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YY 0781-2025Blood pressure transducers (English PDF)

血压传感器

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

September 15, 2025

Implementation date

October 1, 2028

Scope

YY 0781-2025 is the English-translated version of 血压传感器.

YY 0781-2025 is the Chinese standard "Blood pressure transducers". Its scope clause reads: 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. Its clauses include terms and definitions.

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Document preview — YY 0781-2025

National Standard of the People's Republic of China

ICS
11.040.55
Classification
C39
Replacing
YY 0781-2010

Issued by: National Medical Products Administration

Contents

  • Preface
  • Introduction
  • 1.Scope
  • 2 Normative References
  • 3.Terms and Definitions
  • 4 Requirements
  • 5 Tests
  • Appendix A (Informative) Guidelines and Principles

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Similar standards

Editions of YY 0781

EditionTitleRevisionStatus
YY 0781-2025Blood pressure transducerscurrent editionCurrent
YY 0781-2010Blood pressure transducersprevious editionIn force until 2028-10-01

This page sells the current edition, YY 0781-2025. Earlier editions are listed for reference only.

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