Name: CLSI AUTO11 A2 : 2ED 2014
Brand: CLSI
Price: 273.60 USD

INFORMATION TECHNOLOGY SECURITY OF IN VITRO DIAGNOSTIC INSTRUMENTS AND SOFTWARE SYSTEMS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-31-2014

Publisher

Clinical Laboratory Standards Institute

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	Current
Supersedes	CLSI AUTO11 A : 1ED 2006

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