BS ISO 13926-3:2019 Pen Systems Seals for Pen-Injectors for Medical Use

Introducing the BS ISO 13926-3:2019, a comprehensive standard that sets the benchmark for seals used in pen-injectors for medical applications. This standard is an essential resource for manufacturers, healthcare professionals, and regulatory bodies involved in the design, production, and use of pen-injector systems.

Overview

The BS ISO 13926-3:2019 standard provides detailed specifications and guidelines for the seals used in pen-injectors, which are critical components in the delivery of medications. These seals ensure the integrity, safety, and efficacy of the pen-injector systems, which are widely used for administering insulin, hormones, and other injectable medications.

Key Features

• Standard Number: BS ISO 13926-3:2019
• Pages: 16
• Release Date: June 4, 2019
• ISBN: 978 0 580 52435 6
• Status: Standard

Why Choose BS ISO 13926-3:2019?

This standard is crucial for ensuring that pen-injector systems meet the highest quality and safety standards. By adhering to the guidelines set forth in this document, manufacturers can guarantee that their products are reliable and safe for end-users. The standard covers various aspects of seal design, including material selection, performance requirements, and testing methods.

Benefits of Compliance

Compliance with the BS ISO 13926-3:2019 standard offers numerous benefits, including:

• Enhanced Safety: Ensures that seals are designed to prevent leaks and contamination, safeguarding patient health.
• Regulatory Approval: Facilitates easier approval from regulatory bodies by meeting internationally recognized standards.
• Quality Assurance: Provides a framework for consistent quality control in the manufacturing process.
• Market Competitiveness: Demonstrates a commitment to quality and safety, enhancing brand reputation and marketability.

Applications

The BS ISO 13926-3:2019 standard is applicable to a wide range of medical pen-injector systems, including those used for:

• Diabetes management (insulin delivery)
• Hormone therapies
• Biological drugs
• Other injectable treatments

Detailed Content

Spanning 16 pages, this standard provides in-depth information on the following topics:

• Material specifications for seals
• Design and dimensional requirements
• Performance criteria and testing methods
• Quality control and assurance processes
• Guidelines for safe and effective use

Conclusion

The BS ISO 13926-3:2019 standard is an indispensable tool for anyone involved in the development and use of pen-injector systems. By providing clear and comprehensive guidelines, it ensures that these medical devices are safe, effective, and reliable. Whether you are a manufacturer looking to enhance your product line or a healthcare provider seeking to ensure the highest standards of patient care, this standard is an invaluable resource.

Invest in the BS ISO 13926-3:2019 standard today and take a significant step towards ensuring the safety and efficacy of your pen-injector systems.

BS ISO 13926-3:2019

This standard BS ISO 13926-3:2019 Pen systems is classified in these ICS categories:

• 11.040.25 Syringes, needles and catheters

This document specifies the shape, dimensions, material, performance requirements and labelling of seals for pen-injectors for medical use.