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ASTM E3173-18

(Guide)

Standard Guide for Decommissioning and Disposal of Medical Equipment

Standard Guide for Decommissioning and Disposal of Medical Equipment

SIGNIFICANCE AND USE
5.1 This guide identifies common processes to safely decommission and dispose of medical equipment. The objective is to identify common challenges unique to medical equipment to help ensure that the identification, authorization for disposition, and proper sanitization of the equipment is completed prior to disposal teams getting involved in the process.  
5.2 This guide provides information to consider when choosing disposal options in order to effectively manage the entity’s assets.
SCOPE
1.1 This standard guide addresses decommissioning and disposal of medical equipment.  
1.2 Decommissioning and disposal of medical equipment is done when equipment is no longer needed due to obsolescence, is inoperable, or has met a scheduled replacement milestone. Decommissioning is the first physical process in the disposition process and includes proper identification, authorization for disposition, and sanitization of the equipment, as well as removal of Patient Health Information (PHI) or software, or both. Disposal method is dependent upon many factors that will be described in this standard guide.  
1.3 This guide does not include detailed disposal method procedures or sales requirements or restrictions specific to any regulatory body or the various levels of government in which an entity may operate. This guide also provides practices that are common to many operations and provides flexibility to best integrate external requirements.  
1.4 While this standard describes common safety and environmental considerations associated with the decommissioning and disposal of medical equipment, it does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the entity using this standard to establish and apply appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 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
30-Jun-2018
ICS
11.040.01 - Medical equipment in general
Technical Committee
E53 - Asset Management
Drafting Committee
E53.30 - Decommissioning and Disposal of Medical Supplies, Medical Equipment, and Hospitals
Current Stage
Ref Project

Relations

Refers
ASTM E2306-18 - Standard Guide for Disposal of Personal Property Assets
Effective Date
01-Jul-2018
Refers
ASTM E2135-10a(2017) - Standard Terminology for Property and Asset Management
Effective Date
01-May-2017
Referred By
ASTM E2675-22 - Standard Practice for Asset Management System Outcomes
Effective Date
01-Jul-2018

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ASTM E3173-18 - Standard Guide for Decommissioning and Disposal of Medical EquipmentASTM E3173-18 - Standard Guide for Decommissioning and Disposal of Medical Equipment
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ASTM E3173-18 - Standard Guide for Decommissioning and Disposal of Medical Equipment
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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: E3173 − 18
Standard Guide for
1
Decommissioning and Disposal of Medical Equipment
This standard is issued under the fixed designation E3173; 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 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This standard guide addresses decommissioning and
E2135 Terminology for Property and Asset Management
disposal of medical equipment.
E2306 Practice for Disposal of Personal Property
1.2 Decommissioning and disposal of medical equipment is
E2858 Practice for Sales of Personal Property
done when equipment is no longer needed due to obsolescence,
is inoperable, or has met a scheduled replacement milestone.
3. Terminology
Decommissioningisthefirstphysicalprocessinthedisposition
3.1 Definitions—For additional definitions for property and
process and includes proper identification, authorization for
asset management, see Terminology E2135.
disposition, and sanitization of the equipment, as well as
3.2 Definitions of Terms Specific to This Standard:
removal of Patient Health Information (PHI) or software, or
3.2.1 decommission, v—to remove from active service.
both. Disposal method is dependent upon many factors that
3.2.2 medical equipment, n—non-expendable, tangible,
will be described in this standard guide.
moveable property needed for the performance of, primarily or
1.3 This guide does not include detailed disposal method
uniquely, a medical task.
procedures or sales requirements or restrictions specific to any
3.2.3 sanitization, n—the process of removing undesired
regulatory body or the various levels of government in which
features such as chemical, biological contaminants from all
an entity may operate. This guide also provides practices that
surfaces, and personal or sensitive data from data storage
are common to many operations and provides flexibility to best
devices.
integrate external requirements.
1.4 While this standard describes common safety and envi- 4. Summary of Guide
ronmental considerations associated with the decommissioning
4.1 Hospitals and medical organizations decommission and
and disposal of medical equipment, it does not purport to
dispose of many types of highly complex medical devices and
address all of the safety concerns, if any, associated with its
equipment.
use. It is the responsibility of the entity using this standard to
4.2 Entities must understand what equipment is to be
establish and apply appropriate safety, health, and environ-
disposed, ownership and use agreements, and restrictions on
mental practices and determine the applicability of regulatory
disposal as part of the decommissioning process.
limitations prior to use.
4.3 An appraisal by an accredited member of the American
1.5 This international standard was developed in accor-
3
Society ofAppraisers (ASA) or theAssociation of Machinery
dance with internationally recognized principles on standard-
4
and Equipment Appraisers (AMEA) should be performed
ization established in the Decision on Principles for the
prior to decommissioning expensive and complex medical or
Development of International Standards, Guides and Recom-
scientific equipment to better understand the potential value of
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
1
This guide is under the jurisdiction of ASTM Committee E53 on Asset the ASTM website.
3
Management and is the direct responsibility of Subcommittee E53.30 on Decom- American Society of Appraisers (ASA),11107 Sunset Hills Rd, Suite 310,
missioning and Disposal of Medical Supplies, Medical Equipment, and Hospitals. Reston, VA 20190, http://www.appraisers.org.
4
Current edition approved July 1, 2018. Published July 2018. DOI: 10.1520/ Association of Machinery and Equipment Appraisers (AMEA), 315 South
E3173-18. Patrick Street Alexandria, Virginia 22314, http://www.amea.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E3173 − 18
the equipment. In some cases, extensive decommissioning of 7.2 The property office should review every request for the
medicalequipmentpriortosaleortransfe
...

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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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1.2.3 Tubes used for testing described in this guide are cylindrical and uniform in diameter. The test methods describe may not apply to non-cylindrical tubes.  
1.2.4 By use of this guide, medical device manufacturers can characterize the brush part designed for cleaning their device.  
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1.3 Exclusions:  
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Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device

SIGNIFICANCE AND USE
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SCOPE
1.1 This guide describes methods for characterizing the efficacy, under prescribed laboratory conditions, of a brush part designed to clean the external surface of a medical device. The method utilizes force testers to mechanically actuate a brush part across a surface at a constant rate and constant pressure. In the first method, the force required to actuate across the surface is measured. In the next method, which utilizes the same force testers and protocol (actuation motion), the brush part is actuated on a soiled surface and the amount of soil removed is measured, as 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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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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Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

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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SIGNIFICANCE AND USE
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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 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.

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    7 pages
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ASTM
ASTM F2901-19(Guide)
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
    English language
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  • Guide
    5 pages
    English language
    sale 15% off