Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2025); German and English version prEN ISO 11135:2025

Acceptance (approval)*Acceptance specification*Checks*Commissioning*Definitions*Ethylene oxide*Evaluations*Examination (quality assurance)*Germicides*Hygiene*Inspection*Instructions*Maintenance*Medical devices*Medical equipment*Medical products*Medical sciences*Medical technology*Microbiological analysis*Operation*Operators (personnel)*Personnel*Public health*Public health protection*Qualifications*Quality management*Routine tests*Safety*Safety engineering*Safety requirements*Specification (approval)*Sterilization (birth control)*Sterilization (hygiene)*Sterilizers*Storage*Surveillance (approval)*Testing*Validation

Standard No: DIN EN ISO 11135:2025-08  |  Publisher: DIN