Technical Articles

What is BS EN ISO 22301:2010 ?

What is BS EN ISO 22301:2010 and EN ISO 2226:2020?

BS EN ISO 22301:2010 and EN ISO 2226:2020 are both international technical standards that focus on improving safety, efficiency, and compatibility across various industries.

BS EN ISO 22301:2010 is a technical standard that provides guidance on the use of symbols and labels for medical devices. Specifically, it focuses on symbols that can be used to convey important information to users, such as the presence of a hazardous substance or the need for special storage conditions. The main purpose of BS EN ISO 22301:2010 is to improve patient safety and facilitate the proper use of medical devices by ensuring that medical device manufacturers and regulatory bodies are aligned in their efforts to provide clear and consistent communication to healthcare professionals, patients, and end-users.

EN ISO 2226:2020 is an international standard developed by the European Committee for Standardization (CEN) and the International Organization for Standardization (ISO) to provide guidelines and requirements for documenting human factor achievements in manufacturing systems design. This standard aims to integrate human factors considerations into the overall design process, as these factors significantly impact productivity, quality, and safety. By emphasizing the importance of human-centered design, EN ISO 2226:2020 creates a harmonized approach to maximize human performance and minimize errors.

In conclusion, both BS EN ISO 22301:2010 and EN ISO 2226:2020 are important technical standards that aim to improve safety, efficiency, and compatibility across various industries. By adhering to these standards, manufacturers and regulatory bodies can provide clear and consistent communication to healthcare professionals, patients, and end-users, ensuring that medical devices are used safely and effectively.

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