PD IEC/TR 80001-2-1:2012
Current
The latest, up-to-date edition.
Application of risk management for IT-networks incorporating medical devices Step-by-step risk management of medical IT-networks. Practical applications and examples
Hardcopy , PDF
English
10-07-2012
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/62/1
|
| DocumentType |
Standard
|
| Pages |
70
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
IEC/TR 80001-2-1:2012(E), which is a technical report, is a step-by-step guide to help in the application of risk management when creating or changing a medical IT-network. It provides easy to apply steps, examples, and information helping in the identification and control of risks. All relevant requirements in IEC 80001-1:2010 are addressed and links to other clauses and subclauses of IEC 80001-1 are addressed where appropriate (e.g. handover to release management and monitoring). This technical report focuses on practical risk management. It is not intended to provide a full outline or explanation of all requirements that are satisfactorily covered by IEC 80001-1. This step-by-step guidance follows a 10-step process that follows subclause 4.4 of IEC 80001-1:2010, which specifically addresses risk analysis, risk evaluation and risk control. These activities are embedded within the full life cycle risk management process. They can never be the first step, as risk management follows the general process model which sets planning before any action.
| Standards | Relationship |
| IEC TR 80001-2-1:2012 | Identical |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| ISO/IEC 27001:2013 | Information technology — Security techniques — Information security management systems — Requirements |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO/TS 19218-2:2012 | Medical devices Hierarchical coding structure for adverse events Part 2: Evaluation codes |
| ISO/IEC 27002:2013 | Information technology Security techniques Code of practice for information security controls |
| IEC TR 80001-2-2:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC TR 80001-2-3:2012 | Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 27799:2016 | Health informatics Information security management in health using ISO/IEC 27002 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.