BS EN ISO 14630:2012

Comprehensive Healthcare Technology Standard

BS EN ISO 14630:2012 is the essential standard for healthcare technology professionals. This British Standard, identical to ISO 14630:2012, provides comprehensive guidelines and requirements for the design, development, and evaluation of non-active surgical implants.

Ensure Compliance and Quality

Adhering to the specifications outlined in BS EN ISO 14630:2012 is crucial for healthcare organizations and medical device manufacturers. This standard helps ensure that non-active surgical implants meet the highest standards of quality, safety, and performance. Key areas covered include:- Design and development process- Biocompatibility and material selection- Sterilization and packaging- Labeling and instructions for use- Clinical evaluation and post-market surveillance

Improve Patient Outcomes and Safety

By implementing the guidelines in BS EN ISO 14630:2012, healthcare providers and medical device companies can:- Enhance patient safety and minimize the risk of complications- Improve the long-term performance and reliability of surgical implants- Streamline the development and approval process for new medical devices- Demonstrate compliance with regulatory requirements and industry best practices

Comprehensive Technical Specifications

BS EN ISO 14630:2012 covers a wide range of technical requirements and considerations for non-active surgical implants, including:- General design principles- Mechanical properties and testing- Corrosion and degradation resistance- Packaging and sterilization- Labeling and information to be supplied- Clinical evaluation and post-market surveillance

Ensure Compliance and Mitigate Risks

By adhering to the guidelines set forth in BS EN ISO 14630:2012, healthcare organizations and medical device manufacturers can:- Ensure compliance with regulatory requirements and industry standards- Reduce the risk of product recalls, liability issues, and patient harm- Improve the overall quality and performance of surgical implants- Streamline the development and approval process for new medical devices- Demonstrate a commitment to patient safety and quality of care

Accessible Formats

BS EN ISO 14630:2012 is available in both PDF and hardcopy formats, allowing you to access the standard in the format that best suits your needs. Whether you prefer the convenience of a digital document or the tangibility of a physical copy, we have you covered.