PD CEN ISO/TS 16775:2021 - Packaging for Terminally Sterilized Medical Devices

Standard Number: PD CEN ISO/TS 16775:2021

Pages: 154

Released: 2021-11-26

ISBN: 978 0 539 14192 4

Status: Standard

Overview

The PD CEN ISO/TS 16775:2021 standard provides comprehensive guidance on the application of ISO 11607-1 and ISO 11607-2, which are critical for the packaging of terminally sterilized medical devices. This standard is essential for manufacturers, quality assurance professionals, and regulatory bodies involved in the medical device industry.

Why This Standard is Essential

Ensuring the sterility of medical devices is paramount for patient safety and the effectiveness of medical procedures. The PD CEN ISO/TS 16775:2021 standard offers detailed instructions and best practices for the packaging process, ensuring that medical devices remain sterile until they are used. This guidance helps in maintaining the integrity and performance of the devices, thereby reducing the risk of infections and complications.

Key Features

• Comprehensive Guidance: Provides detailed instructions on the application of ISO 11607-1 and ISO 11607-2.
• Industry Standard: Recognized globally as a critical standard for medical device packaging.
• Patient Safety: Ensures the sterility and integrity of medical devices, reducing the risk of infections.
• Regulatory Compliance: Helps manufacturers meet regulatory requirements and quality standards.
• Detailed Documentation: With 154 pages of in-depth information, this standard covers all aspects of medical device packaging.

Who Should Use This Standard?

This standard is indispensable for a wide range of professionals in the medical device industry, including:

• Medical Device Manufacturers
• Quality Assurance Professionals
• Regulatory Affairs Specialists
• Packaging Engineers
• Healthcare Providers

Detailed Content

The PD CEN ISO/TS 16775:2021 standard is divided into several sections, each providing detailed guidance on different aspects of medical device packaging:

• Introduction: Overview of the standard and its importance.
• Scope: Defines the range of applications and limitations of the standard.
• Normative References: Lists the essential references that are indispensable for the application of the standard.
• Terms and Definitions: Provides clear definitions of key terms used in the standard.
• General Requirements: Outlines the general requirements for packaging materials and processes.
• Design and Development: Guidance on the design and development of packaging systems.
• Validation: Detailed instructions on the validation of packaging processes to ensure sterility.
• Manufacturing: Best practices for the manufacturing of packaging materials and systems.
• Quality Control: Procedures for quality control and assurance to maintain the integrity of packaging.
• Labeling: Requirements for labeling to ensure proper identification and usage of medical devices.
• Storage and Transport: Guidelines for the storage and transport of packaged medical devices to maintain sterility.

Benefits of Using This Standard

Adopting the PD CEN ISO/TS 16775:2021 standard offers numerous benefits, including:

• Enhanced Patient Safety: By ensuring the sterility of medical devices, this standard helps in reducing the risk of infections and complications.
• Regulatory Compliance: Helps manufacturers meet international regulatory requirements, facilitating market access and approval.
• Improved Quality Assurance: Provides a framework for quality assurance processes, ensuring the consistency and reliability of packaging systems.
• Cost Efficiency: By following best practices, manufacturers can reduce the risk of product recalls and associated costs.
• Global Recognition: As a globally recognized standard, it enhances the credibility and reputation of manufacturers in the medical device industry.

Conclusion

The PD CEN ISO/TS 16775:2021 standard is an essential resource for anyone involved in the packaging of terminally sterilized medical devices. With its comprehensive guidance and detailed instructions, it ensures the sterility and integrity of medical devices, thereby enhancing patient safety and meeting regulatory requirements. Whether you are a manufacturer, quality assurance professional, or regulatory specialist, this standard provides the necessary tools and knowledge to achieve excellence in medical device packaging.

PD CEN ISO/TS 16775:2021

This standard PD CEN ISO/TS 16775:2021 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 is classified in these ICS categories:

• 11.080.30 Sterilized packaging

This document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2 . It does not add to, or otherwise change, the requirements of ISO 11607-1 and ISO 11607-2 . This is an informative document, not normative. It does not include requirements to be used as basis of regulatory inspection or certification assessment activities.

The guidance can be used to better understand the requirements of ISO 11607-1 and ISO 11607-2 and illustrates the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required that this document be used to demonstrate conformity with them.

Guidance is given for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on validation requirements for forming, sealing and assembly processes is also given.

This document provides information for both healthcare facilities and the medical devices industry for terminally sterilized medical devices.

This document does not provide guidance for applications of packaging materials and systems after their opening. In the use of packaging for other purposes such as a “sterile field” or transport of contaminated items, other regulatory standards will apply.