BS EN ISO 11608-1:2022 Needle-based Injection Systems for Medical Use

Standard Number: BS EN ISO 11608-1:2022

Pages: 86

Released: 2022-06-24

ISBN: 978 0 539 01994 0

Name: Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems

Status: Standard

Overview

The BS EN ISO 11608-1:2022 standard is an essential document for anyone involved in the design, production, and use of needle-based injection systems for medical purposes. This comprehensive standard outlines the requirements and test methods necessary to ensure the safety, reliability, and performance of these critical medical devices.

Key Features

• Comprehensive Coverage: Spanning 86 pages, this standard provides detailed guidelines and specifications for needle-based injection systems.
• Up-to-Date Information: Released on June 24, 2022, this standard reflects the latest advancements and best practices in the field.
• International Recognition: As an ISO standard, it is recognized and respected globally, ensuring that products meeting these requirements are accepted worldwide.
• ISBN: 978 0 539 01994 0, making it easy to reference and locate in libraries and databases.

Why This Standard Matters

Needle-based injection systems are widely used in medical settings for the administration of medications, vaccines, and other therapeutic agents. Ensuring that these devices meet stringent safety and performance criteria is crucial for patient safety and treatment efficacy. The BS EN ISO 11608-1:2022 standard provides a robust framework for manufacturers and healthcare providers to follow, helping to minimize risks and enhance the quality of care.

Detailed Requirements and Test Methods

This standard delves into various aspects of needle-based injection systems, including:

• Design and Construction: Specifications for materials, dimensions, and overall design to ensure compatibility and safety.
• Performance Testing: Methods for evaluating the functionality and reliability of the injection systems under different conditions.
• Safety Features: Guidelines for incorporating safety mechanisms to prevent accidental needle sticks and other hazards.
• Labeling and Documentation: Requirements for clear and accurate labeling, as well as comprehensive documentation to support regulatory compliance.

Who Should Use This Standard?

The BS EN ISO 11608-1:2022 standard is invaluable for a wide range of stakeholders, including:

• Medical Device Manufacturers: Ensuring that products meet international standards for safety and performance.
• Healthcare Providers: Understanding the specifications and requirements of the devices they use to ensure proper handling and administration.
• Regulatory Authorities: Assessing compliance with established standards to protect public health.
• Researchers and Developers: Guiding the development of new and innovative needle-based injection systems.

Benefits of Compliance

Adhering to the BS EN ISO 11608-1:2022 standard offers numerous benefits, including:

• Enhanced Safety: Reducing the risk of device failures and adverse events.
• Improved Performance: Ensuring that injection systems function as intended, providing accurate and reliable delivery of medications.
• Regulatory Approval: Facilitating the approval process by meeting recognized international standards.
• Market Acceptance: Gaining the trust of healthcare providers and patients by demonstrating a commitment to quality and safety.

Conclusion

The BS EN ISO 11608-1:2022 standard is a critical resource for anyone involved in the development, production, and use of needle-based injection systems. By providing detailed requirements and test methods, this standard helps ensure that these essential medical devices are safe, reliable, and effective. Whether you are a manufacturer, healthcare provider, regulatory authority, or researcher, this standard is an invaluable tool for guiding your work and enhancing the quality of care.

BS EN ISO 11608-1:2022

This standard BS EN ISO 11608-1:2022 Needle-based injection systems for medical use. Requirements and test methods is classified in these ICS categories:

• 11.040.25 Syringes, needles and catheters

This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers. This document applies in cases where the NIS incorporates a prefilled syringe. However, stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below). It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). In that case, the system is completely covered by this document and applicable requirements of the ISO 11608 series. Excluded from the scope are: —    stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above); —    NISs that provide continuous delivery and require a delivery rate clinically specified in the medicinal product labelling or determined by a physician based on clinical relevance (i.e. medication efficacy) as would be the case with insulin patch pumps or traditional infusion pumps (e.g. IEC 60601-2-24, ISO 28620) associated with continuous delivery of medicinal products (e.g. insulin); —    NISs with containers that can be refilled multiple times; —    requirements relating to methods or equipment associated with user filling of containers unless they are dedicated accessories (a component necessary for primary function, whether included in the original kitted product or not); —    NISs intended for dental use; —    NISs intended for different routes of administration (e.g. intravenous, intrathecal, intraocular). NOTE       These products that are excluded might benefit from elements in this document but might not completely fulfil the basic safety and effectiveness of such products.