AAMI ST98 2022
$139.74
AAMI ST98:2022, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2022 | 41 |
This standard covers the requirements to validate cleaning processes that are developed by the medical device manufacturer for processing medical devices. This document applies to all medical devices that require cleaning prior to each clinical use of that device. Clinical uses may be in health care facilities, home uses, or use by first responders, etc.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI ST98:2022; Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices |
| 2 | Blank Page |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents Page |
| 6 | Committee representation |
| 9 | Foreword |
| 11 | 1 Scope 1.1 Inclusions 1.2 Exclusions 2 Normative references 3 Terms and definitions |
| 15 | 4 Product definition 4.1 The cleaning validation shall identify: 5 Process definition 5.1 Each specified cleaning process shall be validated for cleaning efficacy. 5.2 The steps for each cleaning process shall be defined. These may include, as applicable: |
| 16 | 5.3 The cleaning process conditions shall be specified. These may include, as applicable: 6 Design of validation methods 6.1 General 6.2 Test soil determination 6.2.1 The type(s) of clinical procedures that represent worst-case soil exposure(s) shall be: 6.2.2 Test soil formulation(s) shall be documented with supporting scientific justification of its relevance to the clinical use of the device(s). 6.2.3 Test soil(s) shall include substances representative of tissue/fluids and any associated processing or procedural chemicals that are contaminants and are intended to be removed during cleaning. |
| 17 | 6.3 Soil application 6.3.1 Soiling shall 6.3.2 The worst-case conditions prior to processing shall be represented; for example, drying during and after soiling for a defined time and a defined temperature to simulate drying immediately after clinical use and during transportation to the proc… 6.4 Simulated use method determination 6.4.1 Multiple, sequential full simulated use and processing cycles shall be performed on the test devices. 6.4.2 Multiple, sequential full simulated use and processing cycles may be performed on the negative device control and positive device control. For the cycle prior to extraction for analyte testing, the negative device control should not be soiled, a… 6.4.3 Simulated use shall consider the worst-case use of the medical device, such as full range of motion actuation, and cauterization or heating (if applicable), that present a greater challenge to cleaning. It should also consider pressure gradients… 6.4.4 For those non-critical medical devices that are only required to be visibly clean as an end point, the test methods subsection need not apply. 6.5 Test method validation 6.5.1 The extraction method (i.e., the method of test soil recovery) shall be validated to establish the recovery efficiency and demonstrate that it is capable of accurately quantifying the defined test soil analyte across a specified range of values … 6.5.2 For critical and semi-critical medical devices and accessories, the extraction method for the test medical device shall be validated for each test soil analyte used for the cleaning validation using at least three replicates. 6.5.3 The analyte detection method(s) shall be validated, and the limit of detection (LOD) and limit of quantitation (LOQ) shall be documented. 6.6 Cleaning validation samples 6.6.1 Cleaning validation shall be done using a sample size sufficient to demonstrate reproducibility. |
| 18 | 6.6.2 The following controls shall be included in the cleaning validation: 7 Validation of cleaning process 7.1 The worst-case process parameters shall be established and incorporated into the cleaning validation protocols. 7.2 During the cleaning validation efficacy testing (which is part of the last simulated use cycle), the cleaning process shall be executed without performing disinfection and/or sterilization, unless cleaning and disinfection are performed as one ste… 7.3 Process steps which could cause test method interference (e.g., high temperatures, lubricants) and result in inaccurate results shall be identified and eliminated, if possible. Either inclusion or elimination of the interference should be adequate… 8 Endpoints 8.1 Classification of medical devices 8.1.1 For critical and semi-critical medical devices categorized by the Spaulding classification, cleaning effectiveness shall be determined by visual examination of all components and surfaces in contact with soil, as well as detection of at least tw… 8.1.2 For non-critical devices categorized by Spaulding classification, cleaning shall be assessed, at a minimum, by visual examination of all components and surfaces that could come in contact with soil. 8.2 General acceptance criteria 8.2.1 After cleaning, the device shall be free of visible contamination. 8.2.2 For an acceptable quantitative analysis, the result of the selected analyte endpoint(s) shall not exceed the acceptance criteria listed in Table 1 for each test sample. |
| 19 | 8.2.3 Use of alternative analytes not listed in Table 1 are not recommended. If an alternative analyte is used to determine the effectiveness of a cleaning process, then use of that analyte shall be scientifically justified, and the method should be v… Table 1—Acceptance criteria for endpoints 8.3 Process residuals |
| 20 | Annex A (informative) Guidance on the application of the normative requirements A.1 Scope A.2 Normative references A.3 Terms and definitions A.4 Product definition |
| 21 | A.5 Process definition A.5.1 Steps of the cleaning process |
| 22 | A.5.2 Characteristics of cleaning agents |
| 23 | A.6 Design of validation methods A.6.1 General A.6.2 Test soil determination A.6.3 Soil application A.6.3.1 Difficult to clean locations could include: |
| 24 | A.6.3.2 Considerations to determine more rigorous conditions include (see ASTM, F3293-18 [20]): A.6.4 Simulated use method determination |
| 25 | A.6.5 Test methods |
| 26 | A.6.6 Samples |
| 28 | A.6.6.1 The control devices should be prepared and processed in the same manner as the test devices: positive control devices should be soiled, and negative control devices should not be soiled. |
| 29 | A.7 Validation of process Table A.1—Examples of Instructions and test protocol specifications to validate them A.7.1.1 Protocols should be designed to test less rigorous implementation of the cleaning instructions. A.7.1.2 Additional considerations for certain cleaning process conditions are: |
| 30 | A.7.1.3 Water quality should be considered and justified. |
| 31 | A.7.1.4 Certain analytes can be affected by the cleaning steps or chemicals. |
| 32 | A.8 Endpoints A.8.1 Classification of medical devices |
| 33 | A.8.2 General acceptance criteria A.8.3 Visual inspection A.8.4 Analytes |
| 34 | A.8.4.1 Clinically relevant analytes |
| 36 | A.8.5 Process residuals |
| 37 | Bibliography |
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