YY 0604-2016 in English
VALIDCardiopulmonary bypass systems―Blood-gas exchangers(oxygenators)
- Issued on:2016-03-23
- Implemented on:2018-01-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$243.00
| Standard No: | YY 0604-2016 |
| Document status: | VALID |
| Title in English: | Cardiopulmonary bypass systems―Blood-gas exchangers(oxygenators) |
| Title in Chinese: | 心肺转流系统血气交换器（氧合器） |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 1~3 business days |
| Issued on: | 2016-03-23 |
| Implemented on: | 2018-01-01 |
| Superseding: |
YY 0604-2007 Cardiovascular implants and artificial organs—Blood-gas exchangers(oxygenators)
|
| ICS Classification: | 11.040.40-Implants for surgery, prosthetics and orthotics |
| Chinese Classification: | C45-Extracorporeal circulation, artificial organ and prosthesis device |
| Professional Classification: | YY-Pharmaceutics |
| Related Keywords: | cardiopulmonary bypass systems
disposable blood-gas exchangers ― blood-gas exchangers oxygenators cardiopulmonary |
| Related Topics: | lung
blood gas YY 0604 2016 cardiopulmonary oxygenation YY+0604+2016 sample changer homologous lung oxygenation blood pressure transducer Oxygenator yy 0604 |
本标准适用于心肺转流系统使用的血气交换器（氧合器），也适用于作为氧合器整体一部分的热交换器。本标准规定了无菌、一次性使用的心肺转流系统使用的血气交换器（氧合器）的要求。
本标准不适用于植入式氧合器、液态氧合器、体外循环管道、分离式热交换器、分离式附件。
Scope
This standard specifies the requirements for sterile, disposable blood-gas exchangers (oxygenators) (hereinafter referred to as oxygenators) used in cardiopulmonary bypass systems. This device is used to supply oxygen to human blood and remove carbon dioxide to assist or replace the respiratory function of the lungs. This standard also applies to related standard documents. This standard does not apply to devices that are not clearly stated.
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