ISO 15223-1:2021 医療機器—製造元から提供される情報とともに使用される記号—パート1：一般要件 | ページ 6

3.1

accompanying information

information accompanying or marked on a medical device or accessory for the user or those accountable for the installation, use, processing, maintenance, decommissioning and disposal of the medical device or accessory, particularly regarding safe use

Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.

Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical description, installation manual, quick reference guide, etc.

Note 3 to entry:Accompanying information is not necessarily a written or printed document but could involve auditory, visual, or tactile materials and multiple media types (e.g. CD/DVD-ROM, USB stick, website).

Note 4 to entry: See Figure 1.

Note 5 to entry: The label can include the information on the packaging of the medical device.

Note 6 to entry: e-documentation can include any or all types of information supplied by the manufacturer partially or entirely.

Note 7 to entry: Marketing information is also known as promotional material.

[SOURCE:ISO 20417:2021,^[15] 3.2, modified — The following text has been removed from the graphic: “Scope of ISO 20417”, defined term reference numbers and a side box containing information outside the scope of ISO 20417. Note 8 to entry has been added.]

3.2

catalogue number

commercial product name

commercial product code

value given by the manufacturer to identify a specific medical device or accessory as it relates to its form/fit, function and process (i.e. manufacturing processes requiring differentiation for the end user)

Note 1 to entry: A catalogue number shall consist of letters or numbers or a combination of these.

Note 2 to entry: For the purposes of this document, commercial product code should not be confused with the US FDA, “product code” or procode classification.

Note 3 to entry: Synonyms for catalogue number are “reference number” or “reorder number”.

Note 4 to entry: See ISO 20417:2021, Figure 2.

[SOURCE:ISO 20417:2021,^[15] 3.3, modified — The cross-reference in Note 4 to entry has been revised to be external to this document.]

3.3

description

normative text which defines the purpose, the application and the use of the symbol (3.19)

[SOURCE:IEC 80416-1:2008,^[19] 3.2, modified — “and optional product area” has been removed.]

3.4

distributor

natural or legal person, different from the manufacturerorimporter, in the supply chain who, on their own behalf, furthers the availability of a medical device or accessory to the user

Note 1 to entry: More than one distributor may be involved in the supply chain.

Note 2 to entry: For the purposes of this document, persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importerordistributor, are not distributors.

Note 3 to entry: Distribution activities alone do not include repackaging or otherwise changing the container, wrapper, or accompanying information of the medical deviceormedical device package other than providing the identification of the distributor.

[SOURCE:ISO 20417:2021,^[15] 3.5]

3.5

importer

natural or legal person who imports a medical device or accessory into a locale that was manufactured in another locale for the purposes of marketing

[SOURCE:ISO 20417:2021,^[15] 3.8]

3.6

information supplied by the manufacturer

information related to the identification and use of a medical device or accessory, in whatever form provided, intended to ensure the safe and effective use of the medical device or accessory

Note 1 to entry: For the purposes of this document, e-documentation is included in information supplied by the manufacturer.

Note 2 to entry: For the purposes of this document, shipping documents and promotional material are excluded from information supplied by the manufacturer. However, some authorities having jurisdiction (defined in ISO 16142-1:2016,^[9] 3.1) can consider such supplemental information as information supplied by the manufacturer.

Note 3 to entry: The primary purpose of information supplied by the manufacturer is to identify the medical device and its manufacturer, and provide essential information about its safety, performance, and appropriate use to the user or other relevant persons.

Note 4 to entry: See Figure 1.

Note 5 to entry: There is guidance or rationale related to information supplied by the manufacturer in Annex A.

[SOURCE:ISO 20417:2021,^[15] 3.10, modified — The cross-reference in Note 2 to entry has been added. Note 5 to entry has been added.]

3.7

instructions for use

IFU

package insert

portion of the accompanying information that is essential for the safe and effective use of a medical device or accessory directed to the user of the medical device

Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with relevant specialized training.

Note 2 to entry: For the purposes of this document, instructions for the professional processing between uses of a medical device or accessory can be included in the instructions for use.

Note 3 to entry:The instructions for use, or portions thereof, can be located on the display of a medical device or accessory.

Note 4 to entry:Medical devices or accessories that can be used safely and effectively without instructions for use are exempted from having instructions for use by some authorities with jurisdiction.

Note 5 to entry: See Figure 1.

[SOURCE:ISO 20417:2021,^[15] 3.11]

3.8

label

<medical device, accessory> written, printed or graphic information appearing on the item itself, on the packaging of each item, or on the packaging of multiple items

Note 1 to entry: For the purposes of this document, the term labelled is used to designate the corresponding act.

Note 2 to entry:Label includes the marking on the medical device or accessory.

Note 3 to entry: For the purposes of this document, information indicated on a graphical user interface (GUI) is considered as appearing on the item.

Note 4 to entry: See Figure 1.

[SOURCE:ISO 20417:2021,^[15] 3.12]

3.9

lot number

batch code

batch number

lot code

production control containing a combination of letters or numbers associated with a single lot or batch

Note 1 to entry: The title of symbol 5.1.5 uses the synonym batch code.

[SOURCE:ISO 20417:2021,^[15] 3.15, modified — Note 1 to entry has been added.]

3.10

manufacturer

natural or legal person with responsibility for the design or manufacture, or both, of a medical device with the intention of making the medical device available for use, under his or her name; whether or not such a medical device is designed or manufactured, or both, by that person themselves or on their behalf by another person(s)

Note 1 to entry: The natural or legal person has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical devices in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction.

Note 2 to entry: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions.

Note 3 to entry: “Design or manufacture, or both”, may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose.

Note 4 to entry: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device.

Note 5 to entry: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device.

Note 6 to entry: An authorized representative, distributororimporter who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer.

Note 7 to entry: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person responsible for the design, manufacture, or both, of that accessory is considered to be a manufacturer.

[SOURCE:ISO 14971:2019,^[8] 3.9]

3.11

marking

information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical device or accessory

Note 1 to entry: For the purposes of this document, the term marked is used to designate the corresponding act.

Note 2 to entry: For the purposes of this document, marking is different from “direct marking” as commonly described in unique device identification (UDI) standards and regulations. A UDI “direct marking” is a type of marking.

Note 3 to entry: See Figure 1.

[SOURCE:ISO 20417:2021,^[15] 3.16]

3.12

medical device

[SOURCE:ISO 13485:2016,^[7] 3.11]

3.13

model number

model

letters, numbers or a combination of these assigned by a manufacturer to distinguish by function or type, a particular medical device, accessoryormedical device family from another

Note 1 to entry: See ISO 20417:2021, Figure 2.

[SOURCE:ISO 20417:2021,^[15] 3.17, modified — The cross-reference in Note 1 to entry has been revised to be external to this document.]

3.14

risk

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

[SOURCE:ISO 14971:2019,^[8] 3.18]

3.15

serial number

production control containing a combination of letters or numbers, selected by the manufacturer, intended for quality control and identification purposes to uniquely distinguish an individual medicaldevice from other medical devices with the same catalogue numberormodel number

[SOURCE:ISO 20417:2021,^[15] 3.22]

3.16

single patient multiple use

<medical device, accessory> intended by the manufacturer to be reused on an individual patient for multiple uses

Note 1 to entry: A single patient multiple use medical device or accessory may require processing between uses.

Note 2 to entry: For an implantable medical device, the duration of a single use is from implanting to explanting the medical device.

[SOURCE:ISO 20417:2021,^[15] 3.25]

3.17

single use

do not re-use

use only once

<medical device, accessory> intended by the manufacturer to be used on an individual patient or specimen during a single procedure and then disposed of

Note 1 to entry: A single use medical device or accessory is not intended by its manufacturer to be further processed and used again.

[SOURCE:ISO 20417:2021,^[15] 3.26]

3.18

sterile

free from viable microorganisms

[SOURCE:ISO 20417:2021,^[15] 3.28]

3.19

symbol

graphical representation appearing on the label or associated documentation, or both, of a medical device that communicates characteristic information without the need for the supplier or receiver of the information to have knowledge of the language of a particular nation or people

Note 1 to entry: The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar objects, including alphanumeric characters (with sufficient justification).

[SOURCE:ISO 20417:2021,^[15] 3.29]