I.S. CEN TS 15260:2006
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH INFORMATICS PRODUCTS
Hardcopy , PDF
08-12-2017
English
10-05-2006
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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Withdrawn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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