ISO 21856:2022 支援製品—一般的な要件とテスト方法 | ページ 6

3.1

applied part

part of an assistive product (3.3) that in normal use (3.20) necessarily comes into physical contact with the user (3.32) to perform its function

3.2

assistant

person who is helping/supporting a person with disability (3.23) in using the assistive product (3.3)

Note 1 to entry: Examples of the ways assistants help persons with disability are pushing wheelchairs operating hoists, and assisting with entering and leaving seats, beds and wheelchairs.

Note 2 to entry: An assistant can be a health care professional or a non-professional, for example, a relative.

3.3

assistive product

instrument, equipment, or technical system intended by the manufacturer (3.15) to be used for the prevention, treatment, or alleviation of or compensation for impairment (3.13)

Note 1 to entry: The definition is not identical to the definition in ISO 9999 because this document is restricted to medical devices.

3.4

assistive product which supports or suspends users

assistive product (3.3) intended to support (3.4.1) or suspend (3.4.2) persons with disability (3.11) and/or an assistant (3.2) or load (3.16)

3.4.1

support

bear or hold up

3.4.2

suspend

hang by attachment to something above

3.5

autonomy

ability to perform intended tasks based on current state and sensing, without human intervention

Note 1 to entry: For a particular application, degree of autonomy can be evaluated according to the quality of decision making and independence from human. For example, metrics for degree of autonomy exist for medical electrical equipment in IEC/TR 60601-4-1.

[SOURCE:ISO 8373:2021, 3.2]

3.6

bedding

items normally placed on a mattress

Note 1 to entry: Bedding includes mattress covers, underlays, incontinence sheets and pads, sheets, blankets, electric blankets, quilts (duvets) and their covers, pillows and bolsters, and pillow cases.

3.7

body mass index

BMI

simple index of weight-for-height that is commonly used to classify underweight, overweight and obesity in adults and defined as the weight in kilograms divided by the square of the height in meters (kg/m²)

3.8

clinical evaluation

means for confirming that an assistive product (3.3) conforms to the intended use (3.14) specified by the manufacturer (3.15)

Note 1 to entry: A clinical evaluation can include a compilation of clinical data, any scientific literature and the results of any clinical investigations, taking into account any relevant standards.

3.9

clinical investigation

clinical trial

clinical study

systematic investigation in one or more human subjects, undertaken to assess the clinical performance, effectiveness or safety of a medical device (3.18)

[SOURCE:ISO 14155:2020, 3.8, modified — Content of Note 1 to entry incorporated to the terms.]

3.10

detachable part

part designed to be unfastened or disconnected without damage to the part or the whole

[SOURCE:ISO 20342-1:2019, 3.10]

3.11

disability

umbrella term for impairments (3.13) , activity limitations and participation restrictions denoting the negative aspects of the interaction between an individual (with a health condition) and that individual's contextual factors (environmental and personal factors)

[SOURCE:ICF 2001, WHO]

3.12

hand-held device

hand-held assistive product

equipment or part of equipment intended to be supported by the hand during normal use (3.20)

3.13

impairment

problem in body function or structure

[SOURCE:ICF 2001, WHO]

3.14

intended use

use of a product, process or service in accordance with the specifications, instructions and information provided by the manufacturer (3.15)

Note 1 to entry: This information includes pre-sale information.

3.15

manufacturer

natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party

3.16

load

permissible weight

3.16.1

maximum user mass

greatest permissible mass of the person using the product, measured in kilograms (kg)

3.16.2

minimum user mass

lowest possible user (3.32) mass needed for activating or using an assistive product (3.3) , measured in kilograms (kg)

3.16.3

maximum load

safe working load

maximum external mechanical load (3.16) (mass) on equipment or an equipment part that is permitted in normal use (3.20)

Note 1 to entry: Depending on the type of assistive product, the maximum load can be either higher or lower than the user mass. In case of a product intended to carry both a user and an assistant and possibly accessories, the maximum load will be higher than the maximum user mass. In case of a product intended for the user to (just) lean on for support, the maximum user mass will be higher than the maximum load.

[SOURCE:IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 3.109, modified —Note 1 to entry added.]

3.17

mechanism

system of parts working together

3.17.1

locking mechanism

mechanism (3.17) that ensure that the assistive product (3.3) will stay in an intended position

3.18

medical device

Note 1 to entry: Devices are different from drugs and their biological evaluation requires a different approach.

Note 2 to entry: Use of the term medical device includes dental devices.

[SOURCE:ISO 13485:2016, 3.11, modified — Parts of the definition removed, Note 1 to entry modified, Note 2 to entry added.]

3.19

mobile assistive product

equipment intended to be moved from one location to another while supported by its own wheels or equivalent means

3.20

normal use

use of a product, process, or service in accordance with the specifications, instructions, and information provided by the manufacturer (3.15) , not only intended for medical use, but also maintenance, service, transport, etc.

Note 1 to entry: Normal use is not to be confused with intended use. While both include the concept of use as intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical purposes, but also maintenance, service, transport, etc. “Medical use” and “medical purpose” include the purpose of assistive products as described in 3.2.

[SOURCE:ISO 17966:2016, 3.19, modified — Note 1 to entry added.]

3.21

operator

person handling the assistive product (3.3)

Note 1 to entry: The operator can either be the user or the assistant.

3.22

pendant control

hand-held device (3.12) , which has a functional connection to the assistive product (3.3) , controlling, e.g. articulations and/or movements

Note 1 to entry: Pendant controls can be wired or wireless, and can integrate other functions, (e.g. communications, radio/TV, etc.).

[SOURCE:IEC 60601-2-52:2009, 201.3.214, modified —"medical bed" replaced with"assistive product","at least" replaced with"e.g."]

3.23

person with disability

person with one or more impairments (3.13) , one or more activity limitations, one or more participation restrictions, or a combination thereof

[SOURCE:ICF 2001, WHO]

3.24

portable assistive product

equipment intended to be moved from one location to another while being carried by one or more persons

3.25

protection side rail

physical barrier that can be a detachable accessory or integral to the overall construction of an assistive product (3.3) and is positioned to the side(s) of the assistive product that will prevent the user (3.32) from getting out of the assistive product by itself

Note 1 to entry: It can be movable, e.g. sliding sides, drop sides, folding sides.

[SOURCE:EN 50637:2017, 201.3.223]

3.26

risk management file

set of records and other documents that are produced by risk management

3.27

robot

programmed actuated mechanism (3.17) with a degree of autonomy (3.5) to perform locomotion, manipulation or positioning

Note 1 to entry: A robot includes the control system and interface of the control system.

[SOURCE:ISO 8373:2021, 3.3, modified — Example removed.]

3.28

side rail

physical barrier, which can be a detachable accessory or integral to the overall construction of an assistive product (3.3) and is mounted to the side(s) of an assistive product

Note 1 to entry: When a side rail is closed/fully raised, it provides a physical barrier, which is intended to reduce the risk of the user accidentally slipping or rolling off the lying support surface.

[SOURCE:EN 50637:2017, 201.3.224, modified]

3.29

single fault condition

condition in which a single means for reducing a risk is defective or a single abnormal condition is present

Note 1 to entry: In this document, a single fault also includes an error of the software.

[SOURCE:ISO 17966:2016, 3.26, modified— Note 1 to entry added.]

3.30

technical documentation

manufacturer's (3.15) data that shows that an assistive product (3.3) conforms to specific requirements

3.31

usability

characteristic of the operator (3.21) interface that establishes effectiveness, efficiency, ease of operator learning and operator learnability and satisfaction

3.32

user

person with a disability (3.11) for whom the assistive product (3.3) is intended