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PD ISO/TR 27809:2007

Current
Current

The latest, up-to-date edition.

Health informatics. Measures for ensuring patient safety of health software
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-31-2007

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Abbreviated terms
4 Outline of the issues
5 General position on medical device controls
6 The border between health software products and medical
   devices
7 Classifying health software products
   7.1 Options
   7.2 Conclusions
8 Options for control measures for health software products
   8.1 Overview
   8.2 Labelling and documentation
   8.3 Clinical evidence
   8.4 Incident reporting
   8.5 Quality systems
   8.6 Design control
   8.7 Risk management
9 Standards relevant to risks of a particular nature
   9.1 General
   9.2 Conclusions
10 Observation on safety and risks in the user domain
   10.1 General
   10.2 Conclusions
11 Taxonomies
   11.1 General
   11.2 Conclusions
12 Summary of conclusions
Annex A (informative) Position regarding medical devices in
                      different countries
Annex B (informative) Analysis of classification procedures
Annex C (informative) Risk management
Bibliography

Describes the control measures required to ensure patient safety in respect to health software products.

This Technical Report considers the control measures required to ensure patient safety in respect to health software products. It does not apply to software which is: necessary for the proper application of a medical device or an accessory to a medical device or a medical device in its own right. This Technical Report is aimed at identifying what standards might best be used or created, and their nature, if health software products were to be regulated or controlled in some other formal or informal or voluntary manner whether national, regional or local. However, it is not the purpose of this Technical Report to recommend whether or not health software products should be regulated. This Technical Report applies to any health software product whether or not it is placed on the market and whether or not it is for sale or free of charge. It is addressed to manufacturers of health software products. NOTE The scope is intended to cover health software products which are not, in practice, covered by medical device regulations. AnnexA considers this matter in detail. This Technical Report acknowledges that, on the boundary, there are health software products which are encompassed by medical device regulations in some countries but not in others and that some definitions of medical devices may appear to cover health software products in general but in practice do not.

Committee
IST/35
DocumentType
Standard
Pages
48
PublisherName
British Standards Institution
Status
Current

Standards Relationship
ISO/TR 27809:2007 Identical

ISO/IEC 27001:2013 Information technology — Security techniques — Information security management systems — Requirements
ISO/TS 22224:2009 Health informatics Electronic reporting of adverse drug reactions
BS 7799-3:2006 Information security management systems Guidelines for information security risk management
EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
ISO 31000:2009 Risk management Principles and guidelines
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
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)
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
IEC 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
PD 6668:2000 MANAGING RISK FOR CORPORATE GOVERNANCE
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
ISO/TS 19218:2005 Medical devices Coding structure for adverse event type and cause
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
AS/NZS 4360:2004 Risk management
ISO/IEC 27005:2011 Information technology Security techniques Information security risk management
ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
ISO/IEC 17799:2005 Information technology Security techniques Code of practice for information security management
ISO 9001:2015 Quality management systems — Requirements
ISO/IEC TR 15271:1998 Information technology Guide for ISO/IEC 12207 (Software Life Cycle Processes)
ISO 14971:2007 Medical devices Application of risk management to medical devices
CEN/TS 15260:2006 Health informatics - Classification of safety risks from health informatics products
ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
ISO/TS 25238:2007 Health informatics Classification of safety risks from health software

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PDF - English
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