British, European and International Standards (BS EN ISO)

All guidance documents within the UK, from HTM to CFPP, relate to external references when providing guidance on procedures and testing.

These are the standards that all countries use to formulate their own guidance on the decontamination of reusable medical devices. Each standard is preceded by an acronym that indicates which part of the world has adopted the document:

  • BS British Standard
  • EN European Norm
  • ISO International Standards Organisation
  • TS Technical Specification

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BS EN ISO 15883

Washer Disinfectors

  • Part 1: General Requirements, terms and definitions and tests
  • Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
  • Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
  • Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
  • Part 5: Test soils and methods for demonstrating cleaning efficacy
  • Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment

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BS EN 14065

Textiles – Laundry – Processed Textiles – Biocontamination Control System

Provides management systems for the microbiological quality of laundry within but not limited to healthcare facilities.


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BS EN 13060

Small Steam Sterilisers

Provides the general requirements of periodic testing for small steam sterilisers within but not limited to general medical facilities and dental practices.


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BS EN 285

Sterilisation – Steam Sterilisers – Large Sterilisers

Provides general performance specifications for large steam sterilisers along with schedules for manufacturer type tests and works tests.


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BS EN ISO 17665

Sterilisation of Healthcare Products – Moist Heat

  • Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
  • Part 2: Guidance on the application of ISO 17665-1

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BS EN 867

Non-biological systems for use in sterilisers

  • Part 1: General Requirements
  • Part 2: Process Indicators (Class A)
  • Part 3: Specification for Class B Indicators for use in the Bowie and Dick test
  • Part 4: Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetration
  • Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S

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BS EN ISO 11140

Sterilisation of Health Care Products – Chemical Indicators

  • Part 1: General Requirements
  • Part 2: Test equipment and Methods
  • Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
  • Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
  • Part 5: Class 2 indicators for Bowie and Dick-type air removal tests