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Whitepaper - ISO 11608 Series Overview

The ISO 11608 standard is closely related to Extractables and Leachables (E&L) in the context of Physical and Functional Testing Services. It is intended to provide valuable updates and pertinent information for customers undergoing testing of combination devices, pharmaceuticals, and other medical products, enhancing their knowledge and understanding of these processes.

 The ISO 11608 series of standards serves as a comprehensive set of guidelines and requirements for needle-based injection systems used in the administration of medicinal products, specifically those intended for parenteral (injectable) use. These standards are designed to ensure the safety, reliability, and quality of these devices throughout their lifecycle, from design and development to manufacturing, testing, and use.

The primary purpose of the ISO 11608 series is to promote patient safety by providing a framework for the design and manufacturing of these devices, as well as establishing criteria for their performance and functionality. By adhering to these standards, manufacturers can ensure that their devices meet the necessary requirements for proper administration of medicinal products, reducing the risk of errors, contamination, or other adverse events.

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