PD ISO/TS 10993-19:2020 Overview

The PD ISO/TS 10993-19:2020 standard is an essential reference document within the realm of health care technology, specifically tailored for professionals involved in the assessment of medical devices. Published on March 16, 2020, this technical specification addresses the essential biological evaluation of medical devices, guiding users through the assessment of potential risks posed by harmful substances resulting from the materials used in manufacturing.

This standard is of paramount importance for manufacturers, regulators, and quality assurance professionals who seek to ensure that their medical devices meet the stringent safety requirements outlined in global health regulations. PD ISO/TS 10993-19:2020 encompasses a nuanced approach to evaluating biological risks linked to device materials, providing a framework that aligns with international standards.

Key Features

• Material Compatibility: Examines the interaction of medical device materials with biological systems, aiding manufacturers in selecting suitable materials to mitigate adverse effects.
• Risk Management: Establishes methodologies for assessing chemical and toxicological risks associated with materials, ensuring comprehensive risk management strategies.
• Framework for Testing: Offers guidelines for in vitro and in vivo testing, promoting consistency and reliability in the evaluation process.
• Compliance and Regulation: Facilitates compliance with international medical device regulations, enhancing the credibility of manufacturers in the global marketplace.

Why Choose PD ISO/TS 10993-19:2020?

Utilizing the PD ISO/TS 10993-19:2020 standard equips health care technology stakeholders with critical insights necessary for safe and effective device design and development. By embracing its guidelines, organizations can not only streamline their product development processes but also bolster their confidence in the safety and efficacy of their medical products.

In an industry driven by innovation and regulatory scrutiny, the adoption of this standard can serve as a competitive advantage. With a comprehensive understanding of biological evaluation, organizations can foster trust with regulatory bodies and healthcare professionals, ensuring that their devices perform safely for end-users.

Availability

The PD ISO/TS 10993-19:2020 standard is available for purchase in both PDF and hardcopy formats for £220.00. By investing in this standard, you are securing a vital asset in your quality assurance and regulatory compliance toolkit.