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Basic data
| Standard ID | YY 0781-2025 (YY0781-2025) |
| Description (Translated English) | Blood pressure transducers |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard |
| Classification of Chinese Standard | C39 |
| Classification of International Standard | 11.040.55 |
| Word Count Estimation | 26,280 |
| Date of Issue | 2025-09-15 |
| Date of Implementation | 2028-10-01 |
| Older Standard (superseded by this standard) | YY 0781-2010 |
| Issuing agency(ies) | National Medical Products Administration |
YY 0781-2025: Blood pressure transducers
---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.
ICS 11.040.55
CCSC39
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0781-2010
Blood pressure sensor
Published on 2025-09-15
Implemented on October 1, 2028
National Medical Products Administration issued
Table of contents
Preface III
Introduction IV
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4 Requirements 3
5 Tests 6
Appendix A (Informative) Guidelines and Principles 14
Figure 1.Relationship between blood pressure sensor accuracy and applied pressure.
Figure 2.Time progression of combined temperature error band tests for drift, zero pressure, and sensitivity.
Figure 3 Circuit test connection 8
Figure 4 Frequency response parameter test 10
Figure 5.Frequency response parameter test (simplified step response test) 11
Figure 6 Leakage current test 13
Figure 7 Defibrillator Tolerance Test 13
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents".
Drafting.
This document replaces YY 0781-2010 "Blood Pressure Sensors". Compared with YY 0781-2010, the only changes are structural adjustments and editorial modifications.
In addition, the main technological changes are as follows.
---The normative references have been changed (see Chapter 2, Chapter 2 of the.2010 edition);
---Some terms and definitions have been changed (see Chapter 3, Chapter 3 of the.2010 edition);
---Change some tagging requirements (see 4.1, 4.1.1 and 4.1.2 in the.2010 version);
---The pressure range has been changed to allow manufacturers to define a wider pressure range (see 4.2.2.1,.2010 version 4.2.2.1);
---The requirements for AC excitation and phase offset have been removed (see 4.2.3.1 and 4.2.3.2 in the.2010 version);
---Electromagnetic compatibility requirements have been added (see 4.4);
---The testing methodology has been changed, and a simplified method has been added to the frequency response test (see Chapter 5, Chapter 5 of the.2010 edition).
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of the Medical Electronic Instruments Subcommittee of the National Technical Committee for Standardization of Medical Electrical Appliances (SAC/TC10/SC5).
The release history of this document and the document it replaces is as follows.
---First released in.2010 as YY 0781-2010;
---This is the first revision.
Introduction
The requirements and tests in this document are designed and developed around devices intended for blood pressure measurement, but not for purposes other than blood pressure.
This type of sensor can also be used to measure physiological parameters. This document primarily focuses on the safety and efficacy of sensors used for blood pressure measurement, and recommends...
It is recommended to focus on ensuring compatibility between dedicated sensors and blood pressure monitoring devices.
Blood pressure sensor
1 Scope
This document specifies the safety and performance requirements for sensors and cables designed for measuring blood pressure via indwelling catheters or direct puncture.
Note 1.This document also provides a reference for users to determine the compatibility between sensors and blood pressure monitoring devices.
Note 2.This document does not specify operating procedures for sensors or monitoring equipment. Therefore, please refer to the appropriate instruction manual for proper installation, balancing, and calibration.
A blood pressure measurement system is absolutely necessary.
This document applies to pressure sensors used to measure blood pressure via catheter or direct vascular puncture, including cables.
This document does not apply to sensors designed to measure other physiological parameters.
Note 3.Appendix A provides explanations of some of the clauses in this document.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB 9706.1-2020 Medical electrical equipment – Part 1.General requirements for basic safety and basic performance
YY/T 0466.1-2023 Symbols for Medical Devices - Part 1.General Requirements
YY 9706.102 Medical Electrical Equipment - Part 1-2.General Requirements for Basic Safety and Basic Performance (Parallel Standard). Electromagnetic Compatibility
Tolerance requirements and tests
YY 9706.234-2021 Medical Electrical Equipment - Parts 2-34.Basic Safety and Basic Performance of Invasive Blood Pressure Monitoring Equipment
Requirements
ISO 80369-7.2021 Small-bore connectors for medical fluids and gases – Part 7.Connectors for intravascular or subcutaneous applications
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
accuracy
The ratio of error (measured value minus true value) to true value (or theoretical value).
Note. Expressed as a percentage.
3.2
balance
With appropriate excitation (3.8), the Wheatstone bridge is symmetrical or comes from the zero-point condition of the bridge output.
3.3
critical damping
The damping value required to produce the minimum settling time for a step input without overshoot.
...
