Units, symbols and colors.

Unit markings: SI units (ISO 1000) or other legal unit of measurement.

Symbols and Safety Identification Colors: Conform to harmonized standards or have a

separate statement from the manufacturer.

Language and country codes

eg.Instruction manuals in different languages should be identified by language codes (ISO
639-1) or by typing in the identification information (eg "English").

The same applies, for example, to the country information of the customer service point
(EN ISO 3166-1) or by typing in the
identification (eg "France").

Dates

In the format YYYY-MM-DD, YYYY-MM or YYYY ( ISO 8601).

NOTE. The format of the date will depend on the requirements of the relevant directive and the
nature of the healthcare device or
accessory in question.

nomenclatures

Breakdown of equipment groups or categories of equipment: In accordance with the

nomenclature according to EN ISO 15225 .

Common terms (eg generally relating to technology or materials used): in accordance with
the nomenclature of CEN / TR 15133 .

Each product must include a batch code (Alphanumeric or machine-readable code, for example)

Communication and its requirements

The starting point is efficient and safe use of the device.

The communication formats shall take into account the user of the product, the conditions of
use and any other type of device.
The format of communication shall be selected on the basis of a risk assessment and shall
take into account the training and
experience of the user of the product .

The name or trade name and address of the manufacturer must appear on the product (s)
(label, instruction manual, packaging, etc.). In addition, if the manufacturer is not established in
the European Community, the name, address and address of the authorized
representative established within the Community must also appear on the label, outer packaging
or instructions for use. (The address must be as specific as possible and must match the
registered office in the same country.)

Accessibility (user- oriented ), readability (conditions of use eg lighting level) ,

availability (information must be available throughout the life of the product) ,
security (protected against distortions, breakdowns and unintentional changes made by the
manufacturer ) , information change data if it affects patient safety) .

Documentation: Information must be maintained in the technical files related to the device in
question. The information may be gathered in one place or, alternatively, reference may be made
to larger documents, such as a quality manual, where such information is already pre-presented.