BS EN ISO 10993-1:2020

Product Overview

The BS EN ISO 10993-1:2020 is a crucial standard in the field of healthcare technology, ensuring safety and performance evaluation of medical devices. This document serves as an essential guide for manufacturers, researchers, and regulatory bodies aiming to assess biological evaluation in accordance with international best practices. With its publication on December 16, 2020, this standard represents an identical adoption of ISO 10993-1:2018, reflecting the latest advancements and requirements in biocompatibility assessment.

Purpose and Scope

BS EN ISO 10993-1:2020 provides a framework for the biological evaluation of medical devices, aiming to ensure the safety of patients and users through effective risk management processes. This standard covers the evaluation of materials used in devices that come into contact with the human body. It lays out the principles and methodologies for assessing the biocompatibility of medical devices, looking specifically at the potential biological risks associated with their use.

Key Features

• Comprehensive Guidance: The standard offers comprehensive directives for the entire biological evaluation process from initial risk assessment to detailed laboratory testing.
• Risk Management Approach: It emphasizes a risk management approach, encouraging device manufacturers to implement systematic procedures for evaluating the biological safety of their products.
• Updated Methodologies: Reflecting the latest research and practices, the standard implements updated methodologies for evaluating materials and interactions at cellular and systemic levels.
• Framework for Evaluation: BS EN ISO 10993-1 provides a clear framework for determining the testing needed based on device type, duration of contact, and potential exposure pathways.

Application

This standard is applicable across a wide range of medical devices, from implantable devices to those used for short-term contact with the body. It provides a foundation for establishing the safety of materials used in these devices, ensuring compliance with regulatory requirements in various markets. Industries involved in medical device manufacturing, testing laboratories, and regulatory authorities will find this document indispensable for both compliance and quality assurance purposes.

Purchasing Information

The BS EN ISO 10993-1:2020 is available in both PDF and hardcopy formats. Priced at £406.00, it represents a valuable investment for stakeholders committed to excellence in medical device safety and regulatory compliance. Ensure that your organization is equipped with the most reliable guidelines by securing your copy today!