Continuous glucose monitoring systems. Design verification and validation of performance. Specification
Continuous glucose monitoring systems. Design verification and validation of performance. Specification
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What is PAS 2600:2025 Continuous glucose monitoring systems – Design verification and validation of performance – Specification about? PAS 2600 specifies requirements for continuous glucose monitoring (CGM) systems intended to be used alone, or in conjunction with, digitally connected medical devices for the purpose of managing diseases or medical conditions related to glycaemic control by lay persons and healthcare professionals.
Who is PAS 2600:2025 Continuous glucose monitoring systems – Design verification and validation of performance – Specification for?
Medical Device Manufacturers Regulatory Authorities Conformity assessment bodies
What does PAS 2600:2025 Continuous glucose monitoring systems – Design verification and validation of performance – Specification cover? This PAS covers continuous glucose monitoring (CGM) systems designed to automatically measure glucose levels in bodily fluids over time. The PAS provides guidance on the design, performance and safety of CGM systems including sensors, transmitters and receivers. It also covers their use in managing glucose levels for individuals with diabetes mellitus and other conditions related to glycaemic control. Additionally, the standard highlights the need for robust clinical data to demonstrate the accuracy and performance of CGM systems. It sets requirements for data protection, cybersecurity and system integrity, ...
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