Overview
ISO 8670-2:1996 - "Ostomy collection bags - Part 2: Requirements and test methods" specifies performance requirements and standardized test methods for one‑piece and multiple‑piece ostomy systems with closed‑ended, open‑ended and urostomy collection bags. This second edition replaces the 1991 edition and is intended to ensure bag integrity, closure retention and safe performance under defined test conditions.
Keywords: ISO 8670-2, ostomy collection bags, test methods, performance requirements, ostomy bags, leakage testing
Key topics and technical requirements
- Scope: Applies to one‑piece and multiple‑piece systems and includes urostomy bags.
- Definitions: Terms such as ostomy bag, stoma, flatus filter, multiple‑piece flange system and test volume are defined (see ISO 8670‑1 for vocabulary).
- General test conditions: Standard test temperature is 23 °C ± 2 °C. Tests are performed on products as supplied to the end user.
- Primary performance requirements:
- Freedom from leakage - tested separately for bags without flanges and for systems with flanges.
- Retention of open‑ended bag closure - closures must remain secure under compressive loading following manufacturer instructions.
- Burst strength (static) - bags must not leak when subjected to a specified compressive force.
- Marking - products must carry at least product code and manufacturer/supplier identification; maximum stoma opening must be marked or given in instructions when applicable.
- Representative test methods (examples from the standard):
- Test volume determination - bag filled with tap water; test volume recorded.
- Leakage tests - coloured water (tap water + 0.3 g/L erythrosin) used to detect leaks; orientation and timed inspections are specified.
- Flange pull/force test - 20 N ± 1 N applied up/down to check flange and coupling leakage.
- Closure retention - 100 N ± 5 N compressive load applied for 1 minute.
- Burst strength - 200 N ± 5 N compressive load applied for 1 minute; inspect for leakage.
- Test reporting: Must reference ISO 8670‑2, include product identification, test date/place, sample count and specific results per the methods.
Practical applications and users
- Manufacturers: design verification, quality control and product development.
- Test laboratories: routine compliance testing and type approval.
- Regulatory bodies and procurement: evaluate conformity for market access and purchasing decisions.
- Third‑party certifiers: conformity assessment and surveillance (the standard recommends considering third‑party certification and ISO 9000 quality system assessment).
- Clinicians and healthcare providers: verify product claims and select appropriate ostomy supplies for patients.
Related standards
- ISO 8670‑1:1996 - Ostomy collection bags - Part 1: Vocabulary (normative reference).
- Relevant quality management standards: ISO 9000 series (for supplier quality system assessment).
This standard is essential for ensuring reliable ostomy bag performance, minimizing leakage risk and supporting consistent test evidence for manufacturers and regulators.