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BAlJMER
DE CONFORMIDADE
DECLARA~AO
DECLARATION
OF CONFORMITY
A empresa:
The company:
BAUMER S.A.
DIVISAO ORTOPEDIA
Av. Prefeito Antonio Tavares Leite, 181 - Parque da Empresa
Magi Mirim - Sao Paulo - Brasil
Declara que, em sua (mica responsabilidade,
0
produto(s):
Declares that, in its own responsability, the product(s):
Implantes
Ortopedicos
Sterile and Non-Sterile
Estereis e Nao-estereis
Orthopaedic Implants
Tipo: Vide relac;ao anexa no Certificado
EC
Type: See attached list in EC Certificate
Produto Classe lIb (Regra 8, Anexo IX)
Class IIb Product (Rule 8, Annex IX)
Declara que esse produto nao
animal.
e
fabricado utilizando-se tecido de origem
Declares that this product is not manufactured with tissues of animal origin.
Declara que esse produto nao
sua composic;ao.
Declares that
composition.
e
e nem possui uma substancia medicinal em
this product is not and does not include a medicinal substance in its
Declara que 0 Sistema de Gestao da Qualidade implementado atende a norma
EN ISO 13485:2003.
Declares that the implemented Quality Management System is in accordance to EN ISO
13485:2003.
Baumer
SA
I
Vendas: 55 (11) 3670.0000 • Fax: 55 (11) 3670.0053 w'Nw.baume:.com.br
• e-mail: [email protected]
Fabrica:Av. Pref.Antonio 1.Leite, 181 • Parqueda Empresa' 13.803-330 • Magi Mirim· SP· Tel: 55 (19)3805.7655 • Fax: 55 (19) 3805.7551
13AlJME.R
Esta em conformidade com:
Conforms
to:
Anexo II da Diretiva de Dispositivos Medicos - 93j42jCEE
Annex II of Medical Devices Directive
Atraves do atendimento
Internacionais:
By compliment
of the following
- 93/42/EEC
das seguintes Normas Tecnicas Harmonizadas e
International
and Harmonized
Technical Standards:
Normas Gerais:
General Standards:
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Baumer
EN 980:2008 - Symbols for use in the labelling of medical devices;
EN 1041:2008 - Information supplied by the manufacturer of medical devices;
EN ISO 11135-1:2007 - Sterilization of health care products - Ethylene oxide - Part 1:
Requirements for development, validation and routine control of a sterilization
process
for medical devices;
EN ISO 11137-1:2006
- Sterilization of health care products - Radiation - Part 1:
Requirements for development, validation and routine control of a sterilization
process
for medical devices;
EN ISO 11137-2:2007
- Sterilization of health care products - Radiation - Part 2:
Establishing the sterilization dose;
EN ISO 13485:2003
- Medical devices
- Quality
management
systems
Requirements for regulatory purposes;
ISOjTR 14283:2004 - Implants for surgery - Fundamental principles;
EN ISO 14630:2009 - Non-active surgical implants - General requirements;
EN ISO 14971:2007 - Medical devices - Application of risk management to medical
devices;
EN ISO 16054:2002 - Implants for surgery - Minimum data sets for surgical implants;
ISO 8828:1988
- Implants
for surgery -- Guidance on care and handling
of
orthopaedic implants;
ASTM F86 - 04 - Standard Practice for Surface Preparation and Marking of Metallic
Surgical Implants;
ASTM F565 - 04(2009)e1
- Standard Practice for Care and Handling of Orthopedic
Implants and Instruments;
ASTM F983 - 86(2005)e1 - Standard Practice for Permanent Marking of Orthopaedic
Implant Components;
ASTM F1980 - 07 - Standard Guide for Accelerated Aging of Sterile Barrier Systems
for Medical Devices.
SA
I
Vendas: 55 (11) 3670.0000 • Fax: 55 (11) 3670.0053 lV#w.b~.ume~.com.br • e-mail: [email protected]
Fabrica:Av. Pref.Antonio T. Leite, 181 • ParqLeda Empresa' 13.803-330 • Magi Mirim' SP· Tel: 55(19) 3805.7655 • Fax: 55 (19) 3805.7551
BAlJMER
Normas para Materiais:
Materials Standards:
• ISO 5832-9:2007 - Implants for surgery - Metallic materials - Part 9: Wrought high
nitrogen stainless steel;
• ISO 9583:1993 - Implants for surgery - Non-destructive
testing -- Liquid penetrant
inspection at metallic surgical implants;
• ASTM F67 - 06 - Standard Specification for Unalloyed Titanium, for Surgical Implant
Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700);
• ASTM F136 - 08e1 - Standard Specification for Wrought Titanium-6
Aluminum-4
Vanadium
ELI (Extra Low Interstitial)
Alloy for Surgical Implant Applications
(UNS
R56401);
• ASTM F138 - 08 - Standard
Specification
for Wrought
18Chromium-14Nickel2.5Molybdenum
Stainless Steel Bar and Wire for Surgical Implants (UNS S31673);
• ASTM F139 - 08 - Standard
Specification
for Wrought
18Chromium-14Nickel2.5Molybdenum
Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673);
• ASTM F601 - 03(2008) - Standard Practice for Fluorescent Penetrant Inspection of
Metallic Surgical Implants;
• ASTM Fl147 - 05 - Standard Test Method for Tension Testing of Calcium Phosphate
and Metal Coatings;
• ASTM F1580 - 07 - Standard Specification for Titanium and Titanium-6
Aluminum-4
Vanadium Alloy Powders for Coatings of Surgical Implants;
• ASTM F1854 - 09 - Standard Test Method for Stereological
Evaluation of Porous
Coatings on Medical Implants;
• ASTM F1978 - 00(2007)e2
- Standard Test Method for Measuring
Abrasion
Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser;
• ASTM F2026 - 08 - Standard Specification for Polyetheretherketone
(PEEK) Polymers
for Surgical Implant Applications.
Normas para Osteosintese:
Osteosynthesis Standards:
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Baumer
EN ISO 14602:2009 - Non-active surgical implants - Implants for osteosynthesis
Particular requirements;
ISO 5835:1991 - Implants for surgery - Metal bone screws with hexagonal drive
connection, spherical under-surface of head, asymmetrical thread - Dimensions;
ISO 5836:1988 - Implants for surgery - Metal bone plates - Holes corresponding to
screws with asymmetrical thread and spherical under-surface;
ISO 5837-1:1985
- Implants for surgery - Intramedullary
nailing systems - Part 1:
Intramedullary
nails with cloverleaf or V-shaped cross-section;
ISO 5837-2:1980
- Implants for surgery - Intramedullary
nailing systems - Part 2:
Medullary pins;
ISO 5838-1:1995 - Implants for surgery - Skeletal pins and wires - Part 1: Material
and mechanical requirements;
ISO 5838-2:1991 - Implants for surgery - Skeletal pins and wires - Part 2: Steinmann
skeletal pins - Dimensions;
ISO 5838-3:1993 - Implants for surgery - Skeletal pins and wires - Part 3: Kirschner
skeletal wires;
ISO 6475: 1989 - Implants for surgery - Metal bone screws with asymmetrical
thread
and spherical under-surface - Mechanical requirements and test methods;
S.A.
I
Vendas: 55 (11) 3670.0000'
Fax: 55 (11) 3670.0053 www.baurrcr.com.br
• e-mail: [email protected]
Fabrica:Av. Pref.Antonio T. Leite, 181 • Parqooda Empresa' 13.803-330 • Magi Mirim' SP· Tel: 55 (19) 3805.7655 • Fax: 55(19) 3805.7551
BAIJMER
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ISO 8615:1991 - Implants for surgery - Fixation devices for use in the ends of the
femur in adults;
ISO 8827:1988 - Implants for surgery - Staples with parallel legs for orthopaedic use
- General requirements;
ISO 9585: 1990 - Implants for surgery - Determination
of bending strength
and
stiffness of b-one plates;
ISO 10334:1994 - Implants for surgery - Malleable wires for use as sutures and other
surgical applications;
ISO 15142-1:2003
- Implants for surgery - Metal intramedullary
nailing systems Part 1: Intramedullary
nails;
ISO 15142-2:2003
- Implants for surgery - Metal intramedullary
nailing systems Part 2: Locking components;
ISO 15142-3:2003
- Implants for surgery - Metal intramedullary
nailing systems Part 3: Connection devices and reamer diameter measurements;
ASTM F366 - 04(2009) - Standard Specification for Fixation Pins and Wires;
ASTM F382 - 99(2008)e1
- Standard Specification and Test Method for Metallic Bone
Plates;
ASTM F384 - 06e1 - Standard Specifications and Test Methods for Metallic Angled
Orthopedic Fracture Fixation Devices;
ASTM F543 - 07e1 - Standard Specification and Test Methods for Metallic Medical
Bone Screws;
ASTM F564 - 02(2006) - Standard Specification and Test Methods for Metallic Bone
Staples;
ASTM F1264 - 03(2007)e2
- Standard
Specification
and Test Methods
for
Intramedullary
Fixation Devices;
ASTM F1541 - 02(2007)e1
- Standard Specification and Test Methods for External
Skeletal Fixation Devices.
Normas para Dispositivos de Coluna:
Spinal Devices Standards:
• ASTM F1582 - 98(2003) - Standard Terminology Relating to Spinal Implants;
• ASTM F1717 - 04 - Standard Test Methods for Spinal Implant
Constructs
in a
Vertebrectomy
Model;
• ASTM F1798 - 97(2008)
- Standard Guide for Evaluating the Static and Fatigue
Properties
of Interconnection
Mechanisms
and Subassemblies
Used in Spinal
Arthrodesis Implants;
• ASTM F2077 - 03 - Test Methods For Intervertebral
Body Fusion Devices;
• ASTM F2193 - 02(2007) - Standard Specifications and Test Methods for Components
Used in the Surgical Fixation of the Spinal Skeletal System;
• ASTM F2706 - 08 - Standard Test Methods for Occipital-Cervical
and OccipitalCervical-Thoracic
Spinal Implant Constructs in a Vertebrectomy
Model.
Representante Legal na Comunidade Europeia:
Legal Representative in European Community:
Gi Bi. S.a.s Di Bisegna Tatiana
Via Rodolfo Lanciani, 26-00019 - Tivoli - Roma - Italy
Baumer
S.A.
I
Vendas: 55 (11) 3670_0000 • Fax: 55 (11) 3670.0053
www.baume:com.br
• e-mail: [email protected]
Fabrica:Av. Pre!.Antonio 1. Leite, 181 • Parqueda Empresa' 13.803-330 • Magi Mirim' SP· Tel: 55 (19) 3805.7655 • Fax: 55 (19) 3805.7551
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BAllMER
Organismo de Certifica~ao:
Notified Body:
Certificado nO:
Certificate nO:
Magi Mirim - SP, Brasil, 6 de Julha de 2009
Mogi Mirim - SP/ Brazil, July, 6/ 2009
e>
Baumer
SA
/~
~-==
Carlos 0 ~ Gallo
Responsavel Tecnico
Technical Responsible
I
Vendas: 55 (11) 3670.0000'
Fax: 55 (11) 3670.0053
Fabrica: Av. Pre!. Antonio T. Leite, 181 • Parque da Empresa'
'",'Ww.b~.Lim,"!·combf • e-mail: [email protected]
13.803-330 • Magi Mirim' SP· Tel: 55 (19) 3805.7655 • Fax: 55 (19) 3805.7551