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 equi...