{
  "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-10",
  "json_url": "https://openlegislation.uk/eu-regulation-2020-1207/article-10.json",
  "legislation": "eur/2020/1207",
  "legislation_title": "Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2020-1207",
  "path": "article/10",
  "kind": "article",
  "number": "10",
  "heading": "Establishment of procedures",
  "text": "1. Prior to starting the reprocessing, reprocessors shall perform a visual check of the single-use devices for damages. They shall test whether movable parts can be correctly moved. If maintenance or adjustment is needed for the single-use device to perform as specified in the instruction for use, the maintenance shall be performed according to the established procedure. The reprocessors shall dispose of damaged or dysfunctional single-use devices.\n2. The reprocessor shall establish a validated decontamination procedure adapted to the properties and characteristics of the single-use device and the risks linked with its use.\n3. Preparation for reprocessing shall not compromise the hygienic state and the functionality of the decontaminated device. If there is a delay exceeding an established time limit in the procedure before cleaning and disinfection or sterilization of single-use device, it shall be adequately pre-cleaned and put in intermediate storage. The single-use devices shall be transported to the reprocessing premises in closed identified and dedicated containers under the conditions set out in a procedure.\n4. The necessary requirements in terms of microbiological and chemical properties of water, chemicals, and other products used in the reprocessing shall be set out in the procedures for each specific cycle.\n5. When choosing cleaning, disinfection and sterilization procedures, priority shall be given to validated automated procedures that ensure their reproducibility. The disinfection shall ensure appropriate bactericidal (including mycobacteria), fungicidal, and virucidal effects, and the effectiveness of the disinfection shall be verified regularly on samples.\n6. Cleaning and disinfectant solutions, and the sterilizing agent if applicable, shall be removed by a validated method described in a procedure.\n7. The sterilization with moist heat (steam sterilization) shall be used where such use is appropriate. However, other validated methods may be chosen according to the properties and characteristics of the single-use device to be reprocessed.\n8. Monitoring of sterilization cycles and release of sterilized single-use devices shall be based on attaining the sterilization parameters within the established and validated tolerances described in a procedure. If not all relevant sterilization parameters can be measured, those physical measurements shall be supplemented by using qualified biological indicators to provide additional assurance that no undetected deviations from the validated cycle occurred.\n9. The packaging system shall be suitable for the content, validated according to relevant standards and the sterilization method used if applicable, for the properties of the reprocessed single-use device and for the intended storage and transportation. The packaging shall enable sterilization and guarantee sterility during the stated shelf life and until use, under proper storage and transportation conditions. If during the reprocessing a problem concerning the functionality, performance, or safety of the single-use device is detected, the problem shall be addressed and the single-use device shall be repaired, if possible, or disposed of if repair is not possible. The cause of the problem shall be investigated in order to verify the continued efficacy of the cycle. If the process is no longer achieving its objective, the cycle shall be modified or reprocessing shall be stopped for that specific single-use device. If any of the steps of the reprocessing fails to meet the requirements laid down in the procedures for that single-use device, it shall not be released for reuse.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2020/1207/article/10",
    "retrieved_at": "2026-11-01T14:42:28.241115+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}