Drugdu.com expert's response:

The medical device testing standard system is extensive and meticulous, covering multiple dimensions such as physical properties, chemical properties, biocompatibility, electrical safety, environmental adaptability, software functionality, sterilization validation, and service life assessment. Below are some core aspects:

I. Physical Property Testing Standards

Testing Items: Dimensional accuracy, surface roughness, material hardness, pressure resistance, tensile strength, sealing performance, wear resistance, fatigue life, motion accuracy, positioning accuracy, etc.

Relevant Standards: GB/T 16886.1, GB 9706.1, YY/T 0287, GB/T 14710, etc.

II. Chemical Property Testing Standards

Testing Items: Material composition, chemical stability, leachables/extractables, residual solvents, additive content, heavy metal content, etc.

Relevant Standards: Specific standards involving material composition analysis, impurity and additive testing, migration testing, etc.

III. Biocompatibility Testing Standards

Testing Items: Cytotoxicity tests, skin sensitization tests, intracutaneous reactivity tests, acute systemic toxicity tests, blood compatibility tests, implantation tests, genotoxicity tests, subchronic toxicity tests, etc.

Relevant Standards: ISO 10993 series standards (e.g., GB/T 16886.3-2019 Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity), GB/T 16886.1, GB/T 16886.3, etc.

IV. Electrical Safety Testing Standards

Testing Items: Insulation resistance, grounding resistance, leakage current, dielectric strength, electromagnetic compatibility, power supply adaptability, temperature rise tests, electrical clearance and creepage distance, battery safety, electrostatic discharge immunity, etc.

Relevant Standards: GB 9706.1 (equivalent to IEC standards), GB 4793.1, YY 0505, GB/T 18268.1, GB 4943.1, etc.

V. Environmental Adaptability Testing Standards

Testing Items: High-temperature tests, low-temperature tests, humidity tests, vibration tests, shock tests, impact tests, transportation tests, salt spray tests, low-pressure tests, mold tests, etc.

Relevant Standards: GB/T 14710, GB/T 2423 series standards (e.g., GB/T 2423.1, GB/T 2423.2), GB/T 4857, etc.

VI. Software Functionality Testing Standards

Testing Items: User interface validation, data integrity, algorithm accuracy, system response time, alarm functionality, data storage and backup, network security, access control, fault recovery, log recording, etc.

Relevant Standards: YY/T 0664, YY/T 0708, GB/T 25000.51, GB/T 16260, etc.

VII. Sterilization Validation Testing Standards

Testing Items: Sterility assurance level, residual sterilant levels, packaging integrity, biological indicator validation, physical parameter confirmation, ethylene oxide residue, radiation dose verification, steam sterilization efficacy, sterile barrier performance, etc.

Relevant Standards: GB 18278, GB 18279, GB 18280, GB/T 14233.1, GB/T 19633, etc.

VIII. Service Life Assessment Standards

Testing Items: Accelerated aging tests, cycle usage counts, material degradation analysis, performance degradation tests, key component lifespan, operational stability, reliability metrics, failure rate statistics, etc.

Relevant Standards: GB/T 34986, YY/T 0681, YY/T 0698, etc.