ISO 11548-2:2001 - Health Care Technology Standard

The ISO 11548-2:2001 is a vital standard in the realm of health care technology, meticulously designed to provide comprehensive specifications and guidelines for the performance and safety evaluation of medical devices. As the second part in a series, it emphasizes the importance of standardization in the health care sector, ensuring both manufacturers and health care professionals operate within a framework that guarantees quality and reliability.

Published on 15th December 2001, this standard addresses crucial parameters necessary for assessing medical devices which facilitate effective patient care. Aligning with international health care protocols, ISO 11548-2:2001 supports manufacturers, regulatory bodies, and health care providers alike in understanding and implementing the necessary evaluations of device performance.

Key Features and Benefits

• Detailed Evaluation Criteria: The standard outlines specific methodologies for testing medical devices, focusing on performance metrics that are essential for patient safety and device efficacy.
• Consistency & Reliability: By adopting these standardized methods, organizations can ensure consistent results, improving the overall reliability of health care technologies in clinical applications.
• Compliance with Global Standards: This document is aligned with international standards, making it an essential reference for manufacturers seeking to expand their markets into regions with stringent health care regulations.
• Support for Innovation: The standard fosters innovation by providing a clear structure for evaluating new methodologies and technologies in the medical device landscape.

Who Should Use This Standard?

ISO 11548-2:2001 is an indispensable resource for a diverse audience within the health care ecosystem, including:

• Medical Device Manufacturers: To ensure that their products meet essential safety and performance benchmarks before reaching the market.
• Health Care Professionals: For making informed decisions regarding the selection and use of medical devices in practice.
• Quality Assurance Specialists: To uphold standards in compliance audits and quality checks relevant to health care technology.
• Regulatory Agencies: For evaluating compliance with health care regulations and standards during the certification processes.

Why Purchase ISO 11548-2:2001?

The purchase of the ISO 11548-2:2001 standard, priced at £157.00, ensures that your organization is equipped with the most reliable guidelines for implementing and assessing technology in the health care sector. Available in both PDF and hardcopy formats, this standard is easily accessible and well-structured, making it a practical addition to your professional library.