ETO Sterilization Validation Regulatory Requirements
Ensuring full compliance with international standards is the cornerstone of Ethylene Oxide (ETO) Sterilization. Validation procedures must follow a rigorous framework to guarantee medical device safety and efficacy. Below is the comprehensive list of ETO Sterilization Regulatory Requirements and ISO standards that govern the industry today.
01
ISO 11135: 2014
Sterilization of health-care products — Ethylene oxide — Requirements for development, validation and routine control of a sterilization process.
02
EN 1422: 2014
Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods.
03
ISO 13485
Medical devices — Quality management systems — Requirements for regulatory purposes.
04
ISO 11138-2: 2017
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes.
05
ISO 10993-7: 2008
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals.
06
AAMI TIR28: 2016
Product adoption and process equivalence for ethylene oxide sterilization.
07
AAMI TIR16: 2017
Microbiological aspects of ethylene oxide sterilization.
08
ISO 11139: 2018
Sterilization of health care products — Vocabulary of terms used in sterilization standards.
09
ISO 11737-1: 2006
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products.
10
ISO 14937: 2009
General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process.
BOCON’s Commitment to Compliance
Navigating the complex landscape of ETO Sterilization Regulatory Requirements can be challenging. BOCON equipment is designed to meet and exceed these global ISO and AAMI standards, ensuring that your sterilization facility passes every audit with confidence. From ISO 11135 validation support to residual analysis guidance (ISO 10993-7), our team is here to support your compliance journey.