BS EN ISO 7886-2:2020 - Standard for Sterile Syringes

The BS EN ISO 7886-2:2020 standard defines the requirements for sterile syringes for single use, offering critical guidance and specifications to manufacturers and users involved in healthcare and medical technology.

Published on May 20, 2020, this document is an identical adoption of ISO 7886-2:2020, ensuring that international best practices in the design, manufacture, and testing of syringes are uniformly applied across various markets. The standard addresses essential aspects of functionality, safety, and sterility, establishing operational parameters that protect both patients and healthcare professionals.

Key elements covered in this standard include:

• Material and Design Specifications: This section details the materials suitable for syringe production, including biocompatibility, resistance to breakage, and chemical compatibility with medications.
• Performance Requirements: BS EN ISO 7886-2:2020 outlines crucial performance metrics, such as accuracy of volume delivery and ease of use, which are vital to ensure effective and safe medication administration.
• Testing Protocols: The standard prescribes rigorous testing methods to confirm that syringes meet the defined requirements. This includes stability tests under various conditions and sterility assurance levels.
• Regulatory Compliance: Adhering to this standard facilitates compliance with various regulatory frameworks, thereby ensuring that products are suitable for use within the healthcare system.

The importance of BS EN ISO 7886-2:2020 cannot be overstated. As healthcare technology evolves, so do the demands placed on medical devices. A rigorous framework provided by this standard is essential for manufacturers looking to produce high-quality sterile syringes that meet the comprehensive needs of modern healthcare.

Purchasing this standard, with an ISBN of 978 0 539 01729 8, at a competitive price of £220.00, ensures that organizations have access to the most up-to-date specifications. The document is available in both PDF format and as a hardcopy, catering to diverse user preferences.

In conclusion, BS EN ISO 7886-2:2020 is an indispensable resource for manufacturers, healthcare providers, and regulatory entities alike, underpinning the quality and safety of sterile syringes in clinical applications. Investing in this standard is a commitment to excellence in healthcare technology.