YY/T 0636.1-2021Medical suction equipment - Part 1: Electrically powered suction equipment (English PDF)

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.

lambda GB/T 3767, which equivalently adopts international standard, is used to replace

ISO 3744 (see A.7);

lambda GB/T 3785.1, which equivalently adopts international standard, is used to replace

IEC 61672-1 (see A.7);

lambda GB/T 4208, which equivalently adopts international standard, is used to replace

IEC 60529 (see 6.5);

lambda GB 9706.1-2020, which modifies and adopts international standard, is used to replace IEC 60601-1:2005 + A1.2012 (see Chapter 4 and 6.5);

lambda GB/T 16273.1, which non-equivalently adopts international standard, is used to replace ISO 7000 (see 11.1);

lambda YY/T 0297, which equivalently adopts international standard, is used to replace

ISO 14155 (see 4.3);

lambda YY/T 0316, which equivalently adopts international standard, is used to replace

ISO 14971 (see 4.1.2);

lambda YY/T 0466.1, which equivalently adopts international standard, is used to replace

ISO 15223-1 (see 11.1);

lambda YY/T 1040.1, which equivalently adopts international standard, is used to replace

ISO 5356-1 (see 6.2.2);

lambda YY/T 1474, which equivalently adopts international standard, is used to replace

IEC 62366 (see 4.2);

lambda YY/T 9706.106, which modifies and adopts international standard, is used to replace IEC 60601-1-6:2010 (see 4.2);

lambda YY 9706.111-2021, which modifies and adopts international standard, is used to replace IEC 60601-1-11:2010 (see 6.5);

lambda YY 9706.112-2021, which modifies and adopts international standard, is used to replace IEC 60601-1-12:2014 (see 6.5).

In comparison with ISO 10079-1:2015 + AMD1.2018, this Part makes the following editorial modifications.

---The suspended paragraph before 4.1 is adjusted into "general electrical safety" (see 4.5);

---The editorial error in 9.6 is modified; the "deviation" of vacuum level and the "deviation" of frequency are added (see 9.6);

---11.1 and 11.2 are combined into "use of symbols" (see 11.1);

---"if applicable" is added [see 11.2 a)];

---"or equivalent mark" is added [see 11.2 c)];

---The restricting requirement of "prefixed with 'LOT'" is deleted [see 11.2 d)];

---The editorial error is modified; in accordance with the requirements of 6.1.3, "vacuum level does not exceed 95 kPa" is modified into "vacuum level 95 kPa" (see A.3);

---The editorial error is modified; in accordance with the requirements of 6.3.1, "A > 0.5" is modified into "A >= 0.5" (see A.4);

---The editorial error is modified; in accordance with the requirements of 7.5.3.2, "vacuum source" is modified into "positive pressure source" (see A.6);

---The editorial error in Figure A.8 is modified; "45 kPa to 85 kPa" is modified into "50 kPa to 90 kPa" (see A.14).

Please be noted that certain content of this document might involve patents. The institution issuing this document shall not undertake the responsibility of identifying these patents.

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.

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.

3 Terms and Definitions

The following terms and definitions are applicable to this document.

Free air flowrate refers to unrestricted airflow through a designated inlet port.

Low flowrate refers to a free air flowrate (3.7) smaller than 20 L/min.

4 General Requirements

In accordance with YY/T 9706.106 and YY/T 1474, the manufacturer shall describe the usability engineering process and the risks associated with poor usability.

If the same level of safety is obtained, the manufacturer may use a different type test than the type described in this Part. Alternative test methods shall be validated in accordance with the test method specified in Appendix A.

5 Cleaning, Disinfection and Sterilization

Where applicable, parts of the suction equipment that may be contaminated shall be disposable, or be cleaned, disinfected or sterilized. These parts include filters, suction tubing and collection containers.

6 Design Requirements

If applicable, at 120% of the maximum vacuum level recommended by the manufacturer or 95 kPa below the atmospheric pressure (whichever is smaller), after 5 min, the collection container shall not implode, rupture or permanently deform, and shall comply with the requirements of Chapter 7 and Chapter 9.

7 Operational Requirements

If the suction equipment can be operated outside its carrying case, the various parts of the suction equipment shall be subject to the drop test and reassembled in accordance with the above-mentioned requirements. If applicable, the reassembled suction equipment shall comply with the relevant requirements of Chapter 9.

8 Physical Requirements for Suction Equipment for Field Use

The mass of the suction equipment intended for field use, including its carrying case or stand, and accessories, shall not exceed 6 kg.

9 Performance Requirements for Vacuum Level and Flowrate

The suction equipment marked with "low vacuum / low flowrate" shall generate a vacuum level of not greater than 20 kPa. When being set at the maximum vacuum level recommended by the manufacturer, the continuous free air flowrate shall be less than 20 L/min.