Overview
EN ISO 8670-2:1996 - "Ostomy collection bags - Part 2: Requirements and test methods" specifies performance criteria and laboratory test methods for one-piece and multiple-piece ostomy systems with closed-ended, open-ended, and urostomy collection bags. This part defines how to evaluate leakage resistance, closure retention and static burst strength, and sets general test conditions (e.g., standard temperature and sample handling). It is intended for manufacturers, test laboratories, regulators and conformity assessment bodies.
Key topics and technical requirements
- Scope: Applies to one- and multiple-piece ostomy systems; complements ISO 8670-1 (vocabulary).
- Performance requirements:
- Freedom from leakage: Bags without flanges and systems with flanges must show no leakage when tested by the specified methods.
- Retention of open-ended closures: Open-ended bag closures must remain in position after compressive loading when used per manufacturer instructions.
- Burst strength (static): Bags must not leak under a defined compressive load.
- Marking: Bags must be marked with product code and manufacturer/supplier name or trademark; maximum stoma-opening size must be marked or stated in instructions.
- General test conditions:
- Standard test temperature: 23 °C ± 2 °C.
- Tests must be performed on products as supplied to end-users.
- Representative test methods and parameters:
- Test volume measurement using water and a rigid transparent plate with a 10 mm hole; result defines volumes used in other tests.
- Leakage tests:
- Bags without flanges: filled with coloured water (erythrosin 0.3 g/L), inspected vertically and horizontally; includes long-duration soak checks (e.g., 17 h horizontal, 4 h vertical).
- Systems with flanges: mechanical force 20 N ± 1 N applied up/down, then filled with coloured water and inspected for junction leakage.
- Retention test: compressive load 100 N ± 5 N for 1 minute to verify closure retention.
- Burst strength (static): compressive load 200 N ± 5 N for 1 minute to check for leakage.
- Test reports must document identification, test conditions, number of samples and results.
Applications and users
- Manufacturers and product designers use the standard to design compliant ostomy bags and flange systems and to prepare technical documentation.
- Independent testing laboratories and quality assurance teams apply the specified methods for product verification and certification.
- Regulators, procurement and clinical procurement specialists reference the standard to set acceptance criteria for marketed ostomy products.
- Third‑party certification bodies may use ISO 8670-2 as the basis for conformity assessment and surveillance.
Related standards
- ISO 8670-1:1996 - Ostomy collection bags - Part 1: Vocabulary.
- ISO 9000 series - Quality management system standards referenced for supplier quality assessment.
- CEN adoption: published as EN ISO 8670-2:1996 / SIST EN ISO 8670-2:2000 in national catalogs.