YY 0465-2019 PDF English
US$359.00 · In stock · Download in 9 secondsYY 0465-2019: Disposable membrane plasmaseparator and plasma component separator Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid YY 0465: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY 0465-2019 | English | 359 |
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|
4 days
|
Disposable membrane plasmaseparator and plasma component separator
| Valid |
| YY 0465-2009 | English | 679 |
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3 days
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Disposable membrane plasmaseparator
| Obsolete |
| YY 0465-2003 | English | 639 |
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5 days
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Single use membrane plasmaseparator
| Obsolete |
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YY 0465-2019: Disposable membrane plasmaseparator and plasma component separator---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0465-2019
Disposable membrane plasmaseparator and plasma component separator
ICS 11.040.40
C45
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0465-2009
Single-use hollow fiber plasma separator and
Plasma component separator
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
Chapter 5 of this standard is mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0465-2009 "single-use hollow fiber plasma separator", compared with YY 0465-2009, except for editing
The main technical changes outside the sexual modification are as follows.
--- Increased the requirements and test methods for the particles to fall off the outer cavity (see 5.5 and 6.5);
--- Increased bacterial endotoxin requirements and test methods (see 5.10 and 6.10);
--- Increased the plasma separator separation of plasma hemoglobin content requirements and test methods (see 5.11 and 6.11);
--- Increased the plasma component filtration rate requirements and test methods for plasma component separators (see 5.13.3 and 6.13.3);
--- Increased the requirements and test methods for the screening factor of plasma component separator proteins (see 5.13.4 and 6.13.4);
--- Increased the validity period requirements and test methods (see 5.15 and 6.15);
--- Revised the test method for pyrogens (see 6.9, 6.7.3 for the.2009 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment (SAC/TC158).
This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute, Guangzhou Kangsheng Biotechnology Co., Ltd., Foshan Boxin Bio
Technology Co., Ltd.
The main drafters of this standard. Wu Jingbiao, He Xiaofan, Luo Jiewei, Ye Xiaoyan.
The previous versions of the standards replaced by this standard are.
---YY 0465-2003;
---YY 0465-2009.
Single-use hollow fiber plasma separator and
Plasma component separator
1 Scope
This standard specifies the terms and definitions, type and model nomenclature for single-use hollow fiber plasma separators and plasma component separators.
Requirements, test methods, inspection rules, marking and packaging, transportation, storage.
This standard applies to single-use hollow fiber plasma separators and plasma component separators. Single-use hollow fiber plasma separation
The device (referred to as a plasma separator) is combined with a plasma separation device to treat various immune, metabolic disorders and certain poisoning diseases. One-time
Hollow fiber plasma component separator (referred to as plasma component separator) is suitable for performing double filtration plasma exchange therapy with plasma separator
In combination, a certain molecular weight substance is separated from the separated plasma by a membrane separation method.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 1962.2 syringes, needles and other medical devices 6% (Ruhr) conical joints Part 2. Locking joints
GB/T 13074 blood purification terminology
GB/T 14233.1-2008 Methods of test for infusions, blood trans
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of test for interaction with blood
GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test
GB/T 16886.10 Biological evaluation of medical devices - Part 10. Stimulation and skin sensitization test
GB/T 16886.11 Biological evaluation of medical devices - Part 11. Systemic toxicity test
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
Pharmacopoeia of the People's Republic of China (2015 Edition)
3 Terms and definitions
The following terms and definitions as defined in GB/T 13074 apply to this document.
3.1
Plasma separation plasmaseparation
The process of separating plasma from blood forms a fraction.
3.2
Plasma separation device plasmaaseparationsystem
A device consisting of a hemodynamic, monitoring, volume balancing system, and plasma separator.
3.3
Plasma component separation plasmacomponentseparation
The process of separating different relative molecular mass substances in plasma.
YY 0465-2019
Disposable membrane plasmaseparator and plasma component separator
ICS 11.040.40
C45
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0465-2009
Single-use hollow fiber plasma separator and
Plasma component separator
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
Chapter 5 of this standard is mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0465-2009 "single-use hollow fiber plasma separator", compared with YY 0465-2009, except for editing
The main technical changes outside the sexual modification are as follows.
--- Increased the requirements and test methods for the particles to fall off the outer cavity (see 5.5 and 6.5);
--- Increased bacterial endotoxin requirements and test methods (see 5.10 and 6.10);
--- Increased the plasma separator separation of plasma hemoglobin content requirements and test methods (see 5.11 and 6.11);
--- Increased the plasma component filtration rate requirements and test methods for plasma component separators (see 5.13.3 and 6.13.3);
--- Increased the requirements and test methods for the screening factor of plasma component separator proteins (see 5.13.4 and 6.13.4);
--- Increased the validity period requirements and test methods (see 5.15 and 6.15);
--- Revised the test method for pyrogens (see 6.9, 6.7.3 for the.2009 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment (SAC/TC158).
This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute, Guangzhou Kangsheng Biotechnology Co., Ltd., Foshan Boxin Bio
Technology Co., Ltd.
The main drafters of this standard. Wu Jingbiao, He Xiaofan, Luo Jiewei, Ye Xiaoyan.
The previous versions of the standards replaced by this standard are.
---YY 0465-2003;
---YY 0465-2009.
Single-use hollow fiber plasma separator and
Plasma component separator
1 Scope
This standard specifies the terms and definitions, type and model nomenclature for single-use hollow fiber plasma separators and plasma component separators.
Requirements, test methods, inspection rules, marking and packaging, transportation, storage.
This standard applies to single-use hollow fiber plasma separators and plasma component separators. Single-use hollow fiber plasma separation
The device (referred to as a plasma separator) is combined with a plasma separation device to treat various immune, metabolic disorders and certain poisoning diseases. One-time
Hollow fiber plasma component separator (referred to as plasma component separator) is suitable for performing double filtration plasma exchange therapy with plasma separator
In combination, a certain molecular weight substance is separated from the separated plasma by a membrane separation method.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 1962.2 syringes, needles and other medical devices 6% (Ruhr) conical joints Part 2. Locking joints
GB/T 13074 blood purification terminology
GB/T 14233.1-2008 Methods of test for infusions, blood trans
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of test for interaction with blood
GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test
GB/T 16886.10 Biological evaluation of medical devices - Part 10. Stimulation and skin sensitization test
GB/T 16886.11 Biological evaluation of medical devices - Part 11. Systemic toxicity test
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
Pharmacopoeia of the People's Republic of China (2015 Edition)
3 Terms and definitions
The following terms and definitions as defined in GB/T 13074 apply to this document.
3.1
Plasma separation plasmaseparation
The process of separating plasma from blood forms a fraction.
3.2
Plasma separation device plasmaaseparationsystem
A device consisting of a hemodynamic, monitoring, volume balancing system, and plasma separator.
3.3
Plasma component separation plasmacomponentseparation
The process of separating different relative molecular mass substances in plasma.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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