YY 0053-2016Haemodialysis and related therapies - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (English PDF)

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 beta2-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 beta2-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.

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.