BS ISO 10865-1:2012 – Comprehensive Guide for Healthcare Technology

The BS ISO 10865-1:2012 standard serves as a critical benchmark within the realm of healthcare technology, specifically addressing the requirements and guidelines for the assessment of the performance of in vitro diagnostic medical devices. Published on November 30, 2012, this document is essential for stakeholders involved in the design, manufacturing, and regulation of health technologies.

Purpose and Scope

The primary objective of BS ISO 10865-1 is to standardize the evaluation process of in vitro diagnostic systems, ensuring the safety and effectiveness of these critical medical devices. This standard provides a detailed framework that promotes consistency among service providers and manufacturers worldwide, facilitating compliance with international regulations and enhancing patient safety.

Key Features

• Identical to ISO 10865-1:2012: The document aligns closely with the International Organization for Standardization’s standards, reinforcing its credibility and global acceptability.
• Detailed Performance Assessment: BS ISO 10865-1 emphasizes rigorous performance evaluation methods, supplying stakeholders with a structured approach to data collection and analysis.
• Comprehensive Guidelines: The standard outlines essential recommendations for the design, development, and selection of diagnostic devices, ensuring that critical factors such as accuracy, reliability, and operational efficiency are not overlooked.
• Support for Regulatory Compliance: By adhering to the guidelines established in this standard, manufacturers can more readily demonstrate compliance with relevant regulatory frameworks, thereby reducing market entry barriers.

Who Should Use This Standard?

BS ISO 10865-1:2012 is an invaluable resource for various professionals, including:

• Healthcare providers looking to ensure the use of reliable diagnostic tools.
• Manufacturers of in vitro diagnostic devices aiming to meet international quality and safety standards.
• Regulatory bodies responsible for overseeing product compliance and safety in medical technologies.
• Clinical researchers conducting studies in the field of diagnostics.

Accessing the Document

The standard is available for purchase at a price of £258.00. It can be accessed in both PDF and hardcopy formats, catering to diverse user preferences. To obtain your copy and leverage this critical resource for your organization, please refer to the ISBN 978 0 580 58966 9.

Conclusion

Implementing the guidelines set forth in BS ISO 10865-1:2012 enables stakeholders to contribute effectively toward enhancing patient safety and operational efficiency in healthcare technology. By adhering to these established protocols, professionals can ensure the integrity and efficacy of in vitro diagnostic medical devices.