8.1.7 Biocompatibility
We declare that the wet materials of the DCP-2000.x pump heads, in the configurations as listed below, satisfy the
following biocompatibility specifications:
Table 17: Single-use pump heads with biocompatibility
FDA 21 CFR
All wet raw materials used in the above mentioned pump heads meet specifications according to FDA 21 CFR (section
177.1520 for Olefin Polymers). This statement is based on declarations provided by our raw material or component
suppliers.
USP VI
The wet raw materials used in the above mentioned pump heads meet the specifications of USP Class VI. The statement
is based on declarations provided by our raw material and component suppliers.
BSE/TSE and Animal Free
Based on declarations provided by our raw material and component suppliers, we believe that the wet materials of the
above mentioned pump heads have been manufactured without coming into contact with animal derived materials and
that they do not contain potential spongiform or transmissible spongiform encephalopathy (BSE/TSE) risk components.
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