CLSI AUTO11 A2 : 2ED 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
INFORMATION TECHNOLOGY SECURITY OF IN VITRO DIAGNOSTIC INSTRUMENTS AND SOFTWARE SYSTEMS
Hardcopy , PDF
English
31-10-2014
05-10-2024
Abstract
Committee Membership
Foreword
1 Scope
2 Terminology
3 Delineation of Vendor and Health Care Organization
Responsibilities
4 Technical Design Guidelines Related to Regulatory
Requirements
5 Process and Operation Requirements
6 Applicability of Requirements to Classes of In Vitro
Diagnostic Systems
References
The Quality Management System Approach
Related CLSI References Materials
This standard specifies technical and operational requirements and technical implementation procedures related to information technology (IT) security of in vitro diagnostic (IVD) systems (devices, analytical instruments, data management systems, etc.) installed at a health care organization (HCO).
| DevelopmentNote |
Supersedes CLSI AUTO11 A. (11/2014)
|
| DocumentType |
Standard
|
| ISBN |
1-56238-980-7
|
| Pages |
64
|
| ProductNote |
Updated publish date
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy |
| CLSI AUTO15 ED 1 : 2019 | Autoverification of Medical Laboratory Results for Specific Disciplines<br> |
| CLSI AUTO16 : 2019 | Next-Generation In Vitro Diagnostic Instrument Interface, 1st Edition |
| CLSI AUTO9 A : 1ED 2006 | REMOTE ACCESS TO CLINICAL LABORATORY DIAGNOSTIC DEVICES VIA THE INTERNET |
| CLSI POCT1 A2 : 2ED 2006 | POINT-OF-CARE CONNECTIVITY |
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