EN ISO 11140-6:2022 PDF

Overview

EN ISO 11140-6:2022 - “Sterilization of health care products - Chemical indicators - Part 6” defines Type 2 chemical indicators and process challenge devices (PCDs) used for performance testing of small steam sterilizers. The standard specifies performance requirements and test methods for both porous and hollow test devices and for the chemical and biological indicators placed inside them. It is intended specifically for small steam sterilizers (as defined by EN 13060) used in healthcare settings and supersedes EN 867-5.

Key topics and requirements

• Scope and intended use
  • Applies to monitoring steam penetration in type B cycles and some type S cycles of small steam sterilizers.
  • Clarifies that the described hollow and porous devices are not surrogate medical devices.
• Reference devices and alternatives
  • Reference Porous Device (RPD): a textile test pack where steam penetration is judged by thermometric means; serves as the benchmark.
  • Alternative Porous Indicator Systems (APISs): commercially produced porous indicator systems that must demonstrate equivalent performance to the RPD.
  • Reference Hollow Device (RHD): lumened device with attached capsule where penetration is judged by inactivation/survival of a specified biological indicator.
  • Alternative Hollow Indicator Systems (AHISs) and alternative hollow devices: must be validated as equivalent to the RHD.
• Performance tests and methods
  • Normative test procedures for RPD/RHD and for validating APIS/AHIS are provided (annexes include detailed test methods).
  • Includes requirements for leakage testing, detector specifications, and performance determination.
  • Chemical indicator dry heat performance, accelerated ageing, marking and labelling requirements are addressed.
• Safety and conformity
  • Contains guidance on hazards, test reproducibility and interlaboratory evaluation results.

Applications

• Validating steam penetration and air removal performance in small steam sterilizers used in:
  • Dental, ambulatory surgery, and small clinic sterilization departments.
  • Medical device manufacturers for type testing of small sterilizers.
• Used in routine commissioning, acceptance testing, and periodic performance checks where full-sized EN 285 test packs are impractical.

Who should use this standard

• Manufacturers of chemical indicators, process challenge devices (PCDs) and sterilizer equipment.
• Sterilization validation laboratories and test houses.
• Hospital sterile services departments (CSSD), infection control teams, and quality/regulatory professionals responsible for sterilizer validation and compliance.

Related standards

• EN 13060 - Small steam sterilizers: definitions and performance categories.
• EN 285 - Large steam sterilizers (context for differences in test methods).
• Other parts of the ISO 11140 series covering chemical indicator types and requirements.

Keywords: EN ISO 11140-6:2022, sterilization, chemical indicators, process challenge devices, small steam sterilizers, type 2 indicators, steam penetration, porous device, hollow device, EN 13060.