What is EN ISO 13485:2016/AC:2019 ?

EN ISO 13485:2016/AC:2019 is a critical technical standard for pharmaceutical manufacturers, which focuses on the validation and control of sterile barrier systems used in the production of medicinal products. The standard is designed to ensure the integrity and sterility of medical products, which are crucial for patient safety and quality of life.

EN ISO 13408-2:2019 provides guidelines for the validation and control of sterile barrier systems, helping pharmaceutical companies minimize the risk of contamination, maintain product quality, and ensure the safety of patients. The standard outlines various aspects of sterile barrier system design, testing, and monitoring, ensuring manufacturers implement robust processes and systems that comply with regulatory requirements.

EN ISO 15763:2019 is a technical standard focused on the management of measurement processes in industries. The standard aims to ensure that measurements carried out by organizations are accurate, reliable, and traceable, ultimately enhancing product quality and customer satisfaction.

EN ISO 15763:2019 provides guidance on implementing effective measurement management systems, addressing key elements such as planning, execution, analysis, documentation, and improvement of measurement processes. This allows organizations to continuously monitor and optimize their measurement systems, ensuring the accuracy and reliability of their measurements.

In conclusion, EN ISO 13408-2:2019 and EN ISO 15763:2019 are essential technical standards that play a crucial role in ensuring the safety and quality of medical products. Compliance with these standards is vital for professional organizations, as it helps maintain the integrity and effectiveness of their sterile barrier systems and measurement management systems.