreword of this part; ---Adjust the suspension section before 4.1 to "General Electric Safety" (see 4.5); ---The limit requirement of "and within 2min" has been added, which is consistent with Appendix B.2.1 (see 7.5.2); ---Fixed the editorial errors in 9.6, and added the negative pressure value "deviation" and frequency "deviation" (see 9.6); --- 11.2a) added "if applicable", 11.2d) deleted the "suffixed with "LOT"" limit requirements (see 11.2); ---Fixed the editorial errors, according to the requirements of 6.1.3, change the "negative pressure value not exceeding 95kPa" to "negative pressure value 95kPa" (see appendix B.3); ---Editing errors were corrected, and "A >0.5" was changed to "A≥0.5" as required in 6.3.1 (see Appendix B.4); ---Editing errors were corrected, and the "negative pressure source" was changed to "positive pressure source" according to the requirements of 7.5.3.2 (see Appendix B.6); ---Fixed the editorial errors in Figure B.8, and changed "45kPa to 85kPa" to "50kPa to 90kPa" (see appendix B.15); ---Adjust appendix D to appendix A, appendix A, appendix B and appendix C to appendix B, appendix C and appendix D (see Appendix A, Appendix B, Appendix C and Appendix D). Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This part was proposed by the State Drug Administration. This part is under the jurisdiction of the National Anesthesia and Respiratory Equipment Standardization Technical Committee (SAC/TC116). Drafting organizations of this section. Shanghai Medical Device Testing Institute, Shanghai Baojia Medical Device Co., Ltd., Jie Rui Enterprise (Shanghai) Co., Ltd. The main drafters of this section. Wang Wei, Li Guihua, Hu Yuegang, Yu Hongyi, Zhang Yanfeng, Zhu Yanzhen, Shao Guoliang, Fu Guoqing. The previous releases of the standards replaced by this part are as follows. ---YY 0636.3-2008. Medical suction equipment part 3. Suction equipment powered by vacuum or positive pressure source

1 Scope

This part of YY/T 0636 specifies the safety and performance requirements for medical suction equipment driven by a vacuum or positive pressure source (Venturi suction). Including additional requirements for suction equipment used in the field and/or transport. This section applies to equipment connected to medical gas piping systems or gas cylinders and Venturi accessories. This equipment can be a stand-alone device or So it is part of the integrated system. Note. Appendix A illustrates the three parts of YY/T 0636 by providing a schematic diagram of a typical system. This section does not apply to. a) Central power system (generated by negative pressure/compressed air), piping systems of vehicles and buildings, and wall connectors; b) Suction catheter, Yankee suction tube and suction head and other end pieces; c) Syringe; d) Dental suction equipment; e) Anesthetic gas purification system; f) Laboratory attraction equipment; g) Autologous infusion system; h) Closed system for wound drainage; i) Mucus extractor, including neonatal mucus extractor; j) Cup suction equipment (for obstetrics); k) Breast pump; l) Fat suction equipment; m) Uterine suction equipment; n) Plume evacuation system.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 3767 Acoustic sound pressure method to determine the sound power level and sound energy level of noise sources. Engineering method for the approximate free field above the reflecting surface (GB/T 3767-2016, ISO 3744.2010, IDT) GB/T 3785.1 Electroacoustic Sound Level Meter Part 1.Specifications (GB/T 3785.1-2010, IEC 61672-1.2002, IDT) GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (GB 9706.1-2020, IEC 60601-1.2005 A1.2012,MOD) GB/T 16273.1 Graphical symbols for equipment Part 1.General symbols (GB/T 12673.1-2008, ISO 7000.2004, NEQ) YY/T 0297 Clinical Investigation of Medical Devices (YY/T 0297-1997, ISO 14155.1996, IDT) YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971.2007, IDT) YY/T 0466.1 Medical devices are used for medical device labeling, marking and providing information symbols. Part 1.General requirements ......

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