BS ISO 16142-1:2016

Overview

BS ISO 16142-1:2016 provides essential principles of safety and performance for medical devices, specifically addressing non-in vitro diagnostic (non-IVD) medical devices. This standard outlines the general essential principles and additional specific principles that manufacturers must adhere to in order to ensure the safety and effectiveness of their products. The standard serves as a guide for selecting relevant standards that align with these principles, thereby facilitating compliance with regulatory requirements.

Key Requirements

• General Essential Principles: The standard identifies fundamental safety and performance requirements applicable to all medical devices, including risk management, usability, and performance validation.
• Specific Essential Principles: Additional requirements tailored to specific categories of non-IVD medical devices are included, addressing unique risks and performance criteria.
• Guidance on Standards Selection: The standard offers guidance on how to select appropriate standards that can demonstrate compliance with the essential principles, ensuring that manufacturers can effectively navigate the regulatory landscape.

Implementation Benefits

Adopting BS ISO 16142-1:2016 can significantly enhance the safety and performance of medical devices. By following the outlined essential principles, manufacturers can:

• Improve product reliability and user safety through comprehensive risk assessment and management.
• Streamline the development process by integrating compliance considerations early in the design phase.
• Facilitate market access by ensuring that products meet both national and international regulatory requirements.
• Enhance customer confidence and satisfaction by demonstrating a commitment to quality and safety.

Compliance Value

Compliance with BS ISO 16142-1:2016 not only meets legal and regulatory obligations but also provides a competitive advantage in the healthcare technology market. By adhering to the essential principles outlined in this standard, manufacturers can:

• Reduce the likelihood of regulatory non-compliance, which can lead to costly penalties and product recalls.
• Establish a robust quality management system that aligns with international best practices.
• Enhance the credibility of their products in the eyes of regulators, healthcare providers, and patients.

In conclusion, BS ISO 16142-1:2016 is an essential standard for manufacturers of non-IVD medical devices. By implementing its principles, organisations can ensure the safety and performance of their products while achieving compliance with regulatory requirements.