ISO 15621:2017
Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation

Standard No.

ISO 15621:2017

Release Date

2017

Published By

International Organization for Standardization (ISO)

Latest

ISO 15621:2017

Scope

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.

ISO 15621:2017 Referenced Document

• ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
• ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
• ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
• ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
• ISO 10993-14:2001 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
• ISO 10993-15:2000 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
• ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
• ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
• ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
• ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
• ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
• ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
• ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
• ISO 11948-1:1996 Urine-absorbing aids - Part 1: Whole-product testing
• ISO 14040:2006 Environmental management - Life cycle assessment - Principles and framework
• ISO 14044:2006 Environmental management - Life cycle assessment - Requirements and guidelines
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 16021:2000 Urine-absorbing aids - Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers
• ISO 6658:2005 Sensory analysis - Methodology - General guidance
• ISO 9999:2016 Assistive products for persons with disability - Classification and terminology

ISO 15621:2017 history

• 2017 ISO 15621:2017 Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation
• 2011 ISO 15621:2011 Urine-absorbing aids - General guidelines on evaluation
• 1999 ISO 15621:1999 Urine-absorbing aids - General guidance on evaluation