YY/T 0583.2-2016Chest drainage systems for single use - Part 2: Type of dry seal valve (English PDF)

Foreword

YY/T 0583 "One-time use of chest drainage device" is divided into two parts.

- Part 1. Watertight;

- Part 2. Dry sealing valve type.

Other types of drainage devices will be developed in other parts of YY/T 0583. This part is part 2 of YY/T 0583.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

YY/T 0583 The one-time use of the thoracic drainage device specified in this section is mainly applicable to the gas caused by various causes Chest, pleural effusion and patients who need to undergo closed drainage after surgery. After thoracic drainage in patients with thoracic cavity residual body, effusion "single To the drainage ", and can accurately measure the drainage fluid is the most basic requirements of clinical drainage. Dry sealing valve type chest drainage device is characterized by a one-way "Dry seal valve" to achieve the residual gas, the one-way drainage of the effusion. Because of its working principle does not depend on the water seal, even in the device in a dumping state It will not lose its anti-reflux. The disadvantage is that it can not be like a water-tight pleural drainage device, so that doctors can observe the water in the water chamber Column volatility state to determine the patient's treatment.

Chest drainage is usually by the patient's own breathing and cough in the natural formation of the pleural cavity pressure to achieve continuous drainage. Clinically for the sake of mention High drainage effect, often with external negative pressure source to help drainage (active drainage or suction drainage). This section deals with the drainage device Attractive control is a design type used to regulate external negative pressure. Clinical can also be used in other ways to regulate the pressure.

Appendix E gives the working principle of the device in the form of an informative appendix.

Dry sealing valve type chest drainage device and water-sealed chest drainage device, the pressure unit also uses cm water column, its purpose is to facilitate clinical Observation and use.

1 Scope

YY/T 0583 this part of the provisions of the sterile supply of dry sealed valve disposable thoracic drainage device (referred to as drainage device)

Claim. The device can be gravity drainage, but also with the negative pressure suction system to achieve suction to attract.

The thoracic drainage catheter inserted into the thoracic cavity of the patient and the autologous blood transfusion system of the thoracic drainage device with autologous blood transfusion system are not required Are included in this section.

2 Normative reference documents

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

GB/T 19633.1-2015 Final sterilization of medical device packaging - Part 1. Materials, sterile barrier systems and packaging systems Claim Disposable use of thoracic drainage devices - Part 1. Water - sealed type YY/T 0583.1-2015

YY/T 0615.1 Requirements for "sterile" medical devices - Part 1. Requirements for final sterilization of medical devices

3 Terms and definitions YY/T 0583.1-2015 and the following

terms and definitions apply to this document.

4 Physical requirements