BS ISO 11608-6:2022 Needle-based Injection Systems for Medical Use

Standard Number: BS ISO 11608-6:2022

Pages: 30

Released: 2022-04-25

ISBN: 978 0 539 02689 4

Name: Needle-based Injection Systems for Medical Use. Requirements and Test Methods On-body Delivery Systems

Status: Standard

Overview

The BS ISO 11608-6:2022 standard is a comprehensive guide that sets forth the requirements and test methods for needle-based injection systems specifically designed for medical use. This standard focuses on on-body delivery systems, ensuring that these devices meet the highest levels of safety, efficacy, and reliability.

Key Features

• Comprehensive Coverage: This standard covers all essential aspects of needle-based injection systems, from design and manufacturing to performance and safety testing.
• 30 Pages of Detailed Information: With 30 pages of in-depth content, this standard provides a thorough understanding of the requirements and test methods for on-body delivery systems.
• Latest Release: Released on April 25, 2022, this standard incorporates the most recent advancements and best practices in the field.
• International Standard: As an ISO standard, it is recognized and respected globally, ensuring that your products meet international quality and safety benchmarks.

Why Choose BS ISO 11608-6:2022?

Choosing the BS ISO 11608-6:2022 standard for your needle-based injection systems ensures that you are adhering to the highest levels of quality and safety. This standard is designed to help manufacturers, healthcare providers, and regulatory bodies ensure that on-body delivery systems are safe, effective, and reliable for medical use.

Ensuring Patient Safety

Patient safety is paramount in the medical field, and this standard provides the guidelines necessary to ensure that needle-based injection systems are safe for use. By following the requirements and test methods outlined in this standard, manufacturers can minimize the risk of device failure and adverse events, thereby protecting patients and enhancing their overall experience.

Enhancing Product Performance

The BS ISO 11608-6:2022 standard outlines rigorous performance criteria that needle-based injection systems must meet. This ensures that these devices deliver medication accurately and consistently, improving treatment outcomes and patient satisfaction. By adhering to this standard, manufacturers can demonstrate their commitment to quality and performance.

Facilitating Regulatory Compliance

Compliance with international standards is often a prerequisite for regulatory approval in many countries. The BS ISO 11608-6:2022 standard provides a clear framework for meeting regulatory requirements, making it easier for manufacturers to gain approval for their products in multiple markets. This can help streamline the approval process and reduce time-to-market for new products.

Detailed Content

The BS ISO 11608-6:2022 standard is divided into several sections, each covering a specific aspect of needle-based injection systems. These sections include:

• Scope and Field of Application: Defines the scope of the standard and the types of devices it covers.
• Normative References: Lists the other standards and documents that are referenced within this standard.
• Terms and Definitions: Provides clear definitions for the key terms used throughout the standard.
• General Requirements: Outlines the general requirements that all needle-based injection systems must meet.
• Design and Manufacturing Requirements: Specifies the design and manufacturing criteria for these devices.
• Performance Requirements: Details the performance criteria that needle-based injection systems must meet to ensure safety and efficacy.
• Test Methods: Describes the test methods that should be used to evaluate the performance and safety of these devices.
• Labeling and Information: Provides guidelines for the labeling and information that should be provided with these devices.

Who Should Use This Standard?

The BS ISO 11608-6:2022 standard is essential for a wide range of stakeholders in the medical field, including:

• Manufacturers: Ensures that needle-based injection systems are designed and manufactured to the highest standards of quality and safety.
• Healthcare Providers: Provides assurance that the devices they use meet rigorous safety and performance criteria.
• Regulatory Bodies: Offers a clear framework for evaluating the safety and efficacy of needle-based injection systems.
• Researchers and Developers: Provides valuable insights into the requirements and test methods for these devices, helping to guide the development of new and innovative products.

Conclusion

The BS ISO 11608-6:2022 standard is an invaluable resource for anyone involved in the design, manufacture, or use of needle-based injection systems for medical use. By adhering to the requirements and test methods outlined in this standard, stakeholders can ensure that these devices are safe, effective, and reliable, ultimately improving patient outcomes and advancing the field of medical technology.

BS ISO 11608-6:2022

This standard BS ISO 11608-6:2022 Needle-based injection systems for medical use. Requirements and test methods is classified in these ICS categories:

• 11.040.25 Syringes, needles and catheters