EN 980-2008 pdf download.Symbols for use in the labelling of medical devices.
This EN 980 specifies symbols for use in the information supplied by the manufacturer with medical devices. The requirements of this European Standard are not intended to apply to symbols specified in other standards. However, every effort should be made to prevent the specifying of different symbols with the same meaning. This standard does not specify the requirements for information to be supplied with medical devices. which are addressed by EN 375, EN 376, EN 591, EN 592 and EN 1041.
2 Normative references
The following referenced documents are indispensable for the application 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.
EN 375, Information supplied by the manufacturer with in vitro diagnostic reagents for professional use EN 376, Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
EN 556-1:2001, Sterilization of medical devices – Requirements for medical devices to be designated STERILE — Part 1: Requirements for terminally stenlized medical devices
EN 591, Instructions for use for in vitro diagnostic instruments for professional use
EN 592. Instructions for use for in vitro diagnostic instruments for self-testing
EN 1041, Information supplied by the manufacturer with medical devices
EN ISO 15225, Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225: 2000)
ISO 8601. Data elements and interchange formats — Information interchange — Representation of dates and times
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
symbol used In medical device labelling
object presented on the label and/or on the device itself and/or associated documentation of a medical device, which may utilise symbolic or iconic presentation, that communicates characteristic information (see 3.4) without relying on knowledge of the language of a particular nation or people by the giver or receiver of the information
3.2
symbolic presentation
abstract pictonal or graphic representation
3.3
Iconic presentation
pictorial or graphic representation using familiar objects including aiphanumenc characters
3.4
characteristic information
mental representation of a property or properties of an object or set of objects
[EN 12264:2005]
4 General requirements
4.1 Proposal of symbols for adoption
4.1.1 Proposals for symbols for adoption into this European Standard shall be submitted by a body contributing to CENICLC/TC 3, that is, one in association, liaison or participating in the work of that committee.
4.1.2 Symbols should only be proposed when they represent requirements already defined in a published standard. E.g.. the requirements represented by 5.8 are defined in EN 556-1.
4.1.3 Symbols being proposed shall be presented following the dimensional criteria and design principles set out in ISO/IEC 80416. Where the presentation is symbolic (see 3.2), alphanumeric characters shall not be part of the symbol. Alphanumeric characters may be used when appropriate and relevant in an iconic symbol (see 3.3).
4.1.4 Any symbol proposed for adoption into this European Standard shall be applicable to a range of devices, at least comprising one category of the Global Medical Device Nomenclature (see EN ISO 15225).
4.1.5 When a symbol is presented for adoption, the following details are required:
a brief, unique title sufficient only to identify the symbol;
— conditions of use for the symbol and identity of proposed audience;
— information on any existing or proposed related symbols;
— information on any validation or evaluation of the symbol in use;
a graphic file (bitmap. JPEG, TIF or similar) with a print-out of the file.
4.2 Requirements for usage
4.2.1 Symbols contained in Clause 5 may be used without explanation in the information supplied by the manufacturer.
4.2.2 The meaning of symbols contained in Clause 6 shall be explained In the information supplied by the manufacturer.
4.2.3 Symbols shown in 5.2 to 5.26 and 6.2 to 6.4 are used to convey the information described in the headings and notes of those sub-clauses.
NOTE 1 Other symbols can be used to convey different information. Many other standards specify symbols for particular purposes and/or for particular kinds of device. The Bibliography lists some of these standards.
NOTE 2 ISO and IEC jointly maintain an on-line database of graphical symbols for use on equipment that contains the complete set of graphical symbols included in ISO 7000, IEC 60417-1 and IEC 60417-2. In that database, each graphical symbol is identified by a reference number and contains a title (in English and French), a graphical representation in GIF and vectorized PDF format, and some additional data as applicable. Various search and navigation facilities allow for easy retrieval of graphical symbols. Information on how to access this database is available through the ISO Store, the IEC Web Store or by contacting your local national standards body.
4.2.4 Symbols presented in this standard shall be reproduced as illustrated with the exception of 5.5 and 5.10. which may be reproduced with or without the enclosure.
NOTE Future editions of this standard may remove this exception for 5.5 and 5.10 and an enclosure may be required as defined in ISO 7000:2004 and ISO 15223-1:2007.EN 980-2008 pdf download.