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ASTM E1985-98(2005)

(Guide)

Standard Guide for User Authentication and Authorization

Standard Guide for User Authentication and Authorization

SIGNIFICANCE AND USE
This guide has three purposes:
4.1.1 To serve as a guide for developers of computer software that provides or makes use of authentication and authorization processes,  
4.1.2 To serve as a guide to healthcare providers who are implementing authentication and authorization mechanisms, and
4.1.3 To be a consensus standard on the design, implementation, and use of authentication and authorization mechanisms.
Additional standards will define interoperable protocols and message formats that can be used to implement these mechanisms in a distributed environment, using specific commercial technologies such as digital signatures.
SCOPE
1.1 This guide covers mechanisms that may be used to authenticate healthcare information (both administrative and clinical) users to computer systems, as well as mechanisms to authorize particular actions by users. These actions may include access to healthcare information documents, as well as, specific operations on those documents (for example, review by a physician).  
1.2 This guide addresses both centralized and distributed environments, by defining the requirements that a single system shall meet and the kinds of information which shall be transmitted between systems to provide distributed authentication and authorization services.  
1.3 This guide addresses the technical specifications for how to perform user authentication and authorization. The actual definition of who can access what is based on organizational policy.

General Information

Status
Historical
Publication Date
31-Oct-2005
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 E1985-98 - Standard Guide for User Authentication and Authorization
Effective Date
01-Nov-2005
Replaced By
ASTM E1985-98(2013) - Standard Guide for User Authentication and Authorization (Withdrawn 2017)
Effective Date
01-Mar-2013

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ASTM E1985-98(2005) - Standard Guide for User Authentication and Authorization
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: E1985 − 98(Reapproved 2005) An American National Standard
Standard Guide for
1
User Authentication and Authorization
This standard is issued under the fixed designation E1985; 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.
5
1. Scope FIPS PUB 112 Password Usage
1.1 This guide covers mechanisms that may be used to
3. Terminology
authenticate healthcare information (both administrative and
3.1 Definitions:
clinical) users to computer systems, as well as mechanisms to
3.1.1 access control list—a piece of access control
authorize particular actions by users. These actions may
information, associated with a target, that specifies the initia-
include access to healthcare information documents, as well as
tors who may access the target.
specific operations on those documents (for example, review
3.1.2 capability—a piece of access control information,
by a physician).
associated with an initiator, which authorizes the holder to
1.2 This guide addresses both centralized and distributed
access some target.
environments, by defining the requirements that a single
3.1.3 claimant—party requesting authentication; may be a
system shall meet and the kinds of information which shall be
person or a device.
transmitted between systems to provide distributed authentica-
tion and authorization services. 3.1.4 initiator—an entity (for example, a user) who requests
access to some object.
1.3 This guide addresses the technical specifications for
3.1.5 principal—legitimate owner of an identity.
how to perform user authentication and authorization. The
actual definition of who can access what is based on organi-
3.1.6 security label—access control information bound to
zational policy.
initiators and targets. The initiator and target labels are com-
pared to determine if access is allowed.
2. Referenced Documents
3.1.7 target—anentity(forexample,afileordocument)that
2
2.1 ASTM Standards:
may be accessed by an initiator.
E1762 Guide for Electronic Authentication of Health Care
3.1.8 verifier—another party seeking to authenticate princi-
Information
pal.
PS100 Provisional Specification for Authentication of
3.2 Acronyms:
Healthcare Information Using Digital Signatures
3.2.1 ACI—Access Control Information
2.2 ANSI Standard:
3.2.2 ACL—Access Control List
X9.45 Enhanced Management Controls Using Digital Sig-
3
natures and Attribute Certificates
3.2.3 ADF—Access Control Decision Function
2.3 Other Standards:
3.2.4 ADI—Access Control Decision Information
ECMA1-219 AuthenticationandPrivilegeAttributeSecurity
3.2.5 AEF—Access Control Enforcement Function
4
Applications with Related Key Distribution Functions
3.2.6 PIN—Personal Identification Number
4. Significance and Use
1
This guide is under the jurisdiction of ASTM Committee E31 on Healthcare
4.1 This guide has three purposes:
Informatics and is the direct responsibility of Subcommittee E31.25 on Healthcare
4.1.1 To serve as a guide for developers of computer
Data Management, Security, Confidentiality, and Privacy.
Current edition approved July 17, 2006. Published January 2006. Originally
software that provides or makes use of authentication and
approved in 1998. Last previous edition approved in 1998 as E1985 – 98. DOI:
authorization processes,
10.1520/E1985-98R05.
4.1.2 To serve as a guide to healthcare providers who are
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
implementing authentication and authorization mechanisms,
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
and
the ASTM website.
3
Available from American National Standards Institute, 11 W. 42nd St., 13th
5
Floor, New York, NY 10036. Available from National Technical Information Service, U.S. Department of
4
Available from ECMA International, Rue du Rhone 114, CH, 1204, Geneva. Commerce, Springfield, VA. http://csrc.nist.gov or www.ntis.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1985 − 98 (2005)
4.1.3 To be a consensus standard on the design, implemen- claimant. The token shall contain information unique to the
tation, and use of authentication and authorization mecha- principal or claimant. The claimant shall present the token as
nisms. proof of identity. A password or PIN may be used to access
informationontoken.Theverifiershallthenverifythetokenof
4.2 Additional standards will define interoperable protocols
the claimant.
and message formats that ca
...

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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
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  • Guide
    7 pages
    English language
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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.

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