ASTM E626-90

Guide for Evaluating Computerized Systems (Withdrawn 1994)

General Information

• Status: Withdrawn
• ICS: 35.240.01 - Application of information technology in general
• Technical Committee: E31 - Healthcare Informatics

Standards Content (Sample)

ASTM Eb2b 90 W 0757530 00bb744 4 W
AMERICAN SOCIETY FOR TESTING AND MATERIALS
d[]b Designation: E 626 - 90
1916 Race SI. Philadelphia, Pa. 19103
Reprinted Ircm lhe Annual Bod< d ASTM Slandaidr, COW@W MTM
II not listed in the current combined index, wiW appear h lho MEI edilion.
Standard Guide for
Evaluating Computerized Systems'
This standard is issued under the fixed designation E 626; 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 (t) indicates an editorial change since the last revision or reapproval.
outputs from the system, and transfer functions that produce
1. Scope
the outputs from the inputs, are identified and described in
1.1 This guide covers the evaluation of a computerized
detail (see Guide E 623).
system that has been installed and accepted from the
3.1.3 functional design-a phase in the development of
supplier. It deais with that system, as a whole, and how that
computerized systems which produces detailed descriptions
system meets the needs for which it was acquired. Evalua-
of the system that are independent of particular hardware
tions within other phases of system development and con-
and software. This includes ali flows of information, timing
struction are covered in the documents describing those
diagrams, and state transition diagrams (see Guide E 730).
phases, or in separate documents.
3,1.4 implementation design-a phase in the development
1.2 This guide is not meant to describe an acceptance
of computerized systems in which hardware and software
testing procedure; however, it does recognize and emphasize
components are selected, and implementation, operation
the need for acceptance testing in other phases.
and maintenance procedures are developed (see Guide
1.3 This standard does not purport to address the safity
E 624).
problems associated with its use. It is the responsibility of the
3.1.5 system assembly, installation, and testing-a phase
user of this standard to establish appropriate safety and
in the development of computerized systems in which
health practices and determine the appiìcabiiìty of regulatory
components are acquired, built, programmed, assembled,
limitations prior to use.
installed, and placed in operation (see Guides E622 and
E 625).
2. Referenced Documents
3.1.6 system evaluation-a phase in the development of
2.1 ASTM Standards:
computerized systems in which the system is compared with
E 622 Generic Guide for Computerized Systems?
its requirements to determine how well the requirements are
E 623 Guide for Developing Functional Requirements
met, to determine possibilities for growth and improvement,
for Computerized Systems'
and to preserve the lessons of this project in preparation for
E 624 Guide for Developing Implementation Designs for
the next one.
Computerized Systems2
3.1.7 system documentation-the accumulated docu-
E 625 Guide for Training Users of Computerized Systems
ments relating to a computerized system that are prepared as
E 627 Guide for Documenting Computerized Systems2
the project proceeds. System documentation is not a separate
E 730 Guide for Developing Functional Designs for Com-
phase. An important product of each of the previous phases
puterized Systems'
is documentation (see Guides E 627 and E 919).
E 731 Guide for the Selection and Acquisition of Com-
3.2 Definitions:
mercially Available Computerized Systems'
3.2.1 For additional terminology, see Terminology E 1013.
E 919 Specification for Software Documentation for a
Computerized System
4. Significance and Use
E 1013 Terminology Relating to Computerized Systems
4.1 The formal system evaluation process enables users to
E 1 113 Guide for Project Definition for Computerized
design better systems in the future.
Systems
4.1.1 The primary purposes of this document are to:
3. Terminology 4.1.1.1 Determine if the installed system meets the needs
specified in the functional requirements.
3.1 Description of Terms Specfie to this Standard:
4.1.1.2 Determine if any necessary requirements were
3.1.1 project definition-a phase in the development of
omitted from the functional requirements. If omitted, docu-
computerized systems in which a brief statement is devel-
ment whether they were assumed or left out of the imple-
oped as to what is to be accomplished and why (see Guides
mentation.
E 622, E 731 and E 11 13).
4.1.1.3 Evaluate if the design concept used is the proper
3.1.2 functional requirements-a phase in the develop
one for this facility.
ment of computerized systems in which ail inputs to and
4.1.1.4 Ascertain if the system supplied fills the needs of
the operation.
I This guideline is under the jurisdiction of ASTM Committee E 31 on 4.1.2 For future consideration:
Computerized Systems and is the direct responsibili
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