ISO13485ISO13485 is the most widely accepted standard by medical device manufacturers worldwide, such as the United States, Japan, Canada, and the European Union. This standard includes specific requirements for this industry and defines other terms such as medical equipment, active medical equipment, active transplant equipment, and sterile medical equipment.
General special requirements for the medical industry (ISO 13485)
Abnormal pressure difference in clean room: pressure difference between filling room and corridor (required to be above+10Pa)
Sterilization parameter exceeds limit: EO sterilization record shows humidity (validation range 60% -80%)
Lack of bioburden monitoring: Production water is required to undergo weekly endotoxin testing as per regulations
Insufficient product cleaning validation: The detection method for residual iron filings in the polishing process has not been validated
UDI identification error: The UDI-DI of the secondary packaging is consistent with the database records
Insufficient equipment calibration range: The calibration point of the heat sealing machine temperature gauge must cover the actual usage range (120-180 ℃)
Violation of material release regulations: Raw materials that must undergo microbiological testing must be put into production in advance
Defects in clean clothing management: Clean clothing must be cleaned within 24 hours when stored in the changing room
Lack of change control: The replacement of mold steel has not undergone biocompatibility assessment
Incomplete sterilization batch records: lack of ventilation time parameters for EO residual amount
