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Article 11 Steps of the reprocessing cycle

United Kingdom

Original text. Later amendments are not shown.

The reprocessing cycle shall cover the following steps, if applicable to the device concerned:

  1. (a)

    pre-treatment at the point of use;

  2. (b)

    transportation, including procedures for safe transportation of hazardous materials;

  3. (c)

    preparation before cleaning;

  4. (d)

    cleaning;

  5. (e)

    thermal disinfection or chemical disinfection;

  6. (f)

    drying;

  7. (g)

    inspection, maintenance, repair and functionality testing;

  8. (h)

    packaging;

  9. (i)

    labelling and provision of instructions for use;

  10. (j)

    sterilization;

  11. (k)

    storage.