USP<88> Class tests are used to evaluate the biocompatibility of rubber and plastic products. These tests consist of a series of in vivo animal studies. The applicable objects include rubber and plastic tubing, connectors, single-use plastic bags, etc. The classification consists of six levels, with the highest level being Class VI. USP Class tests are often required by end customers.

USP 88
Testing Levels and Corresponding Test Items:
6-8 weeks
- One complete sample, each sample requiring 150 cm² or 5 grams
- Three complete samples, each sample requiring 50 cm² or 2 grams
ISO 10993 Biocompatibility Standards
Medical TPV ISO 10993 Biocompatibility Testing
FDA Requirements for Biocompatibility under ISO 10
Amazon Spain WEEE Compliance Deadline: September 3
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