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ASTM F3357-19

(Guide)

Standard Guide for Designing Reusable Medical Devices for Cleanability

Standard Guide for Designing Reusable Medical Devices for Cleanability

SIGNIFICANCE AND USE
4.1 Reusable medical devices have a range of cleanability. The equipment, effort, and time expended for cleaning devices should be feasible in the intended setting. For that reason, it is essential that cleanability be considered during the design phase.  
4.2 The next section highlights features that either have a tendency to retain debris and/or make removing contamination difficult. Individually, the criteria listed in this document may not render a device difficult to clean. Furthermore, it is the manufacturer’s responsibility to consider feasibility and ease of cleaning the device in the clinical environment when designing their device. Although it may not be feasible to remove or modify all of the problematic design features from a device, device manufacturers should be aware of challenging designs for cleaning and take appropriate action for minimizing the impact of these features on cleaning. For example, disassembly may be necessary to thoroughly clean a device, or it may be determined that a device cannot be adequately cleaned, in which case that device would be designated single-use only. In addition, manufacturers should consider the compatibility of their device design with subsequent sterilization or disinfection.
SCOPE
1.1 This guide is intended to provide manufacturers of reusable medical devices design feature guidance to minimize debris retention after use and increase ease of removal of contaminants and cleaning product residuals from devices during cleaning/rinsing and also prepare for subsequent processing steps (for example, sterilization or disinfection).  
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

Status
Published
Publication Date
31-Jul-2019
ICS
11.040.01 - Medical equipment in general
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.15 - Material Test Methods
Current Stage
Ref Project

Relations

Referred By
ASTM E3106-22 - Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation
Effective Date
01-Aug-2019

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ASTM F3357-19 - Standard Guide for Designing Reusable Medical Devices for Cleanability
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3357 − 19
Standard Guide for
1
Designing Reusable Medical Devices for Cleanability
This standard is issued under the fixed designation F3357; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope ANSI/AAMI/ISO 17664:2017 Processing of health care
product – Information to be provided by the medical
1.1 This guide is intended to provide manufacturers of
device manufacturer for the processing of medical devices
reusable medical devices design feature guidance to minimize
3
2.2 CDC Document:
debris retention after use and increase ease of removal of
CDC Guideline for Disinfection and Sterilization in Health-
contaminants and cleaning product residuals from devices
care Facilities, 2008
during cleaning/rinsing and also prepare for subsequent pro-
cessing steps (for example, sterilization or disinfection).
3. Terminology
1.2 This standard does not purport to address all of the
3.1 Definitions:
safety concerns, if any, associated with its use. It is the
3.1.1 automated cleaning—cleaning performed using a ma-
responsibility of the user of this standard to establish appro-
chine that soaks and flushes a device with detergent under
priate safety, health, and environmental practices and deter-
specified conditions using pulsating or high pressure and then
mine the applicability of regulatory limitations prior to use.
rinses it with suitable water allowing its subsequent use or
1.3 This international standard was developed in accor-
further processing (AAMI TIR 34:2014/(R)2017).
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
3.1.2 cleaning—removal of contamination from an item to
Development of International Standards, Guides and Recom-
the extent necessary for further processing or for the intended
mendations issued by the World Trade Organization Technical
use.
Barriers to Trade (TBT) Committee.
3.1.2.1 Discussion—In healthcare facilities, cleaning con-
sists of the removal, usually with detergent and water, of
2. Referenced Documents
adherent organic and inorganic soil (for example, blood,
2
protein substances, and other debris) from the surfaces,
2.1 AAMI Standards:
crevices, serrations, joints, and lumens of instruments, devices,
AAMI TIR30:2011/(R)2016 A compendium of processes,
and equipment by a manual or mechanical process that
materials, test methods, and acceptance criteria for clean-
prepares the items for safe handling and/or further decontami-
ing reusable medical devices
nation (ANSI/AAMI ST79:2010 and A1:2010).
AAMITIR34:2014/(R)2017 Waterforreprocessingofmedi-
cal devices
3.1.3 manual cleaning—removal of contaminants from an
ANSI/AAMIST79:2010andA1:2010 Comprehensiveguide
item to the extent necessary for further processing or for
to steam sterilization and sterility assurance in health care
intended use without the use of an automated process (ANSI/
facilities
AAMI/ISO 17664:2017).
ANSI/AAMI/ISO 11139:2018 Sterilization of health care
3.1.4 O-ring—acirculargasketthatservestosealandfillthe
products – Vocabulary of terms used in sterilization and
space between two objects or surfaces, generally to prevent
related equipment and process standards
leakage of liquids or gases.
ANSI/AAMI/ISO 17665-1:2006(R)2013 Sterilization of
3.1.5 sterile—free from viable microorganisms. (ANSI/
health care products – Moist heat – Part 1: Requirements
AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 11139:2018)
for the development, validation and routine control of a
3.1.6 sterilization—a process that destroys or eliminates all
sterilization process for medical devices
forms of microbial life and is carried out in healthcare facilities
by physical or chemical methods (CDC Guideline for Disin-
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
fection and Sterilization in Healthcare Facilities, 2008).
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved Aug. 1, 2019. Published September 2019. DOI:
3
10.1520/F3357-19. Available from Centers for Disease Control and Prevention (CDC), 1600
2
Available from Association for the Advancement of Medical Instrumentation Clifton Road, Atlanta, GA 30329, https://www.cdc.gov/infectioncontrol/guidelines/
(AAMI), 901 N Glebe Rd Ste 300, Arlington, VA 22203, http://www.aami.org. disinfection/index.html.
Copyright © ASTM International, 100 Barr
...

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4.1 Interactions of items with the MR environment have resulted in serious injuries and death of patients and other individuals. This practice lists hazards that may be present in the MR environment. It specifies marking of items anticipated to enter the MR environment and recommends information that should be included in the associated labeling.  
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SCOPE
1.1 This practice applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.
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5.1 This guide provides two test methods for evaluating the performance characteristics of a brush part designed to clean external surface(s) of a medical device by utilizing force testers.  
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1.4 Exclusions:  
1.4.1 This guide is not intended to be used for brushes designed to clean medical devices using rotational motion.  
1.4.2 This guide does not assess potential damage that may be inflicted by the brush, or degradation of the brush that may occur during repeated use. Brushes with rigid bristles (for example, stainless steel or other metals) are predicted to be more likely to damage medical devices than brushes with flexible bristles (for example, nylon); damage from rigid-bristled brushes should be assessed. Assessing repeated use would require a greatly increased number of test repetitions than what is described in this guide.  
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Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device

SIGNIFICANCE AND USE
5.1 This guide provides test methods for evaluating the performance characteristics of a brush part designed to clean internal channel(s) of a medical device.  
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SCOPE
1.1 Brushes used to clean a medical device after clinical use play an important role in effective reprocessing. This guide describes methods for characterizing, under prescribed laboratory conditions, the efficacy of brush parts designed to clean the internal channels of medical devices. The methods utilize a force tester to mechanically actuate a brush part within a channel: (1) Methods to measure, at an established speed, the force required to move a brush within a channel; (2) Methods utilize the same force tester and protocols to measure soil removal from a soiled tube, another indicator of performance.  
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This specification covers rigid polyurethane foam blocks or sheets recommended for use as a standard material for mechanical testing using orthopedic devices and instruments. Although the physical properties of the foam are in the order of those reported for human cancellous bones, these materials are not intended for implantation into the human body. All materials should conform to the specified quality of appearance, dimensional stability, and composition, and values of void content, compressive strength, compressive modulus, shear strength, shear modulus, and screw pullout.
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SCOPE
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5.1 This guide describes the use of test methods in Guides F3275 and F3276 to assess the service life of a brush part intended to clean a medical device.  
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SCOPE
1.1 This guide describes methods for assessing the service life, under prescribed laboratory conditions, of a brush part designed to clean a medical device. The method utilizes force testers to mechanically actuate a brush part at a constant rate. This action continues until the brush part demonstrates a significant reduction in cleaning power as measured by the force exerted during testing.  
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SIGNIFICANCE AND USE
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.
SCOPE
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:  
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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.  
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5.4 This guide provides specific evaluation techniques for measuring the effectiveness of residue removal processes, as they should be able to yield consistent results that meet the respective performance and cleanliness criteria for the intended use.
SCOPE
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1....

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Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

SIGNIFICANCE AND USE
4.1 The objective of this guide is to recommend a panel of biological tests that can be used in addition to the testing recommended in Practice F748. This guide is designed to detect neurotoxicity caused by medical devices that contact nervous tissue.  
4.2 The testing recommendations should be considered for new materials, established materials with different manufacturing methods that could affect nervous tissue response, or materials used in new nervous tissue applications.  
4.3 Chemical characterization can be used to evaluate similarity for materials with a history of clinical use in a similar nervous tissue application.
SCOPE
1.1 Medical devices may cause adverse effects on the structure and/or function of the nervous system. In this guide, these adverse effects are defined as neurotoxicity. This guide provides background information and recommendations on methods for neurotoxicity testing. This guide should be used with Practice F748, and may be helpful where neurotoxicity testing is needed to evaluate medical devices that contact central and/or peripheral nervous system tissue or cerebral spinal fluid (CSF).
Note 1: The results of these in vitro and in vivo tests may not correspond to actual human response.  
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    5 pages
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  • Guide
    5 pages
    English language
    sale 15% off
ASTM
ASTM F3293-18(Guide)
Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices

SIGNIFICANCE AND USE
5.1 This standard guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.  
5.2 It may help medical device manufacturers identify the most inaccessible locations on their device for inoculation with clinically relevant, simulated-use test soil (see ASTM F3208), thereby allowing testing to evaluate whether or not the medical device can be adequately cleaned.  
5.3 Methods described include pipetting, brushing, immersing, spraying, handling, and other techniques for applying soil.  
5.4 Guidance is given as to how to identify the clinically relevant areas of the device to soil, the time allowed for the soil to dry, and other conditioning considerations based upon assessment of worst-case clinical conditions.
SCOPE
1.1 This guide provides methods and considerations for simulated soiling of reusable medical devices for the purpose of validating cleaning instructions. Techniques for application of soil, as well as incorporation of soil by various means (e.g., actuation of devices) will be described in order to assure worst-case contamination of the surface geometry of medical devices.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    4 pages
    English language
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