Understanding the Basics of EN ISO 218732:2018

The field of technical standards is vast and continuously evolving. Professionals in various industries often encounter different sets of specifications depending on their line of work. One such standard that holds great importance, especially in the medical device industry, is EN ISO 21873-2:2018. This article aims to provide an easy-to-understand explanation of the essentials of this standard.

Scope and Purpose

EN ISO 21873-2:2018, titled "Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling," focuses on establishing guidelines for the safe and ethical utilization of materials derived from animals, including tissues and other derivative products.

This standard aims to ensure that these materials are sourced, collected, and handled in a manner that minimizes risks related to contamination, disease transmission, and other potential hazards. Compliance with this standard is crucial to maintain the quality and safety of medical devices.

Key Elements of the Standard

The standard encompasses several key elements that manufacturers and stakeholders must consider. First and foremost, it emphasizes the need for clear documentation throughout the entire supply chain. This includes keeping records of the origin of animal tissues and derivatives, details of suppliers, and a comprehensive tracking system.

Furthermore, EN ISO 21873-2:2018 stresses the importance of implementing rigorous testing procedures. Manufacturers must conduct appropriate testing to ensure the aBS ENce of pathogens, contaminants, or chemicals that could potentially pose risks to human health when using these materials in medical devices.

Implications for the Industry

Compliance with EN ISO 21873-2:2018 has far-reaching implications for the medical device industry. Adhering to this standard not only enables manufacturers to demonstrate their commitment to quality and safety but also ensures streamlined processes throughout the supply chain.

By implementing the guidelines set forth in this standard, manufacturers can build trust with regulators and end-users, enhance their reputation, and gain a competitive edge. Moreover, elevated safety standards will instill confidence in healthcare professionals, patients, and consumers.