{"id":70,"date":"2011-08-30T12:28:21","date_gmt":"2011-08-30T12:28:21","guid":{"rendered":"http:\/\/www.surgicalholdings.co.uk\/blog\/?p=70"},"modified":"2021-12-06T14:14:48","modified_gmt":"2021-12-06T14:14:48","slug":"what-international-and-harmonised-standards-are-relevant-to-surgical-instruments","status":"publish","type":"post","link":"https:\/\/www.surgicalholdings.co.uk\/blog\/2011\/08\/what-international-and-harmonised-standards-are-relevant-to-surgical-instruments\/","title":{"rendered":"What International and Harmonised Standards are relevant to Surgical Instruments?"},"content":{"rendered":"<p>There are no harmonised standards in place that <a href=\"https:\/\/www.surgicalholdings.co.uk\/\">Surgical Instruments<\/a> can be assessed against to prove quality, specific to their functionality. Standards such as ISO 9001 and 13485 may be referenced, but they do not demonstrate quality, they signify a formalised quality system.&nbsp; The BS 5194 standards document guidelines for each group of surgical<br \/>\ninstruments, specification covered are:<\/p>\n<ul>\n<li>Steel Type<\/li>\n<li>Instrument Hardness<\/li>\n<li>Instrument Finish<\/li>\n<li>Corrosion Resistance<\/li>\n<\/ul>\n<p>Any company selling surgical instruments, should address the following standards in their technical documentation:<\/p>\n<ul>\n<li>BS EN ISO 13485&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2003&nbsp;&nbsp;&nbsp; Medical devices \u2013 QMS \u2013 Requirements for<br \/>\nregulatory purposes<\/li>\n<li>BS EN ISO 14971&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2007&nbsp;&nbsp;&nbsp; Medical devices \u2013 Application of risk<br \/>\nmanagement to medical devices<\/li>\n<li>93\/42\/EEC&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 14\/06\/93&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Official Journal of the European<br \/>\nCommunities \u2013 L169 volume 36<\/li>\n<li>2007\/47\/EC&nbsp;&nbsp;&nbsp;&nbsp; 05\/09\/07&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Amending Council Directive 93\/42\/EEC L<br \/>\n247\/21<\/li>\n<li>MEDDEV 2.12-1 rev 5 04\/2007&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Medical<br \/>\ndevices : Guidance document \u2013 Guidelines on a medical devices vigilance system<\/li>\n<li>MEDDEV 2.12-2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 05\/2004&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Post Market Clinical Follow-up<\/li>\n<li>BS EN 980&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2008&nbsp;&nbsp;&nbsp; Graphical symbols for use in the labelling<br \/>\nof medical devices<\/li>\n<li>BS EN 1041&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2008&nbsp;&nbsp;&nbsp; Information supplied by the manufacturer of<br \/>\nmedical devices<\/li>\n<li>BS 5194 Part 1 ISO 7153-1 1991 Surgical<br \/>\ninstruments. Specification for stainless steel<\/li>\n<li>BS 5194 Part 2&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1989&nbsp;&nbsp;&nbsp; Surgical instruments. Specification for<br \/>\ninstruments with pivot joints<\/li>\n<li>BS 5194 Part 3&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1985&nbsp;&nbsp;&nbsp; Surgical instruments. Specification for<br \/>\ndissecting forceps<\/li>\n<li>BS 5194 Part 4&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1985&nbsp;&nbsp;&nbsp; Surgical instruments. Specification for<br \/>\nscissors, shears &amp; other jointed cutting instruments<\/li>\n<\/ul>\n<p>All of these factors should be covered by the manufacturer, so adherence to these guidelines should be sought, when purchasing new instrumentation.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>There are no harmonised standards in place that Surgical Instruments can be assessed against to prove quality, specific to their functionality. Standards such as ISO <\/p>\n<a class=\"btn-blue l-blog-post-readmore\" href=\"https:\/\/www.surgicalholdings.co.uk\/blog\/2011\/08\/what-international-and-harmonised-standards-are-relevant-to-surgical-instruments\/\" title=\"Read more\">Read more<\/a>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[10,11],"class_list":["post-70","post","type-post","status-publish","format-standard","hentry","category-buying-guide","tag-harmonised-standard","tag-surgical-instrument"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>International and Harmonised Standards - Surgical Holdings<\/title>\n<meta name=\"description\" content=\"There are no harmonised standards that Surgical Instruments can be assessed against to prove quality, specific to their functionality.\" \/>\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.surgicalholdings.co.uk\/blog\/2011\/08\/what-international-and-harmonised-standards-are-relevant-to-surgical-instruments\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"International and Harmonised Standards - 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