Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

Importancia y uso:

5.1 This guide provides information on how to select the test soil(s) that best simulates clinical use for devices. The test soil(s) selected for the validation should be clinically relevant and simulate what the device/component will come into contact with during the clinical procedure.

5.2 This guide will help standardize the test soils used by medical device manufacturers when validating the cleaning procedures of reusable medical devices and reprocessing equipment

5.3 For devices that come into contact with blood, the simulated test soils are blood-based soils, such as those described under 7.1.1-7.1.2.

5.4 For devices that come into contact with mucus, the simulated test soils are those described under 7.1.3.

5.5 For devices that come in contact with soils of a source other than the patient (e.g., bone cement), the simulated test soils should be similar to those described in 7.2. These can be used alone or in combination with 7.1.

5.6 A combination of test soils may be used (e.g., blood with mucus) to simulate clinical soiling. For example, flexible endoscopes may come in contact with a different combination of sources of soiling (e.g., gastrointestinal (GI) tract, vasculature for biopsies) during clinical use.

5.7 Any simulated test soil(s) or formulations can be used for simulated use testing but shall be scientifically justified by the medical device manufacturer.

Subcomité:

F04.15

Referida por:

F3293-18, F3321-19, F3276-22, F3438-24, D8179-18R24, F3275-22

Volúmen:

13.02

Número ICS:

11.040.01 (Medical equipment in general), 11.080.01 (Sterilization and disinfection in general)

Palabras clave:

bone test soil; cleaning; cleaning efficacy; cleaning validation; coagulating blood test soil; extraction efficiency; medical device; non-coagulating blood test soil; non-patient sourced test soil; ophthalmic test soil; patient derived soil; test soil; testing efficacy;