YY 0053-2016 PDF English
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Hemodialysis and relevant therapies - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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| YY 0053-1991 | English | 519 |
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Hollow fiber dialyzer
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YY 0053-2016: Hemodialysis and relevant therapies - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
---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/YY0053-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.30
C 45
Replacing YY 0053-2008
Hemodialysis and Relevant Therapies -
Haemodialysers, Haemodiafilters,
Haemofilters and Haemoconcentrators
(ISO 8637.2010, MOD)
Issued on. MARCH 23, 2016
Implemented on. JANUARY 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative References... 4
3 Requirements... 5
4 Test Methods... 9
5 Marking... 19
Appendix A (Informative) Technical Differences and Causes between this
Standard and ISO 8637.2010... 23
Bibliography... 24
Foreword
This Standard was drafted as per the rules specified in GB/T 1.1-2009.
This Standard replaced YY 0053-2008 Cardiovascular Implants and Artificial Organs -
Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators. The major
technical difference between this Standard and YY 0053-2008 are as follows.
--- According to the content of international standards, the screening coefficient
increased β2-microglobulin; delete the requirement for pressure drop in the
dialysate space; delete the requirement for multiple use of the device;
--- According to the relevant content of international standards, supplement the test
methods for clearance rate and screening coefficient;
--- According to the provisions of relevant national regulations, add the content of
β2-microglobulin clearance rate and chemical properties; inspect as per the
domestic popular methods and projects, which is suitable for China’s national
conditions.
This Standard modified to adopt ISO 8637.2010 Cardiovascular Implants and
Extracorporeal Systems - Haemodialysers, Haemodiafilters, Haemofilters and
Haemoconcentrators. Compared with ISO 8637.2010, this Standard’s major
differences can refer to Table A.1.
Please note that some of the contents of this document may involve patents. The
issuing organization of this document does not assume the responsibility to identify
these patents.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee for
Standardization of Medical Extracorporeal Circulation Equipment (SAC/TC 158).
Drafting organizations of this Standard. Weihai Weigao Blood Purification Products Co.,
Ltd.; and Medical Devices Quality Supervision and Testing Center of China Food and
Drug Administration.
Chief drafting staffs of this Standard. Wu Jingbiao, Fu Yingbo, He Xiaofan, and Mou
Changjun.
This Standard was first-time published in 1991; and first-time revised in 2008.
Hemodialysis and Relevant Therapies -
Haemodialysers, Haemodiafilters,
Haemofilters and Haemoconcentrators
1 Scope
This Standard specifies the technical requirements for haemodialysers,
haemodiafilters, haemofilters and haemoconcenrators used for human body; the
“instruments” involved in this document indicate the above-mentioned products.
2 Normative References
The following documents are essential to the application of this document. For the
dated documents, only the versions with the dates indicated are applicable to this
document; for the undated documents, only the latest version (including all the
amendments) are applicable to this document.
GB/T 1962.2 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and
Certain Other Medical Equipment - Part 2.Lock Fittings (GB/T 1962.2-2001; ISO
594-2.1998, IDT)
3 Requirements
The haemodialysers, haemodiafilters, haemofilters and haemoconcentrators shall be
free of leakage. The adhesion of the product shall be confirmed as per the following
conditions.
4 Test Methods
Appropriate test methods shall be selected to evaluate the pyrogenicity of
haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. The test shall
be performed as per the PRC pharmacopoeia, and shall conform to the provisions of
3.3.
5 Marking
At least the following information is on the single package or can be see through the
single package.
Appendix A
(Informative)
Technical Differences and Causes between this Standard and ISO
8637.2010
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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