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YY/T 0583.1-2015 English PDF

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YY/T 0583.1-2015: Chest drainage systems for single use - Part 1: Type of water-seal
Status: Valid

YY/T 0583.1: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0583.1-2015English549 Add to Cart 5 days [Need to translate] Chest drainage systems for single use - Part 1: Type of water-seal Valid YY/T 0583.1-2015
YY 0583-2005English599 Add to Cart 4 days [Need to translate] Chest draining equipments for single use - Type of water-seal bottle Obsolete YY 0583-2005

PDF similar to YY/T 0583.1-2015


Standard similar to YY/T 0583.1-2015

YY/T 0640   YY/T 0663.2   YY/T 0606.9   YY 0603   YY 0580   YY/T 0583.2   

Basic data

Standard ID YY/T 0583.1-2015 (YY/T0583.1-2015)
Description (Translated English) Chest drainage systems for single use - Part 1: Type of water-seal
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.40
Word Count Estimation 26,261
Date of Issue 2015-03-02
Date of Implementation 2016-01-01
Older Standard (superseded by this standard) YY 0583-2005
Quoted Standard GB/T 14233.1-2008; GB 15810; YY/T 0466.1; ISO 11607-1-2006
Regulation (derived from) The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies) State Food and Drug Administration
Summary This Standard specifies requirements for chest drainage device sterile supply of water-sealed disposable. The device can be gravity drainage can also be connected with the suction system to achieve attract drainage. Insert the patient's chest drainage catheter, requiring dry seal chest drainage device type apparatus body and chest drainage systems with self-blood transfusion of autologous blood transfusion system is not included in the scope of this section. Drainage device intended for carrying a patient does not apply to this section.

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

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Chest drainage systems for single use Part 1. Type of water-seal ICS 11.040.40 C45 People's Republic of China pharmaceutical industry standards Replacing YY 0583-2005 Disposable chest drainage unit Part 1. water-sealed Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released

Table of Contents

Introduction Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Product Structure 3 Physical Requirements 3 5 5.1 Appearance 3 5.2 Anti-error connection 3 5.3 drainage takeover 4 5.3.1 Size 4 5.3.2 anti-deformation 4 5.4 fluid chamber 4 5.4.1 scales 4 5.4.2 * digital scales and measuring interval of 4 5.5 seal chamber 4 5.5.1 water line 4 5.5.2 * water column fluctuations observation unit 4 5.5.3 Dosing port 4 5.6 containing suction control drainage means 5 5.6.1 Level attract controlled 5 5.6.2 Non-controlled water level to attract 5 5.7 * 5 retentive state seal 5.8 tightness 5 5.9 automatic positive pressure relief device 6 5.9.1 General 6 5.9.2 Open pressure of 6 5.9.3 release rate 6 5.9.4 Reliability 6 5.10 manual vacuum release device 6 5.10.1 General 6 5.10.2 Stability 6 5.10.3 release controllability 6 5.10.4 release force 6 5.10.5 Reliability 6 5.11 gas leak of 6 patients 5.12 drainage fluid sampling ports (if any) 6 5.13 Connecting fastness 7 5.14 Compliance 7 5.15 drop 7 5.16 Impact resistance 7 5.17 Stability 7 Suspension means 7 5.18 Sterile 6 7 7 residual ethylene oxide 7 8 type examination 7 9 7 logo 9.1 Single Package mark 7 9.2 Transport Package mark 8 10 Packaging 8 Appendix A (normative) Test method for resistance to deformation drainage takeover 9 Standard Test Method for control error in Appendix B (normative) Non-level formula to attract 10 Annex C (normative) Test method for maintaining water seal 11 Annex D (normative) Test method for sealing system 12 Test methods Appendix E (normative) automatic positive pressure release 13 Annex F (informative) Examples 14 patients with gas leakage test methods Annex G (normative) Compliance Test Method 15 Appendix H (informative) Pressure Drop Test Method 17 Annex I (normative) Test method for drainage devices impact 18 Appendix J (normative) residual ethylene oxide 19 References 20 1 drainage system Schematic diagram 3 Figure 2 the water line and water pressure fluctuation scale sample (partial) 5 Figure B.1 attract non-water-type control error test Legend 10 Figure C.1 water seal retention test legend 11 Figure E.1 automatic release mechanism to release positive pressure test Legend 13 Figure F.1 patient gas leakage test Legend 14 Figure G.1 compliance test system Legend 15 Figure H.1 drop test system Legend 17 Table 1 on the fluid chamber and measuring digital scale interval of 4 Table I.1 impact test water addition 18

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. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This part of the National Technical Committee of Standardization for medical infusion set (SAC/TC106) centralized. This part mainly drafted by. Shandong Province Medical Devices Product Quality Inspection Center. Participated in the drafting of this section. Ningbo Kang Hong Medical Devices Co., Ltd., Tiantai binary instrumentarija, Shanghai Huajia Enterprise Development has Limited on Haiqi Manchester medical technology company, Teleflex Medical Devices Trading (Shanghai) Co., Ltd. The main drafters of this section. Wu Ping, Moupeng Tao, Wan Min, Xu Hui, Lee heart. This section replaces YY 0583-2005. The previous versions of the release YY 0583-2005 case. --- YY 0583-2005.

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. 3.1 For use state conditionforusing Drainage device at (23 ± 2) ℃ conditioning test conditions at least 24h after removing from the package state. If the product before use Assembly required by the user, it is already in the state assembly according to the manufacturer's instructions (including checking) after. Note. This standard refers to the drainage system in the product assembly in this state (including its stabilization device installed to prevent dumping and fixtures). 3.2 Endoleak bypass Unexpected drainage means each channel due to manufacturing defects arising between the cavities. Note. The leak could cause the drainage device function to reduce or dangerous. 3.3 Fluid chamber colectionchamber Means for collecting the drainage of pleural fluid drainage chamber. 1) and ISO 11607-1.2006 equivalent to our standard GB/T 19633.1 currently in the approval stage. 3.4 Seal chamber watersealchamber To provide for drainage of water seal chamber on the drainage device.

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