What is ISO 13408-3: 2018 ?

ISO 13408-3: 2018 is an essential international standard that outlines the requirements for medical device manufacturers to ensure the safety and effectiveness of their products. In this technical article. we will explore the significance of this standard and its key requirements. as well as how it ensures the quality management of medical devices.

ISO 13408-3: 2018 is a standard that provides a systematic framework for medical device manufacturers to ensure regulatory compliance and safety of medical devices. It is tailored specifically to the medical device industry and serves as a harmonizing mechanism for different countries and regions. By adhering to the requirements outlined in ISO 13408-3: 2018. medical device manufacturers can demonstrate their commitment to delivering safe and effective products to the market while complying with legal and regulatory obligations.

ISO 13408-2: 2019 is a technical standard that focuses on the validation and control of sterile barrier systems used in the production of pharmaceutical products. This standard is critical in ensuring the integrity and sterility of medicinal products. particularly those that are terminally sterilized. EN ISO 13408-2: 2019 provides guidelines for the validation and control of sterile barrier systems. including the testing and monitoring processes. to help manufacturers implement robust processes and systems that comply with regulatory requirements.

ISO 13408-3: 2018 plays a vital role in ensuring the safety and effectiveness of medical devices. while complying with legal and regulatory obligations. By adhering to the requirements outlined in this standard. medical device manufacturers can minimize the risk of contamination. maintain product quality. and ensure the safety of patients who rely on their products. EN ISO 13408-2: 2019 is a valuable tool for the validation and control of sterile barrier systems. helping manufacturers to ensure the integrity and sterility of their medical devices.