ISO 45001:2018 is applicable to any organization regardless of its size, type and activities. It is applicable to the OH&S risks under the organization's control, taking into account factors such as the context in which the organization operates and the needs and expectations of its workers and other interested parties.
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices.
The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk.
ISO 14971 Medical devices — Application of risk management to medical devices is an ISO standard for the application of risk management to medical devices.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories.
ISO 13485 is a quality management system standard that allows an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.