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Standards Development
This part of ISO 12505 specifics test methods for characteristics of convex face plates of skin barriers for ostomy aids.
It does not cover medical properties (cytotoxicity, sensitization, irritation/intracutaneous reactivity, buffering effect, microbiological effects, etc.).
The test methods do not individually or collectively define or recommend a product of a specific design, style or size, and do not recommend medical affairs such as treatment, nursing, etc.
In recent years, the field of ostomy care has witnessed significant advancements, particularly in the design, application, and understanding of convexity characteristics in ostomy skin barriers. These characteristics include depth, compressibility, flexibility, tension location, and slope. Convexity is not a one-size-fits-all concept; rather, it involves several dynamic features that contribute to achieving a secure seal for patients living with an ostomy. This standard will attempt to create a unified language, nomenclature, and definition around these characteristics in order to foster collaboration and understanding across industry and clinical practice with the goal of improving patient outcomes. Having a unified language providing agreed metrics of convexity will allow healthcare professionals to more quickly identify the optimal fit for the individual patient, thus reducing the physical and mental risks associated with a sub-optimal fit.
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