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YY/T 1830-2022Electrical pneumatic tourniquet equipment (English PDF)

电动气压止血仪

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

May 18, 2022

Implementation date

May 1, 2023

Scope

YY/T 1830-2022 is the English-translated version of 电动气压止血仪.

YY/T 1830-2022 is the Chinese pharmaceutical industry standard for electrical pneumatic tourniquet equipment, the powered cuff system that blocks blood flow in a limb during surgery.

It sets the requirements and the test methods, covering the accuracy and stability of the cuff pressure and of the timing, the alarms for over-pressure, leakage and elapsed time, the cuffs and tubing and their connections, and the safety and electromagnetic compatibility by reference to the general standards.

It does not apply to equipment made specifically for femoral artery haemostasis, and passive manually inflated devices may refer to it only where applicable. Issued on 18 May 2022, it has applied since 1 May 2023.

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Document preview — YY/T 1830-2022

National Standard of the People's Republic of China

Classification
C 30;C49

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Preface
  • 1 Scope
  • 2 Normative references
  • 3 Definitions and terms
  • 4 Requirements
  • 4.1 Working conditions
  • 4.2 Material Requirements
  • 4.3 Performance Index
  • 4.4 Inflation pressure requirements
  • 4.5 Timing function
  • 4.6 Requirements for air source
  • 4.7 Airbags and Pneumatic Tourniquets
  • 4.8 Pneumatic tourniquet with balloon
  • 4.9 Requirements for the use of pneumatic tourniquets
  • 4.10 Interface requirements for gas pipelines
  • 4.11 System Leak
  • 4.12 Requirements for pressure balance function
  • 4.13 Prompt/Alarm function
  • 4.14 Mobility performance (if applicable)
  • 4.15 Functional requirements for multi-channel models
  • 4.16 Unexpected power outage
  • 4.17 Maximum noise
  • 4.18 Internal power charging indication
  • 4.19 Environmental test
  • 4.20 Electrical Safety Requirements
  • 4.21 Electromagnetic compatibility
  • 4.22 Requirements for alarms
  • 5 Test method
  • 5.1 Test conditions
  • 5.2 Performance Index
  • 5.3 Inflation pressure requirements
  • 5.4 Timing function
  • 5.5 Requirements for air source
  • 5.6 Airbags and pneumatic tourniquets
  • 5.7 Pneumatic tourniquet with bladder
  • 5.8 Requirements for the use of pneumatic tourniquets
  • 5.9 Interface requirements for gas pipelines
  • 5.10 System leakage
  • 5.11 Requirements for pressure balance function
  • 5.12 Prompt/alarm function
  • 5.13 Mobility performance (if applicable)
  • 5.14 Functional requirements for multi-channel models
  • 5.15 Accidental power outage
  • 5.16 Maximum noise
  • 5.17 Internal power charging indication
  • 5.18 Environmental test
  • 5.19 Electrical safety requirements
  • 5.20 Electromagnetic compatibility
  • 5.21 Requirements for alarms

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

1 Scope

This document specifies the requirements and test methods for electropneumatic hemostatic devices.

This document applies to electro-pneumatic compression blocking hemostatic equipment in limb surgery.

This document does not apply to hemostatic equipment specially used for femoral artery hemostasis, nor does it apply to passive manual inflatable hemostatic equipment. Refer to this document as applicable.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB 9706.1 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance

GB/T 14710 Environmental Requirements and Test Methods for Medical Electrical Appliances

YY 9706.102 Medical Electrical Equipment Part 1-2.General Requirements for Basic Safety and Essential Performance Parallel Standard Electromagnetic capacity requirements and tests

YY 9706.108 Medical Electrical Equipment Part 1-8.General Requirements for Basic Safety and Essential Performance Collateral Standard

3 Definitions and Terminology

The terms and definitions defined in GB 9706.1 and the following terms and definitions apply to this document.

3.1 Electrical pneumatic tourniquet equipment

It is used for limb surgery, which uses air pressure compression to temporarily block the blood flow of limbs near the bleeding site of the limbs, so as to achieve Active medical devices for hemostasis.

3.2 Air pressure touriquet

The utility model relates to a long-belt-shaped inflatable part wrapped around the limbs requiring hemostasis when air pressure is used for hemostasis in the operation of the limbs.

3.3 Airbag

A gas medium is filled in a flexible bladder cavity, and the elastic action part is realized by utilizing the gas compressibility.

3.4 Pressure resistance

A mechanical limit used to evaluate a pipeline or cavity structure under internal gas pressure without changing its sealing properties.

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

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