BS EN ISO 8871-2:2020 - Elastomeric Parts for Parenterals and Pharmaceutical Devices

Introducing the BS EN ISO 8871-2:2020, a comprehensive standard that provides essential guidelines for the identification and characterization of elastomeric parts used in parenterals and devices for pharmaceutical use. This standard is a critical resource for professionals in the pharmaceutical industry, ensuring the highest quality and safety of elastomeric components used in medical devices and drug delivery systems.

Key Features of BS EN ISO 8871-2:2020

This standard is meticulously designed to address the specific needs of the pharmaceutical industry, focusing on the following key aspects:

• Identification and Characterization: Provides detailed methodologies for identifying and characterizing elastomeric parts, ensuring they meet the stringent requirements necessary for pharmaceutical applications.
• Comprehensive Coverage: Spanning 32 pages, this standard offers an in-depth exploration of the properties and performance criteria of elastomeric materials used in parenterals and pharmaceutical devices.
• Up-to-Date Information: Released on May 8, 2024, this standard reflects the latest advancements and best practices in the field, ensuring that your processes are aligned with current industry standards.
• International Recognition: As a part of the ISO series, this standard is recognized globally, facilitating international trade and compliance across borders.

Why Choose BS EN ISO 8871-2:2020?

Choosing the BS EN ISO 8871-2:2020 standard means opting for a resource that is not only authoritative but also indispensable for ensuring the quality and safety of pharmaceutical products. Here are some reasons why this standard is a must-have:

• Ensures Compliance: Adhering to this standard helps manufacturers comply with regulatory requirements, reducing the risk of non-compliance and associated penalties.
• Enhances Product Safety: By following the guidelines set out in this standard, manufacturers can enhance the safety and efficacy of their products, protecting end-users and maintaining brand reputation.
• Facilitates Innovation: With clear guidelines and specifications, this standard supports innovation in the development of new pharmaceutical devices and drug delivery systems.
• Supports Quality Assurance: Provides a framework for quality assurance processes, ensuring that elastomeric parts consistently meet high standards of performance and reliability.

Technical Specifications

For those who require detailed technical information, here are the specifications of the BS EN ISO 8871-2:2020 standard:

• Standard Number: BS EN ISO 8871-2:2020
• Pages: 32
• Release Date: May 8, 2024
• ISBN: 978 0 539 02555 2
• Status: Standard

Applications of BS EN ISO 8871-2:2020

This standard is applicable to a wide range of pharmaceutical and medical device applications, including but not limited to:

• Drug Delivery Systems: Ensures the reliability and safety of elastomeric components used in drug delivery systems such as syringes, vials, and infusion pumps.
• Medical Devices: Provides guidelines for elastomeric parts used in various medical devices, ensuring they meet the necessary performance and safety standards.
• Parenteral Packaging: Offers specifications for elastomeric parts used in the packaging of parenteral products, ensuring product integrity and patient safety.

Conclusion

The BS EN ISO 8871-2:2020 standard is an essential tool for professionals in the pharmaceutical and medical device industries. By providing comprehensive guidelines for the identification and characterization of elastomeric parts, this standard ensures that products meet the highest standards of quality and safety. Whether you are involved in manufacturing, quality assurance, or regulatory compliance, this standard is a valuable resource that supports your efforts to deliver safe and effective pharmaceutical products.

BS EN ISO 8871-2:2020

This standard BS EN ISO 8871-2:2020 Elastomeric parts for parenterals and for devices for pharmaceutical use is classified in these ICS categories:

• 11.040.20 Transfusion, infusion and injection equipment

This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.

The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.