What is EN ISO 717-1: 2013+A2: 2019 ?

EN ISO 13408-2: 2019 and EN ISO 31271: 2018 are two important technical standards that help ensure the safety, quality, and effectiveness of pharmaceutical products. EN ISO 13408-2: 2019 is focused on the validation and control of sterile barrier systems used in the production of medicinal products, while EN ISO 31271: 2018 is focused on writing clear, concise, and effective technical documentation.

EN ISO 13408-2: 2019 is a critical standard for pharmaceutical companies as it establishes guidelines for the validation and control of sterile barrier systems. These systems are critical in ensuring the integrity and sterility of medicinal products, particularly those that are terminally sterilized. 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.

EN ISO 31271: 2018 is a standard for quality management systems that provides guidelines for writing clear, concise, and effective technical documentation. The standard emphasizes the importance of clarity, accuracy, and accessibility in technical communication, ensuring that users can understand and effectively use a product or service.

In conclusion, EN ISO 13408-2: 2019 and EN ISO 31271: 2018 are both important technical standards that help ensure the safety, quality, and effectiveness of pharmaceutical products. By adhering to the guidelines outlined in these standards, pharmaceutical companies can maintain high standards for the production and quality of their products, while minimizing the risk of contamination and ensuring the safety of patients