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Sterilization Validation

Sterilization Validation, Total:20 items.

In the international standard classification, Sterilization Validation involves: Pharmaceutics, Sterilization and disinfection.


General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Sterilization Validation

  • GB/T 36036-2018 Verify guidance of cleaning and sterilization for pharmaceutical machinery

Korean Agency for Technology and Standards (KATS), Sterilization Validation

  • KS P ISO 11137:2008 Sterilization of health care products-Requirements for validation and routine control-Radiation sterilization
  • KS P ISO 11137:2003 Sterilization of health care products-Requirements for validation and routine control-Radiation sterilization
  • KS P ISO 11134:2003 Sterilization of health care products-Requirements for validation androutine control-Industrial moist heat sterilization
  • KS P ISO 11134:2008 Sterilization of health care products-Requirements for validation androutine control-Industrial moist heat sterilization

KR-KS, Sterilization Validation

  • KS P ISO 11137-2003 Sterilization of health care products-Requirements for validation and routine control-Radiation sterilization
  • KS P ISO 11134-2003 Sterilization of health care products-Requirements for validation androutine control-Industrial moist heat sterilization

国家食品药品监督管理局, Sterilization Validation

  • YY/T 1608-2018 Sampling methods for radiation sterilization verification dose experiments and sterilization dose audits of medical devices

American National Standards Institute (ANSI), Sterilization Validation

  • ANSI/AAMI ST 67-2003 Sterilization of Health Care Products - Requirements for products labeled "STERILE"
  • ANSI/AAMI TIR39:2009(R2022) Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices

European Committee for Standardization (CEN), Sterilization Validation

  • EN 554:1994 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat
  • EN 550:1994 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
  • EN 552:1994/A1:1999 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation Includes Amendment A1:1999

未注明发布机构, Sterilization Validation

  • BS EN 552:1994(2001) Sterilization of medical devices — Validation and routine control of sterilization by irradiation
  • BS EN 554:1994(1998) Sterilization ofmedical devices — Validation and routine control ofsterilization by moist heat
  • BS EN 550:1994(1998) Sterilization ofmedical devices — Validation and routine control ofethylene oxide sterilization

International Organization for Standardization (ISO), Sterilization Validation

  • ISO 14160:2020 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, developmen
  • ISO 13004:2022 Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD

CEN - European Committee for Standardization, Sterilization Validation

  • EN 552:1994 AMD A1 Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation (Incorporates Amendment A1: 1999)

PT-IPQ, Sterilization Validation

  • NP EN ISO 14160:2000 Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants(ISO 14160-1998)




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