ISO/TS 25238:2007
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 Classification of safety risks from health software
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
15-07-2021
English
04-06-2007
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ISO/TS 25238:2007 is concerned with the safety of patients and gives guidance on the analysis and categorization of hazards and risks to patients from health software products, in order to allow any product to be assigned to one of five risk classes. It applies to hazards and risks which could cause harm to a patient. Other risks, such as financial or organizational risks, are outside the scope of ISO/TS 25238:2007 unless they have the potential to harm a patient.
ISO/TS 25238:2007 applies to any health software product, whether or not it is placed on the market and whether it is for sale or free of charge. Examples of the application of the classification scheme are given.
ISO/TS 25238:2007 does not apply to any software which is necessary for the proper application or functioning of a medical device.
| DocumentType |
Technical Specification
|
| Pages |
24
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| Standards | Relationship |
| DD ISO/TS 25238:2007 | Identical |
| GOST R ISO/TS 25238 : 2009 | Identical |
| NEN NPR ISO/TS 25238 : 2007 | Identical |
| BS EN ISO 13119:2012 | Health informatics. Clinical knowledge resources. Metadata |
| ISO/IEC 15026-1:2013 | Systems and software engineering Systems and software assurance Part 1: Concepts and vocabulary |
| PD ISO/IEC/TR 15026-1:2010 | Systems and software engineering. Systems and software assurance Concepts and vocabulary |
| I.S. EN ISO 13119:2012 | HEALTH INFORMATICS - CLINICAL KNOWLEDGE RESOURCES - METADATA (ISO 13119:2012) |
| ISO/IEEE 11073-00103:2015 | Health informatics — Personal health device communication — Part 00103: Overview |
| EN ISO 13119:2012 | Health informatics - Clinical knowledge resources - Metadata (ISO 13119:2012) |
| CEN/TS 15699:2009 | Health informatics - Clinical knowledge resources - Metadata |
| PD ISO/TS 17938:2014 | Health informatics. Semantic network framework of traditional Chinese medicine language system |
| ISO/TR 27809:2007 | Health informatics Measures for ensuring patient safety of health software |
| 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 |
| 11/30211693 DC : 0 | BS EN ISO 13119 - HEALTH INFORMATICS - CLINICAL KNOWLEDGE RESOURCES - METADATA |
| CSA ISO/IEC TR 15026-1 : 2013 | SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 1: CONCEPTS AND VOCABULARY |
| UNI CEN/TS 15699 : 2009 | HEALTH INFORMATICS - CLINICAL KNOWLEDGE RESOURCES - METADATA |
| CSA ISO/IEC 15026-1 : 2015 | SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 1: 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 |
| IEEE 15026-3-2013 | IEEE Standard Adoption of ISO/IEC 15026-3 -- Systems and Software Engineering -- Systems and Software Assurance -- Part 3: System Integrity Levels |
| 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 |
| I.S. EN ISO 11073-00103:2017 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
| ISO/TS 17938:2014 | Health informatics — Semantic network framework of traditional Chinese medicine language system |
| BS ISO/IEEE 11073-00103 : 2015 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
| PD ISO/TR 27809:2007 | Health informatics. Measures for ensuring patient safety of health software |
| 10/30230297 DC : 0 | BS ISO/IEC 15026-3 - SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 3: SYSTEM INTEGRITY LEVELS |
| 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 EN ISO 11073-00103:2017 | Health informatics. Personal health device communication Overview |
| S.R. CEN TS 15699:2009 | HEALTH INFORMATICS - CLINICAL KNOWLEDGE RESOURCES - METADATA |
| 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 |
| ISO 13119:2012 | Health informatics — Clinical knowledge resources — Metadata |
| EN ISO 11073-00103:2017 | Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015) |
| BS ISO/IEC 15026-1:2013 | Systems and software engineering. Systems and software assurance Concepts and vocabulary |
| UNI EN ISO 13119 : 2013 | HEALTH INFORMATICS - CLINICAL KNOWLEDGE RESOURCES - METADATA |
| DD CEN/TS 15699:2009 | Health informatics. Clinical knowledge resources. Metadata |
| 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 |
| EN 1441 : 1997 | MEDICAL DEVICES - RISK ANALYSIS |
| 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) |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| AS/NZS 4360:2004 | Risk management |
| 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 |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
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