NF EN ISO 14602
Non-active surgical implants - Implants for osteosynthesis - Particular requirements
ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants. In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants.
In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
<p>ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants.</p> <p>In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.</p>
- Avant-proposiv
- Introductionv
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1 Domaine d'application1
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2 Références normatives1
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3 Termes et définitions1
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4 Performances prévues1
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4.1 Généralités1
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4.2 Objectif recherché2
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4.3 Caractéristiques fonctionnelles2
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4.4 Conditions d'utilisation prévues3
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5 Caractéristiques de conception3
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6 Matériaux4
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7 Évaluation de la conception4
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7.1 Généralités4
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7.2 Évaluation préclinique4
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7.3 Évaluation clinique4
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7.4 Surveillance après commercialisation4
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8 Fabrication5
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9 Stérilisation5
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10 Emballage5
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11 Informations fournies par le fabricant5
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11.1 Généralités5
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11.2 Étiquetage5
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11.3 Instructions d'utilisation5
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11.4 Restrictions relatives aux combinaisons5
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11.5 Marquage des implants5
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11.6 Marquage pour utilisations spéciales5
- Annexe A (informative) Correspondance entre les articles de la présente Norme internationale et les principes fondamentaux énoncés dans l'ISO/TR 142836
- Annexe B (informative) Normes internationales ISO se référant aux implants et instruments associés jugés acceptables sur la base de leur utilisation clinique dans le cadre de certaines applications en ostéosynthèse7
- Annexe C (informative) Normes internationales relatives aux matériaux jugés acceptables sur la base d'une utilisation clinique éprouvée10
- Annexe D (informative) Normes relatives aux essais et à l'évaluation de la conception12
- Bibliographie13
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