CLSI AUTO11 P : 1ED 2006

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
The Quality System Approach
Related CLSI/NCCLS Publications

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