ISO 12505-2:2016 PDF

Overview

ISO 12505-2:2016 specifies laboratory test methods for the face plates of skin barriers used in ostomy aids, focusing on wet integrity and adhesive strength. It is intended to evaluate how skin barrier face plates behave when exposed to fluids and how strongly they adhere and peel from a substrate under controlled conditions. This part does not cover medical properties such as cytotoxicity, sensitization, irritation, buffering or microbiological effects.

Key topics and technical requirements

• Scope and exclusions
  • Applies to face plates of skin barriers for ostomy aids.
  • Excludes clinical/medical-property testing (e.g., irritation, microbiology).
• Definitions
  • Wet integrity: ability to maintain physical form when exposed to fluid.
  • Adhesive strength: force required to peel a skin substitute from the skin barrier specimen.
• General test conditions
  • Preferred ambient conditions: 23 ± 2 °C and 50 ± 5 % RH; samples preconditioned 24 h.
  • Reporting precision: wet-integrity results to one decimal place (mm); adhesive-strength to two decimals (N/cm).
• Wet integrity test
  • Simulates exposure to physiological saline (0.9 % NaCl) at 37 °C with stirring for 24 h.
  • Measures inner diameter (D1) and outer discoloured/collapsed diameter (D2) around a punched centre hole (25 mm) to quantify swelling or erosion.
  • Results reported as mean and standard deviation of six specimens.
• Adhesive strength (peel) test
  • 180° peel test using a skin-like film pulled from a fixed barrier specimen.
  • Two typical peel speeds are specified to distinguish low- and high-adhesion products (example speeds in the standard).
  • Test designed to be reproducible for thick, composite skin barrier materials; does not directly equate to clinical performance.

Applications and users

ISO 12505-2 is practical for:

• Manufacturers of ostomy skin barriers - for product development, quality control and comparative testing.
• Independent testing laboratories - to provide standardized, reproducible test reports.
• Regulatory and procurement bodies - to verify product characteristics and claim substantiation.
• Clinicians and product advisors - to understand laboratory performance attributes that may inform clinical selection (with the caveat that lab results are not clinical guarantees).

Related standards

• ISO 12505-1: Test methods - Part 1: Size, surface pH and water-absorbency
• ISO 24214: Vocabulary for skin barriers for ostomy aids

Keywords: ISO 12505-2, skin barrier, ostomy aids, wet integrity test, adhesive strength, peel test, peristomal skin, test methods.