EN 15986:2011

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041.
This European Standard does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.

Symbol zur Kennzeichnung von Medizinprodukten - Anforderungen zur Kennzeichnung von phthalathaltigen Medizinprodukten

Diese Europäische Norm legt Anforderungen an die Kennzeichnung eines Medizinprodukts oder Teil eines Medizinprodukts fest, um das Vorhandensein von Phthalaten anzuzeigen, falls erforderlich nach Anhang I der Richtlinie 93/42/EWG, Abschnitt 7.5, 2. Absatz. Das schließt insbesondere das Format des in der Kennzeichnung zu verwendenden Symbols ein. Die vorliegende Europäische Norm legt keine Anforderungen an die mit einem Medizinprodukt bereitzustellenden Informationen fest, die in EN 980 und EN 1041 angesprochen werden. Diese Europäische Norm legt keine Anforderungen bezüglich des ersten und dritten Abschnitts der Grundlegenden Anforderung 7.5 fest.

Symbole à utiliser pour l’étiquetage des dispositifs médicaux - Exigences relatives à l’étiquetage des dispositifs médicaux contenant des phtalates

La présente Norme européenne spécifie des prescriptions relatives à l’étiquetage de tout dispositif médical ou de parties d’un dispositif médical pour indiquer la présence de phtalates lorsque cela est exigé par l’Annexe I de la Directive 93/42/CEE Section 7.5, 2ème alinéa. Cela comprend notamment le format du symbole devant être utilisé dans l’étiquetage. La présente Norme européenne ne spécifie aucune prescription sur les informations devant être fournies avec les dispositifs médicaux, lesquelles sont abordées dans l’EN 980 et l’EN 1041. La présente Norme européenne ne spécifie pas les prescriptions des 1er et 3ème alinéas de l’exigence essentielle mentionnée en 7.5.

Simboli za označevanje medicinskih pripomočkov - Zahteve za označevanje medicinskih pripomočkov, ki vsebujejo ftalate

Ta evropski standard določa zahteve za označevanje medicinskih pripomočkov ali delov medicinskih pripomočkov za navajanje prisotnosti ftalatov, kadar tako zahteva Priloga I Direktive 93/42/EGS, razdelek 7.5, drugi odstavek. Ta izrecno vključuje format simbola, uporabljenega pri označevanju. Ta evropski standard ne določa zahteve za informacije, priložene medicinskim pripomočkom, ki so naslovljene z EN 980 in EN 1041. Ta evropski standard ne določa zahtev prvega in tretjega odstavka Bistvenih zahtev iz točke 7.5.

General Information

• Status: Published
• Publication Date: 01-Mar-2011
• Withdrawal Date: 29-Sep-2011
• ICS: 01.080.20 - Graphical symbols for use on specific equipment
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.120.01 - Pharmaceutics in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3/WG 1 - Information supplied by the manufacture of medical device
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/433 - Standardisation mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC, amending Directive 93/42/EEC relating to Medical Devices, concerning graphical symbols for use in the labelling of medical devices containing phthalates
• Ref Project: SIST EN 15986:2011 - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.HYDQMHSymbol zur Kennzeichnung von Medizinprodukten - Anforderungen zur Kennzeichnung von phthalathaltigen MedizinproduktenSymbole à utiliser pour l'étiquetage des dispositifs médicaux - Exigences relatives à l'étiquetage des dispositifs médicaux contenant des phtalatesSymbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates11.040.01Medicinska oprema na splošnoMedical equipment in general01.080.20RSUHPRGraphical symbols for use on specific equipmentICS:Ta slovenski standard je istoveten z:EN 15986:2011SIST EN 15986:2011en,fr,de01-julij-2011SIST EN 15986:2011SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 15986
March 2011 ICS 01.080.20; 11.040.01; 11.120.01
English version
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Symbole à utiliser pour l'étiquetage des dispositifs médicaux - Exigences relatives à l'étiquetage des dispositifs médicaux contenant des phtalates
Symbol zur Kennzeichnung von Medizinprodukten - Anforderungen zur Kennzeichnung von phthalathaltigen Medizinprodukten This European Standard was approved by CEN on 22 January 2011.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
CEN Management Centre: CENELEC Central Secretariat:Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels© 2011 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN 15986:2011 E SIST EN 15986:2011

Examples of uses of the symbol given in this European Standard .7Annex B (informative)
Use of the negation symbol . 10Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 11Bibliography . 12 SIST EN 15986:2011
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