|
US$279.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0583.2-2016: Chest drainage systems for single use--Part 2: Type of dry seal valve
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0583.2-2016 | English | 279 |
Add to Cart
|
3 days [Need to translate]
|
Chest drainage systems for single use--Part 2: Type of dry seal valve
| Valid |
YY/T 0583.2-2016
|
PDF similar to YY/T 0583.2-2016
Basic data | Standard ID | YY/T 0583.2-2016 (YY/T0583.2-2016) | | Description (Translated English) | Chest drainage systems for single use--Part 2: Type of dry seal valve | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 14,156 | | Date of Issue | 2016-03-23 | | Date of Implementation | 2017-01-01 | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Issuing agency(ies) | State Food and Drug Administration | YY/T 0583.2-2016: Chest drainage systems for single use--Part 2: Type of dry seal valve---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Chest drainage systems for single use - Part 2. Type of dry seal valve
ICS 11.040.40
C45
People's Republic of China Pharmaceutical Industry Standard
Disposable use of thoracic drainage device
Part 2. Dry sealing valve type
2016-03-23 release
2017-01-01 Implementation
State Food and Drug Administration issued
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.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This part of the National Medical Pipeline Standardization Technical Committee (SAC/TC106) centralized.
This part of the main drafting unit. Shandong Province, medical equipment product quality inspection center.
This part participates in the drafting unit. Shanghai Chester Medical Technology Company, Ningbo Kanghong Medical Instrument Co., Ltd., Telui Fu medical equipment business
(Shanghai) Co., Ltd., Tiantai County Double Star Medical Devices Factory, Shanghai Huajie Enterprise Development Co., Ltd.
The main drafters of this part. Mou Pengtao, Yin Qing, Li Yuanyu, Cai Xiaobin.
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.
Disposable use of thoracic drainage device
Part 2. Dry sealing valve type
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 article
Pieces. 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.
3.1
Negative pressure status display
The drainage device can show the presence of negative pressure in the chamber.
3.2
Dry sealal (one-way valve) drysealvalve (one-wayvalve)
The drainage device may achieve a component that allows the patient to expel the gas during exhalation and to close the passage of the atmosphere with the patient & apos; s chest during inspiration.
3.3
High negative pressure automatic relief valve automatichighnegativepressurereleasevalve
When the negative pressure of the fluid chamber reaches a certain value, it can automatically release the safety protection module.
4 physical requirements
4.1 General
In addition to the drainage device should be consistent with YY/T 0583.1-2015 in 5.1,5.2,5.3.2,5.6,5.8,5.9,5.10,5.12,5.13,5.14
And 5.15, the following physical requirements shall also be met.
4.2 Drainage nozzle size
The length of the drain connection shall be not less than 900 mm and the pipe at the connection with the drainage device shall be of anti-kinking measure and shall be provided with a drainage duct
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0583.2-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 0583.2-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY/T 0583.2-2016_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0583.2-2016_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.
|