Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
1 Scope
This document specifies symbols used to express information supplied for a medical device.
This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements.
These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB/T 2659.1 Codes for the representation of names of countries and their subdivisions - Part 1: Country code (ISO 3166-1: 2020, MOD)
YY/T 0466.2 Medical devices - Symbols to be used with medical device labels labelling, and information to be supplied - Part 2: Symbol development, selection and validation (YY/T 0466.2-2015, ISO 15223-2: 2010, IDT)
ISO 8601-1 Date and time - Representations for information interchange - Part 1: Basic rules
Note: GB/T 7408-2005 Data elements and interchange formats - Information interchange - Representation of dates and times (ISO 8601: 2000, IDT)
ISO 8601-2 Date and time - Representations for information interchange - Part 2: Extensions
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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: The accompanying information shall be regarded as part of the medical device or accessory.
Note 2: The accompanying information can consist of the label, marking, instructions for use, technical description, installation manual, quick reference guide, etc.
Note 3: 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: See Figure 1.
Note 5: The label can include the information on the packaging of the medical device.
Note 6: E?documentation can include any or all types of information supplied by the manufacturer partially or entirely.
Note 7: Marketing information is also known as promotional material.
Note 8: There is guidance and rationale related to accompanying information in ISO 20417: 2021, Annex A.
[Source: GB 20417: 2021, 3.2, modified]
Figure 1 Relationship of terms used to describe information supplied by the manufacturer
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: A catalogue number shall consist of letters or numbers or a combination of these.
Note 2: Commercial product codes cannot be confused with the "product code" or "procode classification" of the US Food and Drug Administration (FDA).
Note 3: Synonyms for catalogue number are "reference number" or "reorder number".
Note 4: See ISO 20417: 2021, Figure 2.
[Source: GB 20417: 2021, 3.3, modified]
3.3
description
normative text which defines the purpose, the application and the use of the symbol (3.18)
[Source: GB/T 23371.1-2013, 3.2, modified]
3.4
distributor
natural or legal person, different from the manufacturer or importer, in the supply chain who, on their own behalf, furthers the availability of a medical device or accessory to the user
Note 1: More than one distributor may be involved in the supply chain.
Note 2: For the purposes of this document, persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors.
[Source: ISO 20417: 2021, 3.5]
3.5
importer
first 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: GB/T 42061-2022, 3.7]
Foreword i
Introduction iv
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Future symbols
4.2 Requirements for usage
4.3 Other symbols
5 Symbols
Annex A (Informative) Guidance and examples of symbol use, including multiple symbols
Annex B (Informative) Use of general prohibition symbol and negation symbol
Bibliography
