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CLSI AUTO11 A : 1ED 2006

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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IT SECURITY OF IN VITRO DIAGNOSTIC INSTRUMENTS AND SOFTWARE SYSTEMS

Superseded date

31-10-2014

Published date

12-01-2013

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Abstract
Committee Membership
Foreword
1 Scope
2 Definitions
  2.1 Acronyms
3 Delineation of Vendor and HCO Responsibilities
4 Technical Design Guidelines Related to Regulatory
  Requirements
  4.1 Preventing Unauthorized Application Usage
  4.2 Preventing Unauthorized Data Access
  4.3 Protection From Malicious Software
  4.4 Security Monitoring
  4.5 Preventing Loss of Data
5 Process and Operational Requirements
  5.1 IT Security Requirements Engineering and Management
  5.2 IT Security Hazard Analysis and Risk Management
  5.3 Vendor System Validation/Verification
  5.4 Vendor Security Audits/Assessments/Tests
  5.5 Documents for HCO
  5.6 Preventive Actions (software patches, virus
      definitions)
6 Applicability to Device Classes
References
Additional References
Summary of Delegate Comments and Committee Responses
The Quality System Approach
Related CLSI/NCCLS Publications

Provides technical and operational requirements as well as technical implementation procedures related to security of IVD systems (devices, analytical instruments, data management systems, etc.) installed at a healthcare organization.

DevelopmentNote
Supersedes NCCLS AUTO11 P. (11/2006)
DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy
Supersedes

CLSI AUTO10 A : 1ED 2006 AUTOVERIFICATION OF CLINICAL LABORATORY TEST RESULTS
CLSI GP37 P : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT

CLSI AUTO9 A : 1ED 2006 REMOTE ACCESS TO CLINICAL LABORATORY DIAGNOSTIC DEVICES VIA THE INTERNET
CLSI AUTO3 A : 1ED 2000 LABORATORY AUTOMATION: COMMUNICATIONS WITH AUTOMATED CLINICAL LABORATORY SYSTEMS, INSTRUMENTS, DEVICES, AND INFORMATION SYSTEMS
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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