BS EN ISO 13408-6:2021 - Sterilization of Healthcare Technology

The BS EN ISO 13408-6:2021 is a critical standard that defines the requirements for the sterilization processes utilized in healthcare technologies. As a part of the broader ISO 13408 series, it focuses specifically on aseptic processing, ensuring the highest levels of sterility in medical and pharmaceutical manufacturing. This essential document is designed for organizations engaged in the production of sterile products and provides comprehensive guidelines that align with best practices and regulatory standards.

Key Features and Scope

• Applicability: BS EN ISO 13408-6:2021 is applicable to all healthcare technologies where sterility is paramount, including bio-pharmaceuticals, medical devices, and laboratory products.
• Guidelines for Aseptic Processing: This standard details the principles of aseptic processing, emphasizing critical controls necessary to minimize contamination risks throughout the manufacturing process.
• Risk Management: The standard encompasses methodologies for risk assessment, helping organizations to systematically identify, evaluate, and mitigate risks associated with aseptic processing.

Technical Specifications

Published on May 24, 2021, and available in both PDF and hardcopy formats, BS EN ISO 13408-6:2021 comprises 48 pages of detailed guidelines and requirements. The standard is identified with an ISBN number 978 0 580 98817 2 and is priced at £406.00.

Compliance and Implementation

Compliance with BS EN ISO 13408-6:2021 is crucial for organizations wishing to demonstrate their commitment to safety and efficacy in sterile product manufacturing. Implementing the practices recommended in this standard not only ensures regulatory compliance but also enhances overall product quality and reliability in the healthcare market.

Why Choose BS EN ISO 13408-6:2021?

This standard stands as an authoritative resource for professionals in healthcare technology, providing a well-defined framework that supports the development of effective sterilization processes. Utilizing this standard promotes operational excellence, boosts consumer confidence, and assures stakeholders of the quality and integrity of sterile products.

Equip your organization with the latest insights and requirements outlined in BS EN ISO 13408-6:2021. Investing in this standard is a step toward achieving excellence in sterile manufacturing practices.