Health Care Technology
Official British Standard
BS EN 62467-1:2015
Comprehensive healthcare technology standard BS EN 62467-1:2015. Ensures medical devices meet rigorous safety and performance requirements. Complies with EN 60077-5:2003, IEC 62467-1:2009.
# BS EN 62467-1:2015: Healthcare Technology Standard## OverviewBS EN 62467-1:2015 is a critical healthcare technology standard that ensures medical devices and equipment meet stringent safety and performance requirements. This standard, identical to EN 60077-5:2003 and IEC 62467-1:2009, provides a comprehensive framework for the design, manufacture, and testing of a wide range of healthcare products.## Key Specifications- **Scope:** Applies to healthcare technology and medical devices, including diagnostic, therapeutic, and assistive equipment- **Compliance:** Meets the requirements of EN 60077-5:2003, EN 62467-1:2015, and IEC 62467-1:2009- **Publication Date:** November 30, 2015- **Format:** Available in PDF and hardcopy## Benefits of ComplianceAdhering to the BS EN 62467-1:2015 standard offers numerous benefits for healthcare organizations and medical device manufacturers:### Improved Patient SafetyThe standard's rigorous safety requirements help ensure that medical devices and equipment pose minimal risk to patients. This includes provisions for electrical safety, mechanical integrity, and the use of biocompatible materials.### Enhanced PerformanceBS EN 62467-1:2015 sets benchmarks for the operational performance of healthcare technology, including reliability, accuracy, and responsiveness. This helps healthcare providers deliver better patient outcomes.### Regulatory ComplianceCompliance with this standard demonstrates that medical devices meet the essential requirements of relevant EU directives, such as the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC). This facilitates market access and regulatory approval.### Competitive AdvantageBy adhering to BS EN 62467-1:2015, medical device manufacturers can differentiate their products and gain a competitive edge in the healthcare technology market.## ConclusionBS EN 62467-1:2015 is a critical standard for the healthcare industry, providing a comprehensive framework for ensuring the safety, performance, and regulatory compliance of medical devices and equipment. Compliance with this standard is essential for healthcare organizations and medical device manufacturers who are committed to delivering high-quality, safe, and effective healthcare technology solutions.
Technical Information
Health Care Technology
BSI Group
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Specification Details
- Medical electrical equipment
- Dosimetric instruments as used in brachytherapy - Instruments based on well-type ionization chambers
Official BSI Standard
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Industry Recognised