iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM E1762-95(2013)

(Guide)

Standard Guide for Electronic Authentication of Health Care Information (Withdrawn 2017)

Standard Guide for Electronic Authentication of Health Care Information (Withdrawn 2017)

SIGNIFICANCE AND USE
4.1 This guide serves three purposes:  
4.1.1 To serve as a guide for developers of computer software providing, or interacting with, electronic signature processes,  
4.1.2 To serve as a guide to healthcare providers who are implementing electronic signature mechanisms, and  
4.1.3 To be a consensus standard on the design, implementation, and use of electronic signatures.
SCOPE
1.1 This guide covers:  
1.1.1 Defining a document structure for use by electronic signature mechanisms (Section 4),  
1.1.2 Describing the characteristics of an electronic signature process (Section 5),  
1.1.3 Defining minimum requirements for different electronic signature mechanisms (Section 5),  
1.1.4 Defining signature attributes for use with electronic signature mechanisms (Section 6),  
1.1.5 Describing acceptable electronic signature mechanisms and technologies (Section 7),  
1.1.6 Defining minimum requirements for user identification, access control, and other security requirements for electronic signatures (Section 9), and  
1.1.7 Outlining technical details for all electronic signature mechanisms in sufficient detail to allow interoperability between systems supporting the same signature mechanism (Section 8 and Appendix X1-Appendix X4).  
1.2 This guide is intended to be complementary to standards under development in other organizations. The determination of which documents require signatures is out of scope, since it is a matter addressed by law, regulation, accreditation standards, and an organization's policy.  
1.3 Organizations shall develop policies and procedures that define the content of the medical record, what is a documented event, and what time constitutes event time. Organizations should review applicable statutes and regulations, accreditation standards, and professional practice guidelines in developing these policies and procedures.
WITHDRAWN RATIONALE
Formerly under the jurisdiction of Committee E31 on Healthcare Informatics, this practice was withdrawn in March 2017. This standard is being withdrawn without replacement due to its limited use by industry.

General Information

Status
Withdrawn
Publication Date
28-Feb-2013
Withdrawal Date
18-Apr-2017
ICS
35.240.80 - IT applications in health care technology
Technical Committee
E31 - Healthcare Informatics
Drafting Committee
E31.25 - Healthcare Data Management, Security, Confidentiality, and Privacy
Current Stage
Ref Project

Relations

Replaces
ASTM E1762-95(2009) - Standard Guide for Electronic Authentication of Health Care Information
Effective Date
01-Mar-2013

Buy Standard

ASTM E1762-95(2013) - Standard Guide for Electronic Authentication of Health Care Information (Withdrawn 2017)ASTM E1762-95(2013) - Standard Guide for Electronic Authentication of Health Care Information (Withdrawn 2017)
PreviousNext
Guide
ASTM E1762-95(2013) - Standard Guide for Electronic Authentication of Health Care Information (Withdrawn 2017)
English language
17 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: E1762 − 95 (Reapproved 2013) An American National Standard
Standard Guide for
Electronic Authentication of Health Care Information
This standard is issued under the fixed designation E1762; 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 ISO 8825-1 1993: Specification of Basic Encoding Rules for
ASN.1
1.1 This guide covers:
ISO 7816 1993: IC Cards with Contacts
1.1.1 Defining a document structure for use by electronic
ISO 10036 1994: Contactless IC Cards
signature mechanisms (Section 4),
2.2 ANSI Standards:
1.1.2 Describing the characteristics of an electronic signa-
ANSI X9.30 Part 3: Certificate Management for DSA, No-
ture process (Section 5),
vember 1994 (ballot copy)
1.1.3 Defining minimum requirements for different elec-
ANSI X9.31 Part 3: Certificate Management for RSA, July
tronic signature mechanisms (Section 5),
1994 (draft)
1.1.4 Defining signature attributes for use with electronic
ANSI X9.31 Part 1: RSA Signature Algorithm, July 1994
signature mechanisms (Section 6),
(ballot copy) (technically aligned with ISO/IEC 9796)
1.1.5 Describing acceptable electronic signature mecha-
ANSI X9.30 Part 1: Digital Signature Algorithm, July 1994
nisms and technologies (Section 7),
(ballot copy) (technically aligned with NIST FIPS PUB
1.1.6 Defining minimum requirements for user
186)
identification, access control, and other security requirements
ANSI X9F1, ANSI X9.45: Enhanced Management Controls
for electronic signatures (Section 9), and
Using Attribute Certificates, September 1994 (draft)
1.1.7 Outlining technical details for all electronic signature
mechanisms in sufficient detail to allow interoperability be-
2.3 Other Standards:
tween systems supporting the same signature mechanism
FIPS PUB 112: Standards on Password Usage, May 1985
(Section 8 and Appendix X1 – Appendix X4).
FIPS PUB 181: Secure Hash Standard, 1994 (technically
aligned with ANSI X9.30–1)
1.2 This guide is intended to be complementary to standards
FIPS PUB 186: Digital Signature Standard, 1994 (techni-
under development in other organizations. The determination
cally aligned with ANSI X9.30–1)
of which documents require signatures is out of scope, since it
PKCS #1: RSA Encryption Standard (version 1.5), Novem-
is a matter addressed by law, regulation, accreditation
ber 1993
standards, and an organization’s policy.
PKCS #5: Password-Based Encryption Standard, 1994
1.3 Organizations shall develop policies and procedures that
PKCS #7: Cryptographic Message Syntax Standard, 1994
define the content of the medical record, what is a documented
event, and what time constitutes event time. Organizations
3. Terminology
shouldreviewapplicablestatutesandregulations,accreditation
3.1 Definitions:
standards, and professional practice guidelines in developing
3.1.1 access control—the prevention of unauthorized use of
these policies and procedures.
a resource, including the prevention of use of a resource in an
2. Referenced Documents unauthorized manner.
3.1.2 accountability—the property that ensures that the
2.1 ISO Standards:
actions of an entity may be traced uniquely to the entity.
ISO9594-8 1993:TheDirectory:AuthenticationFramework
(also available as ITU-S X.509)
3.1.3 attribute—a piece of information associated with the
use of a document.
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare
Informatics and is the direct responsibility of Subcommittee E31.25 on Healthcare
Data Management, Security, Confidentiality, and Privacy. Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
Current edition approved March 1, 2013. Published March 2013. Originally 4th Floor, New York, NY 10036, http://www.ansi.org.
approved in 1995. Last previous edition approved in 2009 as E1762–95 (2009). Available from National Institute of Standards and Technology (NIST), 100
DOI: 10.1520/E1762-95R13. Bureau Dr., Stop 1070, Gaithersburg, MD 20899-1070, http://www.nist.gov.
2 5
Available from ISO, 1 Rue de Varembe, Case Postale 56, CH 1211, Geneve, Available from RSA Data Security, 100 Marine Parkway, Redwood City, CA
Switzerland. 64065.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1762 − 95 (2013)
3.1.4 attribute certificate—a digitally signed data structure 3.1.22 private key—a key in an asymmetric algorithm; the
that binds a user to a set of attributes. possession of this key is restricted, usually to one entity.
3.1.5 authorization—verification that an electronically 3.1.23 public key—a key in an asymmetric algorithm that is
publicly available.
signed transaction is acceptable according to the rules and
limits of the parties involved.
3.1.24 public key certificate—a digitally signed data struc-
3.1.6 authorization certificate—an attribute certificate in ture which binds a user’s identity to a public key.
which the attributes indicate constraints on the documents the
3.1.25 repudiation—denialbyoneoftheentitiesinvolvedin
user may digitally sign.
a communication of having participated in all or part of the
3.1.7 availability—the property of being accessible and communication.
useable upon demand by an authorized entity.
3.1.26 role—the role of a user when performing a signature.
Examples include: physician, nurse, allied health professional,
3.1.8 computer-based patient record (CPR)—the computer-
transcriptionist/recorder, and others.
based patient record is a collection of health information
concerning one person linked by one or more identifiers. In the
3.1.27 secret key—a key in a symmetric algorithm; the
context of this guide, this term is synonymous with electronic
possession of this key is restricted, usually to two entities.
patient record and electronic health record.
3.1.28 signature—the act of taking responsibility for a
3.1.9 computer-based patient record system (CPRS)—the
document. Unless explicitly indicated otherwise, an electronic
CPRS uses the information of the CPR and performs the
signature is meant in this guide.
application functions according to underlying processes and its
3.1.29 signature attribute—an attribute characterizing a
interacting with related data and knowledge bases. CPRS is
given user’s signature on a document.
synonymous with electronic patient record systems.
3.1.30 signature purpose—an indication of the reason an
3.1.10 data integrity—the property that data has not been
entity signs a document. This is included in the signed
altered or destroyed in an unauthorized manner.
information and can be used when determining accountability
3.1.11 data origin authentication—corroboration that the
for various actions concerning the document. Examples in-
source of data received is as claimed.
clude: author, transcriptionist/recorder, and witness.
3.1.12 digital signature—data appended to, or a crypto-
3.1.31 signature time—the time a particular signature was
graphic transformation of, a data unit that allows a recipient of
generated and affixed to a document.
the data unit to prove the source and integrity of the data unit
3.1.32 signature verification—the process by which the
and protect against forgery, for example, by the recipient.
recipient of a document determines that the document has not
3.1.13 document access time—the time(s) when the subject
been altered and that the signature was affixed by the claimed
document was accessed for reading, writing, or editing.
signer. This will in general make use of the document, the
signature, and other information, such as cryptographic keys or
3.1.14 document attribute—an attribute describing a char-
biometric templates.
acteristic of a document.
3.1.33 user authentication—the provision of assurance of
3.1.15 document creation time—the time of the creation of
the claimed identity of an entity.
the subject document.
3.2 Acronyms:
3.1.16 document editing time—the time(s) of the editing of
the subject document. AAMT American Association for Medical Transcription
ABA American Bar Association
3.1.17 domain—a group of systems that are under control of
AHIMA American Health Information Management Association
AIM Advanced Informatics in Medicine
the same security authority.
ASC X3 Accredited Standards Committee X3
3.1.18 electronic document—a defined set of digital
ASC X9 Accredited Standards Committee X9
ASC X12N Accredited Standards Committee X12N
information, the minimal unit of information that may be
CA Certification Authority
digitally signed.
CEN Comité Européen de Normalisation (European Standards Com-
mittee)
3.1.19 electronic signature—the act of attaching a signature
CLC Comité Européen de Normalisation Electrotechnique
byelectronicmeans.Aftertheelectronicsignatureprocess,itis
(CENELEC)
CRL Certificate Revocation List
a sequence of bits associated with an electronic document,
DSA Digital Signature Algorithm (NIST)
which binds it to a particular entity.
EWOS European Workshop for Open Systems
ES Electronic Signature
3.1.20 event time—the time of the documented event.
FDA Food and Drug Administration
FIPS Federal Information Processing Standard
3.1.21 one-way hash function—a function that maps strings
ISO International Standards Organization
of bits to fixed-length strings of bits, satisfying the following
ITSTC International Technology Steering Committee
two properties:
JCAHO Joint Commission on Accreditation of Healthcare Organizations
MAC Message Athentication Code
3.1.21.1 It is computationally infeasible to find for a given
NIST National Institute for Standards and Technology
output an input that maps to this output.
NTP Network Time Protocol
3.1.21.2 It is computationally infeasible to find for a given PCMCIA Personal Computer Memory Card Interface Association
RSA Rivest-Shamir-Adleman (signature algorithm)
input a second input that maps to the same output.
E1762 − 95 (2013)
record systems to be accepted, they must provide an equivalent
SEISMED Secure Environment for Information Systems in Medicine
THIS Trusted Health Information Systems
or greater level of accurate data entry, accountability, and
TTP Trusted Third Party
appropriate quality improvement mechanisms. In this context,
a standard is needed that does not allow a party to successfully
4. Significance and Use
deny authorship and reject responsibility (repudiation).
4.1 This guide serves three purposes:
5.5 The guide addresses the following requirements, which
4.1.1 To serve as a guide for developers of computer
any system claiming to conform to this guide shall support:
software providing, or interacting with, electronic signature
5.5.1 Non-repudiation,
processes,
5.5.2 Integrity,
4.1.2 To serve as a guide to healthcare providers who are
5.5.3 Secure user authentication,
implementing electronic signature mechanisms, and
5.5.4 Multiple signatures,
4.1.3 To be a consensus standard on the design,
5.5.5 Signature attributes,
implementation, and use of electronic signatures.
5.5.6 Countersignatures,
5.5.7 Transportability,
5. Background Information
5.5.8 Interoperability,
5.1 The creation of computer-based patient record systems
5.5.9 Independent verifiability, and
depends on a consensus of electronic signature processes that
5.5.10 Continuity of signature capability.
are widely accepted by professional, regulatory, and legal
5.6 Various technologies may fulfill one or more of these
organizations.The objective is to create guidelines for entering
requirements. Thus, a complete electronic signature system
information into a computer system with the assurance that the
mayrequiremorethanoneofthetechnologiesdescribedinthis
information conforms with the principles of accountability,
guide. Currently, there are no recognized security techniques
data integrity, and non-repudiation. Although various organi-
that provide the security service of non-repudiation in an open
zations have commenced work in the field of electronic
network environment, in the absence of trusted third parties,
signatures, a standard for the authentication of health informa-
other than digital signature-based techniques.
tion is needed. Consequently, this standard is intended as a
national standard for electronic signatures for health care
5.7 The electronic signature process involves authentication
information. Technological advances and increases in the
of the signer’s identity, a signature process according to system
legitimate uses and demands for patient health information led
designandsoftwareinstructions,bindingofthesignaturetothe
the Institute of Medicine (IOM) to convene a committee to
document, and non-alterability after the signature has been
identify actions and research for a computer-based patient
affixed to the document. The generation of electronic signa-
record(CPR).Thecommittee’sreportendorsedtheadoptionof
tures requires the successful identification and authentication
the CPR as the standard for all health care records and the
of the signer at the time of the signature. To conform to this
establishment of a Computer-based Patient Record Institute
guide, a system shall also meet health information security and
(CPRI). National Information Infrastructure initiatives, the
authentication standards. Computer-based patient record sys-
ever increasing complexity of health care delivery, a growing
tems may also be subject to statutes and regulations in some
need for accessible, affordable, and retrievable patient data to
jurisdictions.
support clinical practice, research, and policy development
5.8 While most electronic signature standards in the
support this recommendation. Major issues identified by CPRI
banking, electronic mail, and business sectors address only
as essential to the timely development of CPRs include
digital signature systems, this standard acknowledges the
authentication of electronic signatures (as replacements for
efforts of industry and systems integrators to achieve authen-
paper signatures), as well as patient and provider confidenti-
tication with other methods. Therefore, this standard will not
ality and electronic data security.
be restricted to a single technology.
5.2 User authentication is used to identify an entity (person
or machine) and verify the identity of the entity. Data origin 6. Document Structure
authentication binds that entity and verification to a piece of
6.1 For any data or information for which authentication is
information. The focus of this standard is the application of
required, the system shall:
user and data authentication to information generated
...

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 E2147-18(Specification)
Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems

ABSTRACT
This specification describes the security requirements involved in the development and implementation of audit and disclosure logs used in health information systems. It specifies how to design an access audit log to record all access to patient identifiable information maintained in computer systems, and includes principles for developing policies, procedures, and functions of health information logs to document all disclosure of confidential health care information to external users for use in manual and computer systems. This specification provides for two main purposes, namely: to define the nature, role, and function of system access audit logs and their use in health information systems as a technical and procedural tool to help provide security oversight; and to identify principles for establishing a permanent record of disclosure of health information to external users and the data to be recorded in maintaining it.
SIGNIFICANCE AND USE
4.1 Data that document health services in health care organizations are business records and shall be archived to a secondary but retrievable medium, and readily accessible, such as data that would be archived in a server or cloud storage. Audit data shall be retained for as long as the medical record is maintained, and may not be destroyed before the medical record may legally be destroyed, and in any event, for at least 10 years or for two years after the legal age of majority, unless a longer period of record retention is prescribed by state, federal or other law or regulation.  
4.2 The purpose of audit data and disclosure logs is to document and maintain a permanent, trustworthy, and immutable record of all authorized and unauthorized activities of any nature whatsoever and disclosure of confidential health information {except exclusions per federal and state law [21 CFR 11 Subpart B(e)]}. This further facilitates the purpose that patients, healthcare providers, organizations, and others can obtain a verifiable, self-authenticating record documenting all activities with respect to that record. The process of information disclosure and auditing shall also conform, where relevant, with the Privacy Act of 1974 (3).  
4.3 Audit reports designed for system access provide a precise capability for healthcare providers, organizations, patients, patient representatives, and advocates to see who has accessed and/or manipulated patient information. Because of the significant risk of medical information manipulation in computing environments by authorized and unauthorized users, the audit report is an important management tool to monitor access and any such manipulation retrospectively. In addition, the access and disclosure logs become powerful support documents for disciplinary and legal actions. Moreover, audit reports are essential components to comprehensive security programs in healthcare and vital for the privacy rights of the individual. A patient has a right to ...
SCOPE
1.1 This specification is for the development and implementation of secure audit data and logs for electronically stored health information. It specifies how to design the audit log to record all activities impacting a medical record, for example, creating a new record, entering data into a record, changing or deleting an existing record, and all additional user access data (for example, identification, location, and date and time) to patient-identifiable information maintained in computer systems. Such audit logs shall track not only data entry and modifications, but also simple access and viewing of the patient record, and whether any modifications are made during that access. This specification also includes principles for developing policies, procedures, and functions of health information logs to document all actions regarding identifiable health information for use in both manually entered (paper record) and computer systems.  
1.2 The first purpose of this specification is to defin...

  • Technical specification
    7 pages
    English language
    sale 15% off
ASTM
ASTM E2767-24(Practice)
Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for X-ray Computed Tomography (CT) Test Methods

SIGNIFICANCE AND USE
5.1 Personnel that are responsible for the creation, transfer, and storage of X-ray tomographic NDE data will use this standard. This practice defines a set of information modules that along with Practice E2339 and the DICOM standard provide a standard means to organize X-ray tomography test parameters and results. The X-ray CT test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any tomographic inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record.
SCOPE
1.1 This practice facilitates the interoperability of X-ray computed tomography (CT) imaging equipment by specifying image data transfer and archival storage methods in commonly accepted terms. This document is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of the NEMA Standards Publication titled Digital Imaging and Communications in Medicine (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage, and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE test results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules and a data dictionary that are specific to X-ray CT test methods.  
1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from tomographic test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all the X-ray CT technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology.  
1.3 This practice does not specify:  
1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard.  
1.3.2 The implementation details of any features of the standard on a device claiming conformance.  
1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance.  
1.4 Units—Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. 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.

  • Standard
    11 pages
    English language
    sale 15% off
  • Standard
    11 pages
    English language
    sale 15% off
ASTM
ASTM E3398-23(Guide)
Standard Guide for Digital Neutron Radiography

SIGNIFICANCE AND USE
4.1 Purpose—Practices to be employed for the radiographic examination of materials and components with neutrons using digital neutron detectors are outlined herein. They are intended as a guide for the assessment of a digital neutron radiograph’s characteristics. For information on neutron beam lines for imaging and film neutron radiography, refer to Guide E748.  
4.2 Limitations—Acceptance standards have not been established for any material or production process. Neutron radiography, whether performed by means of a reactor, an accelerator, subcritical assembly, or radioactive source, will be consistent in sensitivity and spatial resolution only if the consistency of all details of the technique, such as neutron source, collimation, geometry, imaging system, etc., are maintained. This guide is limited to the use of digital neutron detectors in combination with neutron conversion materials for image recording. This guide is intended for use with thermal and cold neutron spectrums. The production of thermal neutron radiographs by employing the use of film and appropriate conversion screens is covered in Guide E748.  
4.3 Interpretation and Acceptance Standards—Interpretat- ion and acceptance standards are not covered by this guide. Designation of accept-reject standards is recognized to be within the cognizance of product specifications.  
4.4 Other Aspects of the Neutron Radiographic Process—For many important aspects of neutron radiography such as technique, files, viewing of radiographs, storage of radiographs, film processing, and record keeping, refer to Guide E94, which covers these aspects for X-ray radiography. (See Section 2.)
SCOPE
1.1 This guide covers the evaluation, qualification, and quantification of digital neutron images. These images can be acquired by many methods, including: neutron sensitive imaging plates (Computed Radiography – CR), Digital Detector Arrays – DDA’s (amorphous silicon, CMOS, CCD, etc.), micro-channel plates, neutron sensitive fluoroscopes, neutron sensitive scintillators coupled to optical cameras, digitized radiographic films, and linear diode arrays.  
1.2 This guide does not purport to establish what is considered an acceptable image but is intended to only give guidance on digital neutron imaging, as well as image quality metrics of importance, and how they can be measured and reported.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.

  • Guide
    7 pages
    English language
    sale 15% off
ASTM
ASTM E2699-23(Practice)
Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for Digital X-ray (DX) Test Methods

SIGNIFICANCE AND USE
5.1 Personnel that are responsible for the creation, transfer, and storage of digital X-ray test results will use this standard. This practice defines a set of information modules that, along with Practice E2339 and the DICOM standard, provides a standard means to organize digital X-ray test parameters and results. The digital X-ray test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any digital X-ray inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record.
SCOPE
1.1 This practice covers the interoperability of digital X-ray imaging equipment using Digital Detector Arrays (DDA) as described in Practice E2698 by specifying image data transfer and archival methods in commonly accepted terms. A separate practice, Practice E2738, addresses this topic for digital X-ray imaging equipment using Computed Radiography (CR). This document is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of DICOM NEMA PS3 / ISO 12052 (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage, and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules, and a data dictionary that are specific to digital X-ray test methods.  
1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from digital X-ray test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all the digital X-ray technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology.  
1.3 This practice does not specify:  
1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard.  
1.3.2 The implementation details of any features of the standard on a device claiming conformance.  
1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance.  
1.4 Units—Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The SI units required by this practice 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.

  • Standard
    6 pages
    English language
    sale 15% off
  • Standard
    6 pages
    English language
    sale 15% off
ASTM
ASTM E2738-23(Practice)
Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for Computed Radiography (CR) Test Methods

SIGNIFICANCE AND USE
5.1 Personnel that are responsible for the creation, transfer, and storage of computed radiography NDE data will use this practice. This practice will define a set of information modules that along with the Practice E2339 and the DICOM standard will provide a standard means to organize CR inspection data. The CR inspection data may be displayed and analyzed on any device that conforms to the standard. Personnel wishing to view any CR inspection data stored in accordance with Practice E2339 may use this practice to help them decode and display the data contained in the DICONDE compliant inspection record.
SCOPE
1.1 This practice covers the interoperability of computed radiography (CR) imaging and data acquisition equipment by specifying image data transfer and archival storage methods in commonly accepted terms. This practice is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of NEMA PS3 / ISO 12052 (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage, and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules and a data dictionary that are specific to computed radiography test methods.  
1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from CR test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all standard CR technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology.  
1.3 This practice does not specify:  
1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard.  
1.3.2 The implementation details of any features of the standard on a device claiming conformance.  
1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance.  
1.4 Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The SI units required by this practice are to be regarded as standard. No other units of measurement are included in this practice.  
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
    5 pages
    English language
    sale 15% off
  • Standard
    5 pages
    English language
    sale 15% off
ASTM
ASTM E1475-13(2023)(Guide)
Standard Guide for Data Fields for Computerized Transfer of Digital Radiological Examination Data

SIGNIFICANCE AND USE
3.1 The primary use of this guide is to provide a standardized approach for the data file to be used for the transfer of digital radiological data from one user to another where the two users are working with dissimilar systems. This guide describes the contents, both required and optional for an intermediate data file that can be created from the native format of the radiological system on which the data was collected and that can be converted into the native format of the receiving radiological data analysis system. This guide will also be useful in the archival storage and retrieval of radiological data as either a data format specifier or as a guide to the data elements which should be included in the archival file.  
3.2 Although the recommended field listing includes more than 100 field numbers, only about half of those are regarded as essential and are marked Footnote C in Table 1. Fields so marked must be included in the data base. The other fields recommended provide additional information that a user will find helpful in understanding the radiological image and examination result. These header field items will, in most cases, make up only a very small part of a radiological examination file. The actual stream of radiological data that make up the image will take up the largest part of the data base. Since a radiological image file will normally be large, the concept of data compression will be considered in many cases. Compressed data should be noted, along with a description of the compression method, as indicated in Field No. 92 (see Table 1). (A) Field numbers are for reference only. They do not imply a necessity to include all these fields in any specific data base nor imply a requirement that fields used be in this particular order.(B) Units listed first are SI; those in parentheses are inch-pound (English).(C) Denotes essential field for computerization of examination results, regardless of examination method.(D) Denotes essential field for radiogra...
SCOPE
1.1 This guide provides a listing and description of the fields that are recommended for inclusion in a digital radiological examination data base to facilitate the transfer of such data. This guide sets guidelines for the format of data fields for computerized transfer of digital image files obtained from radiographic, radioscopic, computed radiographic, or other radiological examination systems. The field listing includes those fields regarded as necessary for inclusion in the data base: (1) regardless of the radiological examination method (as indicated by Footnote C in Table 1), (2) for radioscopic examination (as indicated by Footnote F in Table 1), and (3) for radiographic examination (as indicated by Footnote D in Table 1). In addition, other optional fields are listed as a reminder of the types of information that may be useful for additional understanding of the data or applicable to a limited number of applications.  
1.2 It is recognized that organizations may have in place an internal format for the storage and retrieval of radiological examination data. This guide should not impede the use of such formats since it is probable that the necessary fields are already included in such internal data bases, or that the few additions can easily be made. The numerical listing and its order indicated in this guide is only for convenience; the specific numbers and their order carry no inherent significance and are not part of the data file.  
1.3 Current users of Guide E1475 do not have to change their software. First time users should use the XML structure of Table A1.1 for their data.  
1.4 The types of radiological examination systems that appear useful in relation to this guide include radioscopic systems as described in Guide E1000, Practices E1255, E1411, E2597, E2698 and E2737, and radiographic systems as described in Guide E94 and Practices E748, E1742, E2033, E2445, and E2446. Many of the terms used are def...

  • Guide
    7 pages
    English language
    sale 15% off
ASTM
ASTM F3107-14(2023)(Test Method)
Standard Test Method for Measuring Accuracy After Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

SIGNIFICANCE AND USE
5.1 The purpose of this practice is to provide data that can be used for comparison and evaluation of the accuracy of different CAS systems.  
5.2 The use of CAS systems and robotic tracking systems is becoming increasingly common and requires a degree of trust by the user that the data provided by the system meets necessary accuracy requirements. In order to evaluate the potential use of these systems, and to make informed decisions about suitability of a system for a given procedure, objective performance data of such systems are necessary. While the end user will ultimately want to know the accuracy parameters of a system under clinical application, the first step must be to characterize the digitization accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting point accuracy is needed. Parameters such as coordinate system, units of measure, terminology, and operational conditions must be standardized.
SCOPE
1.1 This standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard will include mechanical vibration from: cutting saw (sagittal or reciprocating), burrs, drills, and impact loading. The change in accuracy from detaching and re-attaching or disturbing a restrained connection that does not by design require repeating the registration process of a reference base will also be measured.  
1.2 It should be noted that one system may need to undergo multiple iterations (one for each clinical application) of this standard to document its accuracy during different clinical applications since each procedure may have different exposure to outside forces given the surgical procedure variability from one procedure to the next.  
1.3 All units of measure will be reported as millimeters for this 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.

  • Standard
    5 pages
    English language
    sale 15% off
ASTM
ASTM F2554-22(Practice)
Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems

SIGNIFICANCE AND USE
5.1 The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems.  
5.2 The use of surgical navigation and robotic positioning systems is becoming increasingly common. In order to make informed decisions about the suitability of such systems for a given procedure, their accuracy capability needs to be evaluated under clinical application and compared to the requirements. As the performance of a whole system is constrained by those of its subparts, a preliminary step must be to objectively characterize the accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting accuracy is needed. Parameters such as coordinate system, units of measurement, terminology, and operational conditions must be standardized.
SCOPE
1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be used clinically. Testing a subsystem does not mean that the whole system has been tested. The functionality to be tested based on this practice is limited to the performance (accuracy in terms of bias and precision) of the system regarding point localization in space by means of a pointer. A point in space has no orientation; only multidimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the pointer can produce errors. These errors and the pointer orientation are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end users can compare within a system (for example, with different reference elements or pointers) and between different systems (for example, from different manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated):
(1) Accuracy of a single point relative to a coordinate system.
(2) Sensitivity of tracking accuracy due to changes in pointer orientation.
(3) Relative point-to-point accuracy.  
1.1.1 This method covers all configurations of the evaluated system as well as extreme placements across the measurement volume.  
1.2 This practice defines a standardized reporting format, which includes definition of the coordinate systems to be used for reporting the measurements, and statistical measures (for example, mean, RMS, and maximum error).  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, except for angular measurements, which may be reported in terms of radians or degrees.  
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.

  • Standard
    9 pages
    English language
    sale 15% off
  • Standard
    9 pages
    English language
    sale 15% off
ASTM
ASTM E2891-20(Guide)
Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

SIGNIFICANCE AND USE
4.1 A significant amount of data is generated during pharmaceutical development and manufacturing activities. The interpretation of such data is becoming increasingly difficult. Individual examination of the univariate process variables is relevant but can be significantly complemented by multivariate data analysis (MVDA). MVDA may be particularly appropriate for exploring and handling large sets of heterogenous data, mapping data of high dimensionality onto lower dimensional representations, exposing significant correlations among multivariate variables within a single data set or significant correlations among multivariate variables across data sets. MVDA may extract statistically significant information which may enhance process understanding, decision making in process development, process monitoring and control (including product release), product life-cycle management, and continuous improvement.  
4.2 MVDA is widely used in various industries including the pharmaceutical industry. To achieve a valid outcome, an MVDA model/application should incorporate the following:  
4.2.1 A predefined risk-based objective incorporating one or more relevant scientific hypotheses specific to the application;  
4.2.2 Sufficient relevant data of requisite quality covering the variance space encountered during intended use, that is, pharmaceutical development, or pharmaceutical manufacturing, or both;  
4.2.3 Appropriate data analysis and model utilization practices including considerations on testing, validation, and qualification of all new data prior to using a model to analyze it;  
4.2.4 Appropriately trained staff;  
4.2.5 Appropriate standard operating procedures; and  
4.2.6 Life-cycle management.  
4.3 This guide can be used to support data analysis activities associated with pharmaceutical development and manufacturing, process performance and product quality monitoring in manufacturing, as well as for troubleshooting and investigation events. Technical detai...
SCOPE
1.1 This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process understanding and decision making in pharmaceutical development, and for the release of intermediate and final products after being validated appropriately using a science and risk-based approach.  
1.2 The scope of this guide is to provide general guidelines on the application of MVDA in the pharmaceutical industry. While MVDA refers to typical empirical data analysis, the scope is limited to providing a high level guidance and not intended to provide application-specific data analysis procedures. This guide provides considerations on the following aspects:  
1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status);  
1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers);  
1.2.3 Considerations on the different types of data analysis, model testing, and validation;  
1.2.4 Qualified and competent personnel; and  
1.2.5 Life-cycle management of MVDA model.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    7 pages
    English language
    sale 15% off
  • Guide
    7 pages
    English language
    sale 15% off
ASTM
ASTM E1935-97(2019)(Test Method)
Standard Test Method for Calibrating and Measuring CT Density

SIGNIFICANCE AND USE
5.1 This test method allows specification of the density calibration procedures to be used to calibrate and perform material density measurements using CT image data. Such measurements can be used to evaluate parts, characterize a particular system, or compare different systems, provided that observed variations are dominated by true changes in object density rather than by image artifacts. The specified procedure may also be used to determine the effective X-ray energy of a CT system.  
5.2 The recommended test method is more accurate and less susceptible to errors than alternative CT-based approaches, because it takes into account the effective energy of the CT system and the energy-dependent effects of the X-ray attenuation process.
FIG. 1 Density Calibration Phantom  
5.3 This (or any) test method for measuring density is valid only to the extent that observed CT-number variations are reflective of true changes in object density rather than image artifacts. Artifacts are always present at some level and can masquerade as density variations. Beam hardening artifacts are particularly detrimental. It is the responsibility of the user to determine or establish, or both, the validity of the density measurements; that is, they are performed in regions of the image which are not overly influenced by artifacts.  
5.4 Linear attenuation and mass attenuation may be measured in various ways. For a discussion of attenuation and attenuation measurement, see Guide E1441 and Practice E1570.
SCOPE
1.1 This test method covers instruction for determining the density calibration of X- and γ-ray computed tomography (CT) systems and for using this information to measure material densities from CT images. The calibration is based on an examination of the CT image of a disk of material with embedded specimens of known composition and density. The measured mean CT values of the known standards are determined from an analysis of the image, and their linear attenuation coefficients are determined by multiplying their measured physical density by their published mass attenuation coefficient. The density calibration is performed by applying a linear regression to the data. Once calibrated, the linear attenuation coefficient of an unknown feature in an image can be measured from a determination of its mean CT value. Its density can then be extracted from a knowledge of its mass attenuation coefficient, or one representative of the feature.  
1.2 CT provides an excellent method of nondestructively measuring density variations, which would be very difficult to quantify otherwise. Density is inherently a volumetric property of matter. As the measurement volume shrinks, local material inhomogeneities become more important; and measured values will begin to vary about the bulk density value of the material.  
1.3 All values are stated in SI units.  
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.

  • Standard
    5 pages
    English language
    sale 15% off