The biocompatibility standard requirements for PVC blood bags

PVC blood bags, as medical devices that come into direct contact with blood, strictly adhere to international and domestic relevant standards for their biocompatibility. The following are the detailed requirements for the biocompatibility of PVC blood bags:

Biocompatibility Standard Requirements

Basis of Foundational Standards

YY/T 1617-2018 Calendered Polyvinyl Chloride Film for Blood Bags explicitly requires that blood bag materials comply with medical device biocompatibility requirements, including indicators such as cytotoxicity, sensitization, and hemolysis.

GB 14232.1-2020 Plastic Containers for Human Blood and Blood Components—Part 1: Conventional Blood Bags stipulates that materials must be non-toxic and harmless, with extremely low heavy metal content (e.g., lead and mercury not exceeding 1 part per million).

Specific Performance Indicators

• Cytotoxicity: The impact of material extract on cell growth must comply with GB/T 16886.1, with a cell survival rate ≥70%.
• Sensitization: The Guinea Pig Maximization Test (GPMT) requires a sensitization rate <10%.
• Hemolysis: The in vitro hemolysis test requires a hemolysis rate ≤5%.
• Acute Systemic Toxicity: The mouse intraperitoneal injection test must result in 0% mortality.