Ethylene Oxide (EO) Product Adoption Protocol

SKU: EO-ADOPT
$149.00
$149.00
Unavailable
per item
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
  • MS Word Format
  • ​Digital Content - Instant Download

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

Customer's also viewed

Ethylene Oxide EO Sterilization Validation Procedure | ISO 13485 | FDA QSR Compliant

$149.00
The Ethylene Oxide (EO) Sterilization Validation Procedure governs the requirements for the validation, revalidation, adoption, and routine sterilization of medical devices by EO gas in accordance with ISO 11135:2014.
  • ISO 11135:2014 Compliant
  • TIR28:2016 Compliant
  • ISO 10993-7:2008 / (R) 2012 Compliant
  • ISO 13485:2016 and FDA QSR Compliant 
  • MS Word Format
  • Digital Content - Instant Download
Shop

Gamma Irradiation Sterilization Validation Procedure | ISO 13485 | FDA QSR Compliant

$149.00
The Gamma Irradiation Sterilization Validation Procedure defines the process to validate and monitor medical device products sterilized by gamma radiation. The Gamma Sterilization Validation Procedure applies to all medical devices sterilized by gamma radiation per ISO 11137.
  • ISO 11137 Compliant
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • MS Word Format
  • Digital Content - Instant Download
Shop

Sterile Load Preparation - Release Procedure | ISO 13485 | FDA QSR Compliant

$199.00

The ISO 13485 Sterile Load Preparation and Release Procedure provides instruction preparing sterile loads, inspection of loads pre and post sterilization, and the requirements to release sterile loads for commercial distribution.

  • ISO 13485:2016 Compliant
  • CFR 801.150 Compliant
  • FDA QSR Compliant
  • MS Word Format
  • Digital Content - Instant Download
Shop

Environmental Controls Procedure | ISO 13485 | FDA QSR Compliant

$119.00

The Environmental Controls Procedure establishes cleanroom controls and monitoring requirements for cleanroom or controlled manufacturing environment use and attributes that affect cleanroom performance. ​


  • ISO 14644-2:2015 Compliant
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • MS Word Format
  • Digital Content - Instant Download
Shop
Copyright © 2010-2023