BS EN ISO 8871-3:2004+A1:2019

Comprehensive Healthcare Technology Standard

BS EN ISO 8871-3:2004+A1:2019 is a critical British Standard that specifies requirements for the design, construction, and performance of non-active surgical implants. This standard is an essential reference for healthcare professionals, medical device manufacturers, and regulatory bodies to ensure the safety and quality of surgical implants.

Key Features and Benefits:

- Ensures compliance with the latest regulatory requirements for surgical implants- Provides detailed technical specifications for the design, materials, and testing of non-active surgical implants- Helps to improve patient safety and outcomes by setting high standards for implant quality and performance- Supports the development of innovative and reliable medical devices- Applicable to a wide range of surgical implants, including joint replacements, dental implants, and other prosthetic devices

Detailed Technical Specifications

BS EN ISO 8871-3:2004+A1:2019 covers a comprehensive range of technical requirements for non-active surgical implants, including:- Design and Construction: - Requirements for the design, materials, and manufacturing processes used in the production of surgical implants - Specifications for the dimensional accuracy, surface finish, and mechanical properties of implants - Guidance on the selection of appropriate materials, such as metals, ceramics, and polymers- Performance and Testing: - Detailed test methods for evaluating the mechanical, physical, and chemical properties of surgical implants - Requirements for the assessment of biocompatibility and the potential for adverse biological reactions - Specifications for the sterilization and packaging of implants to ensure sterility and integrity during storage and transportation- Labeling and Documentation: - Requirements for the labeling and packaging of surgical implants, including the provision of essential information for healthcare professionals and patients - Guidance on the documentation and record-keeping necessary to demonstrate compliance with the standard

Ensuring Compliance and Quality

By adhering to the requirements of BS EN ISO 8871-3:2004+A1:2019, healthcare providers, medical device manufacturers, and regulatory bodies can ensure the safety, quality, and performance of non-active surgical implants. This standard is an essential reference for anyone involved in the design, production, or use of these critical medical devices, helping to improve patient outcomes and support the development of innovative healthcare technologies.