{"id":13449,"date":"2024-02-09T15:49:47","date_gmt":"2024-02-09T18:49:47","guid":{"rendered":"https:\/\/www.mscmed.com.br\/?p=13449"},"modified":"2025-05-08T17:20:49","modified_gmt":"2025-05-08T20:20:49","slug":"mudancas-na-norma-iso-21535-protese-de-quadril","status":"publish","type":"post","link":"https:\/\/www.mscmed.com.br\/en\/2024\/02\/09\/mudancas-na-norma-iso-21535-protese-de-quadril\/","title":{"rendered":"Changes to ISO 21535 | Hip Prosthesis"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"13449\" class=\"elementor elementor-13449\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-19b161b elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-sticky-section-no\" data-id=\"19b161b\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f11fc02\" data-id=\"f11fc02\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e0ce5c1 elementor-widget elementor-widget-text-editor\" data-id=\"e0ce5c1\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div><p>A new version of the ISO 21535 standard on implants for hip replacement has been published, with major changes. We are anticipating a major impact, including the potential need to carry out tests that were not mandatory before, such as:<br \/><span style=\"background-color: transparent; color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight );\"><br \/><\/span><\/p><ul><li><span style=\"background-color: transparent; color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight );\">Acetabular Component Fatigue Test<\/span><\/li><li><span style=\"background-color: transparent; color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight );\">Wear test with prior aging of polyethylene<\/span><\/li><\/ul><\/div><ul><li>Wear test with poor positioning<\/li><li>Foreign body wear test<\/li><li>Wear test with rough femoral head<\/li><li>Friction torque test<\/li><\/ul><div>\u00a0<\/div><div>The way in which test results are evaluated has also changed, as the standard now prioritizes the choice of acceptance criteria:<\/div><div>\u00a0<\/div><div>#1 side-by-side test (implants are tested in parallel under identical conditions);<br \/>#2 comparison of the results of tests carried out on the implant under evaluation with the results of tests previously carried out on a reference implant.<\/div><div>\u00a0<\/div><div><strong>Attention!<\/strong> The same criteria are already being applied in the ISO 21536 standard for knee prostheses and later this year the ISO 14630 standard \u2013 which covers any and all surgical implants \u2013 should adopt the same logical scheme. Therefore, only after carrying out at least one of the comparisons mentioned above, the safety and performance of the implant can still be demonstrated through:<\/div><div>\u00a0<\/div><div><ul><li>Biomechanical reasoning, which includes an in-depth analysis of in vivo loads and relevant physiological conditions and justifies the test conditions and results obtained, with a justified safety factor, or<\/li><li>A pre-market clinical investigation,<\/li><\/ul><div>or both.<\/div><div>\u00a0<\/div><\/div><div>Speak to one of our <a href=\"https:\/\/wa.me\/554884452696\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #33cccc;\"><strong>specialists<\/strong><\/span>,<\/a> answer your questions and ensure your product\u2019s compliance with up-to-date standards.\u00a0<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Foi publicada uma nova vers\u00e3o da Norma ISO 21535, sobre implantes para substitui\u00e7\u00e3o de quadril, com grandes altera\u00e7\u00f5es. Estamos prevendo um grande impacto, dentre eles\u00a0 a potencial necessidade da realiza\u00e7\u00e3o de ensaios que antes n\u00e3o eram obrigat\u00f3rios, tais como: Ensaio de Fadiga de componente acetabular Ensaio de desgaste com envelhecimento pr\u00e9vio do polietileno Ensaio de desgaste com mal posicionamento Ensaio de desgaste com corpo estranho Ensaio de desgaste com cabe\u00e7a femoral rugosa Ensaio de torque de fric\u00e7\u00e3o \u00a0A forma de avalia\u00e7\u00e3o dos resultados dos ensaios tamb\u00e9m mudou, pois agora a norma traz uma prioriza\u00e7\u00e3o em rela\u00e7\u00e3o \u00e0 escolha por crit\u00e9rios de aceita\u00e7\u00e3o:\u00a0#1 teste lado a lado (implantes s\u00e3o testados em paralelo sob condi\u00e7\u00f5es id\u00eanticas);#2 compara\u00e7\u00e3o dos resultados dos ensaios efetuados no implante em avalia\u00e7\u00e3o com os resultados dos ensaios efetuados anteriormente num implante de refer\u00eancia.\u00a0Aten\u00e7\u00e3o! Os mesmos crit\u00e9rios j\u00e1 est\u00e3o sendo aplicados na norma ISO 21536, para pr\u00f3teses no joelho e ainda esse ano a norma ISO 14630 &#8211; que abrange todo e qualquer implante cir\u00fargico &#8211; deve adotar o mesmo esquema l\u00f3gico. Portanto, somente ap\u00f3s a realiza\u00e7\u00e3o de pelo menos uma das compara\u00e7\u00f5es citadas anteriormente, a seguran\u00e7a e o desempenho do implante ainda podem ser demonstrados por meio de:\u00a0 Um racioc\u00ednio biomec\u00e2nico, que inclua uma an\u00e1lise aprofundada das cargas in vivo e das condi\u00e7\u00f5es fisiol\u00f3gicas relevantes e justifique as condi\u00e7\u00f5es de ensaio e os resultados obtidos, com um fator de seguran\u00e7a justificado, ou Uma investiga\u00e7\u00e3o cl\u00ednica pr\u00e9-mercado, ou ambos.\u00a0Fale com um de nossos especialistas, tire suas d\u00favidas e garanta a adequa\u00e7\u00e3o do seu produto \u00e0s normas atualizadas.\u00a0<\/p>","protected":false},"author":1,"featured_media":13453,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[220,47,73],"tags":[],"class_list":["post-13449","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-implantes-e-produtos-cirurgicos","category-normas-tecnicas","category-noticias"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Mudan\u00e7as na Norma ISO 21535 | Pr\u00f3tese de Quadril - MSC MED<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.mscmed.com.br\/en\/2024\/02\/09\/mudancas-na-norma-iso-21535-protese-de-quadril\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Mudan\u00e7as na Norma ISO 21535 | Pr\u00f3tese de Quadril - MSC MED\" \/>\n<meta property=\"og:description\" content=\"Foi publicada uma nova vers\u00e3o da Norma ISO 21535, sobre implantes para substitui\u00e7\u00e3o de quadril, com grandes altera\u00e7\u00f5es. Estamos prevendo um grande impacto, dentre eles\u00a0 a potencial necessidade da realiza\u00e7\u00e3o de ensaios que antes n\u00e3o eram obrigat\u00f3rios, tais como: Ensaio de Fadiga de componente acetabular Ensaio de desgaste com envelhecimento pr\u00e9vio do polietileno Ensaio de desgaste com mal posicionamento Ensaio de desgaste com corpo estranho Ensaio de desgaste com cabe\u00e7a femoral rugosa Ensaio de torque de fric\u00e7\u00e3o \u00a0A forma de avalia\u00e7\u00e3o dos resultados dos ensaios tamb\u00e9m mudou, pois agora a norma traz uma prioriza\u00e7\u00e3o em rela\u00e7\u00e3o \u00e0 escolha por crit\u00e9rios de aceita\u00e7\u00e3o:\u00a0#1 teste lado a lado (implantes s\u00e3o testados em paralelo sob condi\u00e7\u00f5es id\u00eanticas);#2 compara\u00e7\u00e3o dos resultados dos ensaios efetuados no implante em avalia\u00e7\u00e3o com os resultados dos ensaios efetuados anteriormente num implante de refer\u00eancia.\u00a0Aten\u00e7\u00e3o! Os mesmos crit\u00e9rios j\u00e1 est\u00e3o sendo aplicados na norma ISO 21536, para pr\u00f3teses no joelho e ainda esse ano a norma ISO 14630 &#8211; que abrange todo e qualquer implante cir\u00fargico &#8211; deve adotar o mesmo esquema l\u00f3gico. Portanto, somente ap\u00f3s a realiza\u00e7\u00e3o de pelo menos uma das compara\u00e7\u00f5es citadas anteriormente, a seguran\u00e7a e o desempenho do implante ainda podem ser demonstrados por meio de:\u00a0 Um racioc\u00ednio biomec\u00e2nico, que inclua uma an\u00e1lise aprofundada das cargas in vivo e das condi\u00e7\u00f5es fisiol\u00f3gicas relevantes e justifique as condi\u00e7\u00f5es de ensaio e os resultados obtidos, com um fator de seguran\u00e7a justificado, ou Uma investiga\u00e7\u00e3o cl\u00ednica pr\u00e9-mercado, ou ambos.\u00a0Fale com um de nossos especialistas, tire suas d\u00favidas e garanta a adequa\u00e7\u00e3o do seu produto \u00e0s normas atualizadas.\u00a0\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.mscmed.com.br\/en\/2024\/02\/09\/mudancas-na-norma-iso-21535-protese-de-quadril\/\" \/>\n<meta property=\"og:site_name\" content=\"MSC MED\" \/>\n<meta property=\"article:published_time\" content=\"2024-02-09T18:49:47+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-05-08T20:20:49+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.mscmed.com.br\/wp-content\/uploads\/2024\/02\/Blog-MSC-MED.png\" \/>\n\t<meta property=\"og:image:width\" content=\"2240\" \/>\n\t<meta property=\"og:image:height\" content=\"1000\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.mscmed.com.br\/2024\/02\/09\/mudancas-na-norma-iso-21535-protese-de-quadril\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.mscmed.com.br\/2024\/02\/09\/mudancas-na-norma-iso-21535-protese-de-quadril\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\/\/www.mscmed.com.br\/#\/schema\/person\/89b5e3be900bb1089fd668003da80f9d\"},\"headline\":\"Mudan\u00e7as na Norma ISO 21535 | Pr\u00f3tese de Quadril\",\"datePublished\":\"2024-02-09T18:49:47+00:00\",\"dateModified\":\"2025-05-08T20:20:49+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.mscmed.com.br\/2024\/02\/09\/mudancas-na-norma-iso-21535-protese-de-quadril\/\"},\"wordCount\":308,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.mscmed.com.br\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.mscmed.com.br\/2024\/02\/09\/mudancas-na-norma-iso-21535-protese-de-quadril\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.mscmed.com.br\/wp-content\/uploads\/2024\/02\/Blog-MSC-MED.png\",\"articleSection\":[\"Implantes e Produtos Cir\u00fargicos\",\"Normas T\u00e9cnicas\",\"Not\u00edcias\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.mscmed.com.br\/2024\/02\/09\/mudancas-na-norma-iso-21535-protese-de-quadril\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.mscmed.com.br\/2024\/02\/09\/mudancas-na-norma-iso-21535-protese-de-quadril\/\",\"url\":\"https:\/\/www.mscmed.com.br\/2024\/02\/09\/mudancas-na-norma-iso-21535-protese-de-quadril\/\",\"name\":\"Mudan\u00e7as na Norma ISO 21535 | Pr\u00f3tese de Quadril - 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Os mesmos crit\u00e9rios j\u00e1 est\u00e3o sendo aplicados na norma ISO 21536, para pr\u00f3teses no joelho e ainda esse ano a norma ISO 14630 &#8211; que abrange todo e qualquer implante cir\u00fargico &#8211; deve adotar o mesmo esquema l\u00f3gico. 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