ASTM F2895-20

Standard Practice for Digital Radiography of Cast Metallic Implants

SIGNIFICANCE AND USE
4.1 The requirements expressed in this practice are intended to control the quality of the digital radiographic image of cast metallic surgical implants.
SCOPE
1.1 This practice covers the procedure for digital radiographic testing of cast metallic surgical implants and related weldments.  
1.2 Digital X-ray is an alternative method for radiography of cast metallic surgical implants and related weldments (see Practice F629).  
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
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, 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: 31-Jan-2020
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaces: ASTM F2895-15 - Standard Practice for Digital Radiography of Cast Metallic Implants
• Effective Date: 01-Feb-2020
• Refers: ASTM E1316-24 - Standard Terminology for <?Pub Dtl?>Nondestructive Examinations
• Effective Date: 01-Feb-2024
• Refers: ASTM E1742/E1742M-23 - Standard Practice for Radiographic Examination
• Effective Date: 15-Dec-2023
• Refers: ASTM E746-23 - Standard Practice for Determining Relative Image Quality Response of Industrial Radiographic Imaging Systems below 4 MeV
• Effective Date: 01-Dec-2023
• Refers: ASTM F629-20 - Standard Practice for Radiography of Cast Metallic Surgical Implants
• Effective Date: 01-Feb-2020
• Refers: ASTM E1316-19b - Standard Terminology for Nondestructive Examinations
• Effective Date: 01-Dec-2019
• Refers: ASTM E1316-19 - Standard Terminology for Nondestructive Examinations
• Effective Date: 01-Mar-2019
• Refers: ASTM E1742/E1742M-18 - Standard Practice for Radiographic Examination
• Effective Date: 01-Mar-2018
• Refers: ASTM E746-18 - Standard Practice for Determining Relative Image Quality Response of Industrial Radiographic Imaging Systems
• Effective Date: 01-Feb-2018
• Refers: ASTM E2698-18 - Standard Practice for Radiographic Examination Using Digital Detector Arrays
• Effective Date: 01-Feb-2018
• Refers: ASTM E1316-18 - Standard Terminology for Nondestructive Examinations
• Effective Date: 01-Jan-2018
• Refers: ASTM E746-17 - Standard Practice for Determining Relative Image Quality Response of Industrial Radiographic Imaging Systems
• Effective Date: 01-Nov-2017
• Refers: ASTM E1316-17a - Standard Terminology for Nondestructive Examinations
• Effective Date: 15-Jun-2017
• Refers: ASTM E1316-17 - Standard Terminology for Nondestructive Examinations
• Effective Date: 01-Feb-2017
• Refers: ASTM E1316-16a - Standard Terminology for Nondestructive Examinations
• Effective Date: 01-Aug-2016

Overview

ASTM F2895-20: Standard Practice for Digital Radiography of Cast Metallic Implants establishes essential guidelines for the digital radiographic examination of cast metallic surgical implants and related weldments. Published by ASTM International, this standard ensures that the quality and reliability of digital X-ray images used in evaluating medical implants meet rigorous requirements. ASTM F2895-20 provides a clear procedure for nondestructive testing (NDT) and supports the migration from traditional radiographic film to digital imaging methods within the medical device industry.

Key Topics

• Scope of Application: Covers the procedures and requirements for using digital radiography as an alternative to film-based methods for cast metallic implants and weldments, such as hip, knee, and dental prosthetics.
• Quality Requirements: Defines controls for image quality, including parameters such as contrast, brightness, gray scale, and sensitivity. Image Quality Indicators (IQIs), or penetrameters, are critical for verifying the adequacy of the radiographic technique.
• Image Processing and Storage: Addresses digital image acquisition, enhancement (contrast, filtration, zoom), and acceptable storage formats. Ensures traceability and reproducibility of digital images.
• Personnel Qualifications: Requires that individuals performing and interpreting radiographic examinations hold certifications in nondestructive testing, such as ASNT SNT-TC-1A, NAS410, or EN 4179.
• Acceptance Criteria: Outlines that product acceptance and rejection criteria should be mutually agreed upon by purchasers and suppliers, referencing applicable ASTM or international standards and digital reference images.
• Safety and Compliance: Clarifies that it is the user’s responsibility to establish health, safety, and regulatory practices before conducting digital radiography.

Applications

ASTM F2895-20 is widely used in the medical device manufacturing sector, particularly for:

• Quality Assurance of Surgical Implants: Ensuring structural integrity and absence of defects in cast metallic implants such as orthopedic and dental implants before clinical use.
• Production Controls: Integrating digital X-ray imaging in manufacturing quality control processes for cast and welded metallic components.
• Research and Development: Supporting the evaluation and development of new implant designs by providing reliable, high-quality digital imagery.
• Regulatory Compliance: Assisting manufacturers in meeting international regulatory requirements for nondestructive evaluation and device certification.
• Archival and Traceability: Providing secure, retrievable digital storage of radiographic images and associated inspection reports-a key factor in post-market surveillance and liability management.

Related Standards

ASTM F2895-20 references multiple standards to support thorough and consistent digital radiography practices, including:

• ASTM E94: Guide for Radiographic Examination Using Industrial Radiographic Film
• ASTM E192: Reference Radiographs of Investment Steel Castings for Aerospace Applications
• ASTM E746: Practice for Determining Relative Image Quality Response of Industrial Radiographic Imaging Systems
• ASTM E1030/E1030M: Practice for Radiographic Examination of Metallic Castings
• ASTM E2007: Guide for Computed Radiography
• ASTM E2033: Practice for Radiographic Examination Using Computed Radiography
• ASTM E2660 / E2669: Digital Reference Images for Investment Steel Castings and Titanium Castings
• ASNT SNT-TC-1A / NAS410 / EN 4179: Personnel Qualification and Certification in Nondestructive Testing

Practical Value

By following ASTM F2895-20, manufacturers and quality assurance professionals in the medical device sector can:

• Achieve definitive, high-quality digital radiographic images for critical implant components
• Facilitate rapid defect detection and accurate assessment, reducing production delays and risk
• Meet international expectations for device quality, traceability, and compliance
• Seamlessly integrate digital radiography technologies into existing nondestructive testing workflows

Utilizing this standard improves confidence in medical device safety and supports the growing use of digital radiography in advanced manufacturing environments.

Standards Content (Sample)

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: F2895 − 20
Standard Practice for
Digital Radiography of Cast Metallic Implants
This standard is issued under the fixed designation F2895; 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* E1030/E1030M Practice for Radiographic Examination of
Metallic Castings
1.1 This practice covers the procedure for digital radio-
E1316 Terminology for Nondestructive Examinations
graphic testing of cast metallic surgical implants and related
E1742/E1742M Practice for Radiographic Examination
weldments.
E2007 Guide for Computed Radiography
1.2 Digital X-ray is an alternative method for radiography
E2033 Practice for Radiographic Examination Using Com-
of cast metallic surgical implants and related weldments (see
puted Radiography (Photostimulable Luminescence
Practice F629).
Method)
1.3 The values stated in either SI units or inch-pound units E2660 Digital Reference Images for Investment Steel Cast-
ings for Aerospace Applications
are to be regarded separately as standard. The values stated in
each system may not be exact equivalents; therefore, each E2669 Digital Reference Images for Titanium Castings
E2698 Practice for Radiographic Examination Using Digital
system shall be used independently of the other. Combining
values from the two systems may result in non-conformance Detector Arrays
F629 Practice for Radiography of Cast Metallic Surgical
with the standard.
Implants
1.4 This standard does not purport to address all of the
2.2 ASNT Standard:
safety concerns, if any, associated with its use. It is the
SNT-TC-1A Personnel Qualification and Certification in
responsibility of the user of this standard to establish appro-
Nondestructive Testing
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
2.3 Aerospace Industry Association (AIA/NAS) Standard:
1.5 This international standard was developed in accor-
NAS410 NAS Certification & Qualification of Nondestruc-
dance with internationally recognized principles on standard-
tive Test Personnel
ization established in the Decision on Principles for the
2.4 European Standard:
Development of International Standards, Guides and Recom-
EN 4179 Aerospace series—Qualification and approval of
mendations issued by the World Trade Organization Technical 5
personnel for non-destructive testing
Barriers to Trade (TBT) Committee.
3. Terminology
2. Referenced Documents
3.1 Definitions—For additional terminology, consult Termi-
2.1 ASTM Standards:
nology E1316.
E94 Guide for Radiographic Examination Using Industrial
3.2 Definitions of Terms Specific to This Standard:
Radiographic Film
3.2.1 contrast, n—difference in gray scale level between an
E192 Reference Radiographs of Investment Steel Castings
area and its immediate surroundings as presented on the final
for Aerospace Applications
digital radiographic image.
E746 Practice for Determining Relative Image Quality Re-
sponse of Industrial Radiographic Imaging Systems 3.2.2 digital image contrast, n—range of gray scale values
in an image in which a high contrast indicates that the image
contains largely black-and-white brightness values with a wide
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
range of gray shades.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.12 on Metallurgical Materials.
Current edition approved Feb. 1, 2020. Published April 2020. Originally
approved in 2010. Last previous edition approved in 2015 as F2895 – 15. DOI: Available from theAmerican Society for Nondestructive Testing, Inc., PO Box
10.1520/F2895-20. 28518, Columbus, OH 43228-0518, http://www.asnt.org.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Aerospace Industries Association (AIA), 1000 Wilson Blvd.,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Suite 1700, Arlington, VA 22209, http://www.aia-aerospace.org.
Standards volume information, refer to the standard’s Document Summary page on Available from European Standards (EN) store, Krimicka 134 318 13 Pilsen
the ASTM website. Czech Republic, http://en-standard.eu.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2895 − 20
3.2.3 electronic imaging, v—means of converting the image quality indicator (IQI). It is not intended for use in judging the
stored on the imaging plate or detector into a standard video size or for establishing acceptance limits of discontinuities.
output format.
3.2.17 penetrameter sensitivity, n—indication of the ability
3.2.4 electronic imaging system, n—system that takes data of the radiographic process to show: (1) the difference in
material thickness by exhibiting a difference of radiographic
from a storage imaging plate or detector and converts it into a
standard analog or digital electronic signal. contrast and (2) detail definition by the resolution of holes of a
specific size.
3.2.5 gray scale, n—numeric values representing display
brightness. 3.2.18 quality level 2, n—quality level designation in which
the 2T hole is visible in a 2 % penetrameter; previously known
3.2.6 gray scale range, n—range of numeric values repre-
as 2–2T sensitivity.
senting the brightest and darkest portion of the image display.
3.2.19 radiation source, n—machine or radioisotope that
3.2.7 image display parameters, n—all variables necessary
emits penetrating radiation.
to standardize the video image.
3.2.20 radiographic image, n—visible image produced by
3.2.7.1 Discussion—These include, but are not limited to,
the penetration of radiation through the material being tested.
brightness, contrast, and linearity.
3.2.21 radiographic quality level, n—ability of a radio-
3.2.8 image processing, v—electronic enhancement of the
graphic procedure to demonstrate a certain penetrameter sen-
raw image signal to improve fine-detail detectability in the test
sitivity.
object and achieve required sensitivity.
3.2.8.1 Discussion—These include, but are not limited to,
3.2.22 recording media, n—recording media and storage
techniques such as noise reduction, contrast enhancement, and
format for mandatory radiographic image storage.
spatial filtering.
3.2.23 recording medium, n—detector that converts radia-
3.2.9 image quality level, n—ability of the inspection sys-
tionintoavisibleimageorasignalthatcanbetransformedinto
tem to demonstrate a specific relative image quality indicator a visible image at a later date.
(RIQI) sensitivity.
3.2.23.1 Discussion—Also known as an imaging plate.
3.2.10 imaging plate, IP, n—radiation sensitive detector that 3.2.24 relative image quality indicator, RIQI, n—image
iscapableofdetectingandstoringinputsignalinformationthat
quality measuring device that is capable of determining mean-
can subsequently be converted into a corresponding optical ingful differences between two or more radiographic imaging
signal.
systems or changes of individual components of radiographic
imaging systems.
3.2.11 IP reader, n—device capable of retrieving stored
information from the imaging plate and converting this infor- 3.2.25 technique, n—category within a method, for
mation into digital data for subsequent viewing on a video example, digital radiographic testing or fluorescent penetrant
monitor. inspection.
3.2.12 masking, n—lead or other high-density material 3.2.26 technique card, n—detailed, written instructions
(may be in the form of a sheet, card, or other documentation)
placed on or around a test object during exposure for the
purpose of minimizing the effect of secondary or scattered that supplement the instructions of a general procedure.
radiation.
3.2.27 test object, n—material, component, or assembly that
3.2.13 material thickness, n—shall be the nominal thickness is the subject of the radiographic examination.
or actual thickness if measured at the area being radiographed.
3.2.28 X-ray control number, n—inspection serial numbers
or code letters used to provide traceability.
3.2.14 National Institute of Standards and Technology,
NIST, n—federal technology agency that develops and pro-
4. Significance and Use
motes measurements, standards, and technology.
4.1 The requirements expressed in this practice are intended
3.2.15 nondestructive inspection (NDI) procedure,
to control the quality of the digital radiographic image of cast
n—written set of instructions that identify equipment
metallic surgical implants.
standardization, parameters, and setup for conducting a non-
destructive test or inspection.
5. Radiographic Methods
3.2.15.1 Discussion—The procedure may be broken into the
following two parts: a general procedure that has the basic 5.1 The radiographic method shall be agreed upon between
the
...

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: F2895 − 15 F2895 − 20
Standard Practice for
Digital Radiography of Cast Metallic Implants
This standard is issued under the fixed designation F2895; 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 practice covers the procedure for digital radiographic testing of cast metallic surgical implants and related weldments.
1.2 Digital X-ray is an alternative method for radiography of cast metallic surgical implants and related weldments (see Practice
F629).
1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in non-conformance with the standard.
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 safety, health, and healthenvironmental 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.
2. Referenced Documents
2.1 ASTM Standards:
E94 Guide for Radiographic Examination Using Industrial Radiographic Film
E192 Reference Radiographs of Investment Steel Castings for Aerospace Applications
E746 Practice for Determining Relative Image Quality Response of Industrial Radiographic Imaging Systems
E1030E1030/E1030M Practice for Radiographic Examination of Metallic Castings
E1316 Terminology for Nondestructive Examinations
E1742E1742/E1742M Practice for Radiographic Examination
E2007 Guide for Computed Radiography
E2033 Practice for Radiographic Examination Using Computed Radiography (Photostimulable Luminescence Method)
E2660 Digital Reference Images for Investment Steel Castings for Aerospace Applications
E2669 Digital Reference Images for Titanium Castings
E2698 Practice for Radiographic Examination Using Digital Detector Arrays
F629 Practice for Radiography of Cast Metallic Surgical Implants
2.2 ASNT Standard:
ASNT–TC–1A SNT-TC-1A Personnel Qualification and Certification in Nondestructive Testing
2.3 Aerospace Industry Association (AIA/NAS) Standard:
NAS410 NAS Certification & Qualification of Nondestructive Test Personnel
2.4 European Standard:
EN 4179 Aerospace series—Qualification and approval of personnel for non-destructive testing
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.12
on Metallurgical Materials.
Current edition approved May 15, 2015Feb. 1, 2020. Published June 2015April 2020. Originally approved in 2010. Last previous edition approved in 20102015 as F2895
– 10.15. DOI: 10.1520/F2895-15.10.1520/F2895-20.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from the American Society for Nondestructive Testing, Inc., PO Box 28518, Columbus, OH 43228-0518, http://www.asnt.org.
Available from Aerospace Industries Association (AIA), 1000 Wilson Blvd., Suite 1700, Arlington, VA 22209, http://www.aia-aerospace.org.
Available from European Standards (EN) store, Krimicka 134 318 13 Pilsen Czech Republic, http://en-standard.eu.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2895 − 20
3. Terminology
3.1 Definitions—For additional terminology, consult Terminology E1316.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 contrast, n—difference in gray scale level between an area and its immediate surroundings as presented on the final digital
radiographic image.
3.2.2 digital image, n—image composed of discrete pixels of digital brightness values.
3.2.2 digital image contrast, n—range of gray scale values in an image in which a high contrast indicates that the image contains
largely black-and-white brightness values with a wide range of gray shades.
3.2.3 electronic imaging, v—means of converting the image stored on the imaging plate or detector into a standard video output
format.
3.2.4 electronic imaging system, n—system that takes data from a storage imaging plate or detector and converts it into a
standard analog or digital electronic signal.
3.2.6 filters, n—sheets of copper or other material placed in the radiation beam either at the X-ray tube or between the specimen
and the detector to improve the quality by selectively removing low-energy radiation from the radiation beam and absorbing
scattered radiation.
3.2.5 gray scale, n—numeric values representing display brightness.
3.2.6 gray scale range, n—range of numeric values representing the brightest and darkest portion of the image display.
3.2.7 image display parameters, n—all variables necessary to standardize the video image.
3.2.7.1 Discussion—
These include, but are not limited to, brightness, contrast, and linearity.
3.2.8 image processing, v—electronic enhancement of the raw image signal to improve fine-detail detectability in the test object
and achieve required sensitivity.
3.2.8.1 Discussion—
These include, but are not limited to, techniques such as noise reduction, contrast enhancement, and spatial filtering.
3.2.9 image quality level, n—ability of the inspection system to demonstrate a specific relative image quality indicator (RIQI)
sensitivity.
3.2.10 imaging plate, IP, n—radiation sensitive detector that is capable of detecting and storing input signal information that can
subsequently be converted into a corresponding optical signal.
3.2.11 IP reader, n—device capable of retrieving stored information from the imaging plate and converting this information into
digital data for subsequent viewing on a video monitor.
3.2.12 masking, n—lead or other high-density material placed on or around a test object during exposure for the purpose of
minimizing the effect of secondary or scattered radiation.
3.2.13 material thickness, n—shall be the nominal thickness or actual thickness if measured at the area being radiographed.
3.2.14 National Institute of Standards and Technology, NIST, n—federal technology agency that develops and promotes
measurements, standards, and technology.
3.2.15 nondestructive inspection (NDI) procedure, n—written set of instructions that identify equipment standardization,
parameters, and setup for conducting a nondestructive test or inspection.
3.2.15.1 Discussion—
The procedure may be broken into the following two parts: a general procedure that has the basic instructions on performing an
inspection and a technique sheet that has the detailed instructions for specific parts.
3.2.16 penetrameter, n—strip of material of the same or similar composition as that of the material being examined representing
a percentage of section thickness and provided with a combination of steps, holes, or quality levels.
3.2.16.1 Discussion—
F2895 − 20
When placed in the path of radiation, the resultant radiographic image demonstrates the quality of the radiographic technique. It
is also known as an image quality indicator (IQI). It is not intended for use in judging the size or for establishing acceptance limits
of discontinuities.
3.2.17 penetrameter sensitivity, n—indication of the ability of the radiographic process to show: (1) the difference in material
thickness by exhibiting a difference of radiographic contrast and (2) detail definition by the resolution of holes of a specific size.
3.2.20 pixel, n—smallest unit of storage in a digital image that can be discretely controlled by the display system.
3.2.20.1 Discussion—
A pixel is described by its horizontal and vertical location within a digital matrix.
3.2.21 pixel intensity value, PV, n—see Practice E746 for description and discussion.
3.2.18 quality level 2, n—quality level designation in which the 2T hole is visible in a 2 % penetrameter; previously known as
2–2T sensitivity.
3.2.19 radiation source, n—machine or radioisotope that emits penetrating radiation.
3.2.20 radiographic image, n—visible image produced by the penetration of radiation through the material being tested.
3.2.25 radiographic inspection, n—use of penetrating radiation source to detect discontinuities in material by presenting their
images on a recording medium suitable for interpretation by qualified personnel.
3.2.21 radiographic quality level, n—ability of a radiographic procedure to demonstrate a certain penetrameter sensitivity.
3.2.22 recording media, n—recording media and storage format for mandatory radiographic image storage.
3.2.23 recording medium, n—detector that converts radiation into a visible image or a signal that can be transformed into a
visible image at a later date.
3.2.23.1 Discussion—
Also known as an imaging plate.
3.2.24 relative image quality indicator, RIQI, n—image quality measuring device that is capable of determining meaningful
differences between two or more radiographic imaging systems or changes of individual components of radiographic imaging
systems.
3.2.30 sensitivity, n—general or qualitative term referring to the size
...