Health Care Technology Official British Standard

ISO 14708-1:2014

Comprehensive medical implant standard ISO 14708-1:2014 outlines requirements for active implantable medical devices. Ensure compliance and patient safety with this essential British Standard.

## ISO 14708-1:2014 - Active Implantable Medical Devices### Comprehensive Standard for Medical Implant Safety and ComplianceISO 14708-1:2014 is the essential British Standard for active implantable medical devices. This comprehensive standard outlines the general requirements for the safety, design, and performance of active implantable devices, ensuring the protection of patient health and safety.Whether you manufacture cardiac pacemakers, neurostimulators, or other active implants, compliance with ISO 14708-1 is critical. This standard provides the technical specifications and testing procedures to verify the safety and functionality of your medical devices.### Key Requirements and Specifications- **General Requirements**: Covers fundamental design, construction, and performance criteria for active implants- **Biocompatibility**: Outlines testing and evaluation of materials used in device construction- **Electromagnetic Compatibility**: Ensures devices are shielded from external electromagnetic interference- **Thermal Safety**: Specifies limits on temperature increases during normal operation and fault conditions- **Reliability and Lifetime**: Defines requirements for device longevity and resistance to mechanical stress### Benefits of ISO 14708-1 Compliance- **Ensure Patient Safety**: Rigorous standards protect patients from device malfunctions or adverse biological reactions- **Streamline Regulatory Approval**: Demonstrate compliance with global medical device regulations- **Enhance Brand Reputation**: Show your commitment to the highest quality and safety standards- **Competitive Advantage**: Meet or exceed industry benchmarks for active implant performance and reliability### Stay Up-to-Date with the Latest StandardsThis 2014 edition of ISO 14708-1 reflects the most current best practices and regulatory requirements for active implantable medical devices. Ensure your products meet these essential standards by ordering your copy today.

Technical Information

Health Care Technology
BSI Group
Specification Details
  • Implants for surgery
  • Active implantable medical devices - General requirements for safety, marking and for information to be provided by the manufacturer
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