PD ISO/TS 10974:2018

Comprehensive Healthcare Technology Standard

PD ISO/TS 10974:2018 is a critical technical specification for the healthcare industry, providing detailed guidance on the assessment and mitigation of risks associated with the use of active implantable medical devices. Developed by the International Organization for Standardization (ISO), this 230-page document is an essential resource for medical device manufacturers, healthcare providers, and regulatory bodies.

Ensure Medical Device Safety and Compliance

This standard outlines a structured, systematic approach to evaluating the interactions between active implantable medical devices and the human body, with a focus on minimizing potential risks and ensuring patient safety. By adhering to the specifications outlined in PD ISO/TS 10974:2018, medical device manufacturers can demonstrate their commitment to quality, safety, and regulatory compliance.

Key Features and Benefits:

• Comprehensive guidance on risk assessment and mitigation for active implantable medical devices• Detailed technical specifications for evaluating device-body interactions, including electromagnetic compatibility and biological effects• Alignment with relevant international standards, ensuring global harmonization and acceptance• Increased confidence for healthcare providers and patients in the safety and reliability of medical devices• Streamlined regulatory approval process, reducing time-to-market and associated costs

Detailed Technical Specifications

PD ISO/TS 10974:2018 covers a wide range of technical considerations, including:• Electromagnetic compatibility (EMC) assessment• Biological effects evaluation• Mechanical and thermal safety analysis• Reliability and durability testing• Labeling and documentation requirementsThe standard also provides guidance on the development of risk management plans, the implementation of quality management systems, and the validation of medical device performance.

Ensure Regulatory Compliance and Patient Safety

By adhering to the specifications outlined in PD ISO/TS 10974:2018, medical device manufacturers can demonstrate their commitment to patient safety and regulatory compliance. This technical specification is an essential tool for navigating the complex landscape of healthcare technology, helping organizations to mitigate risks, streamline the approval process, and ultimately deliver safer, more reliable medical devices to the market.