What is EN ISO 717-1:2013+A1:2015 ?

Title: Understanding EN ISO 717-1:2013+A1:2015: A Comprehensive Guide to Technical Documentation Standards

Technical documentation is a critical aspect of any industry, as it helps ensure consistency, efficiency, and safety.EN ISO 13567:2014 and EN ISO 13408-2:2019 are two of the most significant technical standards that help achieve these goals. In this article, we will provide a comprehensive guide to EN ISO 717-1:2013+A1:2015, which is the international standard for the organization and structuring of technical product documentation using computer-aided design (CAD).

What is EN ISO 13567:2014?

EN ISO 13567:2014 is a standard that provides guidelines for the organization and structuring of technical product documentation using CAD. Its purpose is to establish a common framework for defining and structuring CAD drawings within an organization or industry. By adhering to this standard, companies can improve communication, collaboration, and information exchange among different stakeholders involved in CAD-based projects.

Key Requirements of EN ISO 13567:2014

EN ISO 13567:2014 has several key requirements that companies must meet to ensure compliance with the standard. These requirements include:

The technical product documentation should be organized and structured according to a specific framework.

The technical product documentation should include a description of the design, drawing styles, and symbols used in the design.

The technical product documentation should include a description of the intended users, their roles, and the information they need to access the design.

The technical product documentation should include a description of the design review process, including the stakeholders involved and the criteria they use to review the design.

The technical product documentation should include a description of the design validation process, including the methods used to validate the design and the criteria they use to validate it.

What is EN ISO 13408-2:2019?

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 medicinal products. These systems are critical in ensuring the integrity and sterility of medicinal 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.

Key Requirements of EN ISO 13408-2:2019

EN ISO 13408-2:2019 has several key requirements that companies must meet to ensure compliance with the standard. These requirements include:

The sterile barrier system design should be validated and verified to ensure it meets the requirements of the standard.

The sterile barrier system should be tested to ensure it meets the requirements of the standard.

The results of the testing should be documented and included in the technical product documentation.

The sterile barrier system design should be in compliance with the requirements of the standard.

Conclusion:

EN ISO 717-1:2013+A1:2015 and EN ISO 13408-2:2019 are two significant technical standards that help ensure the consistency, efficiency, and safety of technical product documentation. By adhering to these standards, companies can improve communication, collaboration, and information exchange among different stakeholders involved in their projects. By understanding the key requirements of these standards, companies can minimize the risk of contamination, maintain product quality, and ensure the safety of patients who rely on their products.