konformitätserklärung
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- Milagros Navarro Méndez
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1 konformitätserklärung Wir, der Hersteller, erklären in alleiniger Verantwortung, dass die unten aufgeführten Produkte den einschlägigen Bestimmungen der nachstehenden Richtlinien entsprechen. Kategorie medical Body Composition Analyzer Produkt 514 Optional mit Funkübertragung Klassifizierung als Medizinprodukt Konformitätsbewertungsverfahren für Medizinprodukte x Klasse IIa nach Anhang II ohne (4) der Richtlinie über Medizinprodukte 93/42/EWG Richtlinien: 93/42/EWG 2011/65/EU 1999/5/EG Richtlinie über Medizinprodukte Richtlinie zur Beschränkung der Verwendung bestimmter gefährlicher Stoffe in Elektro- und Elektronikgeräten Richtlinie über Funkanlagen und Telekommunikationsendeinrichtungen und die gegenseitige Anerkennung ihrer Konformität Hersteller: seca gmbh & co. kg Hammer Steindamm Hamburg, Deutschland Made in Germany Benannte Stellen: 93/42/EWG: TÜV SÜD Product Service GmbH Ridlerstrasse München, Deutschland 0123 Diese Konformitätserklärung ist gültig ab dem Datum der Unterzeichnung bis zur Ausstellung einer revidierten Konformitätserklärung aufgrund von Änderung der oben genannten Produkte. Hamburg, 08 / 08 / 2016 Frederik Vogel CEO Development & Manufacturing Seite 1 /2
2 konformitätserklärung Anhang Angewandte harmonisierte Normen, nationale Normen oder andere normativen Dokumente: EN EN EN Medizinische elektrische Geräte - Allgemeine Festlegungen für die Sicherheit Medizinische elektrische Geräte Elektromagnetische Verträglichkeit Medizingeräte-Software - Software-Lebenszyklus-Prozesse EN Elektromagnetische Verträglichkeit und Funkspektrumangelegenheiten (ERM) 2,4GHz EN EN Elektromagnetische Verträglichkeit und Funkspektrumangelegenheiten (ERM) - Gemeinsame Technische Anforderungen Elektromagnetische Verträglichkeit und Funkspektrumangelegenheiten (ERM) - Spezifische Bedingungen für Breitband-Datenübertragungssysteme Seite 2 /2
3 declaration of conformity We, the manufacturer, declare in sole responsibility that the products mentioned below are in conformity with the respective regulations of the following directives. Category medical Body Composition Analyzer Product 514 Optional wireless transmission x Classification medical device Conformity assessment procedure for medical devices Class IIa in accordance with Annex II excluding (4) of the Medical Devices Directive 93/42/EEC Directives: 93/42/EEC 2011/65/EU 1999/5/EC Directive concerning medical devices Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment Directive on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity Manufacturer: seca gmbh & co. kg Hammer Steindamm Hamburg, Germany Made in Germany Notified Bodies: 93/42/EEC: TÜV SÜD Product Service GmbH Ridlerstrasse Munich, Germany 0123 This declaration of conformity is valid from the date of signature until a revised declaration of conformity is issued due to modification of the above-mentioned products. Hamburg, 08 / 08 / 2016 Frederik Vogel CEO Development & Manufacturing Page 1 /2
4 declaration of conformity Annex Applied harmonised standards, national standards or other normative documents: EN EN EN EN EN EN Medical electrical equipment - General requirements for basic safety and essential performance Medical electrical equipment - Electromagnetic compatibility Medical device software - Software life-cycle processes Electromagnetic compatibility and Radio spectrum Matters (ERM) - 2,4GHz Electromagnetic compatibility and Radio spectrum Matters (ERM) - Common technical requirements Electromagnetic compatibility and Radio spectrum Matters (ERM) - Specific conditions for Broadband Data Transmission Systems Page 2 /2
5 declaración de conformidad Nosotros, el fabricante, declaramos bajo nuestra responsabilidad exclusiva que los productos citados posteriormente cumplen las disposiciones pertinentes de las siguientes directivas. Categoría medical Body Composition Analyzer Producto 514 Opcional con transmisión inalámbrica x Clasificación productos sanitarios Procedimiento de evaluación de la conformidad para productos sanitarios Clase IIa según el Anexo II excepto el apartado (4) de la Directiva 93/42/CEE sobre productos sanitarios Directivas: 93/42/CEE 2011/65/UE 1999/5/CE Directiva relativa a los productos sanitarios Directiva del consejo sobre restricciones a la utilización de determinadas sustancias peligrosas en aparatos eléctricos y electrónicos Directiva sobre equipos radioeléctricos y equipos terminales de telecomunicación y reconocimiento mutuo de su conformidad Fabricante: seca gmbh & co. kg Hammer Steindamm Hamburgo, Alemania Made in Germany Organismos notificados: 93/42/CEE: TÜV SÜD Product Service GmbH Ridlerstrasse Múnich, Alemania 0123 Esta declaración de conformidad es válida a partir de la fecha de la firma hasta la emisión de una declaración de conformidad revisada con motivo de la modificación de los productos mencionados anteriormente. Hamburgo, 08 / 08 / 2016 Frederik Vogel CEO Development & Manufacturing Página 1 /2
6 declaración de conformidad Anexo Normas armonizadas aplicadas, normas nacionales y otros documentos normativos: EN EN EN EN EN EN Equipos electromédicos - Requisitos generales para la seguridad básica y funcionamiento esencial Equipos electromédicos - Compatibilidad electromagnética Software de dispositivos médicos - Procesos del ciclo de vida del software Cuestiones de Compatibilidad Electromagnética y Espectro Radiofrecuencia (ERM) - 2,4GHz Cuestiones de Compatibilidad Electromagnética y Espectro Radiofrecuencia (ERM) - Requisitos técnicos comunes Cuestiones de Compatibilidad Electromagnética y Espectro Radiofrecuencia (ERM) - Condiciones específicas para sistemas de transmisión de datos de banda ancha Página 2 /2
7 déclaration de conformité Nous, le fabricant, déclarons en seule responsabilité que les produits mentionnés ci-dessous répondent aux dispositions respectives des directives ci-après. Catégorie medical Body Composition Analyzer Produit 514 En option avec transmission sans fil des donnés Classification comme produit médical Procédure d'évaluation en vue de la conformité des dispositifs médicaux x Classe IIa conformément à l'annexe II à léxclusion du paragraphe (4) de la Directive 93/42/CEE relative aux dispositifs médicaux Directives: 93/42/CEE 2011/65/UE 1999/5/CE Fabricant: Directive relative aux dispositifs médicaux Directive relative à la limitation de l utilisation de certaines substances dangereuses dans les équipements électriques et électroniques Directive concernant les équipements hertziens et les équipements terminaux de télécommunications et la reconnaissance mutuelle de leur conformité seca gmbh & co. kg Hammer Steindamm Hamburg, Allemagne Made in Germany Organismes notifiés: 93/42/CEE TÜV SÜD Product Service GmbH Ridlerstrasse München, Allemagne 0123 La présente déclaration de conformité est valide à compter de la date de sa signature et jusqu'à présentation d'une déclaration de conformité revue et modifiée suite à la modification des dispositifs mentionnés ci-dessus. Hamburg, 08 / 08 / 2016 Frederik Vogel CEO Development & Manufacturing Page 1 /2
8 déclaration de conformité Annexe Normes harmonisées, normes nationales ou autres documents normatifs utilisés: EN EN EN EN EN EN Appareils électromédicaux - Exigences générales pour la sécurité de base et les performances essentielles Appareils électromédicaux - Compatibilité électromagnétique Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel Compatibilité électromagnétique et spectre radioélectrique (ERM) - 2,4GHz Compatibilité électromagnétique et spectre radioélectrique (ERM) - Exigences techniques communes Compatibilité électromagnétique et spectre radioélectrique (ERM) - Exigences spécifiques pour les données en large bande et Hiperlan Page 2 /2
9 deklaracja zgodności Jako producent oświadczamy na własną odpowiedzialność, że poniższe produkty są zgodne z odpowiednimi postanowieniami następujących dyrektyw. Kategoria medical Body Composition Analyzer Produkt 514 Opcjonalnie z bezprzewodową transmisją danych Klasyfikacja jako wyrób medyczny Procedura oceny zgodności wyrobów medycznych x Klasa IIa zgodnie z załącznikiem II bez (4) do dyrektywy 93/42/EWG dotyczącej wyrobów medycznych Dyrektyw: 93/42/EWG 2011/65/UE 1999/5/WE Dyrektywa dotyczącej wyrobów medycznych Dyrektywa w sprawie ograniczenia stosowania niektórych niebezpiecznych substancji w sprzęcie elektrycznym i elektronicznym Dyrektywa w sprawie urządzeń radiowych i końcowych urządzeń telekomunikacyjnych oraz wzajemnego uznawania ich zgodności Producent: seca gmbh & co. kg Hammer Steindamm Hamburg, Niemcy Made in Germany Jednostki akredytowane: 93/42/EWG: TÜV SÜD Product Service GmbH Ridlerstrasse München, Niemcy 0123 Niniejsza deklaracja zgodności jest ważna od daty podpisania do momentu wystawienia jej nowej wersji w związku ze zmianą dotyczącą wyżej wymienionych wyrobów. Hamburg, 08 / 08 / 2016 Frederik Vogel CEO Development & Manufacturing Strona 1 /2
10 deklaracja zgodności Załącznik Zastosowane normy zharmonizowane, normy krajowe lub inne dokumenty normatywne: EN EN EN Medyczne urządzenia elektryczne - Wymagania ogólne dotyczące podstawowego bezpieczeństwa i zasadniczych parametrów funkcjonalnych Medyczne urządzenia elektryczne - Kompatybilność elektromagnetyczna Oprogramowanie wyrobów medycznych - Procesy cyklu życia oprogramowania EN Kompatybilnosc elektromagnetyczna i zagadnienia widma radiowego (ERM) - 2,4GHz EN Kompatybilnosc elektromagnetyczna i zagadnienia widma radiowego (ERM) - Ogólne wymagania techniczne EN Kompatybilnosc elektromagnetyczna i zagadnienia widma radiowego (ERM) - Wymagania szczególowe dla szerokopasmowych systemów transmisji danych Strona 2 /2
11 declaração de conformidade Nós, o fabricante, declaramos sob nossa única responsabilidade que os produtos abaixo especificados cumprem todos os requisitos das seguintes diretivas. Categoria medical Body Composition Analyzer Produto 514 Opcional com transmissão por rádio Classificação como produto médico Procedimentos de avaliação da conformidade para dispositivos médicos x Classe IIa segundo o anexo II sem (4) da Directiva 93/42/CEE relativa a dispositivos médicos Diretivas: 93/42/CEE 2011/65/UE 1999/5/CE Diretiva relativa aos dispositivos médicos Diretiva relativa à restrição do uso de determinadas substâncias perigosas em equipamentos elétricos e electrónicos Directiva relativa aos equipamentos de rádio e equipamentos terminais de telecomunicações e ao reconhecimento mútuo da sua conformidade Fabricante: seca gmbh & co. kg Hammer Steindamm Hamburgo, Alemanha Made in Germany Organismos Notificados: 93/42/CEE: TÜV SÜD Product Service GmbH Ridlerstrasse Munique, Alemanha 0123 Esta declaração de conformidade é válida desde a data da assinatura até à emissão de uma declaração de conformidade revista na sequência de modificações que se verifiquem nos produtos acima mencionados. Hamburgo, 08 / 08 / 2016 Frederik Vogel CEO Development & Manufacturing Página 1 /2
12 declaração de conformidade Anexo Normas harmonizadas aplicadas, normas nacionais e outros documentos normativos: EN EN EN Equipamento de eletromedicina - Requisitos gerais de segurança básica e de desempenho essencial Equipamento de eletromedicina - Compatibilidade eletromagnética Software para dispositivos médicos Processos do ciclo de vida do software EN Assuntos de Espetro Radioelétrico e Compatibilidade Eletromagnética (ERM) 2,4GHz EN Assuntos de Espetro Radioelétrico e Compatibilidade Eletromagnética (ERM) - Requisitos técnicos comuns EN Assuntos de Espetro Radioelétrico e Compatibilidade Eletromagnética (ERM) - Condições específicas para Sistemas de Transmissão de Dados de Banda Larga Página 2 /2
konformitätserklärung
konformitätserklärung Wir, der Hersteller, erklären in alleiniger Verantwortung, dass die unten aufgeführten Produkte den einschlägigen Bestimmungen der nachstehenden Richtlinien entsprechen. Kategorie
konformitätserklärung
konformitätserklärung Wir, der Hersteller, erklären in alleiniger Verantwortung, dass die unten aufgeführten Produkte den einschlägigen Bestimmungen der nachstehenden Richtlinien entsprechen. Kategorie
konformitätserklärung
konformitätserklärung Wir, der Hersteller, erklären in alleiniger Verantwortung, dass die unten aufgeführten Produkte den einschlägigen Bestimmungen der nachstehenden Richtlinien entsprechen. Kategorie
konformitätserklärung
konformitätserklärung Wir, der Hersteller, erklären in alleiniger Verantwortung, dass die unten aufgeführten Produkte den einschlägigen Bestimmungen der nachstehenden Richtlinien entsprechen. Kategorie
konformitätserklärung
konformitätserklärung Wir, der Hersteller, erklären in alleiniger Verantwortung, dass die unten aufgeführten Produkte den einschlägigen Bestimmungen der nachstehenden Richtlinien entsprechen. Kategorie
konformitätserklärung
konformitätserklärung Wir, der Hersteller, erklären in alleiniger Verantwortung, dass die unten aufgeführten Produkte den einschlägigen Bestimmungen der nachstehenden Richtlinien entsprechen. Kategorie
konformitätserklärung
konformitätserklärung Wir, der Hersteller, erklären in alleiniger Verantwortung, dass die unten aufgeführten Produkte den einschlägigen Bestimmungen der nachstehenden Richtlinien entsprechen. Kategorie
konformitätserklärung
konformitätserklärung Wir, der Hersteller, erklären in alleiniger Verantwortung, dass die unten aufgeführten Produkte den einschlägigen Bestimmungen der nachstehenden Richtlinien entsprechen. Kategorie
konformitätserklärung
konformitätserklärung Wir, der Hersteller, erklären in alleiniger Verantwortung, dass die unten aufgeführten Produkte den einschlägigen Bestimmungen der nachstehenden Richtlinien entsprechen. Kategorie
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