ISO 16021:2024 pdf download

ISO 16021:2024 pdf download

ISO 16021:2024 offers guidelines and requirements for the design and execution of evaluations for single-use adult incontinence absorbing products. It outlines the creation of data collection tools and establishes a framework for gathering and documenting feedback from users and their caregivers regarding the acceptability of the products. Additionally, it describes a product diary that can assist in quantifying various aspects of product usage, including wear times, the amount of urine absorbed, and the severity of any leakage.

However, this document does not address direct comparisons between products based on statistical parameters, nor does it provide guidance on measuring the clinical efficacy of the products; such information is available in ISO 14155.

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