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ISO/TR 27809:2007

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

15-07-2021

Language(s)

English

Published date

11-07-2007

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Withdrawn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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