Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation
1Key Takeaways
This document gives guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It provides a context for the procedures described in other International Standards and published testing procedures. General factors relating to incontinence products and their usage are also addressed.
2Expert Interpretation
This in-depth analysis of the ISO 15621:2017 international standard's evaluation requirements for urine/fecal absorbent products covers user needs analysis, product performance indicators, and comparison of laboratory and clinical testing methods, providing a standardized evaluation framework and implementation recommendations for medical institutions, manufacturers, and caregivers.
Analysis of the Standard's Core Content
ISO 15621:2017, the third edition of the standard, establishes a systematic framework for the evaluation of absorbent incontinence devices. The standard constructs an evaluation system based on three dimensions: user-related factors, product characteristics, and the usage environment, with a particular emphasis on the individual needs of end users.
Comparison of key evaluation factors
| Evaluation dimensions | Core indicators | Test methods |
|---|---|---|
| Leakage resistance | Absorption capacity (3.1.2), retention capacity (3.1.6), rewet rate (3.1.7) | ISO 11948-1 laboratory test |
| Skin health | Skin dryness, material skin-friendliness | ISO 10993 biocompatibility assessment |
| Ease of use | Ease of putting on and taking off, difficulty of operation for caregivers | ISO 16021 User Test |
Product Classification and Technological Evolution
The standard clearly defines 5 categories of Absorbent Incontinence Products:
- One-piece underwear(3.2.1): Built-in absorbent core and adjustable fixing system
- Belt-type products(3.2.2): Independent absorbent core with adjustable waistband
- Pads/Liners(3.2.3): Need to be used with elastic mesh pants
- Panty pads(3.2.4): Small products with gender-specific designs
- Pull-up pants (3.2.5): A wearable product designed to resemble ordinary underwear
The emergence of electronic incontinence products (4.2.4) in recent years has enabled automatic monitoring of excretion patterns and promoted the development of personalized care.
Implementation Recommendations
Purchasing Guidelines for Medical Institutions
- Establish a multi-dimensional scoring card (4.5.4): Combine laboratory data (4.5.2) with user trial feedback (4.5.3)
- Focus on evaluating the high absorption performance of night protection products (4.2.4)
- Consider the product's full life cycle cost (4.4.8), including indirect costs such as nursing time and laundry expenses
Key Compliance Points for Manufacturers
- Implement medical device risk management in accordance with ISO 14971
- Use ISO 14040/14044 for environmental life cycle assessment (4.4.6)
- Product information must include clear wearing instructions (4.4.3)
Adaptation solutions for special groups
Adaptation suggestions for different user characteristics (4.2.5):
- People with limited mobility: Choose pull-up pants with tearable sides
- People with cognitive impairment: Choose products that look similar to ordinary underwear
- Active people: We recommend a combination of leak-proof edges and high absorption speed