CLSI AUTO11 A : 1ED 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
31-10-2014
12-01-2013
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Superseded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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