BS EN ISO 22112:2017 - Comprehensive Standard for Medical Device Planning

The BS EN ISO 22112:2017 standard is a crucial document designed for healthcare technology stakeholders engaged in the meticulous planning and assessment of medical devices. This standard presents a systematic approach to the classification and evaluation of medical device performance, ensuring that healthcare providers can operate within established international frameworks while maintaining a focus on patient safety and device efficacy.

Published on September 15, 2017, the BS EN ISO 22112:2017 is an identical adoption of the ISO 22112:2017 and is part of a collection of standards that cater to the evolving landscape of health technology. The standard focuses on various aspects of medical device lifecycle management, including design, testing, risk management, and performance monitoring.

This standard aims to provide clarity and consistency in the healthcare sector, which is vital for maintaining high-quality care. Whether you are a manufacturer, regulatory body, or healthcare provider, adhering to BS EN ISO 22112:2017 will enhance your organization’s ability to meet regulatory requirements and provide safe, effective products to patients.

Key Features of BS EN ISO 22112:2017

• Systematic Framework: The standard outlines a structured methodology to classify and assess medical devices effectively, aligning with international practices.
• Focus on Patient Safety: Key performance indicators and evaluation metrics are integrated to emphasize patient safety throughout the device lifecycle.
• Regulatory Compliance: Ensures compliance with relevant legislative frameworks, aiding organizations in navigating complex regulatory landscapes.
• Enhanced Performance Monitoring: It provides guidelines for continuous monitoring of medical device performance post-market, contributing to ongoing improvements.

Benefits of Implementation

Implementing BS EN ISO 22112:2017 can lead to improved operational efficiencies, reduced errors in device usage, and overall enhancement of patient safety and satisfaction. By adhering to this standard, healthcare organizations can position themselves as leaders in quality assurance, ultimately leading to greater consumer trust and market competitiveness.

Investing in the BS EN ISO 22112:2017 is essential for any organization involved in the healthcare sector aiming to deliver high-quality, compliant medical devices. Available in both PDF and hardcopy formats, this standard can be conveniently accessed and integrated into your organization’s operational framework.

For further details and to purchase this standard, please visit the official standards website.