IEC 82304-1:2016 健康ソフトウェア—パート1：製品の安全性に関する一般的な要件 | ページ 6

3.1

accompanying document

document accompanying health software containing information for the responsible organizationoruser, particularly regarding safety and/or security

[SOURCE: IEC 60601-1:2005, 3.4, modified - Replace"me equipment, me system, equipment and accessory" by"health software" and replace"operator" by"user" and added “and/or security”.]

3.2

anomaly

any condition that deviates from the expected based on requirements specifications, design documents, standards, etc. or from someone’s perceptions or experiences.

Note 1 to entry: Anomalies can be found during, but not limited to, the review, test, analysis, compilation, or use of health software or applicable documentation.

[SOURCE: Based on IEEE 1044:1993, 3.1]

3.3

harm

injury or damage to the health of people, or damage to property or the environment

[SOURCE: ISO/IEC Guide 51:2014, 3.1]

3.4

hazard

potential source of harm

Note 1 to entry: Potential sources of harm include breach of security and reduction of effectiveness.

[SOURCE: ISO/IEC Guide 51:2014, 3.2, modified - Note 1 to entry has been added.]

3.5

hazardous situation

circumstance in which people, property or the environment is/are exposed to one or more hazards

[SOURCE: ISO/IEC Guide 51:2014, 3.4]

3.6

* health software

software intended to be used specifically for managing, maintaining or improving health of individual persons, or the delivery of care

Note 1 to entry: Health software fully includes what is considered software as a medical device (see rationale in A.1).

Note 2 to entry: The scope of this document refers to the subset of health software that is intended to run on general computing platforms.

3.7

health software product

combination of health software and accompanying documents

3.8

intended use

intended purpose

use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer

[SOURCE: ISO 14971:2007, 2.5]

3.9

IT-network

information technology network

a system or systems composed of communicating nodes and transmission links to provide physically linked or wireless transmission between two or more specified communication nodes

Note 1 to entry: The scope of the IT-network in this document is defined by the responsible organization based on where the health software in the IT-network is located and the defined use of the IT-network. It can contain IT infrastructure, home health, or general computing components or systems not intended by design to be used in a healthcare setting. See also 7.2.3.2.

[SOURCE: IEC 61907:2009, 3.1.1, modified – The definition has been rephrased and Note 1 to entry has been added.]

3.10

manufacturer

natural or legal person with responsibility for the design, development, packaging, or labelling of a health software product, or adapting a health software product before it is placed on the market or put into service, regardless of whether these operations are carried out by that person or on that person's behalf by a third party

Note 1 to entry: For a definition of labelling, see ISO 13485:2016, 3.8.

Note 2 to entry: Developer” or “developer organization” are commonly used terms instead of manufacturer in the context of health information technology.

3.11

residual risk

risk remaining after risk control measures have been taken

[SOURCE: ISO 14971:2007, 2.15]

3.12

responsible organization

entity accountable for the use and proper operation of a health software product

Note 1 to entry: An accountable entity is, for example, a hospital, a healthcare provider, or a telehealth organization.

[SOURCE: IEC 60601-1:2005, 3.101, modified – Replaced" maintenance of an me equipment or an me system" by" proper operation of a health software product".]

3.13

risk

combination of the probability of occurrence of harm and the severity of that harm

Note 1 to entry: The probability of occurrence includes the exposure to a hazardous situation and the possibility to avoid or limit the harm

[SOURCE: ISO/IEC Guide 51:2014, 3.9, modified – Note 1 to entry updated to remove the reference to hazardous event.]

3.14

risk analysis

systematic use of available information to identify hazards and to estimate the risk

[SOURCE: ISO/IEC Guide 51:2014, 3.10]

3.15

risk assessment

overall process comprising a risk analysis and a risk evaluation

[SOURCE: ISO/IEC Guide 51:2014, 3.11]

3.16

risk control

process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels

[SOURCE: ISO/IEC Guide 63:2012, 2.12]

3.17

risk evaluation

process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk

[SOURCE: ISO/IEC Guide 63:2012, 2.14]

3.18

risk management

systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk

[SOURCE: ISO/IEC Guide 63:2012, 2.15]

3.19

safety

freedom from unacceptable risk

[SOURCE: ISO/IEC Guide 63:2012, 2.16]

3.20

security

protection of information and data so that unauthorized persons or systems cannot read or modify them and authorized persons or systems are not denied access to them

[SOURCE: ISO 12207:2008, 4.39]

3.21

software maintenance

Note 1 to entry: See also ISO/IEC 14764:2006.

3.22

user

person interacting with the health software product

Note 1 to entry: In general, a user is not considered to be a responsible organization, except for consumer type health software products, e.g., for personal health applications, or products to be used by lay persons.

3.23

validation

confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination such as performing alternative calculations or reviewing documents.

Note 2 to entry: The word “validated” is used to designate the corresponding status.

Note 3 to entry: The use conditions for validation can be real or simulated.

[SOURCE: ISO 9000:2015, 3.8.13]

3.24

verification

confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents.

Note 2 to entry: The activities carried out for verification are sometimes called a qualification process.

Note 3 to entry: The word “verified” is used to designate the corresponding state.

[SOURCE: ISO 9000:2015, 3.8.12]