• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 8-549
ASTM F3208-20
Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
1.1 This guide describes methods for selecting test soils for cleaning validations based upon the characteristics of the soil, the physical characteristics of the device, and the clinical use of the device.

1.2 This guide describes the preparation and use of some test soils for the validation of cleaning instructions for reusable medical devices.

1.3 Reusable medical devices such as endoscopes, arthroscopic shavers, surgical instruments, and suction tubes are exposed to biological soils during clinical use. Preparation of these devices for reuse requires cleaning and disinfection and/or sterilization as applicable. Adequate cleaning is the first step in a process intended to prevent contaminant transfer to the next patient and medical practitioner. The soils, if inadequately removed, can interfere with disinfection and sterilization processes, as well as performance of the device. Acceptance criteria are based either on a visual assessment or quantitatively specified marker(s) endpoint(s) of the soil or both (ISO/TS 15883-5, Section 1). Endpoints after cleaning should be based upon possible interference with disinfection/sterilization, risk to the patient or health care worker from the contaminant during further handling, and endpoints for cleaning established in the scientific literature.

1.4 The test soils are designed to simulate the contaminants that medical devices are likely to come in contact with during clinical use. The test soils discussed in this guide are a mixture of constituents that simulate what is commonly found in human secretions, blood, tissue, and bone fragments/shavings as well as non-patient derived soil (e.g., bone cement, lubricants, and dyes) during clinical procedures. The test soils also simulate the physical parameters (e.g., viscosity, adhesion) of clinical material to which the medical devices will be exposed.

1.5 Exclusion:

1.5.1 This guide does not include methods to validate cleaning processes to remove residues from manufacturing

1.5.2 This guide does not describe the soil/inoculum used for validation of disinfection or sterilization instructions. Disinfection or sterilization validation requires separate testing that is independent of cleaning validation studies.

1.5.3 Test soils described are not intended for use by health care facilities to verify the effectiveness of their cleaning process.

1.5.4 The test soil recipes are not intended to encompass every biological residue with which a medical device is likely to come into contact.

1.6 Test soil formulations not described in this guide may be clinically relevant and may be more appropriate for simulated-use testing depending upon the clinical use of the medical device. The burden is upon the medical device manufacturer to determine and justify scientifically the selection of test soil(s).
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Issued March 2015 (Updated June 2017).

AAMI TIR30: 2011/(R)2016 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.

AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Anne D. Lucas
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Groups (STG)
Materials (primary)
*These are provided as examples and others may be applicable.