What is ISO/IEC 30115:2018 ?

Title: Understanding ISO/IEC 30115:2018 and ISO 14155:2018

Introduction

In today's fast-paced technological world, the need for standardized processes and procedures is more critical than ever. With the increasing number of regulations and industry standards, it can be overwhelming for organizations to keep up. One such standard that plays a crucial role in ensuring the quality and safety of technical drawings is EN ISO 31105:201In this article, we will explore the key elements of this standard and its importance in technical settings.

EN ISO 31105:2018 is an international standard developed by the European Committee for Standardization (CEN) and International Organization for Standardization (ISO). Its primary purpose is to provide guidance on technical documentation and specified requirements for the preparation of technical drawings. The standard aims to ensure clear communication of design, dimensions, and specifications across different industries and countries.

ISO 14155:2018 is another international standard that is relevant in the field of medical devices. It is an essential standard for the design, conduct, recording, and reporting of clinical investigations involving medical devices. The primary objective of ISO 14155:2018 is to ensure the ethical and scientific integrity of these investigations.

What is EN ISO 31105:2018?

EN ISO 31105:2018 is a standard that provides guidelines for the design, conduct, recording, and reporting of technical drawings. The standard is divided into five parts, each of which covers a specific aspect of technical documentation. These parts include:

* Part 1: Technical documentation - This part covers the general principles and requirements for technical documentation.

* Part 2: Specified requirements for the preparation of technical drawings - This part provides the specific requirements for the preparation of technical drawings, such as the use of standardized symbols and the inclusion of relevant information.

* Part 3: Technical specifications - This part covers the technical specifications that must be included in the technical documentation.

* Part 4: Pattern drawings - This part provides the requirements for creating patterns and drawings that represent the technical specifications.

* Part 5: Test procedures - This part covers the requirements for conducting tests to verify the conformity of the technical documentation.

The primary objective of EN ISO 31105:2018 is to ensure clear communication of design, dimensions, and specifications across different industries and countries. By following the guidelines outlined in this standard, manufacturers can demonstrate compliance with regulatory requirements and industry best practices.

What is ISO 14155:2018?

ISO 14155:2018 is an international standard that is relevant in the field of medical devices. It is an essential standard for the design, conduct, recording, and reporting of clinical investigations involving medical devices.

The primary objective of ISO 14155:2018 is to ensure the ethical and scientific integrity of these investigations. The standard provides guidelines for the design, conduct, recording, and reporting of clinical investigations, including the use of standardized symbols and the inclusion of relevant information.

ISO 14155:2018 is divided into four parts, each of which covers a specific aspect of the standard. These parts include:

* Part 1: Introduction - This part provides an overview of the standard and its purpose.

* Part 2: Clinical investigations - This part provides guidelines for the design, conduct, recording, and reporting of clinical investigations.

* Part 3: Ethical considerations - This part provides guidelines for ensuring the ethical conduct of clinical investigations.

* Part 4: Reporting and documentation - This part provides guidelines for the reporting and documentation of clinical investigations.

Conclusion

In conclusion, EN ISO 31105:2018 and ISO 14155:2018 are two essential standards that should be familiar to all technical organizations. By following the guidelines outlined in these standards, manufacturers can ensure the quality and safety of their products, while also demonstrating compliance with regulatory requirements and industry best practices.