International Standard
ISO20417
Secondedition2026-03
besuppliedbythemanufacturer Medicaldevices-Informationto
Dispositifs medicaux-Informations afournir parle fabricant
COPYRIGHTPROTECTEDDOCUMENT
ISO 20417:2026(en)
Contents
5.1 Units of measurement. 135.2 Graphical information. Language and country identifiers. 135.3 5.3.1 Language identifiers. 14 145.4 5.3.2 Dates. Country identifiers. 14 145.5 Full address. Model number. 145.6 5.7 Catalogue number 15 155.8 5.9 Unique device identifier. Production controlidentifiers. 15 155.10 Types of use/reuse 165.11 Sterile. 16
Requirementsforacpanyinginformation 16
6.1 Requirements for information to be supplied on the label. 166.1.1 6.1.2 Identification of themanufacturer. Minimumrequirementsforthe label 16 176.1.3 6.1.4 Identification of the medical device or accessory. Other labelrequirements 20 176.1.5 Consult instructions foruse 216.2 6.1.6 Identificationrequirements for detachable ponents of amedical deviceoraccessory Safety signs. 21 226.3 Durability ofmarkings. Legibility of the label. 236.4 6.5 Information to be provided on the packaging 23 236.5.1 6.5.2 General information. Packaging for the lay user. 25 236.5.3 Special conditions indicated on the packaging Sterile packaging 256.6 6.5.4 Requirements for information in the instructions for use and technical description. 27 266.6.1 6.6.2 Requirements for instructions for use. General. .27 286.6.3 Additionalrequirementsfortheinstructionsforuseforalayuser6.6.4 6.6.5 Requirements for technical description. Requirements for e-documentation. 36
7.1 7.2 Importer. Distributor. 36 .377.3 7.4 Repackaging Translation.7.5 Regulatory identification 38
ISO 20417:2026(en)
Annex D (informative) Reference to the IMDRF essential principles and labelling guidance. 43Bibliography. Annex E (informative) Alphabetized index of defined terms 47 50
ISO 20417:2026(en)
Foreword
bodies (ISo member bodies). The work of preparing International Standards is normally carried out throughhas been established has the right to be represented on that mittee. International organizations ISO technical mittees. Each member body interested in a subject for which a technical mitteegovernmental 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 describedin the ISO/IEC Directives Part 1. In particular the different approval criteria needed for the different typesISO/IEC Directives Part 2 (see
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)patent(s). ISO takes no position concerning the evidence validity or applicability of any claimed patentthis may not represent the latest information which may be obtained from the patent database available at ISO shall not be held responsible for identifying any or all such patent rights.
constitute an endorsement. Any trade name used in this document is information given for the convenience of users and does not
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general aspects for products withahealth purpose including medicaldevices in collaboration with theand corresponding general aspects for medical devices in accordance with the Agreement on technicalcooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 20417:2021) which has been technicallyrevised.
The main changes are as follows:
--update of the normative references;deletion of item b) in Clause 4 and of item d) 1) in 6.1.2.
-deletion of the former informative Annexes D F G and H;
Any feedback or questions on this document should be directed to the user's national standards body. Aplete listing of these bodies can be found at
