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  • Ethylene Oxide (EO) Product Adoption Protocol

Ethylene Oxide (EO) Product Adoption Protocol

SKU: EO-ADOPT
$149.00
$149.00
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The Ethylene Oxide (EO) Product Adoption Protocol documents the product adoption evaluation process, per TIR28:2016, conducted when adding new medical devices into an existing EO sterilization cycle that has been previously validated.  
  • TIR28:2016 Compliant
  • ​ISO 11135:2014 Compliant
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Ethylene Oxide Product Adoption Protocol

​The Ethylene Oxide (EO) Product Adoption Protocol documents the product adoption evaluation process, per TIR28:2016, conducted when adding new medical devices into an existing EO sterilization cycle that has been previously validated.  

EO Product Adoption Overview

The EO product adoption protocol provides a thorough review of products being considered for adoption into a validated EO sterilization cycle. The protocol serves as a guide and as final documentation justifying the addition of a product into an existing sterilization process. 

​The EO product adoptions protocol includes review of the following:
  • Design characteristics
  • ​Material characteristics​
  • Sterile barrier system
  • Load characteristics
  • ​other characteristics

EO Product Adoption Compliance

The EO Product Adoption Protocol is ISO 11135:2014, TIR28:2016 and FDA compliant.
For more information about our EO Product Adoption Protocol please contact us at info@aplyon.com 

RELATED LINKS

Ethylene Oxide Sterilization Validation Procedure
​Gamma Irradiation Sterilization Validation Procedure
EO Product Adoption Protocol
EO Product Adoption Protocol

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      • ISO 13485 Quality Management System Manual
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        • Engineering Change Notice Procedure
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        • Training Procedure
        • Facility Inspection Procedure
        • Respiratory Protection Procedure
        • Biohazard Procedure
        • Lockout - Tagout Procedure
        • Preventive Maintenance Procedure
      • ISO 13485 PRODUCT REALIZATION PROCEDURES >
        • ISO 13485 DESIGN - DEVELOPMENT PROCEDURES >
          • Design Control Procedure
          • Customer Requirements Validation
          • Human Factors - Usability Engineering Procedure
          • Design Review Procedure
          • Risk Management Procedure
          • Design Transfer Procedure
          • Shelf Life Procedure
          • Technology Transfer Procedure
          • Design Verification - Validation Procedure
          • Design Risk Management Procedure
          • Design Analysis Procedure
          • Biocompatibility - Toxicity Testing Procedure
          • ISO 13485 Label Review and Approval Procedure
          • Unique Device Identification Procedure
          • Software Development Procedure
          • Software Clinical Evaluation Procedure
          • Clinical Evaluation Procedure
          • Clinical Investigation Procedure
          • Product Performance Specification Procedure
          • CE Marking Procedure
        • ISO 13485 PURCHASING PROCEDURES >
          • Supplier Management Procedure
          • Purchase Order Procedure
        • ISO 13485 PRODUCTION - SERVICE PROVISION PROCEDURES >
          • Cleanroom Design and Validation Procedure
          • Environmental Controls Procedure
          • Controlled Environment Cleaning Procedure
          • Sterile Load Preparation - Release Procedure
          • Gamma Irradiation Sterilization Validation Procedure
          • Ethylene Oxide EO Sterilization Validation Procedure
          • Software Validation Procedure
          • Installation Qualification (IQ) Procedure
          • Medical Device Process Validation
          • Validation Protocols - Reports Procedure
          • Process Risk Management Procedure
          • Device History Record
          • Identification Procedure
          • Lot Inspection Procedure
          • First Article Inspection Procedure
          • Line Clearance Procedure
          • ISO 13485 Contract Review Procedure
        • ISO 13485 CONTROL MONITORING MEASUREMENT DEVICES PROCEDURES >
          • Calibration System Procedure
      • ISO 13485 MEASUREMENT ANALYSIS IMPROVEMENT >
        • Complaint Handling Procedure
        • Complaint Trending Procedure
        • Nonconforming Material Procedure
        • Corrective - Preventive Action Procedure
        • Internal Audit Procedure
        • Medical Device Report MDR Procedure
        • Product Hold Procedure
        • Remedial Action - Recall Procedure
        • Statistical Techniques Procedure
        • Post Market Surveillance Procedure
        • Post Market Clinical Follow Up Plan
        • Post Market Clinical Follow Up Evaluation Report
        • Periodic Safety Update Report (PSUR) Procedure
        • Vigilance Procedure
        • Failure Investigation Procedure
    • VALIDATION PROTOCOLS >
      • Clinical Investigation Report
      • Clinical Investigation Plan
      • Ethylene Oxide (EO) Product Adoption
      • Accelerated Aging Study
      • Injection Mold Validation Procedure
      • Medical Device Software Development Plan
      • Final Cleaning Orthopedic Implants
      • Bar Sealer Operational Qualification OQ Protocol
      • Bar Sealer Performance Qualification PQ Protocol
      • Bar Sealer Qualification Protocol Bundle OQ - PQ
      • Tray Sealer Operational Qualification OQ Protocol
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      • Tray Sealer Qualification Protocol Bundle OQ - PQ
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