BS EN ISO 25539-1:2017

The BS EN ISO 25539-1:2017 standard, officially cataloged under the ISBN 978 0 539 00881 4, represents a critical component in the field of health care technology, specifically addressing the characteristics and requirements for the assessment of medical devices that are introduced into the vascular system.

As an identical international standard recognized by the European Committee for Standardization, it serves as a comprehensive authoritative guide for professionals involved in medical device evaluation and development. This document, released on March 31, 2017, provides comprehensive guidelines designed to ensure the safety and efficacy of vascular intervention devices.

At a price point of £330.00, this invaluable reference features specifications that highlight testing protocols and performance criteria that must be adhered to during procurement and usage phases, ensuring that every step in the device lifecycle meets strict safety and quality standards.

Key Features

• Standardized Testing Methods: Contains established methodologies for testing vascular medical devices to ensure consistent and reliable results.
• Performance Characterization: Details specific performance characteristics essential for evaluating a device's suitability for application in healthcare.
• Regulatory Compliance: Facilitates adherence to regulatory requirements necessary for device approval in various markets.
• Comprehensive Data Interpretation: Provides guidelines for interpreting data obtained from performance tests, thus supporting informed decision-making in clinical settings.

This standard is essential for manufacturers, healthcare professionals, and regulatory bodies engaged in the life cycle of vascular devices, from conception through to clinical use. With a focus on ensuring patient safety and optimizing performance outcome metrics, BS EN ISO 25539-1:2017 is a pivotal resource that aids in fostering innovation within the health care sector.

The guidelines set forth in this document not only assist in the design and manufacturing phases but also play a crucial role in post-market surveillance and device evaluation, thereby contributing to ongoing health care improvements.

In summary, BS EN ISO 25539-1:2017 stands at the intersection of technology and patient safety. By applying its rigorous standards, practitioners and manufacturers can enhance the quality of healthcare delivery, ensuring that vascular medical devices meet the highest standards of performance and reliability.

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