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European Norms (EN) and/or International Standards (ISO) for sterilizers, packaging material, sterilization monitoring and validation

1. ISO/TS 11139 Terms and definitions in sterilization standards
2. EN ISO 11138 Biological indicators to test sterilization processes

  • Part I General requirements
  • Part II for ethylene oxide sterilization (strips and self-contained)
  • Part III for moist heat sterilization (strips and self-contained)
  • Part IV for dry heat sterilization
  • Part V for low-temperature-steam-formaldehyde sterilization
  • Part VI for hydrogen peroxide vapour sterilization processes (Draft)

EN ISO 14161 Guidance for the selection, use and interpretation of results for the validation and routine monitoring of the sterilization of medical products with biological indicators
3. EN ISO 11140 Non-biological (chemical) indicators to test sterilization processes

  • Part I Classification and general requirements (of classes 1-6)
  • Part II not applicable (DIN EN ISO 18472)
  • Part III Requirements Bowie-Dick test sheets
  • Part IV Test procedure for the Bowie-Dick-Simulation Test for steam penetration according to the
    European standard EN 285 (7 kg)
  • Part V Test procedure for the Bowie-Dick-Simulation Test for air removal (only ISO) according to the AAMI test pack (4 kg)
  • Part VI Class 2 indicators and process challenge devices for use in performance testing for steam sterilizers

EN ISO 15882 Guidance for selection, use and interpretation of results for chemical indicators
(currently updated to conform with the new EN-ISO 11140 Standard)
4. Standards for validation of medical devices
EN ISO 17665 Requirements for the development, validation and routine control
(replaces EN 554) of steam sterilization processes

  • Part I Requirements
  • Part II Guidance

EN ISO 11135 Requirements for the development, validation and routine control(replaces EN 550) of ethylene oxide sterilization processes

  • Part I Requirements
  • Part II Guidance

EN ISO 11137 Radiation sterilization(replaces EN 552) Part I Requirements for validation and routine control

  • Part II Selection of dose setting for products
  • Part III Guidance

EN ISO 14937 General requirements for the characterization of sterilization products and the
development, validation and routine monitoring of sterilization processes
EN 15424 Validation of Low Temperature-Steam-Formaldehyde (LTSF) Processes
EN ISO 17664 Information to be provided by the manufacturer for the processing
of re-sterilizable medical devices
ISO 14971 Application of risk management to medical devices
5. EN 868 Packaging materials for sterilization

  • Part I replaced by EN ISO 11607-1
  • Part II Requirements and tests for sterilization wraps
  • Part III Requirements and tests for paper to manufacture bags
  • Part IV Requirements and tests for paper bags
  • Part V Requirements and tests for heat sealable pouches and reel material made of paper
    and/or plastic and/or laminates
  • Part VI Requirements and tests for paper to manufacture bags for ethylene oxide and
    irradiation sterilization
  • Part VII Requirements and tests for adhesive coated paper to manufacture bags for ethylene
    oxide and irradiation sterilization
  • Part VIII Requirements and tests for reusable containers
  • Part IX Uncoated non-woven materials of polyolefines for use in the manufacturing of heat sealable
    pouches, reels and lids – Requirements and test methods
  • Part X Adhesive coated non-woven materials of polyolefines for use in the manufacturing of heat
    sealable pouches, reels and lids – Requirements and test methods


EN-ISO 11607 Packaging for terminally sterilized medical devices

  • Part I Requirements for materials, sterile barrier systems and packaging
  • Part II Validation requirements for forming, sealing and assembly processes
    It has been decided to merge EN 868 Part I and ISO 11607 Part I and II in the future.
  • 6. EN ISO 15883 Requirements for washers-disinfectors

  • Part I General requirements, definitions and tests
  • Part II Surgical instruments, anesthetic equipment, hollow ware, utensils, glassware etc.
  • Part III Human waste containers (bed pan WD)
  • Part IV Thermo-labile re-usable instruments including endoscopes
  • Part V Test soils and methods for demonstrating cleaning efficacy
  • Part VI Requirements and tests for general purpose washer-disinfectors employing thermal
    disinfection
  • Part VII Requirements and tests for general purpose washer-disinfectors employing chemical
    disinfection for bedframes, bedside tables, transport carts, containers, surgical tables,
    furnishings and surgical clogs


7. Technical requirements for sterilizers

  • EN 285:2008 Healthcare steam sterilizers > 54 l
    To the BD type test the hollow load type test according EN 867-5 had been added to
    assure that hollow devices and MIS instruments can be sterilized
  • EN 13060 Small steam sterilizers < 54 l
    Type B sterilizers require fractionated vacuum and must pass the hollow load test (EN 867-5).
  • EN 14180 Low temperature steam-formaldehyde sterilizers
    Requirements and testing methods
  • EN 1422 Ethylene oxide sterilizers – Requirements and testing methods
  • EN ISO 18472 Resistometer (Test sterilizer) for biological and chemical indicators
    DIN 58951 Steam sterilizers for laboratories – Part II: Requirements
    All sterilizers (re-)sterilizing medical products are medical devices (MDs) and classified as 2b in
    the Medical-Device-Directive (MDD).
  • EN 14180 Low temperature steam-formaldehyde sterilizers
    Requirements and testing methods
  • EN 1422 Ethylene oxide sterilizers – Requirements and testing methods
  • EN ISO 18472 Resistometer (Test sterilizer) for biological and chemical indicators

DIN 58951 Steam sterilizers for laboratories – Part II: Requirements
All sterilizers (re-)sterilizing medical products are medical devices (MDs) and classified as 2b in
the Medical-Device-Directive (MDD)
8. ISO 11737 Microbiological methods

  • Part I Estimation of population of micro-organisms on products
  • Part II Tests of sterility performed in the validation of a sterilization process
    ISO 10993 Biological evaluation of medical devices
  • Part I Selection of test
  • Part II Animal welfare requirements
  • Part III Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • Part IV Selection of tests for interactions with blood
  • Part V Tests for cytotoxicity: in vitro methods
  • Part VI Tests for local effects after implantation
  • Part VII Ethylene oxide sterilization residuals
  • Part VIII Clinical investigation
  • Part IX Degradation of materials related to biological testing
  • Part X Tests for irritation and sensitization
  • Part XI Tests for systemic toxicity
  • Part XII Sample preparation and reference material
  • Part XIII Identification and quantification of degradation products from polymeric medical devices
  • Part XIV Identification and quantification of degradation products from ceramics
  • Part XV Identification and quantification of degradation products from metals and alloys
  • Part XVI Toxicokinetic study design for degradation products and leachables
  • Part XVIIEstablishment of allowable limits for leachable substances