I.S. CEN TS 15260:2006
Withdrawn
HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH INFORMATICS PRODUCTS
Hardcopy , PDF
English
05-10-2006
12-08-2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Principles of hazard and risk analysis
6 Assignment of a risk class to a health informatics product
7 The analytical process
8 Examples of assignment of risk classes to products
9 Relationship of risk classes to design and control of
production of products
Annex A (informative) Health informatics products and
medical devices: rationale
Annex B (informative) Examples of assignment of Risk Classes
Annex C (informative) Illustration of the nature of the
relationship between risk classes and potential
controls for risk management
Bibliography
Pertains to hazards and risks which could cause harm to a patient. Other risks such as financial or organisational are out of scope unless they have the potential to harm a patient.
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| Standards | Relationship |
| CEN/TS 15260:2006 | Identical |
| IEC 61508-5:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 5: Examples of methods for the determination of safety integrity levels (see Functional Safety and IEC 61508) |
| IEC 61508-4:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 4: Definitions and abbreviations (see Functional Safety and IEC 61508) |
| IEC 61508-3:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508) |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO/IEC Guide 73:2002 | Risk management — Vocabulary — Guidelines for use in standards |
| ISO/IEC 17799:2005 | Information technology — Security techniques — Code of practice for information security management |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| IEC 61508-6:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3 (see Functional Safety and IEC 61508) |
| IEC 61508-1:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508) |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| IEC 61508-7:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 7: Overview of techniques and measures (see Functional Safety and IEC 61508) |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| IEC 61508-2:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 2: Requirements for electrical/electronic/programmable electronic safety-related systems (see Functional Safety and IEC 61508) |
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