EN 12006-3:1998

EN 12006-3:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices". This standard covers: This European Standard specifies particular requirements for endovascular devices. With regard to safety, this standard gives in addition to EN ISO 14630, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. NOTE 1: Vascular occluders are not addressed in this standard. For the time being the requirements as stated in EN ISO 14630:1997 apply for these products. NOTE 2: Due to the variations in the design of the implants covered by this standard and in some cases due to the relatively recent development of some of these implants, acceptable standardized in vitro tests and long term results of clinical trials are not always available. Where no test method is described in this standard a complete description of the validated test method and sample preparation procedure used should be documented by the manufacturer. With regard to design evaluation, where a specific standardized test is not described, guidance is given by referring to current scientific literature (see Annex A). This standard aims to ensure that manufacturers will address all aspects of design evaluation that relate to the safety of the product. As further scientific and clinical data become available, appropriate revision of the standard will be necessary.

This European Standard specifies particular requirements for endovascular devices. With regard to safety, this standard gives in addition to EN ISO 14630, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. NOTE 1: Vascular occluders are not addressed in this standard. For the time being the requirements as stated in EN ISO 14630:1997 apply for these products. NOTE 2: Due to the variations in the design of the implants covered by this standard and in some cases due to the relatively recent development of some of these implants, acceptable standardized in vitro tests and long term results of clinical trials are not always available. Where no test method is described in this standard a complete description of the validated test method and sample preparation procedure used should be documented by the manufacturer. With regard to design evaluation, where a specific standardized test is not described, guidance is given by referring to current scientific literature (see Annex A). This standard aims to ensure that manufacturers will address all aspects of design evaluation that relate to the safety of the product. As further scientific and clinical data become available, appropriate revision of the standard will be necessary.

EN 12006-3:1998 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 12006-3:1998 has the following relationships with other standards: It is inter standard links to EN 12006-3:1998+A1:2009, EN 12006-3:1998/prA1; is excused to EN 12006-1:1999. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 12006-3:1998 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. 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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