What is EN ISO 10993-33: 2021 ?

EN ISO 10993-33: 2021 is a standard published by the International Organization for Standardization (ISO) that outlines the procedures for assessing the potential for skin irritation and delayed-type hypersensitivity in medical devices. The standard is part of a series of ISO 10993 standards that aim to ensure the safety of medical devices.

The scope of EN ISO 10993-33: 2021 is to provide guidance on evaluating the genotoxicity, carcinogenicity, and reproductive toxicity of medical devices. This includes the assessment of the potential for skin irritation, including contact dermatitis and eczema, as well as the potential for delayed-type hypersensitivity.

EN ISO 10993-33: 2021 is relevant to a wide range of medical devices, including surgical instruments, diagnostic tools, and pharmaceuticals. It is important for manufacturers to comply with the standard's requirements in order to ensure the safety and effectiveness of their products.

Impact on Different Sectors

EN ISO 10993-33: 2021 is important for various sectors, including healthcare, aerospace, and automotive. In the healthcare sector, for example, medical devices such as syringes, catheters, and pacemakers must comply with the standard's requirements to ensure the safety and effectiveness of the products.

In the aerospace and automotive sectors, EN ISO 10993-33: 2021 is also relevant to ensure the safety of products such as aircraft parts, automotive parts, and in-flight systems.

EN ISO 10993-33: 2021 is an essential standard that helps ensure the quality and safety of medical devices. By following the guidelines outlined in the standard, manufacturers can minimize the risk of skin irritation and hypersensitivity in medical devices, ultimately leading to better patient outcomes.