What is EN ISO 13485:2012/A2:2019 ?

EN ISO 13485:2012/A2:2019 is an essential international standard for medical devices that aims to establish and maintain a quality management system (QMS) to meet regulatory requirements and ensure the safety, efficacy, and reliability of their products in the healthcare industry. This standard is designed specifically for medical devices, providing a framework for organizations to effectively control their operations, minimize risks, and deliver safe and reliable products consistently.

EN ISO 13485:2012/A2:2019 is divided into two parts, EN ISO 13485:2012 and EN ISO 13485:2012/A2:201The first part, EN ISO 13485:2012, focuses on the establishment and maintenance of an effective QMS, while the second part, EN ISO 13485:2012/A2:2019, addresses the key requirements for validating and controlling sterile barrier systems used in the production of pharmaceutical products.

EN 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 designed to ensure the safety and quality of pharmaceutical products, particularly those that are terminally sterilized.

The primary purpose of EN ISO 13408-2:2019 is to establish guidelines for the validation and control of sterile barrier systems used in pharmaceutical manufacturing processes. These systems are critical in ensuring the integrity and sterility of medicinal products, particularly those that are terminally sterilized.

EN ISO 13408-2:2019 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. By adhering to the requirements outlined in EN ISO 13408-2, pharmaceutical companies can minimize the risk of contamination, maintain product quality, and ensure the safety of patients who rely on their products.

In conclusion, EN ISO 13485:2012/A2:2019 is an essential international standard for medical devices that provides a framework for organizations to meet regulatory requirements and ensure the safety, efficacy, and reliability of their products in the healthcare industry. EN 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, ensuring the safety and quality of pharmaceutical products.