{"id":14212,"date":"2018-01-05T15:25:55","date_gmt":"2018-01-05T14:25:55","guid":{"rendered":"https:\/\/www.rct-online.de\/magazin\/usp-class-vi-zulassung\/"},"modified":"2025-07-11T16:12:27","modified_gmt":"2025-07-11T14:12:27","slug":"usp-class-vi-approval","status":"publish","type":"post","link":"https:\/\/www.rct-online.de\/magazin\/en\/usp-class-vi-approval\/","title":{"rendered":"USP Class VI approval \u2013 What Does it Mean?"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_73 ez-toc-wrap-center counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.rct-online.de\/magazin\/en\/usp-class-vi-approval\/#Who_Is_Behind_the_USP_Classification\" title=\"Who Is Behind the USP Classification?\">Who Is Behind the USP Classification?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.rct-online.de\/magazin\/en\/usp-class-vi-approval\/#Biocompatibility_%E2%80%93_What_Is_it\" title=\"Biocompatibility \u2013 What Is it?\">Biocompatibility \u2013 What Is it?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.rct-online.de\/magazin\/en\/usp-class-vi-approval\/#How_Does_USP_Class_Classification_Work\" title=\"How Does USP Class Classification Work?\">How Does USP Class Classification Work?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.rct-online.de\/magazin\/en\/usp-class-vi-approval\/#Biocompatible_Plastics_with_USP_Class_VI_Certification\" title=\"Biocompatible Plastics with USP Class VI Certification\">Biocompatible Plastics with USP Class VI Certification<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.rct-online.de\/magazin\/en\/usp-class-vi-approval\/#DIN-ISO-10993_Classification_and_FDA_Conformity\" title=\"DIN-ISO-10993 Classification and FDA Conformity\">DIN-ISO-10993 Classification and FDA Conformity<\/a><\/li><\/ul><\/nav><\/div>\n<p style=\"text-align: justify;\">Plastics used in medical technology and pharmaceuticals are classified into six biocompatibility classes in the United States Pharmacopeia (USP), the US pharmacopoeia. To assign elastomers and other polymeric materials to one of these classes, they undergo various tests that determine biological reactivity in vivo \u2013 that is, in living organisms.<\/p>\n<blockquote><p>USP Class VI represents the strictest class and is considered equivalent to pharmaceutical approval for polymeric materials.<\/p><\/blockquote>\n<p style=\"text-align: justify;\">Plastics have long replaced materials such as metal, wood and glass in many areas of life and are therefore indispensable. It is not surprising that they have also found their way into medical technology.<\/p>\n<figure id=\"attachment_921\" aria-describedby=\"caption-attachment-921\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-921 size-full\" title=\"Disposable syringes\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Einwegspritzen-e1515166659724.jpg\" alt=\"Disposable syringes\" width=\"600\" height=\"300\" srcset=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Einwegspritzen-e1515166659724.jpg 600w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Einwegspritzen-e1515166659724-300x150.jpg 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-921\" class=\"wp-caption-text\">\u00a9 Sonja Birkelbach \/ Fotolia.com<\/figcaption><\/figure>\n<p style=\"text-align: justify;\">Plastics are used in diverse medical fields, both inside and outside the human body. Prostheses, implants, suture materials, tubing or disposable syringes are just a few examples that must meet specific material requirements. To ensure the best possible compatibility and thus safety for patients, a uniform classification system is essential. One of the most commonly used classifications is the USP classification, which will be explained in this article.<\/p>\n<p><a href=\"https:\/\/www.rct-online.de\/en\/tubes-hoses\/tubing-made-of-elastomers-soft-rubber\/tpe-tubing\/28519\/tpe-s-tubing-for-medical-engineering-and-pharmaceutical-technology\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-909 size-full\" title=\"TPE-S Tubing for Medical Engineering and Pharmaceutical Technology\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/TPE-S-Schlauch-Pharma-und-Medizintechnik.jpg\" alt=\"TPE-S Tubing for Medical Engineering and Pharmaceutical Technology\" width=\"600\" height=\"600\" srcset=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/TPE-S-Schlauch-Pharma-und-Medizintechnik.jpg 600w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/TPE-S-Schlauch-Pharma-und-Medizintechnik-150x150.jpg 150w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/TPE-S-Schlauch-Pharma-und-Medizintechnik-300x300.jpg 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/a><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Who_Is_Behind_the_USP_Classification\"><\/span>Who Is Behind the USP Classification?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>USP is, as already mentioned, the abbreviation for the official US pharmacopoeia United States Pharmacopeia, which sets quality standards for medicines, but also for dietary supplements and food ingredients. It is published annually together with the <em>National Formulary<\/em> (NF). The publisher of the work is the non-profit, non-governmental organisation called the United States Pharmacopeial Convention (also usually abbreviated as USP), based in Rockville, Maryland, USA.<\/p>\n<p><center><a href=\"https:\/\/www.rct-online.de\/en\/tubes-hoses\/tubing-made-of-elastomers-soft-rubber\/epdmpp-tubing\/28518\/epdm\/pp-pharmaceutical-tubing\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-898 size-full\" title=\"EPDM\/PP Pharmaceutical Tubing | complying with the USP Class IV\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/EPDM-PP-Pharmaschlauch.jpg\" alt=\"EPDM\/PP Pharmaceutical Tubing | complying with the USP Class IV\" width=\"300\" height=\"300\" srcset=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/EPDM-PP-Pharmaschlauch.jpg 300w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/EPDM-PP-Pharmaschlauch-150x150.jpg 150w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a> <a href=\"https:\/\/www.rct-online.de\/en\/tubes-hoses\/tubings-and-pipes-made-of-rigid-plastics\/pe-tubing\/28712\/hytrel\/pvc-pharmaceutical-composite-and-particle-tubing\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-899 size-full\" title=\"HYTREL\u00ae\/PVC Pharmaceutical Composite and Particle Tubing | meets USP standards\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/HYTREL-PVC-Pharma-Verbund-und-Partikelschlauch.jpg\" alt=\"HYTREL\u00ae\/PVC Pharmaceutical Composite and Particle Tubing | meets USP standards\" width=\"300\" height=\"300\" srcset=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/HYTREL-PVC-Pharma-Verbund-und-Partikelschlauch.jpg 300w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/HYTREL-PVC-Pharma-Verbund-und-Partikelschlauch-150x150.jpg 150w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a><\/center><\/p>\n<p style=\"text-align: justify;\">The primary goal of the USP is to maintain and improve human health. Through binding guidelines for the manufacture of medicines and medical products, the quality of examined substances is guaranteed. This increases the safety of patients and consumers. The correct identity of the active substance, active ingredient strength, quality, purity and composition are evaluated. Both manufacturers and regulatory authorities are guided by the established standards. Both prescription and non-prescription medicines must comply with USP-NF standards under US federal law.<\/p>\n<figure id=\"attachment_924\" aria-describedby=\"caption-attachment-924\" style=\"width: 600px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-924 size-full\" title=\"Medications\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Medikamente.jpg\" alt=\"Medications\" width=\"600\" height=\"400\" srcset=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Medikamente.jpg 600w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Medikamente-300x200.jpg 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><figcaption id=\"caption-attachment-924\" class=\"wp-caption-text\">\u00a9 PhotoSG \/ Fotolia.com<\/figcaption><\/figure>\n<p style=\"text-align: justify;\">The Food and Drug Administration (FDA) is responsible for regulating compliance with the guidelines in the USA. In 1990, Article &lt;88&gt; of the USP pharmacopoeia first established test protocols and guidelines for medicine packaging, which were then transferred to plastics used in medicine and medical technology due to similar requirements.<\/p>\n<blockquote>\n<p style=\"text-align: justify;\">The most important basic prerequisite for use in the living body or on humans is the biocompatibility of the material used.<\/p>\n<\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"Biocompatibility_%E2%80%93_What_Is_it\"><\/span>Biocompatibility \u2013 What Is it?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Ideally, contact with the living system with which, for example, an implant is in contact produces no adverse effect whatsoever. According to IUPAC (International Union of Pure and Applied Chemistry), this is defined as biocompatibility. Adverse effects can include, for example, the release of toxic substances or rejection of the polymer by surrounding tissue. Therefore, USP classification represents a measure of the biocompatibility of a polymeric material.<\/p>\n<p><a href=\"https:\/\/www.rct-online.de\/en\/tube-hose-connectors\/connectors-made-of-plastic\/luer-lock-connectors\/28868\/luer-lock-adapter-female-with-male-thread\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-911 size-full\" title=\"Luer-Lock Adapter (Female) with Male Thread | suitable for max. 10 bar (at +20 \u00b0 C)\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Luer-Lock-Adapter-weiblich-mit-Aussengewinde.jpg\" alt=\"Luer-Lock Adapter (Female) with Male Thread | suitable for max. 10 bar (at +20 \u00b0 C)\" width=\"600\" height=\"250\" srcset=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Luer-Lock-Adapter-weiblich-mit-Aussengewinde.jpg 600w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Luer-Lock-Adapter-weiblich-mit-Aussengewinde-300x125.jpg 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/a><\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_Does_USP_Class_Classification_Work\"><\/span>How Does USP Class Classification Work?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\" data-start=\"3595\" data-end=\"4137\">Depending on the application, medical materials must meet specific requirements. For example, a USP Class I classification is sufficient for a product with skin contact, whilst USP Class VI is required for use as an implant or in contact with the bloodstream. Furthermore, contact duration is also an important criterion for deciding which guideline is necessary. For example, for contact with mucous membrane surfaces, Class I is prescribed for under 24 hours, Class III for 1 to 30 days, and Class V for application duration over 30 days.<\/p>\n<p><a href=\"https:\/\/www.rct-online.de\/de\/schlaeuche\/gummischlaeuche-elastomerschlaeuche\/epdmpp-schlaeuche\/tpe-s-schlauch-fuer-die-medizin-und-pharmatechnik\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-905 size-full\" title=\"TPE-S Tubing for Medical Engineering and Pharmaceutical Technology | USP Class IV and 6.6.1\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/TPE-S-Schlauch-Medizin-und-Pharmatechnik.jpg\" alt=\"TPE-S Tubing for Medical Engineering and Pharmaceutical Technology | USP Class IV and 6.6.1\" width=\"600\" height=\"600\" srcset=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/TPE-S-Schlauch-Medizin-und-Pharmatechnik.jpg 600w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/TPE-S-Schlauch-Medizin-und-Pharmatechnik-150x150.jpg 150w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/TPE-S-Schlauch-Medizin-und-Pharmatechnik-300x300.jpg 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/a><\/p>\n<p style=\"text-align: justify;\">To obtain a USP Class VI classification, the following tests of the material itself, as well as various extracts of this material, are carried out in external testing laboratories. The following three test areas can be broadly distinguished:<\/p>\n<ul>\n<li style=\"text-align: justify;\"><strong>Acute systemic toxicity:<\/strong> Determination of acute irritant effects on skin contact, inhalation and ingestion.<\/li>\n<li style=\"text-align: justify;\"><strong>Intracutaneous reactivity:<\/strong> The test material is brought into direct contact with the tissue for which it is intended in normal use.<\/li>\n<li style=\"text-align: justify;\"><strong>Implantation test:<\/strong> The tissue reaction after implantation into a living organism. The duration is typically five days.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">These tests are carried out at fixed exposure times and temperatures to ensure comparability of results. Although biocompatibility testing must take place on the finished medical device, it is important for the manufacturer that all raw materials used are also tested and meet the requirements of the end product.<\/p>\n<blockquote>\n<p style=\"text-align: justify;\">USP Class VI approval is applied and accepted for pharmaceutical and medical products in many countries worldwide.<\/p>\n<\/blockquote>\n<h2><span class=\"ez-toc-section\" id=\"Biocompatible_Plastics_with_USP_Class_VI_Certification\"><\/span>Biocompatible Plastics with USP Class VI Certification<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">A variety of elastomers and thermoplastics are used in medical technology. They are used, for example, as manufacturing or coating materials for seals, <a href=\"https:\/\/www.rct-online.de\/en\/seals-and-gaskets\/o-rings\">O-rings<\/a> and tubing for medical devices.<\/p>\n<p><center><a href=\"https:\/\/www.rct-online.de\/en\/seals-and-gaskets\/o-rings\/fep-encapsulated-o-rings\/30630\/high-performance-fep-encapsulated-fpm-o-rings\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-894 size-full\" title=\"High-Performance FEP-Encapsulated FPM O-Rings for food-grade, pharmaceutical and medical applications\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/FEP-ummantelte-FPM-O-Ringe.jpg\" alt=\"High-Performance FEP-Encapsulated FPM O-Rings for food-grade, pharmaceutical and medical applications\" width=\"300\" height=\"300\" srcset=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/FEP-ummantelte-FPM-O-Ringe.jpg 300w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/FEP-ummantelte-FPM-O-Ringe-150x150.jpg 150w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a> <a href=\"https:\/\/www.rct-online.de\/en\/seals-and-gaskets\/o-rings\/fpm-o-rings\/30637\/high-performance-fpm-o-rings-metric\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-895 size-full\" title=\"High-Performance FPM O-Rings (metric) specifically designed for use in process engineering applications\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/FPM-O-Ringe-metrisch.jpg\" alt=\"High-Performance FPM O-Rings (metric) specifically designed for use in process engineering applications\" width=\"300\" height=\"300\" srcset=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/FPM-O-Ringe-metrisch.jpg 300w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/FPM-O-Ringe-metrisch-150x150.jpg 150w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a><\/center><\/p>\n<p style=\"text-align: justify;\">Biocompatible plastics such as polyethylene (PE), polystyrene (PS), polyvinyl chloride (PVC), polycarbonate (PC), polypropylene (PP) or polymethyl methacrylate (PMMA) are used as standard.<\/p>\n<p><center><a href=\"https:\/\/www.rct-online.de\/en\/tubes-hoses\/tubing-made-of-elastomers-soft-rubber\/silicone-tubing\/28680\/silicone-pump-tubing-fitted-with-3-stoppers\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-890 size-full\" title=\"Silicone Pump Tubing Fitted with 3 Stoppers\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Silikon-Pumpenschlauch-3-Stopper.jpg\" alt=\"Silicone Pump Tubing Fitted with 3 Stoppers\" width=\"300\" height=\"300\" srcset=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Silikon-Pumpenschlauch-3-Stopper.jpg 300w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Silikon-Pumpenschlauch-3-Stopper-150x150.jpg 150w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a> <a href=\"https:\/\/www.rct-online.de\/en\/tubes-hoses\/tubing-made-of-elastomers-soft-rubber\/silicone-tubing\/28691\/silicone-tubing-for-medical-engineering\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-891 size-full\" title=\"Silicone Tubing for medical technology, hospital equipment, sterile technology, and hygiene applications\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Silikonschlauch-Medizintechnik.jpg\" alt=\"Silikonschlauch Medizintechnik\" width=\"300\" height=\"300\" srcset=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Silikonschlauch-Medizintechnik.jpg 300w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Silikonschlauch-Medizintechnik-150x150.jpg 150w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a><\/center><\/p>\n<p style=\"text-align: justify;\"><a href=\"https:\/\/www.rct-online.de\/en\/tubes-hoses\/application-fields-for-tubings\/medical-tubing\">Medical tubing<\/a> is often made from elastomers such as silicone or TYGON\u00ae. Fully fluorinated polymers are also often used because they are both biocompatible and chemically virtually inert. They also have a low coefficient of friction, can be easily sterilised and have advantageous dielectric properties.<\/p>\n<p><a href=\"https:\/\/www.rct-online.de\/en\/tubes-hoses\/tubing-made-of-elastomers-soft-rubber\/pvc-tubing-tygon-tubing\/28624\/tygon-tubing-for-medical-engineering\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-902 size-full\" title=\"TYGON\u00ae tubing for surgical and medical technology applications | suitable for peristaltic pumps\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/TYGON-Schlauch-Medizintechnik.jpg\" alt=\"TYGON\u00ae tubing for surgical and medical technology applications | suitable for peristaltic pumps\" width=\"600\" height=\"300\" srcset=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/TYGON-Schlauch-Medizintechnik.jpg 600w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/TYGON-Schlauch-Medizintechnik-300x150.jpg 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/a><\/p>\n<p style=\"text-align: justify;\">Other materials that have a firm place in medical technology are polyvinylidene fluoride (PVDF) and polytetrafluoroethylene (PTFE). They are frequently used as materials for microporous filter membranes (0.01 to 10 \u03bcm) for sterile filtration and for the removal of fine particles.<\/p>\n<p><a href=\"https:\/\/www.rct-online.de\/en\/tube-hose-connectors\/connectors-made-of-plastic\/screw-joints-for-rigid-tubes-and-pipes\/29052\/high-pure-straight-pipe-connector-made-of-pfa\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-887 size-full\" title=\"High-Pure Straight Pipe Connector made of PFA | dual-sided tube connection\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Gerader-Rohrverbinder-PFA.jpg\" alt=\"High-Pure Straight Pipe Connector made of PFA | dual-sided tube connection\" width=\"600\" height=\"250\" srcset=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Gerader-Rohrverbinder-PFA.jpg 600w, https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Gerader-Rohrverbinder-PFA-300x125.jpg 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/a><\/p>\n<p style=\"text-align: justify;\">In addition to these two plastics, many other fluoropolymers such as perfluoroalkoxy polymers (PFA), fluoroethylene propylene (FEP) and ethylene-tetrafluoroethylene copolymer (ETFE) are also used.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"DIN-ISO-10993_Classification_and_FDA_Conformity\"><\/span>DIN-ISO-10993 Classification and FDA Conformity<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p style=\"text-align: justify;\">Besides USP Class VI approval, which is actually often seen merely as a minimum requirement for biocompatibility, the DIN-ISO-10993 standard is gaining increasing importance. This test procedure is significantly more time-consuming and expensive. Even though the ISO-10993 standard is the stricter standard, it is still advisable to consider whether such certification is necessary for the intended use of the biocompatible material or finished product. For the majority of applications, a USP Class VI classification or even a lower USP Class certification is sufficient.<\/p>\n<p><a href=\"https:\/\/www.rct-online.de\/en\/tube-hose-connectors\/connectors-made-of-plastic\/barb-connectors\/28955\/straight-barb-connector-with-female-thread-made-of-pp-pvdf-or-ptfe\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft wp-image-913 size-full\" title=\"Straight Barb Connector with Female Thread made of PP, PVDF or PTFE\" src=\"https:\/\/www.rct-online.de\/magazin\/wp-content\/uploads\/2018\/01\/Gerade-Schlauchtuelle-Innengewinde-aus-PP-PVDF-PTFE.jpg\" alt=\"Straight Barb Connector with Female Thread made of PP, PVDF or PTFE\" width=\"300\" height=\"200\" \/><\/a><\/p>\n<p style=\"text-align: justify;\">One also frequently reads about FDA-approved materials. FDA conformity is particularly important for use in the food sector.<\/p>\n<p style=\"text-align: justify;\">Paragraph CFR 21.177.2600 of the FDA guidelines, for example, deals with &#8220;rubber articles intended for repeated use&#8221;.<\/p>\n<p style=\"text-align: justify;\">It lists approved elastomers and substances used for their manufacture. FDA conformity is usually listed alongside USP Class VI certification.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Plastics used in medical technology and pharmaceuticals are classified into six biocompatibility classes in the United States Pharmacopeia (USP), the US pharmacopoeia. To assign elastomers and other polymeric materials to one of these classes, they undergo various tests that determine biological reactivity in vivo \u2013 that is, in living organisms. USP Class VI represents the &hellip;<\/p>\n","protected":false},"author":7,"featured_media":11237,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,2748],"tags":[3030,3055,3068,3067,2932,2753,3033,3034,3065,2943,2927,3058,3057,3037,3060,3059,2762,3061,2905,2763,3062,2774,2775,3063,2776,2906,2769,3066,3056,3051,3064,2779,3052],"class_list":["post-14212","post","type-post","status-publish","format-standard","has-post-thumbnail","","category-all-articles","category-materials-in-chemistry","tag-adapter-en","tag-biocompatible","tag-certification","tag-composite-hose","tag-epdm-en","tag-fda-en","tag-fep-en","tag-fpm-en","tag-hose-barb","tag-hose-connector","tag-hoses","tag-hospital-technology","tag-hygiene-technology","tag-luer-lock-en","tag-medical-technology","tag-medicine","tag-o-rings","tag-particle-hose","tag-pfa-en","tag-pharmaceutical-hose","tag-pharmaceutical-technology","tag-pp-en","tag-ptfe-en","tag-pump-hose","tag-pvc-en","tag-pvdf-en","tag-silicone","tag-sterile-technology","tag-surgery","tag-tpe-s-en","tag-tube-connector","tag-tygon-en","tag-usp-class-vi-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>USP Class VI approval \u2013 What Does it Mean? 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