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ISO / ISO 15223-1:2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements

ISO 15223-1:2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/CLC/JTC 3, Quality management and corresponding general aspects for medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This fourth edition cancels and replaces the third edition (ISO 15223-1:2016), which has been technically revised.

The main changes compared to the previous edition are as follows:

— addition of 20 symbols that were validated as per ISO 15223-2;

— addition of 5 symbols previously published in ISO 7000, ISO 7001 and IEC 60417;

— deletion of the defined term “labelling”;

— inclusion of defined terms from ISO 20417, ISO 13485 and ISO 14971;

— expansion of the examples given in Annex A;

— information about European regulations has been moved to informative notes throughout.

A list of all parts in the ISO 15223 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

Medical device manufacturers and others in the supply chain must provide specific information on the medical device itself, as part of the packaging, or in the accompanying information. For simplicity and to avoid translation of text, this information can be provided as symbols that have a specific meaning. This document does not specify the information that needs to be provided, but does specify internationally recognized symbols for the provision of this specific information.

The symbols included in this document have been published in ISO 7000, ISO 7001, IEC 60417 or have been subjected to a formal symbol validation process.

This document is intended to be used by manufacturers of medical devices who market products in countries where there are specific language requirements. These symbols allow for a consistent portrayal of information. It can also be used by consumers or end users of medical devices who draw their supplies from a number of sources and can have varied language capabilities.

In this document, the conjunctive “or” is used as an “inclusive or”; so a statement is true if any combination of the conditions is true.

Terms defined in Clause 3 are shown in italic type throughout the document.

In this document, the following verbal forms are used:

— “shall” indicates a requirement;

— “should” indicates a recommendation;

— “may” indicates a permission;

— “can” indicates a possibility or a capability;

— “must” indicates an external constraint that is not a requirement of the document.

Information marked as “NOTE” is intended to assist the understanding or use of the document. “Notes to entry” used in Clause 3 provide additional information that supplements the terminological data and can contain provisions relating to the use of a term.

Symbols added during the revision of this document were placed at the end of the pertinent section of Table 1 to preserve the numbering of existing symbols and facilitate easy referencing of existing symbols in other documents.

NOTE

Numbers given in square brackets throughout the document refer to the Bibliography.

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 are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

  • ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code
  • ISO 8601-1 Date and time — Representations for information interchange — Part 1: Basic rules
  • ISO 8601-2 Date and time — Representations for information interchange — Part 2: Extensions
  • ISO 15223-2 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp

— IEC Electropedia: available at http://www.electropedia.org/

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

The accompanying information shall be regarded as part of the medical device or accessory.

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

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).

See Figure 1.

The label can include the information on the packaging of the medical device.

e-documentation can include any or all types of information supplied by the manufacturer partially or entirely.

Marketing information is also known as promotional material.

There is guidance or rationale related to accompanying information in ISO 20417:2021,[15] Annex A.

Figure 1
Relationship of terms used to describe information supplied by the manufacturer

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

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)

A catalogue number shall consist of letters or numbers or a combination of these.

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

Synonyms for catalogue number are “reference number” or “reorder number”.

See ISO 20417:2021.

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)

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 manufacturer or importer, in the supply chain who, on their own behalf, furthers the availability of a medical device or accessory to the user

More than one distributor may be involved in the supply chain.

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.

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

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

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

For the purposes of this document, e-documentation is included in information supplied by the manufacturer.

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.

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.

See Figure 1.

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

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

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

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

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.

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

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.

See Figure 1.

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

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

Label includes the marking on the medical device or accessory.

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

See Figure 1.

ISO 20417:2021,[15] 3.12

3.9 lot number

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

The title of symbol 5.1.5 uses the synonym batch code.

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)

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.

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.

“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.

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.

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.

An authorized representative, distributor or importer 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.

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.

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

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

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.

See Figure 1.

ISO 20417:2021,[15] 3.16

3.12 medical device

instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

— diagnosis, prevention, monitoring, treatment or alleviation of disease;

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

— investigation, replacement, modification, or support of the anatomy or of a physiological process;

— supporting or sustaining life;

— control of conception;

— disinfection of medical devices;

— providing information by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means

Products which may be considered to be medical devices in some jurisdictions but not in others include:

— disinfection substances;

— aids for persons with disabilities;

— devices incorporating animal or human tissues, or both;

— devices for in vitro fertilization or assisted reproduction technologies.

ISO 13485:2016,[7] 3.11

3.13 model number

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

See ISO 20417:2021.

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

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 medical device from other medical devices with the same catalogue number or model number

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

A single patient multiple use medical device or accessory may require processing between uses.

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

ISO 20417:2021,[15] 3.25

3.17 single use

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

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

ISO 20417:2021,[15] 3.26

3.18 sterile

free from viable microorganisms

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

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

ISO 20417:2021,[15] 3.29

4 General requirements

4.1 Future symbols

  1. a) Future symbols proposed for inclusion in this document shall be validated in accordance with ISO 15223-2. Symbols registered under ISO 7000, ISO 7010, or IEC 60417 are exempt.
  2. b) Any symbol proposed for inclusion in this document shall be applicable to a range of medical devices and have global or regional applicability.

4.2 Requirements for usage

  1. a) When a need to use symbols as an appropriate method for conveying information essential for the proper use of a medical device is identified, the symbols given in Table 1 may be marked on the medical device, appear on its packaging or in information supplied by the manufacturer.

    NOTE

    ISO and IEC maintain an online database of graphical symbols for use on equipment, which contains the complete set of graphical symbols included in ISO 7000, ISO 7001 and IEC 60417 available at https://www.iso.org/obp/ui/#home. This database shows each graphical symbol and identifies it by a reference number and a title. The graphical symbols are available in different formats (e.g. AI, DWG, EPS) and some additional data, as applicable, is provided.

  2. b) The manufacturer shall determine the appropriate size for the symbol to be legible for its intended function.

    NOTE 1

    This document does not specify colours or minimum size for the symbols in Table 1, nor does it specify the relative size of symbols and that of indicated information.

    NOTE 2

    Guidance on the application of graphical symbols is found in IEC 80416-3:2002+A1:2011[20].

    NOTE 3

    Guidance on the use of the general prohibition symbol and the negation symbol is found in Annex B.

  3. c) All dates and times presented in association with symbols shall use the conventions set out in ISO 8601-1 and ISO 8601-2.

4.3 Other symbols

Other standards specify additional symbols that are applicable to particular kinds or groups of medical devices or to particular situations. The bibliography provides examples of sources for additional symbols.

5 Symbols

  1. a) When appropriate, information essential for proper use shall be indicated on the medical device, its packaging, or in the accompanying information by using the corresponding symbols given in Table 1.
  2. b) A manufacturer may use any appropriate symbol.

    NOTE 1

    Table 1 has been organized into symbol categories for ease of use. The category into which a symbol is grouped does not have any significance as far as usage is concerned. The order of appearance of symbols and the categories in which they are placed are not prioritized. Examples of the use of symbols can be found in Annex A.

    NOTE 2

    Each symbol in the ISO/IEC symbols database (available at https://www.iso.org/obp/ui/#home) has a reference number and registration date. This information is given in the final column of Table 1.

Table 1
Symbols to convey medical device information
Reference
number and graphic		 Title Description Requirements Notes Restrictions
of use		 ISO/IEC symbol number and
registration date
5.1 Manufacture
5.1.1 Manufacturer Indicates the
medical device
manufacturer		 This symbol shall be accompanied by the name and address of the
manufacturer
adjacent to the symbol.		 NOTE 1 This symbol is used to indicate information that is required in Europe and can be required by other authorities having jurisdiction.

NOTE 2 For use in Europe the full definition of “manufacturer” is given in EU Regulations 2017/745[23] and 2017/746.[24] Other jurisdictions can have unique definitions.

NOTE 3 The date of manufacture, as well as the name and address of the manufacturer, can be combined in one symbol.

 — ISO 7000-3082

2011-10-02
5.1.2 Authorized representative in the European Community/
European Union		 Indicates the
authorized
representative in
the European
Community/
European Union		 This symbol shall be accompanied by the name and address of the authorized representative,
adjacent to the symbol.		 NOTE 1 This symbol is used to indicate information that is required in the European Community/European Union.

NOTE 2 Additional guidance can be found in ISO 20417[15],
ISO 18113-1[10],
ISO 18113-2[11],
ISO 18113-3[12],
ISO 18113-4[13] and
ISO 18113-5[14].

NOTE 3 If multiple symbols (i.e. Authorized Representative, Importer, Distributor, Translation, or Repackaging) identify the same responsible entity, the name and address need not be duplicated, and all applicable symbols can be grouped together next to the single address.

 — N/A
5.1.3 Date of
manufacture		 Indicates the date when the medical device was manufactured This symbol shall be accompanied by a date to indicate the date of manufacture. This shall be expressed in accordance with ISO 8601-1.

The date shall be located adjacent to the symbol.

 — The use of this symbol
precludes the use of symbol 5.1.11 with a date of
manufacture.		 ISO 7000-2497

2004-01-15
5.1.4 Use-by date Indicates the date after which the medical device is not to be used This symbol shall be accompanied by a date to indicate that the medical device should not be used after the end of the year, month or day shown.

The date shall be expressed in
accordance with
ISO 8601-1.

The date shall be located adjacent to the symbol.

 NOTE Synonyms for “use-by date” are “use by”, “expiry date” and
“expiration date”.		 — ISO 7000-2607

2004-01-15
5.1.5 Batch code Indicates the manufacturer’s batch code so that the batch or lot can be identified This symbol shall be accompanied by the manufacturer’s batch code adjacent to the symbol. NOTE Synonyms for “batch code” are “lot number”, “lot code” and “batch number”. — ISO 7000-2492

2004-01-15
5.1.6 Catalogue
number		 Indicates the manufacturer’s catalogue number so that the medical device can be identified This symbol shall be accompanied by the manufacturer’s catalogue number adjacent to the symbol. NOTE Synonyms for “catalogue number” are “commercial product name”, “commercial product code”, stock keeping unit, “reference number” and “reorder number”. — ISO 7000-2493

2004-01-15
5.1.7 Serial number Indicates the manufacturer’s serial
number so that a
specific medical device can be
identified		 This symbol shall be accompanied by the manufacturer’s
serial number adjacent to the symbol.		 — — ISO 7000-2498

2004-01-15
5.1.8 Importer Indicates the entity importing the
medical device into the locale		 This symbol shall be accompanied by the name and address of the importing entity
adjacent to the
symbol.		 NOTE If multiple symbols (i.e. Authorized Representative, Importer, Distributor, Translation, or Repackaging) identify the same responsible entity, the name and address need not be duplicated. — ISO 7000-3725

2019-11-01
5.1.9 Distributor Indicates the entity distributing the medical device into the locale This symbol shall be accompanied by the name and address of the distributing entity adjacent to the symbol. NOTE If multiple symbols (i.e. Authorized Representative, Importer, Distributor, Translation, or Repackaging) identify the same responsible entity, the name and address need not be duplicated. — ISO 7000-3724

2019-11-01
5.1.10 Model number Indicates the model number or type number of a product This symbol shall be accompanied by the model number of the product adjacent to the symbol. — — IEC 60417-6050

2012-07-14
5.1.11 Country of
manufacture		 To identify the country of manufacture of products In the application of this symbol, the “CC” shall be replaced by either the two-letter country code or the three letter
country code defined in ISO 3166-1.

The date of manufacture may be added adjacent to this symbol.

 NOTE Not all authorities with jurisdiction recognize the two letter or three letter country codes found in ISO 3166-1. The use of this symbol with a date of
manufacture precludes the use of symbol 5.1.3.		 IEC 60417-6049

2012-07-14
5.2 Sterility
5.2.1 Sterile Indicates a medical device that has been subjected to a sterilization process — — Use of this symbol
precludes the use of symbols 5.2.2 to 5.2.5 or 5.2.10.		 ISO 7000-2499

2004-01-15
5.2.2 Sterilized using aseptic processing techniques Indicates a medical device that has been manufactured using accepted aseptic techniques — NOTE Aseptic techniques can include filtration. Use of this symbol
precludes the use of symbol 5.2.1.		 ISO 7000-2500

2004-01-15
5.2.3 Sterilized using ethylene oxide Indicates a medical device that has been sterilized using ethylene oxide — — Use of this symbol
precludes the use of symbol 5.2.1.		 ISO 7000-2501

2004-01-15
5.2.4 Sterilized using irradiation Indicates a medical device that has been sterilized using irradiation — — Use of this symbol
precludes the use of symbol 5.2.1.		 ISO 7000-2502

2004-01-15
5.2.5 Sterilized using steam or dry heat Indicates a medical device that has been sterilized using steam or dry heat — — Use of this symbol
precludes the use of symbol 5.2.1.		 ISO 7000-2503

2004-01-15
5.2.6 Do not
resterilize		 Indicates a medical device that is not to be resterilized — — This symbol is only to be used when there is an accompanying Sterile symbol (5.2.1 to 5.2.5 or 5.2.10).

This symbol is not to be used on reusable medical devices that are intended to be sterilized between uses.

 ISO 7000-2608

2004-01-15
5.2.7 Non-sterile Indicates a medical device that has not been subjected to a sterilization process — — This symbol should only be used to
distinguish
between
identical or similar medical devices sold in both sterile and non-sterile conditions.

Use of this symbol precludes the use of symbols 5.2.1 to 5.2.5 and 5.2.10.

 ISO 7000-2609

2004-01-15
5.2.8 Do not use if package is damaged and consult instructions for use Indicates that a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information — NOTE 1 This symbol can also mean “Do not use if the product sterile barrier
system or its packaging is
compromised”.

NOTE 2 For products that do not have instructions for use, the recommendation to consult them does not apply.

 — ISO 7000-2606

2004-01-15
5.2.9 Sterile fluid path Indicates the presence of a sterile fluid path within the medical device in cases when other parts of the medical device, including the exterior, might not be supplied sterile The method of sterilization shall be indicated in the empty portion of the symbol, as appropriate.

The part of the medical device that is sterile shall be identified in the information supplied by the manufacturer.

 — — ISO 7000-3084

2011-10-05
5.2.10 Sterilized using vaporized
hydrogen
peroxide		 Indicates a medical device that has been sterilized using vaporized hydrogen peroxide — NOTE  The use of this symbol in
Europe is explained in EN 556-1:2001,[21] 4.1 and the associated note.		 Use of this symbol
precludes the use of symbol 5.2.1.		 N/A
5.2.11 Single sterile barrier system Indicates a single sterile barrier system This symbol shall be placed adjacent to or in combination with symbol 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.9 or 5.2.10. NOTE 1 A solid line identifies a sterile barrier system.

NOTE 2 Additional information on
sterile barrier systems can be found in ISO 11607-1[5] and ISO 11607-2[6].

 — ISO 7000-3707

2019-10-18
5.2.12 Double sterile barrier system Indicates two sterile barrier systems This symbol shall be placed adjacent to or in combination with symbol 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.9 or 5.2.10. NOTE 1 A double solid line indicates a double sterile barrier system.

NOTE 2 Additional information on
sterile barrier systems can be found in ISO 11607-1[5] and ISO 11607-2[6].

 — ISO 7000-3704

2019-10-18
5.2.13 Single sterile barrier system with protective packaging inside Indicates a single sterile barrier
system with protective packaging inside		 This symbol shall be placed adjacent to or in combination with symbol 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.9 or 5.2.10. NOTE 1 The protective packaging located inside the sterile barrier system is designed to prevent damage to the contents or to help with aseptic presentation. It does not provide a microbial barrier to maintain sterility.

NOTE 2 Additional information on
sterile barrier systems can be found in ISO 11607-1[5] and ISO 11607-2[6].

 — ISO 7000-3708

2019-10-18
5.2.14 Single sterile barrier system with protective packaging outside Indicates a single sterile barrier
system with protective packaging outside		 This symbol shall be placed adjacent to or in combination with symbol 5.2.1, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.9 or 5.2.10. NOTE 1 The protective packaging located outside the sterile barrier system is designed to prevent damage to the sterile barrier system and the contents. The protection can be against physical hazards, particulate contamination or other environmental hazards, but it does not include a microbial barrier.

NOTE 2 Additional information on
sterile barrier systems can be found in ISO 11607-1[5] and ISO 11607-2[6].

 — ISO 7000-3709

2019-10-18
5.3 Storage
5.3.1 Fragile, handle with care Indicates a medical device that can be broken or
damaged if not
handled carefully		 — — — ISO 7000-0621

2014-06-04
5.3.2 Keep away from sunlight Indicates a medical device that needs protection from light sources — NOTE This symbol can also mean “Keep away from heat”. — ISO 7000-0624

2014-06-04
5.3.3 Protect from heat and radioactive sources Indicates a medical device that needs protection from heat and radioactive sources — NOTE 1 This symbol can also mean “Keep away from sunlight and radioactive sources”.

NOTE 2 Radioactive sources include ionizing radiation.

 — ISO 7000-0615

2004-01-15
5.3.4 Keep dry Indicates a medical device that needs to be protected from moisture — NOTE This symbol can also mean “Keep away from rain” as referenced in ISO 7000. — ISO 7000-0626

2014-06-04
5.3.5 Lower limit of temperature Indicates the lower limit of temperature to which the medical device can be safely exposed The lower limit of temperature shall be indicated adjacent to the lower horizontal line. — — ISO 7000-0534

2004-01-15
5.3.6 Upper limit of temperature Indicates the upper limit of temperature to which the medical device can be safely exposed The upper limit of temperature shall be indicated adjacent to the upper horizontal line. — — ISO 7000-0533

2004-01-15
5.3.7 Temperature limit Indicates the temperature limits to which the medical device can be safely exposed The upper and lower limits of temperature shall be indicated adjacent to the upper and lower horizontal lines. — — ISO 7000-0632

2014-06-04
5.3.8 Humidity
limitation		 Indicates the range of humidity to which the medical device can be safely exposed The humidity limitation shall be indicated adjacent to the upper and lower horizontal lines. — — ISO 7000-2620

2004-01-15
5.3.9 Atmospheric pressure
limitation		 Indicates the range of atmospheric
pressure to which the medical device can be safely exposed		 The atmospheric pressure limitations shall be indicated adjacent to the upper and lower horizontal lines. — — ISO 7000-2621

2004-01-15
5.4 Safe use
5.4.1 Biological risks Indicates that there are potential biological risks associated with the medical device — NOTE This symbol is not to be confused with the safety sign “Biological hazard” ISO 7010-W009. — ISO 7000-0659

2004-01-15
5.4.2 Do not re-use Indicates a medical device that is intended for one single use only — NOTE Synonyms for “Do not re-use” are “single use” and “use only once”. — ISO 7000-1051

2004-01-15
5.4.3 Consult
instructions for use or consult
electronic
instructions for use		 Indicates the need for the user to consult the instructions for use — NOTE 1 Synonym for “Consult instructions for use” is “Consult operating instructions”.

NOTE 2 See also ISO 20417[15] and the safety sign ISO 7010-M002.

NOTE 3 See A.16 for examples and for use in directing users to consult the
electronic instructions for use.

 — ISO 7000-1641

2004-01-15
5.4.4 Caution Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences The symbol variant ISO 7000-0434B (“Caution”) may be used. — “This symbol shall not be used solely to mean “consult
instructions for use”.		 ISO 7000-0434A

2004-01-15
5.4.5 Contains or
presence of
natural rubber
latex		 Indicates the presence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of a medical device — NOTE This symbol is intended to warn those people who can have allergic
reactions to certain latex proteins.		 This symbol should not be used for medical devices containing “synthetic rubber”. Application of ISO 7000, symbol 2725

2005-09-08
5.4.6 Contains human blood or plasma derivatives Indicates a medical device that contains or incorporates human blood or plasma derivatives The embedded cross may be
deleted or
replaced with
another element appropriate with cultural
requirements.		 — — ISO 7000-3701

2010-10-18
5.4.7 Contains a
medicinal
substance		 Indicates a medical device that contains or incorporates a medicinal
substance		 The embedded cross may be
deleted or
replaced with
another element
appropriate with cultural
requirements.		 — — ISO 7000-3702

2019-10-18
5.4.8 Contains
biological
material of
animal origin		 Indicates a medical device that contains
biological tissue, cells, or their
derivatives,
of animal origin		 — — — ISO 7000-3699

2019-10-18
5.4.9 Contains
biological
material of
human origin		 Indicates a medical device that contains
biological tissue, cells, or their
derivatives,
of human origin		 — — — ISO 7000-3700

2019-10-18
5.4.10 Contains
hazardous
substances		 Indicates a medical device that contains substances that can be carcinogenic, mutagenic, reprotoxic (CMR), or substances with endocrine disrupting properties — NOTE The term “substances” is used to indicate a single substance or multiple substances. — ISO 7000-3723

2019-11-01
5.4.11 Contains nano materials Indicates a medical device that contains nano materials — — — ISO 7000-3703

2019-10-18
5.4.12 Single patient multiple use Indicates a medical device that may be used multiple times (multiple procedures) on a single patient — — — ISO 7000-3706

2019-10-18
5.5 IVD-specific
5.5.1 In vitro
diagnostic
medical device		 Indicates a medical device that is
intended to be
used as an in vitro
diagnostic medical device		 — NOTE For use in Europe, the full
definition of “in vitro diagnostic medical
device” is given in EU Regulation 2017/746.[24] Other jurisdictions can have unique definitions.		 This symbol should only be used to identify in vitro diagnostic medical devices or their accessories
and not to specify that the medical device is for “in vitro use”.		 N/A
5.5.2 Control Indicates a control material that is intended to verify the performance of another medical device — NOTE For negative controls, use
symbol 5.5.3 and for positive controls use symbol 5.5.4.		 — N/A
5.5.3 Negative control Indicates a control material that is intended to verify the results in the expected negative range — — — ISO 7000-2495

2004-01-15
5.5.4 Positive control Indicates a control material that is intended to verify the results in the expected positive range — — — ISO 7000-2496

2004-01-15
5.5.5 Contains
sufficient for
<n> tests		 Indicates the total number of tests that can be performed with the medical device The number of tests that can be performed with the medical device shall appear adjacent to the symbol. NOTE This symbol is suitable for use with all medical devices including in vitro diagnostic medical devices. — ISO 7000-0518

2004-01-15
5.5.6 For IVD
performance
evaluation only		 Indicates an IVD medical device that is intended to be used only for evaluating its performance characteristics before it is placed on the market for medical diagnostic use — NOTE 1 A synonym is “IVD for investigational use only”.

NOTE 2 A medical device that is for in vitro diagnostic performance evaluation only is not intended to be used for an in vitro diagnostic examination for medical purposes (i.e. to yield diagnostic results).

 This symbol shall not appear jointly with symbol 5.5.1. ISO 7000-3083

2011-10-03
5.6 Transfusion/infusion
5.6.1 Sampling site Indicates a medical device or blood processing application that includes a system dedicated to the collection of samples of a given substance stored in the medical device or blood container — — This symbol is not to be associated with a site on a patient where samples are taken. ISO 7000-2715

2005-09-08
5.6.2 Fluid path Indicates the presence of a fluid path — NOTE The term “fluid” means a
liquid or gas.		 — ISO 7000-2722

2005-09-08
5.6.3 Non-pyrogenic Indicates a medical device that is non-pyrogenic — — — ISO 7000-2724

2005-09-08
5.6.4 Drops per
millilitre		 Indicates the
number of drops per millilitre		 The number of drops per millilitre is specified; 20 is shown as an example and shall be replaced by the appropriate number of drops per millilitre. — — ISO 7000-2726

2005-09-08
5.6.5 Liquid filter
with pore size		 Indicates an infusion or transfusion system of the medical device that contains a filter of a particular nominal pore size The nominal pore size of the filter is specified; 15 is shown as an example and shall be replaced by the appropriate pore size. — — ISO 7000-2727

2005-09-08
5.6.6 One-way valve Indicates a medical device with a valve that allows flow in only one direction — NOTE It is important for the user to know that the flow is only possible in one direction and cannot be reversed. — ISO 7000-2728

2005-09-08
5.7 Others
5.7.1 Patient number Indicates a unique number associated with an individual patient When used, the symbol shall appear adjacent to the patient number or next to a space provided to record it. NOTE The hash mark (#) is part of the symbol. — ISO 7000-2610

2004-01-15
5.7.2 Patient name Indicates the name of the patient When used, the symbol shall
appear adjacent to the patient name or next to a space provided to record it.		 — — ISO 7000-3726

2019-11-01
5.7.3 Patient
identification		 Indicates the identification data of the patient When used, the symbol shall
appear adjacent to the patient identification or next to a space provided to record it.		 NOTE The question mark (?) is part of the symbol. — IEC 60417-5664

2002-10-07
5.7.4 Patient
information
website		 Indicates a website where a patient can obtain additional information on the medical product This symbol shall
be accompanied
by the web
address adjacent
to the symbol.		 NOTE Usage is to indicate location of information available to the patient. — ISO 7000-3705

2019-10-18
5.7.5 Health care
centre or
doctor		 Indicates the
address of the
health care centre
or doctor where medical information about the
patient may be found		 When used, the symbol shall appear adjacent to the address of the health care centre or doctor or next to a space provided to record it. NOTE The embedded cross can be
deleted or replaced with another
element appropriate with cultural
requirements.		 — ISO 7001

PI PF 044

2013-05-31
5.7.6 Date Indicates the date that information was entered or a medical procedure took place When used, the symbol shall appear adjacent to the date appropriate for the use of this symbol or next to a space provided to record it. — — IEC 60417-5662

2002-10-07
5.7.7 Medical device Indicates the item is a medical device — NOTE For use in Europe the full definition of “medical device” is given in EU Regulation 2017/745.[23] Other jurisdictions can have unique definitions. — N/A
5.7.8 Translation Indicates that the original medical device information has undergone a translation which supplements or
replaces the
original information		 This symbol shall be accompanied by the name and address of the entity that is responsible for the translation activity adjacent to the symbol. NOTE If multiple symbols (i.e. Authorized Representative, Importer, Distributor, Translation, or Repackaging) identify the same responsible entity, the name and address need not be duplicated. This symbol shall only be used when the translation activity was undertaken by someone other than the manufacturer. ISO 7000-3728

2019-11-01
5.7.9 Repackaging Indicates that a modification to the original medical device packaging configuration has occurred This symbol shall be accompanied by the name and address of the entity that is responsible for the repackaging activity adjacent to the symbol. NOTE 1 Depending on the authority
having jurisdiction, additional information (i.e. date of repackaging) can be needed.

NOTE 2 If multiple symbols (i.e. Authorized Representative, Importer, Distributor, Translation, or Repackaging) identify the same responsible entity, the name and address need not be duplicated.

 This symbol shall only be used when the repackaging activity was undertaken by someone other than the
manufacturer.		 ISO 7000-3727

2019-11-01
5.7.10 Unique device identifier Indicates a carrier that contains unique device
identifier
information		 This symbol may be used when multiple data carriers are present on the label. If used, this symbol shall be placed adjacent to the unique device identifier carrier. NOTE This symbol identifies the UDI carrier, including the AIDC and human readable information. — N/A

Annex A Guidance and examples of symbol use, including multiple symbols

NOTE 1

These examples show the requested information (e.g. Name, Address, Date, etc.) on the right side of the symbol or below it. If the association between the symbol and the requested information is unambiguous, a manufacturer can choose to put the requested information to the left or above the symbol.

NOTE 2

If needed, manufacturers may make modifications to symbols as explained in IEC 80416-3:2002,.[20]

A.1 Guidance

Terms 3.1 (accompanying information) and 3.6 (information supplied by the manufacturer) are very similar and their application can vary by authorities having jurisdiction. ISO 20417:2021,[15] Annex A provides additional clarification.

A.2 Examples of use of symbol 5.1.1, “Manufacturer”

A.3 Examples of use of symbol 5.1.1, “Manufacturer”, combined with 5.1.3, “Date of manufacture”

A.4 Example of use of symbol 5.1.2, “Authorized representative in the European Community/European Union”

Examples for an authorized
representative in the
European Community/
European Union

A.5 Examples of use of symbol 5.1.3, “Date of manufacture”

A.6 Examples of use of symbol 5.1.4, “Use-by date”

A.7 Examples of use of symbol 5.1.5, “Batch code”

A.8 Examples of use of symbol 5.1.6, “Catalogue number”

A.9 Examples of use of symbol 5.1.7, “Serial number”

A.10 Examples of use of symbol 5.1.8, “Importer”

A.11 Examples of use of symbol 5.1.9, “Distributor”

A.12 Examples of use of symbol 5.1.11, “Country of manufacture”

NOTE 1 CC is

the two or three letter country code as defined in ISO 3166-1.

NOTE 2

Country of manufacture is determined by the manufacturer.

A.13 Examples of use of symbol 5.2.9 for “Sterile fluid path”

NOTE 1

Medical device contains a sterile fluid path that has been sterilized using ethylene oxide.

NOTE 2

Medical device contains a sterile fluid path that has been sterilized using irradiation.

NOTE 3

Medical device contains a sterile fluid path that has been sterilized using steam or dry heat.

A.14 Examples of use of symbol 5.3.8, “Humidity limitation”

A.15 Example of use of symbol 5.3.9, “Atmospheric pressure limitation”

A.16 Example of use of symbol 5.4.3, “Consult instructions for use or consult electronic instructions for use” for an electronic instruction for use (eIFU)

NOTE

The eIFU indicator can be a manufacturer’s website URL or some other appropriate indication that the instructions for use are available in an electronic format.

A.17 Examples of use of symbol 5.5.5, “Contains sufficient for <n> tests”

A.18 Example of use of symbol 5.7.1, “Patient number”

A.19 Examples of use of symbol 5.7.8, “Translation”

A.20 Examples of use of symbol 5.7.9, “Repackaging”

A.21 Examples of use of symbol 5.7.10, “Unique device identifier”

A.22 Examples of use of symbols 5.2.11 to 5.2.14 in conjunction with symbols 5.2.1 to 5.2.5, 5.2.9 or 5.2.10

A.23 Explanation on how to deal with multiple symbols used together

The symbols EC REP, Importer, Distributor, Repackaging and Translation each have a note indicating that when multiple symbols all apply to the same responsible entity, the name and address need not be duplicated. The following shows some of the possible ways that may be accomplished.

The intent is for the name and address to be unambiguously associated with the symbols. Additional graphical elements may be used for the association. Several additional graphical elements are shown below.

When two symbols apply, the symbols may appear grouped vertically or horizontally with the name and address adjacent to the symbols [i.e. either above, below, to the left, or to the right].

When three symbols apply, the symbols may appear grouped vertically or horizontally with the name and address adjacent to the symbols [i.e. either above, below, to the left, or to the right].

When four or five symbols apply, the symbols may appear grouped in any convenient way that is unambiguous, with the name and address adjacent to the symbols. [i.e. ether above, below, to the left, to the right, or with the grouping].

Annex B Use of general prohibition symbol and negation symbol

B.1 General prohibition symbol

The general prohibition symbol (as used in ISO 3864-1[1]) is intended to indicate a prohibited action. For medical device labelling, the prohibition circle with a diagonal bar should be used to mean “do not”, e.g. symbol 5.4.2 “Do not re-use”. It is sometimes used out of context in medical device labels, e.g. to mean “does not contain”. It is important that usage be consistent with the intended meaning so that hazards do not arise from misunderstanding.

B.2 Negation symbol

Manufacturers wishing to communicate the meaning “does not” or “is not” where a symbol expressing this meaning does not exist, should follow the method set out in IEC 80416-3:2002[20] (a large “X” placed over the symbol). Although it is not generally recommended that this symbology be used with any of the symbols given in this document, the use of the negation symbol is permitted.

Bibliography

  • [1] ISO 3864-11

    1 The graphical symbol collections of ISO 7000, ISO 7001 and ISO 7010 can be previewed and purchased on the Online Browsing Platform (OBP), www.iso.org/obp.

    Graphical symbols — Safety colours and safety signs — Part 1: Design principles for safety signs and safety markings
  • [2] ISO 70001) Graphical symbols for use on equipment — Registered symbols
  • [3] ISO 7001 1) Graphical symbols — Public information symbols
  • [4] ISO 7010 1) Graphical symbols — Safety colours and safety signs — Registered safety signs
  • [5] ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • [6] ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
  • [7] ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
  • [8] ISO 14971:2019 Medical devices — Application of risk management to medical devices
  • [9] ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
  • [10] ISO 18113-1 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
  • [11] ISO 18113-2 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
  • [12] ISO 18113-3 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
  • [13] ISO 18113-4 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
  • [14] ISO 18113-5 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
  • [15] ISO 20417:2021 Medical devices — Information to be supplied by the manufacturer
  • [16] IEC 60417 (database), Graphical symbols for use on equipment
  • [17] IEC TR 60878 Graphical symbols for electrical equipment in medical practice
  • [18] IEC 62570 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
  • [19] IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment — Part 1: Creation of graphical symbols for registration
  • [20] IEC 80416-3: 2002+A1:2011 Basic principles for graphical symbols for use on equipment — Part 3: Guidelines for the application of graphical symbols
  • [21] EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated “STERILE” — Part 1: Requirements for terminally sterilized medical devices
  • [22] EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
  • [23] (EU) 2017/745, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. OJ L 117, Official Journal of the European Union, pp. 1-175
  • [24] (EU) 2017/746, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices. OJ L 117, Official Journal of the European Union, pp. 176-332