BS EN 14136:2004

Overview of BS EN 14136:2004

BS EN 14136:2004 is a crucial standard in the health care technology sector, addressing the safety and efficacy of medical devices. This standard defines protocols for the assessment and validation of medical systems, ensuring that health care providers can operate with minimized risk.

Key Specifications

• ISBN: 0 580 43819 8
• Price: £134.00
• Status: Identical to EN 14136:2004, published on May 26, 2004
• Format: Available in both PDF and hardcopy

Importance of Compliance

Compliance with BS EN 14136:2004 guarantees that health care technology products meet rigorous safety and performance criteria. Organizations adhering to this standard benefit from:

• Enhanced patient safety through rigorous testing and validation
• Increased trust from regulatory bodies, stakeholders, and patients alike
• Improved market access across Europe and beyond, as compliance ensures alignment with EU directives

Applications in Health Care

BS EN 14136:2004 is utilized by manufacturers and developers in various health care domains, including:

• Medical device production
• Health care software development
• Clinical laboratory equipment
• Home care and monitoring devices

Benefits of Implementing BS EN 14136:2004

Adopting the guidelines outlined in this standard provides organizations with numerous advantages:

• Facilitation of safer medical technology through improved design processes
• Streamlined approval processes for new devices and systems
• Holistic risk management strategies that address potential hazards

Conclusion

BS EN 14136:2004 represents a fundamental step toward ensuring the reliability and safety of health care technology. It is essential for any organization seeking to elevate their standards of practice and product quality in the competitive medical device market.