{"id":232,"date":"2023-07-24T01:45:12","date_gmt":"2023-07-24T01:45:12","guid":{"rendered":"https:\/\/srtub.com\/?p=232"},"modified":"2023-07-24T01:45:12","modified_gmt":"2023-07-24T01:45:12","slug":"miert-akarjak-az-orvosi-szilikoncsovek-gyartoi-az-iso-13485-tanusitast-megszerezni","status":"publish","type":"post","link":"https:\/\/srtub.com\/hu\/miert-akarjak-az-orvosi-szilikoncsovek-gyartoi-az-iso-13485-tanusitast-megszerezni\/","title":{"rendered":"Mi\u00e9rt akarnak az orvosi szilikoncs\u00f6vek gy\u00e1rt\u00f3i ISO 13485 tan\u00fas\u00edtv\u00e1nyt szerezni?"},"content":{"rendered":"<p>El\u0151sz\u00f6r is, egy r\u00f6vid bevezet\u00e9s az ISO 13485 tan\u00fas\u00edt\u00e1s, ISO13485 k\u00ednai nev\u0171 \"orvosi eszk\u00f6z\u00f6k min\u0151s\u00e9gir\u00e1ny\u00edt\u00e1si rendszere a szab\u00e1lyoz\u00e1si k\u00f6vetelm\u00e9nyekhez\" Mivel az orvostechnikai eszk\u00f6z\u00f6k speci\u00e1lis term\u00e9kek az \u00e9letek megment\u00e9s\u00e9re \u00e9s a betegs\u00e9gek megel\u0151z\u00e9s\u00e9re, csak az ISO9000 szabv\u00e1ny \u00e1ltal\u00e1nos k\u00f6vetelm\u00e9nyei szerint szab\u00e1lyozni nem el\u00e9g, ez\u00e9rt az ISO szervezet kihirdette az ISO13485: 1996-os verzi\u00f3j\u00e1t a szabv\u00e1ny (YY \/ T0287 \u00e9s YY \/ T0288) az orvostechnikai eszk\u00f6z\u00f6k gy\u00e1rt\u00f3i sz\u00e1m\u00e1ra, hogy speci\u00e1lis k\u00f6vetelm\u00e9nyeket t\u00e1masszon a biztons\u00e1g \u00e9s a hat\u00e9konys\u00e1g min\u0151s\u00e9g\u00e9re vonatkoz\u00f3an, hogy szerepet j\u00e1tsszon az orvostechnikai eszk\u00f6z\u00f6k min\u0151s\u00e9g\u00e9ben. Az ISO13485: 1996-os szabv\u00e1nyv\u00e1ltozat (YY\/T0287 \u00e9s YY\/T0288), amely k\u00fcl\u00f6nleges k\u00f6vetelm\u00e9nyeket terjeszt el\u0151 az orvostechnikai eszk\u00f6z\u00f6k gy\u00e1rt\u00f3inak min\u0151s\u00e9gir\u00e1ny\u00edt\u00e1si rendszer\u00e9re vonatkoz\u00f3an, \u00e9s j\u00f3 szerepet j\u00e1tszik az orvostechnikai eszk\u00f6z\u00f6k min\u0151s\u00e9g\u00e9nek el\u0151mozd\u00edt\u00e1s\u00e1ban a biztons\u00e1g \u00e9s a hat\u00e9konys\u00e1g el\u00e9r\u00e9se \u00e9rdek\u00e9ben.<\/p>\n<p>A 2017 november\u00e9ig \u00e9rv\u00e9nyes v\u00e9grehajt\u00e1si v\u00e1ltozat az ISO13485:2016 \"Az orvostechnikai eszk\u00f6z\u00f6k min\u0151s\u00e9gir\u00e1ny\u00edt\u00e1si rendszereinek szab\u00e1lyoz\u00e1si c\u00e9l\u00fa haszn\u00e1lat\u00e1ra vonatkoz\u00f3 k\u00f6vetelm\u00e9nyek\". A n\u00e9v \u00e9s a tartalom megv\u00e1ltozott az el\u0151z\u0151 v\u00e1ltozathoz k\u00e9pest.<\/p>\n<div id=\"attachment_225\" style=\"width: 1478px\" class=\"wp-caption alignnone\"><img fetchpriority=\"high\" decoding=\"async\" aria-describedby=\"caption-attachment-225\" class=\"wp-image-225\" src=\"https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Silicone-Tube-Advantages-300x186.jpg\" alt=\"Szilikoncs\u0151 el\u0151nyei\" width=\"1468\" height=\"910\" srcset=\"https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Silicone-Tube-Advantages-18x12.jpg 18w, https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Silicone-Tube-Advantages-200x124.jpg 200w, https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Silicone-Tube-Advantages-300x186.jpg 300w, https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Silicone-Tube-Advantages-400x248.jpg 400w, https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Silicone-Tube-Advantages.jpg 450w\" sizes=\"(max-width: 1468px) 100vw, 1468px\" \/><p id=\"caption-attachment-225\" class=\"wp-caption-text\">Szilikoncs\u0151 el\u0151nyei<\/p><\/div>\n<p>Ek\u00f6zben az ISO 13485 tan\u00fas\u00edt\u00e1snak a k\u00f6vetkez\u0151 fontos jelent\u0151s\u00e9ge van:<\/p>\n<p>1, a v\u00e1llalkoz\u00e1s ir\u00e1ny\u00edt\u00e1si szintj\u00e9nek jav\u00edt\u00e1sa \u00e9s jav\u00edt\u00e1sa, a jogi kock\u00e1zatok elker\u00fcl\u00e9se \u00e9s a v\u00e1llalkoz\u00e1s l\u00e1that\u00f3s\u00e1g\u00e1nak n\u00f6vel\u00e9se;<br \/>\n2\u3001A term\u00e9kek min\u0151s\u00e9gi szintj\u00e9nek jav\u00edt\u00e1sa \u00e9s biztos\u00edt\u00e1sa, hogy a v\u00e1llalkoz\u00e1sok nagyobb gazdas\u00e1gi el\u0151ny\u00f6kh\u00f6z jussanak;<br \/>\n3, el\u0151seg\u00edti a kereskedelmi akad\u00e1lyok felsz\u00e1mol\u00e1s\u00e1t, a nemzetk\u00f6zi piacra val\u00f3 bel\u00e9p\u00e9st;<br \/>\n4, el\u0151seg\u00edti a term\u00e9kek versenyk\u00e9pess\u00e9g\u00e9nek fokoz\u00e1s\u00e1t, n\u00f6veli a term\u00e9kek piaci r\u00e9szesed\u00e9s\u00e9t.<br \/>\n5\u3001A hat\u00e9kony kock\u00e1zatkezel\u00e9s r\u00e9v\u00e9n hat\u00e9konyan cs\u00f6kkenti a term\u00e9kmin\u0151s\u00e9gi balesetek vagy nemk\u00edv\u00e1natos esem\u00e9nyek kock\u00e1zat\u00e1t.<br \/>\n6\u3001A munkav\u00e1llal\u00f3k felel\u0151ss\u00e9gtudat\u00e1nak, lelkesed\u00e9s\u00e9nek \u00e9s elk\u00f6telezetts\u00e9g\u00e9nek jav\u00edt\u00e1sa.<\/p>\n<p>Szilikoncs\u0151gy\u00e1rt\u00f3k\u00e9nt az ISO 13485 tan\u00fas\u00edt\u00e1s nem csak a v\u00e1llalkoz\u00e1s erej\u00e9nek elismer\u00e9se, hanem egyfajta meger\u0151s\u00edt\u00e9s \u00e9s a term\u00e9kmin\u0151s\u00e9g garanci\u00e1ja is, amely az orvostechnikai eszk\u00f6z\u00f6k gy\u00e1rt\u00f3inak t\u00f6bbs\u00e9g\u00e9t biztosabb v\u00e1laszt\u00e1st \u00e9s bizalmat adhat a garanci\u00e1ban.<\/p>\n<p>Ha egy\u00e9b k\u00e9rd\u00e9sei vannak a szilikoncs\u00f6vekkel kapcsolatban, akkor jelentkezzen be a Srtub hivatalos weboldal\u00e1ra (www.srtub.com), ahol professzion\u00e1lis szilikoncs\u00f6ves 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[&#8230;]<\/p>","protected":false},"author":1,"featured_media":181,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"_joinchat":[],"footnotes":""},"categories":[25],"tags":[],"class_list":["post-232","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-technology"],"jetpack_featured_media_url":"https:\/\/srtub.com\/wp-content\/uploads\/2023\/07\/Medical-Grade-Silicone-Tube.jpg","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/srtub.com\/hu\/wp-json\/wp\/v2\/posts\/232","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/srtub.com\/hu\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/srtub.com\/hu\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/srtub.com\/hu\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/srtub.com\/hu\/wp-json\/wp\/v2\/comments?post=232"}],"version-history":[{"count":1,"href":"https:\/\/srtub.com\/hu\/wp-json\/wp\/v2\/posts\/232\/revisions"}],"predecessor-version":[{"id":233,"href":"https:\/\/srtub.com\/hu\/wp-json\/wp\/v2\/posts\/232\/revisions\/233"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/srtub.com\/hu\/wp-json\/wp\/v2\/media\/181"}],"wp:attachment":[{"href":"https:\/\/srtub.com\/hu\/wp-json\/wp\/v2\/media?parent=232"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/srtub.com\/hu\/wp-json\/wp\/v2\/categories?post=232"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/srtub.com\/hu\/wp-json\/wp\/v2\/tags?post=232"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}