BS EN ISO 11135:2014+A1:2019 - The Essential Standard for Ethylene Oxide Sterilization

The British Standard BS EN ISO 11135:2014+A1:2019 outlines stringent requirements for the validation and routine control of sterilization processes utilizing ethylene oxide (EO). This essential document is tailored for organizations involved in the health care technology sector, serving to ensure that sterile medical devices meet both safety and efficacy standards.

As the healthcare landscape becomes increasingly complex, adherence to reliable and recognized standards is paramount. BS EN ISO 11135 provides a comprehensive framework for manufacturers and sterilization service providers, ensuring that sterilization procedures effectively eliminate all viable microorganisms without compromising the quality of the medical devices. The latest amendment, A1:2019, updates and clarifies the existing protocol, reflecting advancements in sterilization technology and practices.

Key Features of BS EN ISO 11135:2014+A1:2019

• Identical Adoption: This international standard is an identical adoption of ISO 11135:2014, ensuring consistency in global practices.
• Comprehensive Guidance: Provides detailed methodologies for validating ethylene oxide sterilization processes, including dose verification, environmental considerations, and biological indicator selection.
• Risk Management: Guides institutions in assessing risks associated with the sterilization process, aligning practices with international safety standards.
• Quality Assurance: Establishes requirements for routine control of ethylene oxide sterilization, ensuring ongoing compliance with established manufacturer specifications.

Benefits of Compliance

Compliance with BS EN ISO 11135:2014+A1:2019 not only ensures regulatory acceptance but also enhances operational efficiency. Organizations that implement its guidelines can expect to see:

• Improved product safety for patients and users.
• Increased confidence from regulatory bodies and stakeholders.
• Enhanced marketability of sterile medical devices.

Purchase and Format

This standard is available in both PDF and hardcopy formats, priced at £330.00, and is an essential resource for any organization involved in the sterilization of medical devices. By choosing BS EN ISO 11135:2014+A1:2019, you equip your institution with the tools necessary to ensure best practices in ethylene oxide sterilization.

Invest in BS EN ISO 11135:2014+A1:2019 to solidify your commitment to quality, safety, and compliance in healthcare technology.