|
US$559.00 ยท In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1839-2022: Cardiopulmonary bypass systems - Venous bubble traps
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1839-2022 | English | 559 |
Add to Cart
|
5 days [Need to translate]
|
Cardiopulmonary bypass systems - Venous bubble traps
| Valid |
YY/T 1839-2022
|
PDF similar to YY/T 1839-2022
Basic data | Standard ID | YY/T 1839-2022 (YY/T1839-2022) | | Description (Translated English) | Cardiopulmonary bypass systems - Venous bubble traps | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C45 | | Word Count Estimation | 27,255 | | Issuing agency(ies) | State Drug Administration | YY/T 1839-2022: Cardiopulmonary bypass systems - Venous bubble traps---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.
Cardiopulmonary bypass systems - Venous bubble traps
ICS 11.040.40
CCSC45
People's Republic of China Pharmaceutical Industry Standard
Cardiopulmonary bypass system venous bubble trap
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 2
5 Test method 4
Appendix A (informative) Technical differences between this document and ISO 18241.2016 and their reasons9
Appendix B (Informative) Connector Example 11
Reference 20
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document uses the redrafted method to modify and adopt ISO 18241.2016 "Cardiovascular Implants and Extracorporeal Systems Cardiopulmonary Bypass Systems Static
Pulse Bubble Trap" and Amendment No. 1..2019 "Joint".
There are technical differences between this document and ISO 18241.2016 and Amendment No. 1, and the clauses involved in these differences have been adopted on the outside
The vertical line (|) in the blank position of the page number is marked, and Appendix A gives a list of the corresponding technical differences and their reasons.
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of the National Standardization Technical Committee of Medical Extracorporeal Circulation Equipment (SAC/TC158).
This document is drafted by. Guangdong Provincial Institute of Medical Device Quality Supervision and Inspection, Mai Kewei (Shanghai) Medical Equipment Co., Ltd., Tianjin Plastics
Research Institute Ltd.
The main drafters of this document. Xu Suhua, Liang Zexin, Li Shengxia, Hong Liangtong, Nie Yongsheng, Chen Huayan, Ke Jun, He Xiaofan, Yan Lin.
Cardiopulmonary bypass system venous bubble trap
1 Scope
This document specifies a single-use sterile venous bubble trap for evacuating venous air bubbles during surgery supported by extracorporeal circulation
requirements and test methods.
This document applies to single-use sterile venous bubble traps.
NOTE. Surgical procedures requiring cardiopulmonary bypass support can include cardiopulmonary bypass, extracorporeal membrane oxygenation, and venous bypass for living transplants.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 14233.1 Test methods for medical infusion, blood transfusion and injection equipment - Part 1.Chemical analysis methods
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process (GB/T 16886.1-
2011, ISO 10993-1.2009, IDT)
GB/T 16886.11 Biological Evaluation of Medical Devices Part 11.Systemic Toxicity Test (GB/T 16886.11-2011,
ISO 10993-11.2006, IDT)
GB 18279.1 Sterilization of Healthcare Products Ethylene Oxide Part 1.Development, Validation and Routine Control of Sterilization Processes for Medical Devices
requirements (GB 18279.1-2015, ISO 11135-1.2007, IDT)
GB 18280.1 Sterilization Radiation for Healthcare Products Part 1.Requirements for Development, Validation and Routine Control of Sterilization Processes for Medical Devices
Seek (GB 18280.1-2015, ISO 11137-1.2006, IDT)
GB/T.19974 Characterization of Sterilization Factors for Sterilization of Healthcare Products and Development, Validation and Routine Control of Sterilization Processes for Medical Devices
General requirements for (GB/T.19974-2018, ISO 14937.2009, IDT)
YY/T 0681.1 Sterile Medical Device Packaging Test Methods Part 1.Guidelines for Accelerated Aging Test
YY/T 1556-2017 Test method for particle contamination of medical infusion, blood transfusion and injection equipment
ISO 80369-7.2016 Small bore connectors for medical liquids and gases - Part 7.Connectors for intravascular or subcutaneous applications
Pharmacopoeia of the People's Republic of China
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
venousbubbletrap venousbubbletrap
Extracorporeal device for evacuating venous air bubbles.
3.2
bloodpathway
In intended clinical applications, venous bubble traps contain channels for blood.
|