SIST 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
• Public Enquiry End Date: 19-Nov-2009
• Publication Date: 16-Jun-2011
• ICS: 01.080.20 - Graphical symbols for use on specific equipment
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 23-May-2011
• Due Date: 28-Jul-2011
• Completion Date: 17-Jun-2011
• 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: EN 15986:2011 - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

Overview

EN 15986:2011 (CEN) specifies a standardized symbol and labelling requirements for medical devices (or parts of devices) that contain certain phthalates when labelling is required by Annex I of Directive 93/42/EEC (Section 7.5, 2nd paragraph). The standard defines the format and usage of a single symbol indicating the presence of phthalates and explains how that symbol must be presented and referenced in manufacturer information. EN 15986:2011 supports regulatory compliance across the EU and provides a presumption of conformity with the relevant Essential Requirement when implemented.

Key topics and technical requirements

• Scope: Applies where Directive 93/42/EEC requires labelling for phthalates; specifically relevant for phthalates classified as CMR category 1 or 2 under table 3.2 of Annex VI of Regulation (EC) No 1272/2008.
• Symbol: Defines a standardized symbol for “CONTAINS OR PRESENCE OF PHTHALATE” (derived from ISO 7000-2725).
• Accompanying designation: The symbol must be accompanied by the abbreviated designation of the particular phthalate(s) used (e.g., DEHP, DBP, BBP) located adjacent to the symbol.
• Where to label: The symbol shall be marked on the medical device itself and/or on the unit packaging or sales packaging as appropriate.
• Information supplied: The meaning of the symbol must be explained in manufacturer-supplied documentation (instructions for use). EN 15986 does not define the full content of that information (see EN 980 and EN 1041 for labelling and information requirements).
• Negation symbol: Use of the general negation (large “X” over a symbol) is permitted following EN 80416-3, though its use with this phthalate symbol is not generally recommended.
• Limitations: EN 15986 does not cover the 1st and 3rd paragraphs of Essential Requirement 7.5 and does not replace EN 980 / EN 1041 for general information requirements.

Applications and users

• Medical device manufacturers - to design compliant labels and packaging for devices containing regulated phthalates.
• Regulatory affairs & quality teams - to demonstrate conformity with Directive 93/42/EEC labelling obligations.
• Notified bodies and auditors - to assess labelling compliance during conformity assessment.
• Purchasers, hospitals and clinicians - to identify devices that contain specific phthalates and apply precautions for high‑risk patient groups.
• Design and procurement - helps selection of alternative materials or mitigation measures where phthalate exposure is a concern.

Related standards and references

• EN 980, EN 1041 - information supplied by the manufacturer / other labelling requirements
• Regulation (EC) No 1272/2008 - classification of hazardous substances (CMR categories)
• ISO 7000 / ISO 15223-1 - graphical symbols for equipment and medical device labelling
• EN 80416-3 - guidance on negation symbols

Keywords: EN 15986:2011, phthalates, medical device labelling, symbol, DEHP, DBP, BBP, Directive 93/42/EEC, Regulation (EC) No 1272/2008, CEN.

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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