DECLARACIÓN DE CONFORMIDAD DE MODIFICACIÓN PM CLASE I- II

Transcripción

1 Ministerio de Salud Secretaría de Políticas, Regulación e Institutos A.N.M.A.T. ANEXO II DECLARACIÓN DE CONFORMIDAD DE MODIFICACIÓN PM CLASE I- II Número de revisión: 00 Fecha de Emisión de la Declaración revisión 00-Disposición Autorizante o su reválida: 03/01/2018 Número de PM: Nombre Descriptivo del producto: Oximetros de Pulso Código de identificación y nombre técnico UMDNS: Oximetros de pulso Clase de Riesgo: Clase II Marca de (los) producto(s) médico(s): Nonin Modelos (en caso de clase II y equipos): 8500/8500M Oximetro de pulso portatil 9600 Oximetro de pulso Avant 9700 Oximetro de pulso Avant 2500 PalmSAT Oximetro de pulso portatil 2500A PalmSAT Oximetro de pulso portatil 9500 Oximetro de pulso para el dedo 9550 Oximetro de pulso para el dedo Oximetro de pulso para el dedo Onyx Vantage 9590 Composición cuali-cuanti porcentual exacta (si corresponde): N/A Indicación/es autorizada/s: PM Número: Página 1 de 8 Página 1 de 8

2 Para la medición y presentación en pantalla de la saturación de oxigeno funcional de la hemoglobina arterial y la frecuencia de pulso de pacientes adultos, pediátricos y neonatales, en entornos hospitalarios, ambulatorios, domiciliarios y servicio medico de emergencia. Están diseñados para la medición esporádica y/o la supervisión continua de pacientes en condiciones de buena o mala perfusión, con o sin movimiento, por parte de profesionales médicos capacitados. Período de vida útil (si corresponde): 6 años Método de Esterilización (si corresponde): N/A Forma de presentación: 1 Unidad Condición de venta: Venta Exclusiva a Profesionales e Instituciones Sanitarias Nombre del fabricante: Nonin Medical Inc Lugar/es de elaboración: st Ave North, Plymouth, MN 55441, Estados Unidos En nombre y representación de la firma Rocimex SRL, el responsable legal y el responsable técnico declaran bajo juramento que los productos médicos enumerados en el presente Anexo, satisfacen los Requisitos Esenciales de Seguridad y Eficacia (R.E.S.E.) previstos por la Disposición ANMAT N 4306/99, que cumplen y se encuentra a disposición de la Autoridad Sanitaria la documentación técnica que contenga los requerimientos solicitados en los Anexos III.B y III.C del Reglamento Técnico aprobado por Disposición ANMAT N 2318/02 (TO 2004) y Disposición ANMAT Nº 727/13. CUMPLIMIENTO DE R.E.S.E. DISPOSICIÓN ANMAT N 4306/99 Y GESTIÓN DE RIESGO ENSAYO/VALIDACION/GESTION DE RIESGO LABORATORI O/N DE PROTOCOLO FECH A DE EMISI PM Número: Página 2 de 8 Página 2 de 8

3 ÓN 1- PERFORMANCE STANDARDS IEC :2010, Medical Electrical Equipment General requirements for basic safety and essential performance Usability IEC :2003 Medical Electrical Equipment Part 18:General requirements for safety Collateral Standard: General requirements, tests & guidance for alarm systems in medical electrical equipment & medical electrical systems EMC STANDARDS EN :2007, Class B Medical Electrical Equipment - Part 1-2: General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility - Requirements & Tests ENVIROMNMENTAL STANDARDS EN 1789:2007, Medical used in the home healthcare environment SAFETY STANDARDS ISO :2009, Biological evaluation of medical devices Part 1: Evaluation and testing IEC :1988/A2:1995Medical Electrical Equipment; Part 1 Particular Requirements for Safety IEC , 3rd Edition, Medical Electrical Equipment; Part 1 Particular Requirements for Safety SOFTWARE STANDARDS ANSI/AAMI/IEC 62304:2006 Medical device software Software life cycle processes MANUFACTURING STANDARDS DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment LABELING STANDARDS ISO , -2:2012, Graphical Symbols for Use in the Labeling of Medical Devices EN 1041:2013, Information Supplied by the Manufacturer with Medical Devices USABILITY REPORTS IEC :2010, Medical Electrical Equipment General requirements for basic safety and essential performance Usability CLINICAL STANDARDS ISO 14155:2011, Clinical investigation of medical devices for human subjects 2- PERPFORMANCE STANDARDS IEC :2010, Medical Electrical Equipment General requirements for basic safety and essential performance Usability IEC :2003 Medical Electrical Equipment Part 18: General requirements for safety Collateral Standard: General requirements, tests & guidance for alarm systems in medical electrical equipment & medical electrical systems EMC STANDARDS EN :2007, Class B Medical Electrical Equipment - Part 1-2: General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility - PM Número: Página 3 de 8 Página 3 de 8

4 Requirements & Tests ENVIROMNMENTAL STANDARDS EN 1789:2007, Medical used in the home healthcare environment SAFETY STANDARDS ISO :2009, Biological evaluation of medical devices Part 1: Evaluation and testing IEC :1988/A2:1995Medical Electrical Equipment; Part 1 Particular Requirements for Safety IEC , 3rd Edition, Medical Electrical Equipment; Part 1 Particular Requirements for Safety SOFTWARE STANDARDS ANSI/AAMI/IEC 62304:2006 Medical device software Software life cycle processes MANUFACTURING STANDARDS DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment LABELING STANDARDS ISO , -2:2012, Graphical Symbols for Use in the Labeling of Medical Devices EN 1041:2013, Information Supplied by the Manufacturer with Medical Devices USABILITY REPORTS IEC :2010, Medical Electrical Equipment General requirements for basic safety and essential performance Usability CLINICAL STANDARDS ISO 14155:2011, Clinical investigation of medical devices for human subjects 3- PERPFORMANCE STANDARDS IEC :2010, Medical Electrical Equipment General requirements for basic safety and essential performance Usability IEC :2003 Medical Electrical Equipment Part 18:General requirements for safety Collateral Standard: General requirements, tests & guidance for alarm systems in medical electrical equipment & medical electrical systems EMC STANDARDS EN :2007, Class B Medical Electrical Equipment - Part 1-2: General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility - Requirements & Tests ENVIROMNMENTAL STANDARDS EN 1789:2007, Medical used in the home healthcare environment SAFETY PM Número: Página 4 de 8 Página 4 de 8

5 STANDARDS ISO :2009, Biological evaluation of medical devices Part 1: Evaluation and testing IEC :1988/A2:1995Medical Electrical Equipment; Part 1 Particular Requirements for Safety IEC , 3rd Edition, Medical Electrical Equipment; Part 1 Particular Requirements for Safety SOFTWARE STANDARDS ANSI/AAMI/IEC 62304:2006 Medical device software Software life cycle processes MANUFACTURING STANDARDS DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment LABELING STANDARDS ISO , -2:2012, Graphical Symbols for Use in the Labeling of Medical Devices EN 1041:2013, Information Supplied by the Manufacturer with Medical Devices USABILITY REPORTS IEC :2010, Medical Electrical Equipment General requirements for basic safety and essential performance Usability CLINICAL STANDARDS ISO 14155:2011, Clinical investigation of medical devices for human subjects 4- PERPFORMANCE STANDARDS IEC :2010, Medical Electrical Equipment General requirements for basic safety and essential performance Usability IEC :2003 Medical Electrical Equipment Part 18:General requirements for safety Collateral Standard: General requirements, tests & guidance for alarm systems in medical electrical equipment & medical electrical systems EMC STANDARDS EN :2007, Class B Medical Electrical Equipment - Part 1-2: General Requirements for Safety. Collateral Standard: Electromagnetic Compatibility - Requirements & Tests ENVIROMNMENTAL STANDARDS EN 1789:2007, Medical used in the home healthcare environment SAFETY STANDARDS ISO :2009, Biological evaluation of medical devices Part 1: Evaluation and testing IEC :1988/A2:1995Medical Electrical Equipment; Part 1 Particular Requirements for Safety IEC , 3rd Edition, Medical Electrical Equipment; Part 1 Particular Requirements for Safety SOFTWARE STANDARDS ANSI/AAMI/IEC 62304:2006 Medical device software Software life cycle processes MANUFACTURING STANDARDS DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 on the restriction of the use of certain hazardous PM Número: Página 5 de 8 Página 5 de 8

6 substances in electrical and electronic equipment LABELING STANDARDS ISO , -2:2012, Graphical Symbols for Use in the Labeling of Medical Devices EN 1041:2013, Information Supplied by the Manufacturer with Medical Devices USABILITY REPORTS IEC :2010, Medical Electrical Equipment General requirements for basic safety and essential performance Usability CLINICAL STANDARDS ISO 14155:2011, Clinical investigation of medical devices for human subjects 5- ENVIROMNMENTAL STANDARDS EN 1789:2007, Medical used in the home healthcare environment 6- MEDDEV 2.7.1:2009, Evaluation of Clinical Data: a guide for Manufacturers and Notified Bodies 7.1 ISO :2009, Biological evaluation of medical devices Part 1: Evaluation and testing UL , 1st Edition, , Medical Electrical Equipment, Part 1: General Requirements for Safety, Clauses 42 and 43, Reference only CAN/CSA-C22.2 No M90, 1st Edition, 2003, Medical Electrical Equipment, Part 1: General Requirements for Safety, Clauses 42 and ISO :2003, Biological evaluation of medical devices Part 1: Evaluation and testing 8.6 ISTA-2A:2007, Packaged Products 150 lb (68kg) or Less, non-simulation Integrity Performance test Procedure 9.2 EN 1041: A1:2013, Information supplied by the manufacturer with medical devices IEC :2007, Medical Electrical Equipment - Part 1: General Requirements for Safety 2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests 9.3 EN 1041: A1:2013, Information supplied by the manufacturer with medical devices 10.3 IEC :2001 Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard Electromagnetic compatibility Requirements & Tests IEC :2000, Medical Electrical Equipment Part 4-1: General Requirements for Safety, collateral Standard: Programmable Electrical Medical Systems CISPR11:1997/A2:2002, Industrial, scientific and medical (ISM) radio-frequency equipment Electromagnetic disturbance characteristics - Limits and methods of measurement IEC :2001 Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard PM Número: Página 6 de 8 Página 6 de 8

7 Electromagnetic Compatibility Requirements & Test 12.4 IEC :2003 Medical Electrical Equipment Part 18:General requirements for safety Collateral Standard: General requirements, tests & guidance for alarm systems in medical electrical equipment & medical electrical systems 12.5 IEC :2007, Medical Electrical Equipment - Part 1: General Requirements for Safety 2. Collateral Standard: Electromagnetic Compatibility - Requirements & Tests IEC :2007, Medical Electrical Equipment - Part 1: General Requirements for Safety 2. Collateral Standard: Electromagnetic Compatibility - Requirements & Tests 13.1 EN 1041:2013, Information supplied by the manufacturer with medical devices ISO , -2:2012, Graphical symbols for use in the labeling of medical devices IEC :2007, 0 Medical Electrical Equipment Part 1: General Requirements for 0 Safety, Amendment No. 2. Collateral Standard: Electromagnetic Compatibility Requirements and Tests 13.2 EN 1041: A1:2013, Information supplied by the manufacturer with medical devices ISO , -2:2012, Graphical symbols for use in the labeling of medical devices 13.3 EN 1041: A1:2013, Information supplied by the manufacturer with medical devices ISO , -2:2012, Graphical symbols for use in the labeling of medical devices 13.4 EN 1041: A1:2013, Information supplied by the manufacturer with medical devices 13.5 EN 1041: A1:2013, Information supplied by the manufacturer with medical devices 13.6 EN 1041: A1:2013, Information supplied by the manufacturer with medical devices ISO , -2:2012, Graphical symbols for use in the labeling of medical devices IEC :2007, Medical Electrical Equipment Part 1: General Requirements for Safety, Amendment No. 2. Collateral Standard: Electromagnetic Compatibility Requirements and Tests MEDDEV 2.7.1:2009, Evaluation of Clinical Data: A Guide for Manufacturers and Notified Bodies ISO Clinical investigation of medical devices for human subjects El responsable legal y su responsable técnico son responsables de la veracidad de la documentación e información presentada y declaran bajo juramento mantener en su establecimiento y a disposición de la autoridad sanitaria la documentación allí declarada y la que establece la Disposición 727/13, bajo apercibimiento de lo que establece la Ley N , el Decreto N 341/92 y las que correspondan del Código Penal en caso de falsedad. En caso de inexactitud o falsedad de la información o documentación, la Administración Nacional podrá suspender, cancelar, prohibir la comercialización y solicitar retiro del mercado de lo ya autorizado e iniciar los sumarios que pudieran corresponder. LUGAR Y FECHA: Argentina, 05 enero 2018 PM Número: Página 7 de 8 Página 7 de 8

8 Responsable Legal Firma y Sello Responsable Técnico Firma y Sello Ministerio de Salud Secretaría de Políticas, Regulación e Institutos A.N.M.A.T. La presente DECLARACIÓN DE CONFORMIDAD ha sido emitida de acuerdo con las previsiones de la Disposición ANMAT Nº 727/13 y N 5706/17, quedando inscripta la modificación en el Registro Nacional de Productores y Productos de Tecnología Médica (R.P.P.T.M.) a favor de Rocimex SRL bajo el número PM en la Ciudad de Buenos Aires a los días 05 enero 2018 Se autoriza la comercialización del/los producto/s identificados en la presente declaración de conformidad, la cual mantendrá la vigencia que consta en la Declaración inicial revisión 00 o Disposición Autorizante o su reválida. Dirección de Evaluación de Registro Firma y Sello Dirección Nacional de Productos Médicos Firma y Sello Tramitada por Expediente N : PM Número: Página 8 de 8 Página 8 de 8