BS EN ISO 16061:2021 - Instruments for Use in Association with Non-Active Surgical Implants

Standard Number: BS EN ISO 16061:2021

Pages: 24

Released: 2021-04-06

ISBN: 978 0 580 51548 4

Status: Standard

Overview

The BS EN ISO 16061:2021 is a comprehensive standard that outlines the general requirements for instruments used in conjunction with non-active surgical implants. This standard is essential for manufacturers, healthcare professionals, and regulatory bodies involved in the design, production, and application of surgical instruments that are used alongside non-active implants.

Purpose and Scope

This standard provides a framework to ensure that instruments used with non-active surgical implants meet the necessary safety and performance criteria. It is designed to facilitate the harmonization of regulatory requirements and to support the development of high-quality surgical instruments that enhance patient safety and surgical outcomes.

Key Features

• Comprehensive Guidelines: The standard offers detailed guidelines on the design, materials, and testing of instruments to ensure compatibility and safety when used with non-active surgical implants.
• Quality Assurance: It emphasizes the importance of quality management systems in the manufacturing process to maintain high standards of product quality and reliability.
• Safety and Performance: The standard sets out the essential safety and performance requirements that instruments must meet to be deemed suitable for use in surgical procedures.
• International Applicability: As an ISO standard, it is recognized internationally, making it a valuable resource for global manufacturers and healthcare providers.

Benefits of Compliance

Adhering to the BS EN ISO 16061:2021 standard offers numerous benefits, including:

• Enhanced Patient Safety: By ensuring that instruments meet stringent safety and performance criteria, the risk of complications during surgical procedures is minimized.
• Regulatory Compliance: Compliance with this standard helps manufacturers meet regulatory requirements in various jurisdictions, facilitating market access and reducing the risk of non-compliance penalties.
• Improved Product Quality: The standard's emphasis on quality management systems ensures that products are consistently manufactured to high standards, enhancing their reliability and effectiveness.
• Increased Market Competitiveness: Manufacturers that adhere to international standards are often viewed more favorably by healthcare providers, leading to increased trust and market opportunities.

Target Audience

This standard is particularly relevant for:

• Manufacturers: Companies involved in the design and production of surgical instruments for use with non-active implants will find this standard invaluable for ensuring product quality and compliance.
• Healthcare Professionals: Surgeons and other medical practitioners can rely on the standard to ensure that the instruments they use meet the necessary safety and performance criteria.
• Regulatory Bodies: Organizations responsible for the oversight of medical devices can use this standard as a benchmark for evaluating the safety and efficacy of surgical instruments.

Conclusion

The BS EN ISO 16061:2021 standard is a critical resource for anyone involved in the development, production, or use of instruments associated with non-active surgical implants. By providing a clear set of guidelines and requirements, it helps ensure that these instruments are safe, effective, and of the highest quality. Compliance with this standard not only enhances patient safety but also supports manufacturers in meeting regulatory requirements and achieving market success.

BS EN ISO 16061:2021

This standard BS EN ISO 16061:2021 Instruments for use in association with non-active surgical implants. General requirements is classified in these ICS categories:

• 11.040.99 Other medical equipment
• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment.

This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.

With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.

This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.