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CLSI AUTO11 A2 : 2ED 2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by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

Available format(s)

Hardcopy , PDF

Superseded date

05-10-2024

Superseded by

CLSI AUTO11:2024

Language(s)

English

Published date

31-10-2014

€403.79
Excluding VAT

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Superseded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
Supersedes

CLSI AUTO9 A : 1ED 2006 REMOTE ACCESS TO CLINICAL LABORATORY DIAGNOSTIC DEVICES VIA THE INTERNET
CLSI LIS2 A2 : 2ED 2004 SPECIFICATION FOR TRANSFERRING INFORMATION BETWEEN CLINICAL INSTRUMENTS AND COMPUTER SYSTEMS
CLSI POCT1 A2 : 2ED 2006 POINT-OF-CARE CONNECTIVITY

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