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YY 0053-2016 English PDF

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YY 0053-2016: Hemodialysis and relevant therapies - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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YY 0053: Historical versions

Standard IDUSDBUY PDFDeliveryStandard Title (Description)Status
YY 0053-2016115 Add to Cart Auto, 9 seconds. Hemodialysis and relevant therapies - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Valid
YY 0053-2008160 Add to Cart Auto, 9 seconds. Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators Obsolete
YY 0053-1991519 Add to Cart 4 days Hollow fiber dialyzer Obsolete

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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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