BS EN ISO 11608-3:2022 - Needle-based Injection Systems for Medical Use

Standard Number: BS EN ISO 11608-3:2022

Pages: 36

Released: 2023-11-13

ISBN: 978 0 539 29073 8

Name: Needle-based injection systems for medical use. Requirements and test methods Containers and integrated fluid paths

Status: Standard

Overview

Introducing the BS EN ISO 11608-3:2022, the definitive standard for needle-based injection systems for medical use. This comprehensive document outlines the requirements and test methods for containers and integrated fluid paths, ensuring the highest level of safety and efficacy in medical injection systems.

Why Choose BS EN ISO 11608-3:2022?

In the rapidly evolving field of medical technology, maintaining up-to-date standards is crucial. The BS EN ISO 11608-3:2022 provides the latest guidelines and testing protocols to ensure that your needle-based injection systems meet the highest international standards. Here’s why this standard is indispensable:

• Comprehensive Coverage: Spanning 36 pages, this standard covers every aspect of needle-based injection systems, from design and materials to performance and safety.
• Latest Release: Published on November 13, 2023, this is the most current standard, incorporating the latest advancements and research in the field.
• International Recognition: As an ISO standard, it is recognized and respected globally, ensuring that your products meet international benchmarks.
• Detailed Requirements and Test Methods: Provides clear and detailed requirements and test methods for containers and integrated fluid paths, ensuring consistency and reliability in your products.

Key Features

The BS EN ISO 11608-3:2022 standard is packed with essential features designed to enhance the quality and safety of needle-based injection systems:

• Design Specifications: Detailed guidelines on the design and construction of containers and integrated fluid paths to ensure optimal performance and safety.
• Material Requirements: Specifications for materials used in the construction of needle-based injection systems to ensure biocompatibility and durability.
• Performance Testing: Comprehensive test methods to evaluate the performance of needle-based injection systems under various conditions.
• Safety Protocols: Guidelines to ensure the safety of both patients and healthcare providers, including protocols for preventing contamination and ensuring accurate dosing.
• Quality Assurance: Procedures for quality control and assurance to maintain high standards in production and performance.

Who Should Use This Standard?

The BS EN ISO 11608-3:2022 is an essential resource for a wide range of professionals in the medical and healthcare industries, including:

• Medical Device Manufacturers: Ensure your products meet the highest standards of safety and performance.
• Quality Assurance Professionals: Implement rigorous testing and quality control procedures.
• Regulatory Affairs Specialists: Stay compliant with international regulations and standards.
• Healthcare Providers: Ensure the safety and efficacy of the medical devices you use.
• Researchers and Developers: Stay at the forefront of medical technology with the latest guidelines and protocols.

Benefits of Compliance

Adhering to the BS EN ISO 11608-3:2022 standard offers numerous benefits, including:

• Enhanced Safety: Ensure the highest level of safety for patients and healthcare providers.
• Improved Performance: Optimize the performance and reliability of your needle-based injection systems.
• Regulatory Compliance: Meet international regulatory requirements and avoid costly non-compliance issues.
• Market Acceptance: Gain the trust and confidence of healthcare providers and patients worldwide.
• Competitive Advantage: Stand out in the market with products that meet the highest standards of quality and safety.

Conclusion

The BS EN ISO 11608-3:2022 is an indispensable standard for anyone involved in the design, manufacture, and use of needle-based injection systems. With its comprehensive guidelines and detailed test methods, it ensures that your products meet the highest standards of safety, performance, and quality. Stay ahead in the competitive medical device market by adhering to this essential standard.

Invest in the BS EN ISO 11608-3:2022 today and ensure that your needle-based injection systems are at the forefront of medical technology, providing safe and effective solutions for healthcare providers and patients worldwide.

BS EN ISO 11608-3:2022

This standard BS EN ISO 11608-3:2022 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 design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1. It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture. This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022). This document is not applicable to the following products: —    sterile hypodermic needles; —    sterile hypodermic syringes; —    sterile single-use syringes, with or without needle, for insulin; —    containers that can be refilled multiple times; —    containers intended for dental use; —    catheters or infusion sets that are attached or assembled separately by the user.