Biocompatibility Testing for Passive Medical Devices

Passive surgical instruments refer to tools used during surgical procedures, including scalpels, scissors, forceps, needles, tweezers, clamps, dissectors, guides, irrigators, puncture devices, staplers, and sutures made of metal or non-metal materials. Most passive surgical instruments are classified as Class II medical devices, with some categorized as Class III due to higher risk levels.

Before market launch, manufacturers of passive surgical instruments are required to provide test reports from qualified third-party testing institutions.

Testing Items:

1. Mandatory Testing

- Sterility Testing

2. Recommended Testing

biocompatibility testing can be conducted based on product requirements. Generally, the following are routine tests:

- cytotoxicity testing

- Irritation Testing (e.g., skin irritation)

- Skin sensitization testing

For stapling or suturing devices and materials that are in prolonged contact with tissue, the following additional tests are required:

- Acute Systemic Toxicity Testing

- Subacute Systemic Toxicity Testing

- Genotoxicity Testing

Testing Items and Estimated Timelines:

- Sterility Testing

Standards: GB14233.2, ISO11737-2:2019, Chinese Pharmacopoeia (ChP), United States Pharmacopeia (USP)

Duration: ~3 weeks

- Cytotoxicity Testing

Standards: GB/T 16886.5-2017, iso 10993-5:2009, EN iso 10993-5:2009

Duration: ~2 weeks

- Skin Sensitization Testing

Standards: GB/T 16886.10-2017, iso 10993-10:2010, EN ISO 10993-10:2013

Duration: ~5 weeks

- Irritation or Intracutaneous Reactivity (Skin Irritation Test)

Standards: GB/T 16886.10-2017, ISO 10993-10:2010, EN ISO 10993-10:2013

Duration: ~2 weeks

- Acute Systemic Toxicity Testing

Standards: GB/T 16886.11-2011, ISO 10993-11:2017, EN ISO 10993-11:2009

Duration: ~2 weeks

- Subacute Systemic Toxicity Testing

Standards: GB/T 16886.11-2011, ISO 10993-11:2017, EN ISO 10993-11:2009

Duration: ~2 weeks

- Genotoxicity Testing

Standards: GB/T 16886.3-2019, ISO 10993-3:2014, EN ISO 10993-3:2014

Duration: ~5 weeks

China's JJR Laboratory is equipped with comprehensive biocompatibility, microbiological, physicochemical, and product performance laboratories. It has cultivated a team of experienced technical professionals capable of efficiently conducting sterility, microbiological, bacterial endotoxin, biocompatibility, and physicochemical and mechanical performance tests for passive surgical instruments. These capabilities fully meet the testing requirements for FDA registration and international certification of passive medical devices.