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
Public Enquiry End Date
19-Nov-2009
Publication Date
16-Jun-2011
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
23-May-2011
Due Date
28-Jul-2011
Completion Date
17-Jun-2011

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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
SIST EN 15986:2011
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

EN 15986:2011 (E) 2 Contents Page Foreword ..............................................................................................................................................................31Scope ......................................................................................................................................................52Terms and definitions ...........................................................................................................................53Requirements for usage ........................................................................................................................54Symbol labelling phthalates .................................................................................................................6Annex A (informative)

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

EN 15986:2011 (E) 3 Foreword This document (EN 15986:2011) has been prepared by Technical Committee CEN/CENELEC/TC 3 “Quality management and corresponding general aspects for medical devices”, the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2011, and conflicting national standards shall be withdrawn at the latest by September 2011. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive 93/42/EEC. For relationship with EU Directive 93/42/EEC, see informative Annex ZA, which is an integral part of this document. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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 the United Kingdom.

SIST EN 15986:2011

EN 15986:2011 (E) 4 Introduction This European Standard has been prepared to give expression to the legislative preference within the European Union for the use of symbols to provide information for the safe use of medical devices, and to the legislative requirement for labelling to show the presence of certain phthalates in medical devices. This European Standard contains requirements for the labelling of medical devices or parts of medical devices containing phthalates requiring labelling, as required by the consolidated Medical Devices Directive 93/42/EEC, as amended by Directive 2007/47/EC. Labelling of medical devices or parts of medical devices containing particular phthalates is required because some have been classified as CMR 1 & 2, i.e. they could exhibit carcinogenic, mutagenic or reprotoxic/developmental effects. Not all the reproductive and developmental toxicity of phthalates to the human body have been confirmed. However, it has recently been suggested that precautions be taken to limit the exposure of humans particularly that of high risk patient groups. Phthalates have been extensively used as plasticizers due to the increased flexibility they impart to polyvinyl chloride (PVC), a plastic polymer used in a wide array of products including medical devices. From a user's point of view, a symbol conveys information in order that the user may assess the suitability of the medical device in order to mitigate risks to the patient. Due to the fact a number of phthalates with known and unknown biological effects exists on the market this European Standard includes only one symbol for medical devices “containing particular phthalates”. The requirements in the consolidated Medical Devices Directive 93/42/EEC, as amended by Directive 2007/47/EC define which medical devices containing phthalates have to be marked with the symbol. When the user has been informed that the product contains those particular phthalates precautionary actions can be found in the instruction for use. Annex B provides information about the use of the general prohibition symbol.

SIST EN 15986:2011

EN 15986:2011 (E) 5 1 Scope 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

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