YY/T 0878.2-2015 in English
VALIDTest for complement activation of medical devices―Part 2:Serum alternative pathway complement activation
- Issued on:2015-03-02
- Implemented on:2016-01-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$214.00
本标准规定了医疗器械体外旁路途径补体激活作用的试验方法。本标准中的“血清”和“补体”可通用,意指将血清用作补体来源。
本标准适用于固态样品的补体激活试验。
Scope
This part of YY/T 0878 provides test methods for complement activation of the alternative pathway in vitro of medical devices. This section applies to solid samples. In this section, the terms "serum" and "complement" are used interchangeably and mean that serum is used as a source of complement. This section does not address the function, modification or consumption of individual complement components and complement derived from plasma.

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