YY/T 0583.1-2015Chest drainage systems for single use - Part 1: Type of water-seal (English PDF)

Foreword

YY/T 0583 "disposable chest drainage unit" into parts intended for publication. Currently it plans to release the following components.

--- Part 1. water-sealed; This section YY/T Section 10583 of. This section drafted in accordance with GB/T 1.1-2009 given rules.

This Part replaces YY 0583-2005 "disposable chest drainage unit water-sealed", compared with YY 0583-2005, the main Technical changes are as follows.

--- Expanding the scope of the standard, so that the chest drainage unit contains liquid and use water seal drainage mixed together;

--- Cancel the division of the drainage device type;

--- Cancellation of the product description tag;

--- Increased drainage takeover kink measures recommended requirements;

--- Increased tolerance requirements tick maximum scale value, and modify its illustrated example;

--- To water seal the water column fluctuations observation unit holding requirement has been modified, and adds the corresponding test methods;

--- Modify the tightness test requirements;

--- Increased requirements for automatic positive pressure relief device;

--- Increased the drainage device manual vacuum release device, the patient gas leakage meter, non-water-type suction control means, drainage sampling Dosing mouth and piercing mouth and other optional equipment requirements;

--- Increasing the drainage system pressure drop Recommended requirements;

--- Modify the drainage device of ethylene oxide residues in the test methods and requirements;

--- Single Package Marking a nominal increase in the volume of fluid drainage labeling requirements.

Introduction

This Part of the water-sealed disposable chest drainage unit is mainly applied to a variety of causes pneumothorax, pleural effusion and After surgery the patient needs to be closed drainage. Residual gas within the patient chest surgery after chest drainage, fluid "one-way drainage", and can Accurate measurement of drainage fluid drainage is clinically the most basic requirements, water-sealed thoracic drainage device according to the section involved is around this basic Requirements to design.

Pleural drainage is usually spontaneous breathing by the patient cough and pleural cavity pressure naturally formed to achieve continuous drainage. In order to improve the clinical High drainage effect, often by means of an external pressure source to help drainage (drainage or drainage for the initiative). On this part of the drainage device involved Suction control chamber is used to regulate the negative pressure on the outside of one design pattern. Clinically, it may also be used in other ways the regulator.

Medical personnel can observe the color change of state fluid cavity drainage device drainage of fluid to determine whether there is active bleeding within the chest. for Water-sealed thoracic drainage device, but also by observing the amplitude of fluctuations in the water column of water fluctuation observation unit to determine the effect of drainage and lung expansion Zhang case, in order to take appropriate therapeutic measures. This requires a range of water fluctuations observed in the observation units marked scale (in cm water column As a unit), so that the water column fluctuations in clinical observation and recording.

Fluctuations in the water column of water-sealed chest drainage unit observation, the water level control formula attract centimeters of water are used as a unit, and its purpose is to facilitate temporary Bed observe and use. Disposable chest drainage unit Part 1. water-sealed

1 Scope

YY/T 0583 provisions of this part of the chest drainage device supplied sterile single-use water-seal (abbreviation. drainage device) to be begging. The gravity drainage device can also be connected with a suction system to achieve attract drainage.

Inserted into the patient's chest chest drainage catheter, chest drainage device on dry-type seal chest drainage devices and autologous blood transfusion system with autologous Blood transfusion system requirements are not included within the scope of this.

Intended for drainage system does not apply to patients carrying this section.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 14233.1-2008 Infusion, transfusion, injection equipment - Part 1. Chemical analysis

GB 15810 single-use sterile syringes Symbols - Part 1 YY/T 0466.1 Medical Devices medical equipment for marking, labeling and information. General requirements

ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1. materials, sterile barrier systems and packaging systems in claim 1)

3 Terms and Definitions

The following terms and definitions apply to this document.