BS ISO 16142-2:2017

Overview

BS ISO 16142-2:2017 provides essential principles of safety and performance for medical devices, specifically focusing on in vitro diagnostic (IVD) medical devices. This standard outlines general essential principles and additional specific essential principles that must be adhered to in order to ensure the safety and effectiveness of IVD devices. It serves as a crucial guide for manufacturers, regulatory bodies, and compliance professionals in the healthcare technology sector.

Key Requirements

The standard delineates a comprehensive framework that includes:

• General Essential Principles: These principles apply to all medical devices and encompass aspects such as risk management, performance evaluation, and post-market surveillance.
• Specific Essential Principles for IVDs: These principles address unique considerations for IVD devices, including analytical and clinical performance, as well as the need for appropriate labelling and instructions for use.
• Guidance on Standards Selection: The standard provides direction on selecting relevant standards that can be used to demonstrate compliance with the essential principles.

Implementation Benefits

Adopting BS ISO 16142-2:2017 can yield significant benefits for organisations involved in the design, manufacture, and regulation of IVD medical devices:

• Enhanced Safety: By following the essential principles outlined in the standard, manufacturers can mitigate risks associated with IVD devices, ensuring patient safety.
• Improved Compliance: Compliance with this standard facilitates adherence to regulatory requirements, thereby streamlining the approval process for new devices.
• Market Confidence: Demonstrating compliance with recognised standards can enhance market confidence among healthcare providers and patients, fostering trust in the safety and efficacy of IVD products.

Compliance Value

Compliance with BS ISO 16142-2:2017 not only aids in meeting regulatory obligations but also positions organisations favourably in a competitive market. The standard is aligned with international best practices, thereby facilitating global market access for IVD devices. Furthermore, it provides a structured approach to risk management and performance evaluation, which are critical components of the medical device lifecycle.

In conclusion, BS ISO 16142-2:2017 is an essential resource for compliance professionals and manufacturers of IVD medical devices. By adhering to its principles, organisations can ensure the safety and performance of their products, ultimately contributing to better health outcomes.