Overview
EN ISO 11140-3:2009 - Sterilization of health care products - Chemical indicators - Part 3 defines requirements for Class 2 chemical indicator systems used in the Bowie and Dick‑type steam penetration test. This European adoption of ISO 11140-3:2007 (including Corr.1:2007) specifies how chemical indicators must perform when used with the standard test pack described in EN 285. The document focuses on indicator system performance, labelling and quality assurance for detection of steam penetration into wrapped goods and porous loads processed in steam sterilizers.
Key Topics
- Scope and intended use: Indicators are designed specifically for the steam penetration (Bowie and Dick‑type) test for wrapped goods such as surgical instruments and porous materials. The standard governs indicator behavior, not the construction or performance of the test pack itself.
- Indicator format and design: Requirements for the visual format and substrate of Class 2 indicators to ensure clear, reliable readouts after exposure to steam.
- Performance requirements: Criteria for indicator sensitivity to steam penetration and resistance to processing conditions. The standard includes normative test methods for assessing indicator change under steam, dry heat and aging.
- Packaging, labelling and instructions: Mandatory information to support correct use (e.g., intended use with EN 285 standard test pack) and traceability.
- Quality assurance and shelf life: Requirements and test procedures for manufacturing quality control, accelerated ageing and determination of shelf life.
- Normative test methods (Annexes A–K): Detailed methods for:
- Strength after steam sterilization
- Measurement of colour/reflectance density
- Colour change in dry saturated steam and dry heat
- Accelerated ageing, transfer to test pack, shelf‑life determination
- Steam exposure apparatus, air injection systems and the standard test pack configuration
- Regulatory alignment: Annex ZA maps the standard to essential requirements of EU Directive 93/42/EEC for medical devices.
Applications
- Routine Bowie and Dick‑type daily performance checks of steam sterilizers in hospitals and central sterile services departments (CSSDs).
- Product development and quality control by chemical indicator manufacturers to demonstrate compliance with international requirements for Class 2 indicators.
- Third‑party test laboratories and regulatory bodies assessing indicator performance and shelf life.
- Sterilizer manufacturers and service engineers using indicators during validation, commissioning and preventive maintenance to detect steam penetration or air removal issues.
Related Standards
- EN 285 - Standard test pack and test method for steam sterilizers (used in combination with EN ISO 11140‑3 indicators).
- ISO 11140-1 - General requirements for chemical indicators (defines Class 2 indicators).
- EN ISO 15882 - Guidance for selection, use and interpretation of chemical indicator results.
Keywords: EN ISO 11140-3:2009, Bowie and Dick test, Class 2 indicator, chemical indicators, steam penetration test, EN 285, sterilization of health care products.