iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM F2503-20

(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
4.1 Interactions of medical devices and other items with the MR environment has resulted in serious injuries and death of patients and other individuals. Additionally, hazards stemming from equipment malfunction are of concern. Section 4.2 lists possible direct and indirect causes of hazards in the MR environment.  
4.2 Potential direct and indirect causes of hazards:  
4.2.1 Direct causes:
4.2.1.1 mechanical causes, including magnetically induced displacement force, torque, and vibration
4.2.1.2 electromagnetic causes, including induction (heating, stimulation) and discharge (spark gap)
4.2.1.3 acoustic causes  
4.2.2 Indirect causes:
4.2.2.1 malfunction of items, for example of vital components such as valves, monitors and pumps  
4.3 This practice provides a uniform system for marking to indicate the conditions for which it has been determined that a medical device or other item may be safely placed and used in the MR environment. 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 international standard applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment.  
1.2 The purpose of this practice is to mark items that might be brought into the MR environment and to recommend information that should be included in the marking.  
1.3 The standard specifies the permanent marking of items, which are used in an MR environment, by means of terms and icons.  
1.4 MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard practice (see X1.5).  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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.  
1.7 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
Historical
Publication Date
31-Jan-2020
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

Buy Standard

ASTM F2503-20 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance EnvironmentASTM F2503-20 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
PreviousNext
Standard
ASTM F2503-20 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
English language
9 pages
sale 15% off
Preview
sale 15% off
Preview
REDLINE ASTM F2503-20 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance EnvironmentREDLINE ASTM F2503-20 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
PreviousNext
Standard
REDLINE ASTM F2503-20 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
English language
9 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2503 − 20
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 F2503; 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.
2
1. Scope 2.2 ASTM Standards:
F2052 Test Method for Measurement of Magnetically In-
1.1 This international standard applies to the practice of
duced Displacement Force on Medical Devices in the
marking of items that might be used in the magnetic resonance
Magnetic Resonance Environment
(MR) environment.
F2119 Test Method for Evaluation of MR Image Artifacts
1.2 The purpose of this practice is to mark items that might
from Passive Implants
be brought into the MR environment and to recommend
F2182 Test Method for Measurement of Radio Frequency
information that should be included in the marking.
Induced Heating On or Near Passive Implants During
Magnetic Resonance Imaging
1.3 The standard specifies the permanent marking of items,
which are used in an MR environment, by means of terms and F2213 Test Method for Measurement of Magnetically In-
duced Torque on Medical Devices in the Magnetic Reso-
icons.
nance Environment
1.4 MR image artifacts are not considered to be a perfor-
2.3 Other Standards:
mance issue and so are not addressed in this international
IEC 60601-2-33 Medical Electrical Equipment—Part 2-33:
standard practice (see X1.5).
Particular Requirements for the Safety of Magnetic Reso-
1.5 The values stated in SI units are to be regarded as 3
nance Equipment for Medical Diagnosis
standard. No other units of measurement are included in this
ISO 14971 Medical Devices—Application of Risk Manage-
standard. 4
ment to Medical Devices
1.6 This standard does not purport to address all of the
ISO/IEC Guide 51 Safety Aspects—Guidelines for their
4
safety concerns, if any, associated with its use. It is the
Inclusion in Standards
responsibility of the user of this standard to establish appro-
ISO TS 10974 Assessment of the Safety of Magnetic Reso-
priate safety, health, and environmental practices and deter-
nance Imaging for Patients with an Active Implantable
4
mine the applicability of regulatory limitations prior to use.
Medical Device
1.7 This international standard was developed in accor-
3. Terminology
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
3.1 Definitions:
Development of International Standards, Guides and Recom-
3.1.1 harmful interaction—unintended direct or indirect in-
mendations issued by the World Trade Organization Technical
teraction of items with MR equipment, especially with the
Barriers to Trade (TBT) Committee.
static magnetic field, the gradient fields and the RF fields of the
MR equipment, that can pose hazards to patients or other
2. Referenced Documents
persons.
2.1 The following referenced documents are indispensable
3.1.1.1 Discussion—In this context, the affected image qual-
for the application of this document. For dated references, only
ity or image artifacts are not considered to be a harmful
the edition cited applies. For undated references, the latest
interaction.
edition of the referenced document (including any amend-
ments) applies.
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
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Standards volume information, refer to the standard’s Document Summary page on
Surgical Materials and Devices and is the direct responsibility of Subcommittee the ASTM website.
3
F04.15 on Material Test Methods. Available from International Electrotechnical Commission (IEC), 3, rue de
Current edition approved Feb. 1, 2020. Published February 2020. Originally Varembé, P.O. Box 131, CH-1211 Geneva 20, Switzerland, http://www.iec.ch.
4
approved in 2005. Last previous edition approved in 2013 as F2503–13. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2503-20. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2503 − 20
3.1.2 hazard—potential source of harm. ISO/IEC Guide 51 via additional language the conditions in which an item can be
used safely within the MR environment.
3.1.3 item—object that might be brought into the MR
3.1.13 MR Safe—an item that poses no known hazards
environme
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2503 − 13 F2503 − 20
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 F2503; 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
1.1 This international standard applies to the practice of marking of items that might be used in the magnetic resonance (MR)
environment.
1.2 The purpose of this practice is to mark items that might be brought into the MR environment and to recommend information
that should be included in the marking.
1.3 The standard specifies the permanent marking of items, which are used in an MR environment, by means of terms and icons.
1.4 MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard
practice (see X1.5).
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.7 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.
2. Referenced Documents
2.1 The following referenced documents are indispensable for the application of this document. For dated references, only the
edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
2
2.2 ASTM Standards:
F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic
Resonance Environment
F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic
Resonance Imaging
F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance
Environment
2.3 Other Standards:
IEC 60601-2-33 Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic Resonance
3
Equipment for Medical Diagnosis
4
ISO 14971 Medical Devices—Application of Risk Management to Medical Devices
4
ISO/IEC Guide 51 Safety Aspects—Guidelines for their Inclusion in Standards
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.15
on Material Test Methods.
Current edition approved June 1, 2013Feb. 1, 2020. Published July 2013February 2020. Originally approved in 2005. Last previous edition approved in 20082013 as
F2503–08.–13. DOI: 10.1520/F2503-13.10.1520/F2503-20.
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 the ASTM website.
3
Available from International Electrotechnical Commission (IEC), 3, rue de Varembé, P.O. Box 131, CH-1211 Geneva 20, Switzerland, http://www.iec.ch.
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2503 − 20
ISO TS 10974 Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical
4
Device
3. Terminology
3.1 Definitions:
3.1.1 harmful interaction—unintended direct or indirect interaction of items with MR equipment, especially with the static
magnetic field, the gradient fields and the RF fields of the MR equipment, that can pose hazards to patients or other persons.
NOTE 1—In this context, the affected image quality or image artifacts are not considere
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

ASTM
ASTM F2503-23e1(Practice)
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.
SCOPE
1.1 This practice applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.
Note 1: “Medical devices and other items” will be referred to as “items” for the remainder of this practice.  
1.2 The practice specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.  
1.3 MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination (see X1.12).  
1.4 The values stated in SI units are to be regarded as standard.  
1.5 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.  
1.6 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.

  • Standard
    15 pages
    English language
    sale 15% off
ASTM
ASTM F3276-22(Guide)
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
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.  
5.1.1 The first test method utilizes a force tester to measure the force required to actuate a brush part across a surface. This is an indicator of the friction a brush exerts on a surface, a parameter of cleaning effectiveness.  
5.1.2 The second test method measures the removal of soil from a surface by a brush part actuated across the surface. This is a further indicator of the effectiveness of a brush part to loosen and remove soil from a surface.  
5.2 By providing objective, repeatable methods for evaluating performance under test conditions, this guide can improve the ability to assess the effectiveness of various brush part designs
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.  
1.2 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices.  
1.3 Inclusions:  
1.3.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part, under prescribed laboratory conditions, with a test method that simulates the cleaning challenge of a defined target area(s) of a medical device. This also makes it possible to compare one brush part design to another.  
1.3.2 By use of this guide, manufacturers of cleaning brushes will be able to evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s) and evaluate modifications to design and construction that might improve performance.  
1.3.3 By use of this guide, this information can also be shared with the users of the brushes (medical device reprocessors) to help them evaluate the performance of commercially available brushes.  
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.  
1.4.3 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters that are tested (for example, test soil, drying time, surface area, and materials, etc.) that are tested.  
1.4.4 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device, including use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete cleaning instructions validation. Separate medical device cleaning instruction validation studies must be conducted.  
1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated...

  • Guide
    11 pages
    English language
    sale 15% off
  • Guide
    11 pages
    English language
    sale 15% off
ASTM
ASTM F3275-22(Guide)
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.  
5.1.1 The force required to move a brush part within a tube, an indicator of the friction a brush exerts on a surface, is a parameter of cleaning effectiveness and should be measured.  
5.1.2 The removal of soil from a tube by a brush part moved in a tube is a further indicator of the effectiveness of a brush to loosen and remove soil from a tube and should be measured.  
5.2 By providing objective, repeatable methods for evaluating performance, this guide can improve the ability to assess the effectiveness, under test conditions, of various brush part designs.
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.  
1.2 Inclusions:  
1.2.1 This guide describes objective, quantifiable, and reproducible methods for evaluating the cleaning characteristics of a brush part under prescribed laboratory conditions, with test methods that simulate the cleaning challenge of a defined target area(s) of a medical device. This also makes possible the comparison of one design of a brush part to another.  
1.2.2 In this guide, a brush part is one that is intended to be moved within a tube.  
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.  
1.2.5 By use of this guide, manufacturers of cleaning brushes can evaluate and characterize the cleaning performance of their brushes for the target area(s) of medical device(s), including allowing a comparison with existing brush part designs offered on the market. Further, they are able to evaluate modifications to designs and construction that might improve performance.  
1.2.6 This information can also be shared with the users of the brushes (medical device reprocessors) to help them evaluate the performance of commercially available brushes.  
1.3 Exclusions:  
1.3.1 This guide does not assess potential damage that may be inflicted by the brush. For instance, brushes with rigid bristles (for example, stainless steel or other metals) or other abrasive materials are more likely to damage medical devices than brushes with flexible bristles (for example, nylon) or more pliable materials. Potential damage from more abrasive materials should be assessed.  
1.3.2 This guide does not specify acceptance criteria, and the results will be dependent on the specific parameters (for example, test soil, drying time, channel inside diameter and material, and so forth) that are tested.  
1.3.3 This guide is not intended to constitute all steps required to conduct validation of cleaning instructions for a medical device, including the use of brushes for this purpose, but provides methods that may be part of a broader protocol to conduct a complete cleaning instructions validation.  
1.3.4 If a brush is intended to clean a specific device(s), cleaning validation shall include testing with that device(s).  
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if an...

  • Guide
    12 pages
    English language
    sale 15% off
  • Guide
    12 pages
    English language
    sale 15% off
ASTM
ASTM F3438-21(Guide)
Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) 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 This guide helps medical device manufacturers to identify the appropriate method(s) for detecting and quantifying markers for the simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.  
5.3 This guide describes various test methods for the different analytes.
SCOPE
1.1 This standard guide provides methods and considerations for detecting and quantifying test soil(s) from reusable medical device(s) that result from simulated-use testing of medical devices during validation of the cleaning procedures as described in the instructions for use (IFU) provided by the medical device manufacturer.  
1.2 The methods described are for detecting and measuring markers (analytes) that are components within the most common test soils and are relevant to the clinical use of the device. Appropriate test soils without protein, carbon, or carbohydrates (for example, bone) will require other methods.  
1.3 This is a part of a series of ASTM standard guides for validating cleaning instructions. The scope of the first guide in the series is selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods for inoculating medical devices with test soil. The third in the series (Guide F3321) describes methods for extracting soils for measuring residual soil on medical devices after the performance of cleaning process. This is the fourth guide in the series and describes the methods of detecting and quantifying residual analytes on the device.  
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 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.  
1.6 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
    7 pages
    English language
    sale 15% off
ASTM
ASTM F1839-08(2021)(Specification)
Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

ABSTRACT
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.
SIGNIFICANCE AND USE
5.1 This specification describes the compositional requirements, physical requirements, mechanical requirements, and test methods for rigid unicellular polyurethane foam for use in testing orthopaedic devices or instruments.  
5.2 This foam described in this specification is not intended to replicate the mechanical properties of human or animal bone. The requirements of this specification are intended to provide a consistent and uniform material with properties on the order of human cancellous bone to use as a test medium when testing various orthopaedic devices, such as bone screws.
SCOPE
1.1 This specification covers rigid unicellular polyurethane foam for use as a standard material for performing mechanical tests utilizing orthopaedic devices or instruments. The specification is applicable to sheets or blocks of foam, or foam that is made by the user using a two-part liquid mixture.  
1.2 This specification covers polyurethane foam material that is used in the laboratory for mechanical testing, as described in 1.1. These materials are not intended for implantation into the human body.  
1.3 The foam described herein possesses mechanical properties which are on the order of those reported for human cancellous bone. See Appendix X1, Rationale, for further information regarding the appropriateness of using the specified foam as a model for human cancellous bone.  
1.4 This specification covers compositional requirements, physical requirements, mechanical requirements, and test methods for rigid polyurethane foam in the solid final form.  
1.5 This specification provides qualification criteria for vendor or end user processes and acceptance criteria for individual material lots.  
1.6 This specification provides mechanical properties of five different grades of foam in the solid final form. A foam that does not meet the specified mechanical properties shall be identified as an ungraded foam.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.8 The following precautionary statement pertains to the test method portion only, Section 8, of this specification: 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.  
1.9 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.

  • Technical specification
    6 pages
    English language
    sale 15% off
ASTM
ASTM F3487-20(Guide)
Standard Guide for Assessing the Service Life of a Brush Part Intended to Clean a Medical Device

SIGNIFICANCE AND USE
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.  
5.2 In the case of a brush part intended to clean a lumen, the force required to move a brush part within a tube, an indicator of the friction a brush exerts on a surface, is a measurable parameter that can change over time and will decrease as the brush part loses integrity.  
5.3 In the case of a brush part intended to clean the external surface, the force required to move the brush across a surface and the pressure the brush exerts on that surface are measurable parameters that can change over time and will decrease as the brush part loses integrity.  
5.4 By providing objective, repeatable methods for evaluating performance under test conditions, this guide can improve the ability to assess the effectiveness of various brush part designs.
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.  
1.2 The test methods utilized in this guide are those described in Guides F3275 and F3276. In this guide, the number of repetitions is open-ended and determined by the measurable fatigue of the brush part as measured by a reduction in force, as well as any observation of wear or damage to the brush part.  
1.3 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices. Instructions for use from the brush manufacturer should supply information related to the service life of the brush. This may be stated in terms of (1) a time period; (2) the number of uses; (3) inspection of the brush for wear and damage.  
1.4 Inspection for wear should always be a part of the instructions for use of a brush. Application of this guide can help to determine like mode(s) of observable failure of a brush part.  
1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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.  
1.7 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
    sale 15% off
ASTM
ASTM F3208-20(Guide)
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:  
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...

  • Guide
    9 pages
    English language
    sale 15% off
  • Guide
    9 pages
    English language
    sale 15% off
ASTM
ASTM F3335-20(Guide)
Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion

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....

  • Guide
    7 pages
    English language
    sale 15% off
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.

  • Guide
    7 pages
    English language
    sale 15% off
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
    sale 15% off
  • Guide
    5 pages
    English language
    sale 15% off