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YY/T 0636.1-2021 English PDF (YYT0636.1-2021)

YY/T 0636.1-2021 English PDF (YYT0636.1-2021)

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YY/T 0636.1-2021: Medical suction equipment -- Part 1: Electrically powered suction equipment

YY/T 0636.1-2021
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.10
C 46
Replacing YY 0636.1-2008
Medical Suction Equipment - Part 1: Electrically Powered
Suction Equipment
(ISO 10079-1:2015, MOD)
ISSUED ON: MARCH 9, 2021
IMPLEMENTED ON: MAY 1, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 4
1 Scope ... 8
2 Normative References ... 8
3 Terms and Definitions ... 10
4 General Requirements ... 12
4.1 Risk Management ... 12
4.2 Usability ... 13
4.3 Clinical Investigation ... 13
4.4 Biophysical or Modeling Research ... 14
4.5 General Electrical Safety ... 14
4.6 Test Methods ... 14
5 Cleaning, Disinfection and Sterilization ... 14
6 Design Requirements ... 14
6.1 Collection Container ... 14
6.2 Connections ... 15
6.3 Suction Tubing ... 16
6.4 Vacuum Level Indicators ... 16
6.5 Spillage on Electrically Powered Suction Equipment ... 17
7 Operational Requirements ... 17
7.1 Ease of Operation ... 17
7.2 Dismantling and Reassembly ... 17
7.3 Mechanical Shock ... 17
7.4 Stability ... 18
7.5 Protective Devices ... 18
7.6 Noise ... 19
7.7 Air Leakage ... 19
8 Physical Requirements for Suction Equipment for Field Use ... 20
8.1 * Dimensions ... 20
8.2 Mass ... 20
9 Performance Requirements for Vacuum Level and Flowrate ... 20
9.1 High Vacuum / High Flowrate Equipment ... 20
9.2 Medium Vacuum Equipment ... 20
9.3 Low Vacuum / Low Flowrate Equipment ... 21
9.4 Low Vacuum / High Flowrate Equipment ... 21
9.5 Thoracic Drainage Equipment for Adults ... 21
9.6 Intermittent Vacuum Equipment ... 21
9.7 Vacuum Regulators with Fixed Setting ... 22
9.8 Vacuum Regulators with Variable Setting ... 22
9.9 Equipment Intended for Pharyngeal Suction ... 22
9.10 Battery Powered Transportable Suction Equipment ... 22
9.11 Interruption of Power Supply ... 22
10 * Environmental Tolerance of Suction Equipment for Field and / or Transport Use ... 23
10.1 Operating Conditions ... 23
10.2 Storage ... 23
11 Information Provided by the Manufacturer (labeling and instructions for use) ... 23 11.1 Use of Symbols ... 23
11.2 Equipment Labeling ... 23
11.3 Instructions for Use ... 25
Appendix A (normative) Test Methods ... 27
Appendix B (informative) Rationale Statement ... 39
Appendix C (informative) Lumen Size and Its Effect on Flowrate ... 40
Appendix D (informative) Schematic Diagram of Suction Equipment ... 41 Bibliography ... 42
Foreword
The series standard Medical Suction Equipment is divided into three parts: ---Part 1: Electrically Powered Suction Equipment;
---Part 2: Manually Powered Suction Equipment;
---Part 3: Suction Equipment Powered from a Vacuum or Positive Pressure Gas Source. This is Part 1.
This Part was drafted in accordance with the rules provided in GB/T 1.1-2009. This Part serves as a replacement of YY 0636.1-2008 Medical Suction Equipment - Part 1: Electrically Powered Suction Equipment - Safety Requirements. In comparison with YY 0636.1-2008, apart from editorial modifications, the main technical changes are as follows: ---Some chapters and clauses based on GB 9706.1 are deleted; the structure of the standard is adjusted.
---The requirements for “Scope” are modified; the description of the relations between YY 0636.1 and GB 9706.1 is deleted; “Figure 1 -- Schematic Diagram of Suction Equipment” is moved to Appendix D; equipment inapplicable to this Part is deleted (see Chapter 1 and Appendix D; Chapter 1 of Version 2008);
---“Normative References” is modified (see Chapter 2; Chapter 2 of Version 2008); ---Some terms and definitions are added, modified and deleted (see Chapter 3; Chapter 3 of Version 2008);
---The requirements for “general requirements” are added (see Chapter 4); ---The requirements for “spillage on electrical suction equipment” are added (see 6.5); ---The requirements for “ease of operation” are added (see 7.1);
---The requirements and test methods for “low vacuum / high flowrate equipment” are added (see 9.4 and A.10);
---The requirements and test methods for “intermittent vacuum equipment” are added (see 9.6 and A.12);
---The requirements and test methods for “vacuum regulators with fixed setting” are added (see 9.7 and A.13);
---The requirements and test methods for “vacuum regulators with variable setting” are added (see 9.8 and A.14);
---The appendixes of “test methods” and “rationale statement” are added (see Appendix A and Appendix B);
---The requirements for “labeling of equipment” and “instructions for use” are modified (see 11.2 and 11.3; Chapter 6 of Version 2008);
---The requirements for “stability” are modified (see 7.4; 10.4 of Version 2008); ---The requirements for “vacuum level indicators” are modified (see 6.4; 56.8 in 16.3 of Version 2008);
---The requirements for “inlet port” are modified (see 6.2.2; 56.12 in 16.3 of Version 2008); ---The requirements and test methods for “high vacuum / high flowrate equipment” are modified (see 9.1 and A.9; 59.5 in 16.6 of Version 2008);
---The requirements and test methods for “medium vacuum equipment” are modified (see 9.2 and A.9; 59.6 in 16.6 of Version 2008);
---The requirements for “collection container” are modified (see 6.1 and A.2; 59.11 in 16.6 of Version 2008);
---The requirements for “thoracic drainage equipment for adults” are modified (see 9.5; 59.8 in 16.6 of Version 2008);
---“over-temperature”, “fire protection”, “pressure vessel and pressurized parts”, “electrostatic charge”, “material of applied parts in contact with patient’s body”, “accuracy of working data and prevention of hazardous output” and “abnormal operational and fault condition: environmental tests” are deleted (see Chapter 13 ~ Chapter 15 of Version 2008);
---Appendix A ~ Appendix L, Appendix N and Appendix P, which are based on GB 9706.1, are deleted (see Appendix A ~ Appendix L, Appendix N and Appendix P of Version 2008).
This Part adopts the re-drafting method in the modification and adoption of international standard ISO 10079-1:2015 + AMD1: 2018 Medical Suction Equipment - Part 1: Electrically Powered Suction Equipment.
In comparison with ISO 10079-1:2015 + AMD1: 2018, the main differences are as follows: ---In terms of Normative References, this Part makes adjustments with technical differences to adapt to the technical conditions of China. The adjustments are intensively reflected in Chapter 2 “Normative References”. See the specific adjustments below:
 GB/T 3767, which equivalently adopts international standard, is used to replace ISO 3744 (see A.7);
Medical Suction Equipment - Part 1: Electrically Powered
Suction Equipment
1 Scope
This Part of YY/T 0636 specifies the safety and performance requirements for electrically powered medical and surgical suction equipment.
This Part applies to equipment used for healthcare facilities, for example, hospitals, as well as patients’ homecare, and in the field and transport.
This Part does not apply to:
a) Central power systems (generated by vacuum / compressed air), piping systems of vehicles and buildings, and wall connectors;
b) End-pieces, such as: suction catheters, drains, curettes, Yankauer suckers and suction tips;
c) Syringes;
d) Dental suction equipment;
e) Anesthetic gas purification system;
f) Laboratory suction equipment;
g) Auto-transfusion systems;
h) Mucus extractors, including neonatal mucus extractors;
i) Suction equipment with collection containers located downstream of the vacuum pump;
j) Ventouse equipment (for obstetric use);
k) Suction equipment marked for endoscopy only;
l) Plume evacuation systems.
2 Normative References
The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document.
GB/T 3767 Acoustics - Determination of Sound Power Levels and Sound Energy Levels of Noise Sources Using Sound Pressure - Engineering Methods for an Essentially Free Field over a Reflecting Plane (GB/T 3767-2016, ISO 3744:2010, IDT)
GB/T 3785.1 Electroacoustics - Sound Level Meters - Part 1: Specifications (GB/T 3785.1- 2010, IEC 61672-1:2002, IDT)
GB/T 4208 Degrees of Protection Provided by Enclosure (IP code) (GB/T 4208-2017, IEC 60529:2013, IDT)
GB 9706.1-2020 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005 + A1:2012, MOD)
GB/T 16273.1 Graphical Symbols for Use on Equipment - Part 1: Common 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 Medical Devices - Application of Risk Management to Medical Devices (YY/T 0316-2016, ISO 14971:2007, IDT)
YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels, Labeling and Information to be Supplied - Part 1: General Requirements (YY/T 0466.1-2016, ISO 15223-1:2012, IDT)
YY/T 1040.1 Anesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets (YY/T 1040.1-2015, ISO 5356-1:2004, IDT)
YY/T 1474 Medical Devices - Application of Risk Management to Medical Devices (YY/T 1474-2016, IEC 62366:2007, IDT)
YY/T 9706.106 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability (YY/T 9706.106-2021, IEC 60601-1-6: 2013, MOD)
YY 9706.111-2021 Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment (IEC 60601-1-11:2015, MOD)
YY 9706.112-2021 Medical Electrical Equipment - Part 1-12: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Intended for Use in the Emergency Medical Services Environment (IEC 60601-1-12:2014, MOD)
IEC/TR 60878 Graphical Symbols for Electrical Equipment in Medical Practice ISO 80369 (all parts) Small-bore Connectors for Liquids and Gases in Healthcare Applications EN 1041 Information Supplied by the Manufacturer of Medical Devices
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 Collection Container
Collection container refers to a container for collecting liquids and solid particles. 3.2 Drainage
Drainage refers to the discharge of liquids, solid particles or gases from body cavities or wounds. 3.3 End-piece
End-piece refers to a part that is applied to the patient’s suction equipment, starting at the location of the inhaled substance and ending at the first detachable connection. NOTE: for example, the commonly used end-pieces are Yankauer suckers and suction catheters. 3.4 Exhaust Port
Exhaust port refers to an opening, through which, the exhaust gas is discharged. 3.5 Field Use
Field use refers to the use of suction equipment outside healthcare facilities and household environments.
3.6 Filter
Filter refers to a device that retains particulate matters.
3.7 Free Air Flowrate
Free air flowrate refers to unrestricted airflow through a designated inlet port. 3.8 High Flowrate
High flowrate refers to a free air flowrate (3.7) greater than or equal to 20 L/min. 3.9 High Vacuum
High vacuum refers to a vacuum level (3.23) greater than or equal to 60 kPa.

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