EN 15986:2011
(Main)Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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
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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Frequently Asked Questions
EN 15986:2011 is a standard published by the European Committee for Standardization (CEN). Its full title is "Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates". This standard covers: 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.
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.
EN 15986:2011 is classified under the following ICS (International Classification for Standards) categories: 01.080.20 - Graphical symbols for use on specific equipment; 11.040.01 - Medical equipment in general; 11.120.01 - Pharmaceutics in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 15986:2011 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC; Standardization Mandates: M/433. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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SIST EN 15986:2011は、医療機器のラベリングにおけるフタル酸エステルの存在を示すためのシンボルに関する要件を定めた欧州標準です。この標準は、EU指令93/42/EECの付属書I第7.5条に基づいて、特定の条件下でフタル酸エステルを含む医療機器やその部品において必要とされるラベル表示の要件を明確にしています。 本標準の強みは、その明確なスコープにあります。フタル酸エステルを含む医療機器を使用する際には、患者や使用者に対して適切に情報を提供することが求められるため、具体的なラベルの形式やデザインが定義されています。これにより、医療機器メーカーは、製品がフタル酸エステルを含む場合に適切な警告や指示を効果的に伝えることが可能となります。 また、SIST EN 15986:2011は、EN 980やEN 1041とは異なり、医療機器に関する他の情報を提供するための要件は規定していません。この点も明確性の一部であり、特定のテーマに絞った内容となっているため、製品の設計や開発において必要な情報を迅速かつ容易に取り入れることができます。 さらに、この標準は、医療業界における安全性と透明性を高めるための重要なツールです。フタル酸エステルの使用に関する情報を適切に表示することにより、患者や医療専門家が製品選定を行う際の判断材料を提供します。このように、SIST EN 15986:2011は、医療機器のラベリングにおける重要な規範であり、規制遵守に寄与するものとなっています。
The standard EN 15986:2011 is a pivotal document that delineates the requirements for the labelling of medical devices containing phthalates, ensuring compliance with Annex I of Directive 93/42/EEC. Its scope is specifically oriented towards the format of a symbol that must be employed in the labelling of medical devices, thereby providing clear visual identification of phthalates in these products. One of the significant strengths of EN 15986:2011 is its focused approach to phthalate-related labelling. By standardizing the symbol used for indicating the presence of phthalates, the standard enhances consumer awareness and safety, facilitating informed decisions when using medical devices. This is especially relevant given the increasing scrutiny around phthalates due to their potential health risks. The requirement for such labelling aligns with broader regulatory efforts to ensure transparency in the medical device market. Furthermore, the standard's clear delineation of its scope, specifying that it does not address the broader requirements for information supply covered by EN 980 and EN 1041, is an asset. This clarity helps manufacturers understand the limits of the standard, allowing them to navigate compliance processes more effectively without redundancy. In summary, EN 15986:2011 is a comprehensive and relevant standard that plays a critical role in the regulation of medical devices containing phthalates, enhancing safety and compliance in the healthcare sector. Its emphasis on a standardized symbol not only empowers consumers but also streamlines the labelling process for manufacturers, reflecting its importance in the evolving landscape of medical device regulation.
표준 EN 15986:2011은 의료기기에 사용되는 라벨링의 기준을 명확하게 규정하고 있으며, 특히 프탈레이트의 존재를 나타내기 위한 기호의 형식에 중점을 두고 있습니다. 이 유럽 표준은 93/42/EEC 지침의 부록 I 제7.5항의 요구 사항에 따라 필요시 의료기기나 그 일부의 라벨에 프탈레이트 존재 여부를 표시하는 데 필요한 요건을 정의합니다. 이 표준의 주요 강점은 의료기기 라벨링의 일관성을 강화하고, 소비자에게 위험을 명확히 알릴 수 있는 기호 형식의 세부 지침을 제공한다는 점입니다. 이러한 명확한 기준은 의료기기 제조업체와 사용자 간의 신뢰를 증진시키며, 안전한 사용을 도모합니다. 또한, EN 15986:2011은 프탈레이트가 포함된 의료기기에 대한 투명성을 확보하여, 소비자가 보다 잘-informed한 결정을 내릴 수 있도록 합니다. 그러나 이 표준은 의료기기와 관련된 모든 정보를 제공하기 위한 요구 사항을 포함하고 있지 않으며, 이에 대한 사항은 EN 980 및 EN 1041에서 다루고 있습니다. 즉, EN 15986:2011은 특정 요구 사항에 초점을 맞추고 있어, 전체적인 의료기기 라벨링에 필요한 모든 요구사항을 아우르지는 않습니다. 그러나 그 한정된 범위 속에서도 유용한 지침을 제공하며, 의료기기 라벨링의 표준화에 기여하고 있습니다. 결론적으로, EN 15986:2011은 의료기기에 포함된 프탈레이트의 존재를 알리기 위한 기호 라벨링의 요구 사항을 체계적으로 정리하여, 관련 산업에서의 일관성을 확보하는 데 중요한 역할을 하고 있습니다.
La norme SIST EN 15986:2011 est essentielle pour garantir la sécurité et l'information adéquate concernant l'utilisation de dispositifs médicaux contenant des phtalates. Son champ d'application précise les exigences relatives à l'étiquetage des dispositifs médicaux ou de leurs parties, spécifiquement pour indiquer la présence de phtalates, conformément à l'annexe I de la directive 93/42/EEC, section 7.5, deuxième paragraphe. Les forces de cette norme résident dans sa clarté et sa précision. Elle définit un symbole standardisé pour l'étiquetage des dispositifs médicaux, ce qui facilite la reconnaissance et la compréhension par les utilisateurs, les professionnels de santé et les patients. Cette standardisation est cruciale, car elle contribue à l'harmonisation des informations fournies sur les dispositifs médicaux en Europe, assurant ainsi une communication cohérente des risques associés à l'utilisation de phtalates. En outre, la norme met l'accent sur la conformité réglementaire et permet aux fabricants de respecter les exigences de la législation européenne en matière de sécurité des patients. Bien qu'elle ne couvre pas les exigences relatives à l'information à fournir avec les dispositifs médicaux, qui sont traitées par les normes EN 980 et EN 1041, elle comble un vide important en fournissant des directives spécifiques sur l'étiquetage. La pertinence de la norme SIST EN 15986:2011 est indéniable dans le contexte actuel des préoccupations croissantes concernant l'impact des phtalates sur la santé. En établissant des exigences claires pour l’étiquetage, elle permet aux utilisateurs de prendre des décisions éclairées et contribue à l'augmentation de la transparence dans l'industrie des dispositifs médicaux. La normalisation des symboles favorise également l'accessibilité de l'information, ce qui est crucial dans un environnement où la sécurité des patients est primordiale.
Die Norm EN 15986:2011 stellt eine klare und praxisorientierte Grundlage für die Kennzeichnung von medizinischen Geräten dar, die Phthalate enthalten. Ihr Anwendungsbereich ist entscheidend, da sie spezifische Anforderungen festlegt, um die Anwesenheit von Phthalaten gemäß den Vorgaben von Anhang I der Richtlinie 93/42/EEC, Abschnitt 7.5, 2. Absatz anzuzeigen. Diese Norm fokussiert sich auf die Entwicklung eines Symbols, das eine wichtige Rolle im Kennzeichnungsprozess von medizinischen Geräten spielt. Ein wesentliches Stärke der Norm liegt in ihrer Erforderlichkeit für die Sicherheit und Transparenz im Umgang mit medizinischen Geräten. Durch die klare Definition des Symbols wird sichergestellt, dass Anwender und Patienten umgehend auf potenzielle Risiken hingewiesen werden, die von Phthalaten ausgehen könnten. Dies steigert nicht nur die Benutzerfreundlichkeit, sondern fördert auch das Vertrauen in die Verwendung dieser Produkte. Die Relevanz der EN 15986:2011 in der aktuellen medizinischen Geräteindustrie kann nicht hoch genug eingeschätzt werden. Angesichts der zunehmend strengen regulatorischen Anforderungen und der wachsenden Sensibilisierung der Öffentlichkeit gegenüber chemischen Inhaltsstoffen in Produkten, bietet die Norm einen unverzichtbaren Leitfaden. Sie unterstützt Hersteller dabei, ihre Produkte rechtskonform zu kennzeichnen und gewährleistet gleichzeitig, dass die Benutzer über wichtige Sicherheitsinformationen verfügen. Ein weiterer positiver Aspekt ist, dass die Norm nicht in den Bereich der Informationen geht, die mit medizinischen Geräten bereitgestellt werden, da diese Anforderungen durch die Normen EN 980 und EN 1041 abgedeckt sind. Dies ermöglicht es EN 15986:2011, sich vollständig auf die klare und spezifische Darstellung der Kennzeichnungsanforderungen zu konzentrieren, ohne in andere regulatorische Bereiche zu interferieren. Insgesamt bietet die EN 15986:2011 einen wichtige Standardisierung, die sowohl für Hersteller als auch für Verbraucher von großer Bedeutung ist. Die gezielte Fokussierung auf das Symbol für die Kennzeichnung und die klare Aufschlüsselung der relevanten Anforderungen machen diese Norm zu einem Schlüsselwerkzeug in der sicheren Anwendung von medizinischen Geräten, die Phthalate enthalten.
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