Annex-1 Sterilization Cycle Data Entry Form.docx

Annex-2 Sterilization In & Out Data Entry Form.docx

Annex-3 Sterilization Cycle Biological Indicator Layout Plan.docx

Annex-4 Sterilization Unit Layout Plan.docx

Annex-5 Biological Indicator Test Report.docx

Ethylene Oxide Sterilization Instruction.docx

Ethylene Oxide Sterilization Instruction And Its Annexes

ISO 13485

ISO 11135

EN 1422

EN 556-1

The ways of sterilizing Medical Devices with Ethylene Oxide, one of the traditional sterilization methods, can be seen in this instruction. Attachments regarding physical and microbiological monitoring are among the documents.

Mechsoft

MadgeTech

Biyolog

Biologist

Trainer&Consultant of Accreditation TS EN ISO IEC 17025  

Kalite Yönetim Sistemleri Danışmanı

ISO 17020 Danışmanı/Teknik Uzmanı

ISO 17020 Consultant/Expert

Sterilizasyon Uzmanı

Cleanroom Validation Training

ISO 15189 QMS Training

Modul A, B Auditor Training

ISO 17020 QMS Training

ISO 11137 Training

ISO 11135 Training

Bioburden and Sterility Test Training

ISO 17025 KYS, Measurement Uncertainty, Method Validation Training

ISO 14644-1, ISO 14644-2 & ISO 14644-3 Training

FDA Training

Cleanroom Design Training

Clinical Evaluation Training

Cleanroom Management, Personel & Cleaning Training

TS EN ISO 17021 Auditor Training

IEST-RP-CC034.4 HEPA Filter Leak Test Training

IEST-RP-CC006.3 Testing Cleanrooms Training

EN ISO 19011 Internal Audit Training

EN ISO 13485 QMS Training

ISO 14971 Risk Management Training

MDR Transition Training

Talimat

Form