What is EN ISO 13408-1:2018 ?

EN ISO 13408-1:2018 and ISO 13408-2:2019 are two important technical standards that are critical in ensuring the safety and quality of pharmaceutical and medical device products. EN ISO 13408-1:2018 is a technical standard focused on the validation and control of sterile barrier systems used in the production of pharmaceutical products. On the other hand, ISO 13408-2:2019 is a standard specifically tailored to the medical device industry, which is designed to provide a systematic framework for ensuring the safety, quality, and regulatory compliance of medical devices.

ISO 13408-1:2018 provides guidance on various aspects of sterile barrier system design, testing, and monitoring, helping manufacturers implement robust processes and systems that comply with regulatory requirements. The standard is essential in ensuring the integrity and sterility of medicinal products, particularly those that are terminally sterilized. By adhering to the requirements outlined in ISO 13408-1:2018, pharmaceutical and medical device companies can minimize the risk of contamination, maintain product quality, and ensure the safety of patients who rely on their products.

ISO 13408-2:2019 is an international standard that is designed to provide a comprehensive system for ensuring the safety, quality, and regulatory compliance of medical devices. The standard is tailored to the medical device industry and provides a systematic framework for manufacturers to demonstrate their commitment to delivering safe and effective products to the market. By adhering to the requirements outlined in ISO 13408-2:2019, medical device manufacturers can ensure that their products meet regulatory requirements and are safe for use.

In conclusion, EN ISO 13408-1:2018 and ISO 13408-2:2019 are two important technical standards that are critical in ensuring the safety and quality of pharmaceutical and medical device products. By adhering to these standards, manufacturers can minimize the risk of contamination, maintain product quality, and ensure the safety of patients who rely on their products. These standards provide a framework for manufacturers to implement robust processes and systems that comply with regulatory requirements and ensure that their products are safe for use.