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ASTM F2503-05

(Practice)

Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

SIGNIFICANCE AND USE
Medical devices and other items have caused serious injuries and death for patients and other individuals in the MR environment.
This practice provides a uniform system for marking to indicate the MR conditions that have been determined to be acceptable for a medical device or other item. It provides simple visual icons and terms which are intended to reduce injuries and other mishaps that occur when items that pose hazards in the MR environment are brought into the MR environment.
SCOPE
1.1 This practice covers the marking of medical devices and other items to indicate their safety in the magnetic resonance (MR) environment.
1.2 The purpose of this practice is to (1) recommend that items that may be brought into the MR environment be permanently marked to indicate the MR environment to which a specific item may safely be exposed, and (2) recommend information that should be included in the marking. It is recognized that direct marking on the item is not practical for implants and certain other medical devices. Where direct marking is not practical, this practice recommends that the marking be included in the labeling and on patient information cards (see 7.1).
1.3 Image artifact is not considered to be a safety issue and so is not addressed in this practice (see X1.5).
1.4 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
31-Jul-2005
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

Replaced By
ASTM F2503-08 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Effective Date
01-Oct-2008
Referred By
ASTM F1541-17 - Standard Specification and Test Methods for External Skeletal Fixation Devices
Effective Date
01-Aug-2005
Referred By
ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
Effective Date
01-Aug-2005
Referred By
ASTM F382-17 - Standard Specification and Test Method for Metallic Bone Plates
Effective Date
01-Aug-2005
Referred By
ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
Effective Date
01-Aug-2005
Referred By
ASTM F384-17 - Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Effective Date
01-Aug-2005
Referred By
ASTM F3437-23 - Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation
Effective Date
01-Aug-2005
Referred By
ASTM F2213-17 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Effective Date
01-Aug-2005
Referred By
ASTM F1264-16e1 - Standard Specification and Test Methods for Intramedullary Fixation Devices
Effective Date
01-Aug-2005
Referred By
ASTM F3395/F3395M-19 - Standard Specification for Neurosurgical Head Holder Devices
Effective Date
01-Aug-2005
Referred By
ASTM F564-17 - Standard Specification and Test Methods for Metallic Bone Staples
Effective Date
01-Aug-2005
Referred By
ASTM F2182-19e2 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Effective Date
01-Aug-2005
Referred By
ASTM F1781-21 - Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
Effective Date
01-Aug-2005
Referred By
ASTM F2978-20 - Standards Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
Effective Date
01-Aug-2005
Referred By
ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
Effective Date
01-Aug-2005

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ASTM F2503-05 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance EnvironmentASTM F2503-05 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
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ASTM F2503-05 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation:F2503–05
Standard Practice for
Marking Medical Devices and Other Items for Safety in the
1
Magnetic Resonance Environment
This standard is issued under the fixed designation F 2503; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope duced Torque on Medical Devices in the Magnetic Reso-
nance Environment
1.1 This practice covers the marking of medical devices and
2.2 Other Standards:
other items to indicate their safety in the magnetic resonance
ISO 3864-1:2002(E) Graphical Symbols—Safety Colours
(MR) environment.
and Safety Signs—Part 1: Design Principles for Safety
1.2 The purpose of this practice is to (1) recommend that
3
Signs in Workplaces and Public Areas
items that may be brought into the MR environment be
ISO 13485:2003(E) Medical Devices—Quality Manage-
permanently marked to indicate the MR environment to which
ment Systems—Requirements for Regulatory Purposes,
a specific item may safely be exposed, and (2) recommend
3
definition 3.7
information that should be included in the marking. It is
4
ISO/IEC Guide 51:1999, definition 3.5
recognized that direct marking on the item is not practical for
IEC 60601-2-33, Ed. 2.0 Medical Electrical Equipment—
implants and certain other medical devices. Where direct
Part2:ParticularRequirementsfortheSafetyofMagnetic
marking is not practical, this practice recommends that the
4
Resonance Equipment for Medical Diagnosis
marking be included in the labeling and on patient information
cards (see 7.1).
3. Terminology
1.3 Image artifact is not considered to be a safety issue and
3.1 Definitions:
so is not addressed in this practice (see X1.5).
3.1.1 hazard—potential source of harm. ISO/IEC
1.4 This standard does not purport to address all of the
Guide 51
safety concerns, if any, associated with its use. It is the
3.1.2 item—medical device or other object that may be
responsibility of the user of this standard to establish appro-
brought into the MR environment.
priate safety and health practices and determine the applica-
3.1.3 magnetically induced displacement force—force pro-
bility of regulatory limitations prior to use.
ducedwhenamagneticobjectisexposedtothespatialgradient
2. Referenced Documents of a static magnetic field. This force will tend to cause the
2 object to translate in the spatial gradient of the static magnetic
2.1 ASTM Standards:
field.
F 2052 Test Method for Measurement of Magnetically In-
3.1.4 magnetically induced torque—torque produced when
duced Displacement Force on Medical Devices in the
a magnetic object is exposed to a magnetic field. This torque
Magnetic Resonance Environment
will tend to cause the object to align itself along the magnetic
F2119 Test Method for Evaluation of MR Image Artifacts
field in an equilibrium direction that induces no torque.
from Passive Implants
3.1.5 magnetic induction or magnetic flux density (B in
F 2182 Test Method for Measurement of Radio Frequency
T)—that magnetic vector quantity which at any point in a
Induced Heating Near Passive Implants During Magnetic
magnetic field is measured either by the mechanical force
Resonance Imaging
experiencedbyanelementofelectriccurrentatthepoint,orby
F 2213 Test Method for Measurement of Magnetically In-
the electromotive force induced in an elementary loop during
any change in flux linkages with the loop at the point. The
magnetic induction is frequently referred to as the magnetic
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.15 on Material Test Methods.
Current edition approved Aug. 1, 2005. Published August 2005.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036.
4
Standards volume information, refer to the standard’s Document Summary page on Available from International Electrotechnical Commission (IEC), 3 rue de
the ASTM website. Varembé, Case postale 131, CH-1211, Geneva 20, Switzerland.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F2503–05
field. B isthestaticfieldinanMRsystem.Plaintypeindicates constant, 42.56 MHz/T for protons, and B is the static
0
...

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Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

SIGNIFICANCE AND USE
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.  
4.2 This practice provides a uniform system of visual icons and terms for marking items for use in the MR environment.
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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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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:  
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.  
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SIGNIFICANCE AND USE
5.1 Materials used in medical devices are selected in part for their biocompatibility, meaning that they have been demonstrated to have an acceptable biological response for the intended application. During manufacturing, most devices are exposed to a variety of processing steps and materials that have the potential to adversely affect the inherent biocompatibility of the device if they are not adequately removed prior to use.  
Note 1: For a fine powder, depending upon application, a new biological risk assessment may be required.  
5.2 In additive manufacturing, components are in most cases built layer-by-layer, allowing unprecedented freedom to design complex devices. This makes it possible to build devices that are very difficult to clean, such as topological optimized parts, small internal channels, lattice structures, and especially reticulated porous structures for bone ingrowth and fixation.  
5.3 Powdered fusion AM presents additional challenges. Components come out of the build volume with residual powder filling all open spaces within the device. The majority of the excess powder is typically removed by a combination of vibratory shaking, blowing with compressed gas, vacuuming, and ultrasonic cleaning in a solvent. However, the particles are typically very small and can become lodged in internal features such as pores, making removal difficult. Furthermore, particles that were immediately adjacent to the component during manufacturing can be partially sintered to the surface. Those particles can be extremely difficult to remove, are indistinguishable from loose particles when observed by most techniques, and may be at risk of detaching during the intended use of the device.  
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
1.1 This standard provides guidance for assessing the manufacturing material residues in medical devices fabricated using additive manufacturing (AM) techniques, specifically, from powder bed fusion AM technologies.  
1.1.1 Some of the techniques discussed in this guide may be applicable to devices fabricated by other types of AM equipment (e.g., stereolithography). Given each AM technique’s characteristics and post-processing challenges, there could be additional risks or considerations associated with some AM techniques or materials that are not addressed by this guide.  
1.2 This guide covers several qualitative and quantitative assessments of the presence and amount of residue remaining in or obtained by extraction in aqueous or organic solvents from powder bed fusion AM medical components.  
1.2.1 This guide identifies techniques to qualitatively determine the presence of residue and a technique to quantitatively assess it. It does not set acceptance criteria or acceptable limits for residues remaining in built parts. These methods are not the only methods to determine the presence or quantity of residual material in additive manufactured medical components.  
1.3 This guide pertains to devices in their finished state (after post-processing and subsequent manufacturing processes), as applicable. This guide may also be used to evaluate the effectiveness of cleaning processes between critical steps in the manufacturing process, to ensure minimal AM residue remains for cleaning processes downstream.  
1.4 This guide is not intended to evaluate the residue level in medical components that have been cleaned for reuse.  
1.5 Different cleaning methods, including high energy processes, can potentially damage small structures in AM parts. This guide does not address measurement or mitigation of this risk.  
1.6 This guide does not address the manufacturing occupational health issues of working with small particles (e.g., breathing hazards).  
1....

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ASTM
ASTM F3357-19(Guide)
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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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.

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