EN ISO 7864:2016 is an international standard that provides requirements for sterile hypodermic syringes with or without needles. This technical article aims to explain the key points of the standard in a simple and easy-to-understand manner.
Specifications and Features
The standard specifies various requirements for syringes, including their design, materials, dimensions, and performance. These specifications ensure the safety, reliability, and quality of the syringes used in medical applications.
The standard covers a wide range of syringe sizes, from 0.5 ml to 50 ml, and includes both single-use and reusable syringes. It also provides guidelines for compatibility with other medical devices and accessories, such as needles, needle hubs, and plungers.
Sterility and Packaging
One of the crucial aspects covered by EN ISO 7864:2016 is the requirement for sterility. The standard establishes procedures and requirements for ensuring that syringes are free from microorganisms before use. It outlines sterilization techniques, packaging materials, and labeling requirements specifically designed to maintain sterility throughout the shelf life of the product.
Quality Control and Compliance
In order to comply with the standard, manufacturers must establish and maintain strict quality control systems. This involves conducting various tests and inspections throughout the manufacturing process to ensure that the syringes meet the specified requirements. The standard also emphasizes the importance of proper documentation and traceability of each syringe produced.
Compliance with EN ISO 7864:2016 is essential for manufacturers to demonstrate the safety, efficacy, and reliability of their syringes. It provides reassurance to healthcare professionals and patients that the syringes meet international standards and are suitable for use in medical procedures.
Overall, EN ISO 7864:2016 plays a critical role in ensuring the quality and safety of hypodermic syringes. By setting out clear requirements and guidelines, it provides a standardized approach to manufacturing, testing, and packaging of these essential medical devices.
Nina She