YY/T 1804-2021Anaesthetic and respiratory equipment-Spirometers intended for the measurement of time forced expired volumes in humans (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard uses the redrafted method to modify and adopts ISO 26782:2009 "Anesthesia and Respiratory Equipment for Measuring Human Time Forced Exhalation" Quantitative Spirometer.

The technical differences between this standard and ISO 26782:2009 and their reasons are as follows.

--- Regarding normative reference documents, this standard has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment.

The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows.

- Replacing IEC 60601-1:2005 with GB 9706.1-2020 modified to adopt international standards (see 4.1, 4.2, 8.1);

- Replace ISO 14937 with GB/T 19974 which is equivalent to adopting international standards (see 9.3);

- Replace ISO 10993-1 (see Chapter 10) with GB/T 16886.1 which is equivalent to adopting international standards.

--- Air flow direction indication of user-removable components sensitive to air flow direction, changed from "need to use arrow to indicate air flow direction" "There shall be an indication of the direction of airflow" [see 5.4.1a)]. This standard has made the following editorial changes.

Respiratory Society)", add "Respiratory Branch of Chinese Medical Association", and add references to Appendix D and Appendix E content;

---In 5.5.1a) "Note. In some countries, when the manufacturer does not have a local commercial registration, it is required to provide the name of the local authorized agent. name and address. "Revised" Note. When the manufacturer has no commercial registration in China, it is required to provide the name and address. ";

--- For editorial errors in ISO 26782:2009, this standard has been modified as follows.

- In the description of Figure A.1, "2---t0=0.75s" is changed to "2---t0=0.075s";

- In B.4.5, "n---Defined test waveform number (1~15)" is changed to "n---Defined test waveform number (1~13)";

- The first paragraph in Appendix C "Table C.1 contains the number of 10 test waveforms used to test the definition of the performance of the spirometer in Appendix B. "Spirometer" is replaced by "Table C.1 contains the mathematics of the 13 test waveforms used to test the definition of spirometer performance in Appendix B. expression".

Introduction

A spirometer is a medical device used to record physiological lung volumes within the spirometric range.

The volume of air that a patient can exhale within a certain period of time after maximal inspiration is a reliable method for evaluating lung function. Spirometry assessment It is used to screen individuals at risk for lung disease, to make objective measurements in the presence of lung disease, to assess symptoms and preoperative risk, and to document the efficacy of therapeutic interventions. fruit. Spirometers can also be used to evaluate lung disability, public health, and clinical trials.

Society) and the Chinese Society of Respiratory Medicine have played an important role in the standardization of pulmonary function tests including pulmonary function guidelines[6],[7] big effect. But so far there is no national spirometry standard to regulate the accuracy and repeatability of spirometry. Such standards are based on the customer A conceptual test method based on testing a series of carefully selected, well-defined test waveforms (such as those issued by ATS) tolerance.

The development of this standard solves this problem, allowing the spirometers used by clinicians to achieve accuracy, repeatability, electrical safety, etc. recognized standard.

The minimum safety requirements specified in this standard are for the purpose of using spirometers to ensure safety to a practical level. The relevant test specifications are given immediately following the requirements.

For some important requirements, see the rationale notes provided in the "Rationale" section in Appendix A. Learn about making these requests The reasons for this will not only facilitate the proper application of this standard, but will, in due course, be driven by changes in clinical practice or technological developments.

Push version revisions. However, this appendix is not a normative requirement of this standard.

In this standard, refer to the provisions providing the rationale in Appendix A, marked with an asterisk (*) in the text.

In this standard, see Appendix D for information on environmental impacts.

In this standard, see Appendix E for the correspondence between this standard and the basic principles of ISO /T R16142.

1 Scope

This standard specifies the requirements for a spirometer for use in assessing the lung function of persons weighing more than 10 kg.

This standard applies to all spirometers that measure forced expiratory volume over time, regardless of the measurement method used. Spirometer can be integrated part of a pulmonary function device, or a separate device.

This standard does not apply to equipment intended to continuously monitor patients.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB 9706.1-2020 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1. 2012, MOD)

GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in Risk Management Process (GB/T 16886.1- 2011, ISO 10993-1:2009, IDT)

GB/T 19974 Characterization of Sterilization Factors for Sterilization of Healthcare Products and Development, Validation and Routine Control of Sterilization Processes for Medical Devices General requirements for (GB/T 19974-2018, ISO 14937:2009, IDT)

YY/T 0466.1-2016 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1: General Requirements Seek (ISO 15223-1:2012, IDT)

3 Terms and Definitions

The following terms and definitions apply to this document.