CLSI AUTO11 P : 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
31-10-2006
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
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.
| DocumentType |
Miscellaneous Product
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy |
| CLSI QMS13 A : 1ED 2011 | QUALITY MANAGEMENT SYSTEM: EQUIPMENT |
| CFR 45(PTS1-199) : OCT 2017 | PUBLIC WELFARE - SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL ADMINISTRATION - SUBTITLE B - REGULATIONS RELATING TO PUBLIC WELFARE |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| FIPS PUB 180 : 2002 | SECURE HASH STANDARD |
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