ISO/TR 27809:2007
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 Measures for ensuring patient safety of health software
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
15-07-2021
English
11-07-2007
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ISO/TR 27809:2007 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.
ISO/TR 27809:2007 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 ISO/TR 27809:2007 to recommend whether or not health software products should be regulated.
ISO/TR 27809:2007 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.
| DocumentType |
Technical Report
|
| Pages |
38
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| Standards | Relationship |
| NEN NPR ISO/TR 27809 : 2007 | Identical |
| GOST R ISO/TR 27809 : 2009 | Identical |
| PD ISO/TR 27809:2007 | Identical |
| AAMI IEC TIR 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 |
| PD ISO/IEC/TR 15026-1:2010 | Systems and software engineering. Systems and software assurance Concepts and vocabulary |
| ISO/IEEE 11073-00103:2015 | Health informatics — Personal health device communication — Part 00103: Overview |
| BS ISO/IEEE 11073-00103 : 2015 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
| CSA ISO/IEC TR 15026-1 : 2013 | SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 1: CONCEPTS AND VOCABULARY |
| CSA ISO/IEC 15026-1 : 2015 | SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 1: CONCEPTS AND VOCABULARY |
| I.S. EN ISO 11073-00103:2017 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
| ISO/IEC 15026-1:2013 | Systems and software engineering Systems and software assurance Part 1: Concepts and vocabulary |
| ISO/TR 17522:2015 | Health informatics Provisions for health applications on mobile/smart devices |
| PD IEC/TR 80001-2-2:2012 | Application of risk management for IT-networks incorporating medical devices Guidance for the disclosure and communication of medical device security needs, risks and controls |
| BS ISO/IEC 15026-1:2013 | Systems and software engineering. Systems and software assurance Concepts and vocabulary |
| 13/30268559 DC : 0 | BS ISO/IEC 15026-1 - SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 1: CONCEPTS AND VOCABULARY |
| BS EN ISO 11073-00103:2017 | Health informatics. Personal health device communication Overview |
| ISO/TS 20405:2018 | Health informatics Framework of event data and reporting definitions for the safety of health software |
| ISO/IEC TR 15026-1:2010 | Systems and software engineering Systems and software assurance Part 1: Concepts and vocabulary |
| 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 |
| EN ISO 11073-00103:2017 | Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015) |
| PD ISO/TR 17522:2015 | Health informatics. Provisions for health applications on mobile/smart devices |
| IEEE 11073-00103-2012 | Health informatics - Personal health device communication Part 00103: Overview |
| IEEE/ISO/IEC 15026-1-2014 | IEEE Standard Adoption of ISO/IEC 15026-1--Systems and Software Engineering--Systems and Software Assurance--Part 1: Concepts and Vocabulary |
| 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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