YY/T 0636.2-2021 English PDF

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YY/T 0636.2-2021: Medical suction equipment - Part 2: Manually powered suction equipment
Status: Valid

YY/T 0636.2: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0636.2-2021	409	Add to Cart	4 days	Medical suction equipment - Part 2: Manually powered suction equipment	Valid
YY 0636.2-2008	599	Add to Cart	3 days	Medical suction equipment. Part 2: Manually powered suction equipment	Obsolete

Similar standards

YY/T 0636.1   YY 0671.1   YY 0600.1   YY/T 0486   YY/T 0339   YY/T 0636.3   

Basic data

Standard ID: YY/T 0636.2-2021 (YY/T0636.2-2021)
Description (Translated English): Medical suction equipment - Part 2: Manually powered suction equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C46
Word Count Estimation: 22,246
Issuing agency(ies): State Drug Administration

YY/T 0636.2-2021: Medical suction equipment - Part 2: Manually powered suction equipment

---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 2.Manually powered suction equipment ICS 11.040.10 C46 People's Republic of China Pharmaceutical Industry Standards Replace YY 0636.2-2008 Medical suction equipment Part 2.Manually drive the suction device (ISO 10079-2.2014,MOD) Released on 2021-03-09 2022-04-01 implementation Issued by the National Medical Products Administration

Table of contents

Foreword Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 General requirements 3 4.1 Risk Management 3 4.2 Availability 3 4.3 Clinical investigation 3 4.4 Biophysics or model research 4 5 Cleaning, disinfection and sterilization 4 6 Design requirements 4 6.1 Collection container 4 6.2 Connection 4 6.3 Attraction pipeline 5 6.4 Negative pressure indicator 5 7 Operation requirements 5 7.1 Easy to operate 5 7.2 Disassembly and reassembly 5 7.3 Mechanical shock 5 7.4 Stability 6 7.5 Guard 6 7.6 Soaking 6 8 Physical requirements for attraction equipment used in the field and transport 6 8.1 *Size 6 8.2 Quality 6 9 Performance requirements for negative pressure value and flow rate 7 9.1 Negative pressure 7 9.2 Free air flow 7 9.3 Pharyngeal suction 7 10 *Environmental tolerance of suction equipment used in the field and/or transport 7 10.1 Working conditions 7 10.2 Storage 7 11 Mark 7 11.1 Use of symbols 7 11.2 Equipment 7 11.3 Equipment or carrying case 8 12 Information provided by the manufacturer 8 Appendix A (informative appendix) Schematic diagram of suction equipment 10 Appendix B (Normative Appendix) Test Method 11 Appendix C (informative appendix) Basic principles 15 Appendix D (informative appendix) Lumen size and its effect on flow 16 Reference 17

Foreword

YY/T 0636 "Medical Suction Equipment" 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 2 of YY/T 0636. This section was drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces YY 0636.2-2008 "Medical Suction Equipment Part 2.Manually Driven Suction Equipment". With YY 0636.2- Compared with.2008, the technical changes except for editorial changes are as follows. ---Modified "Scope", moved "Figure 1 Schematic Diagram of Suction Equipment" to Appendix A, and changed it to "Figure A.1 YY/T 0636 Covered Attraction Equipment diagram", delete the equipment that is not applicable to this part (see Chapter 1 and Appendix A, Chapter 1 of the.2008 edition) ---Modified the normative references (see Chapter 2); ---Add, modify and delete some terms and definitions (see Chapter 3); ---Added the "General Requirements" requirements and test methods (see Chapter 4); ---Added the requirement of "pollution protection device" (see 7.5.1); ---Added the requirement of "Lumen size and its effect on flow" (see Appendix D); --- Amended the "cleaning, disinfection and sterilization" requirements (see Chapter 5, Chapter 4 of the.2008 edition); ---Modified the "connection" requirement (see 6.2, 5.1 of the.2008 edition); ---Modified the "easy to operate" requirements (see 7.1, 6.1 of the.2008 edition); ---Modified the requirements of "mechanical shock" (see 7.3, 6.3 of the.2008 edition); --- Modify the "stability" requirements (see 7.4, 6.5 in the.2008 edition); ---Modified "Environmental tolerance of suction equipment used in the field and/or transportation" (see Chapter 10, Appendix B.10.2.1~B.10.2.4, Chapter 9 of the.2008 edition and the requirements of A.9.2.1~A.9.2.4); ---Modified the requirements of "Use of Symbols", "Equipment" and "Equipment or Carrying Case" (see Chapter 11, Chapter 10 of the.2008 edition); ---Modified the "information provided by the manufacturer" requirements (see Chapter 12, Chapter 11 of the.2008 edition); --- Deleted the "terminal piece" requirement (see 5.3 of the.2008 edition); --- Deleted the "special collection container volume typical range table" (see Appendix B of the.2008 edition); This part uses the redrafting law to modify and adopt the international standard ISO 10079-2.2014 "Medical suction equipment Part 2.Manual drive Attracting equipment. Compared with ISO 10079-2.2014, the main differences and reasons for this part 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 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 (see 4.1.2) with YY/T 0316-2016 which is equivalent to adopting international standards; ● Replace ISO 15223-1 (see 11.1) with YY/T 0466.1-2009, which is equivalent to the international standard; ● Replace ISO 5356-1 (see 6.2.2) with YY/T 1040.1-2015 which is equivalent to adopting international standards; ● Replace IEC 62366 (see 4.2) with YY/T 1474-2016 which is equivalent to adopting international standards; Compared with ISO 10079-2.2014, this part has made the following editorial changes. --- Deleted the "labeled'LOT'" limit requirements [see 11.2d)]; ---Fixed the editorial errors. According to the requirements of 6.1.3, the "negative pressure value does not exceed 95kPa" is changed to "the negative pressure value 95kPa" (see B.3); --- Editing errors have been revised. According to the requirements of 6.1.3, "A >0.5" was changed to "A≥0.5" (see B.4). 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. The main drafters of this section. Yu Hongyi, Li Guihua, Wang Wei, Zhang Yanfeng, Fu Guoqing, Shao Guoliang. The previous releases of the standards replaced by this part are as follows. ---WS2-173-1973; ---YY 0101-1993; ---YY 0636.2-2008. Medical suction equipment Part 2.Manually drive the suction device

1 Scope

This part of YY/T 0636 specifies the safety and performance requirements of manually driven suction equipment used for pharynx suction. This part of YY/T 0636 applies to equipment that is operated by foot pedal, manual operation or both. Appendix A provides an example of a typical system The figure illustrates the three parts of YY/T 0636. Artificially driven suction equipment is usually used outside of medical and health care institutions, and is often described as field use or transportation use. Use in these situations may involve extreme weather or terrain conditions. YY/T 0636 This part also includes Additional requirements for the suction equipment for the loss. This part of YY/T 0636 does not apply to the following content. a) Suction catheter, Yankee suction tube and suction head and other end pieces; b) Dental suction equipment; c) Mucus extractor, including neonatal mucus extractor.

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 16273.1 Graphical symbols for equipment Part 1.General symbols (GB/T 16273.1-2008, 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 (YY/T 0466.1-2016,ISO 15223-1.2012,IDT) YY/T 1040.1 Cone joints for anesthesia and respiratory equipment Part 1.Cone head and cone sleeve (YY/T 1040.1-2015, ISO 5356-1.2004, IDT) YY/T 1474 Application of medical device usability engineering to medical devices (YY/T 1474-2016, IEC 62366.2007, IDT) ISO 80369 (all parts) Small bore connectors for medical liquids and gases (Smal-boreconnectorsforliquidsand gasesinhealthcareapplications) EN1041 Information provided by the manufacturer of medical devices (Informationsuppliedbythemanufacturerofmedicalde- vices)

3 Terms and definitions

The following terms and definitions apply to this document. ......

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