ISO 11137-1:2025

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ISO 11137-1:2025 is an international standard focused on the sterilization of health care products using radiation, specifically detailing the requirements for developing, validating, and controlling radiation sterilization processes for medical devices. It provides guidance on ensuring the effectiveness and reliability of radiation sterilization methods, such as those using Cobalt 60, Cesium 137, electron beams, and X-rays.