ETO Sterilization Validation Regulatory Requirements
Ensuring full compliance with international standards is the cornerstone of 环氧乙烷 (排队) 消毒. 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
国际标准化组织 11135: 2014
Sterilization of health-care products — Ethylene oxide — Requirements for development, validation and routine control of a sterilization process.
02
在 1422: 2014
Sterilizers for medical purposes — Ethylene oxide sterilizers — Requirements and test methods.
03
国际标准化组织 13485
Medical devices — Quality management systems — Requirements for regulatory purposes.
04
国际标准化组织 11138-2: 2017
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes.
05
国际标准化组织 10993-7: 2008
Biological evaluation of medical devices — Part 7: 环氧乙烷灭菌残留物.
06
AAMI TIR28: 2016
Product adoption and process equivalence for ethylene oxide sterilization.
07
AAMI TIR16: 2017
Microbiological aspects of ethylene oxide sterilization.
08
国际标准化组织 11139: 2018
Sterilization of health care products — Vocabulary of terms used in sterilization standards.
09
国际标准化组织 11737-1: 2006
Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products.
10
国际标准化组织 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. 从 国际标准化组织 11135 验证 support to residual analysis guidance (国际标准化组织 10993-7), our team is here to support your compliance journey.