BS EN ISO 11607-1:2020+A1:2023 - Packaging for Terminally Sterilized Medical Devices

Ensure the highest standards of safety and reliability with the latest edition of the BS EN ISO 11607-1:2020+A1:2023 standard. This comprehensive document sets forth the essential requirements for materials, sterile barrier systems, and packaging systems used in terminally sterilized medical devices.

Key Features and Benefits

Released on November 6, 2023, this updated standard is an indispensable resource for manufacturers, quality assurance professionals, and regulatory bodies involved in the production and oversight of medical device packaging. With 84 pages of detailed guidelines, this standard ensures that your packaging systems meet the highest levels of safety and efficacy.

Comprehensive Coverage

The BS EN ISO 11607-1:2020+A1:2023 standard provides a thorough framework for the design, validation, and routine control of packaging systems. It covers:

• Materials: Specifications for the materials used in packaging to ensure they are suitable for sterilization and maintain their integrity throughout the product's shelf life.
• Sterile Barrier Systems: Requirements for the sterile barrier systems that protect the medical device from contamination until the point of use.
• Packaging Systems: Guidelines for the overall packaging system, including the design and validation processes to ensure it meets regulatory requirements and performs reliably under various conditions.

Why Choose BS EN ISO 11607-1:2020+A1:2023?

Adhering to this standard is crucial for several reasons:

• Regulatory Compliance: Ensure your packaging systems comply with international regulations, reducing the risk of non-compliance and potential recalls.
• Patient Safety: Protect patients by ensuring that medical devices remain sterile and effective until they are used.
• Quality Assurance: Implement robust quality control measures to maintain the integrity and performance of your packaging systems.
• Market Access: Facilitate access to global markets by meeting internationally recognized standards.

Technical Specifications

Here are the key technical details of the BS EN ISO 11607-1:2020+A1:2023 standard:

• Standard Number: BS EN ISO 11607-1:2020+A1:2023
• Pages: 84
• Released: 2023-11-06
• ISBN: 978 0 539 15558 7
• Name: Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems
• Status: Standard

Who Should Use This Standard?

This standard is essential for a wide range of professionals, including:

• Medical Device Manufacturers: Ensure your products are packaged to the highest standards of safety and reliability.
• Quality Assurance Professionals: Implement and maintain robust quality control measures for packaging systems.
• Regulatory Bodies: Oversee and enforce compliance with international packaging standards.
• Healthcare Providers: Ensure the medical devices you use are packaged to maintain sterility and effectiveness.

Stay Ahead with the Latest Updates

The BS EN ISO 11607-1:2020+A1:2023 standard includes the latest amendments and updates, ensuring you have the most current information at your fingertips. By staying up-to-date with the latest standards, you can ensure your packaging systems are always in compliance with the latest regulatory requirements and best practices.

Invest in Quality and Safety

Investing in the BS EN ISO 11607-1:2020+A1:2023 standard is an investment in the quality and safety of your medical device packaging systems. By adhering to this standard, you can ensure that your products meet the highest levels of safety and reliability, protecting both patients and your brand's reputation.

Conclusion

Don't compromise on the quality and safety of your medical device packaging systems. The BS EN ISO 11607-1:2020+A1:2023 standard provides the comprehensive guidelines you need to ensure your packaging systems meet the highest standards of safety and efficacy. With detailed requirements for materials, sterile barrier systems, and packaging systems, this standard is an essential resource for anyone involved in the production and oversight of medical device packaging.

Order your copy of the BS EN ISO 11607-1:2020+A1:2023 standard today and ensure your packaging systems are always in compliance with the latest international standards.

BS EN ISO 11607-1:2020+A1:2023

• 11.080.30 Sterilized packaging