{"id":386776,"date":"2024-10-20T03:36:59","date_gmt":"2024-10-20T03:36:59","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10993-122021-tc\/"},"modified":"2024-10-26T06:36:24","modified_gmt":"2024-10-26T06:36:24","slug":"bs-en-iso-10993-122021-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10993-122021-tc\/","title":{"rendered":"BS EN ISO 10993-12:2021 &#8211; TC"},"content":{"rendered":"<p>This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the <span class=\"std\"> <span class=\"std-ref\">ISO&nbsp;10993 series<\/span><\/span>.<\/p>\n<p>Specifically, this document addresses the following:<\/p>\n<ul>\n<li>\n<p>test sample selection;<\/p>\n<\/li>\n<li>\n<p>selection of representative portions from a medical device;<\/p>\n<\/li>\n<li>\n<p>test sample preparation;<\/p>\n<\/li>\n<li>\n<p>experimental controls;<\/p>\n<\/li>\n<li>\n<p>selection of, and requirements for, reference materials;<\/p>\n<\/li>\n<li>\n<p>preparation of extracts.<\/p>\n<\/li>\n<\/ul>\n<p>This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.<\/p>\n<p>Extractions for chemical characterization are covered in <span class=\"std\"> <span class=\"std-ref\">ISO&nbsp;10993-18<\/span><\/span>. <span class=\"xref\">Clause 7<\/span>, <span class=\"xref\">8<\/span>, <span class=\"xref\">9<\/span>, <span class=\"xref\">10<\/span> [with the exception of 10.3.5 and 10.3.11 b)], and <span class=\"xref\">11<\/span> can apply to extractions for chemical characterization. Information given in <span class=\"xref\">C.1<\/span> to <span class=\"xref\">C.4<\/span> can also be relevant.<\/p>\n<h4>PDF Catalog<\/h4>\n<table border=\"1px\" class=\"des-table\">\n<tr>\n<th>PDF Pages<\/th>\n<th>PDF Title<\/th>\n<\/tr>\n<tr>\n<td><b>52<b><\/td>\n<td>National foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>56<b><\/td>\n<td>European foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>57<b><\/td>\n<td>Annex ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/745 aimed to be covered  <\/td>\n<\/tr>\n<tr>\n<td><b>60<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>61<b><\/td>\n<td>Introduction  <\/td>\n<\/tr>\n<tr>\n<td><b>63<b><\/td>\n<td>1 Scope <br \/> 2 Normative references <br \/> 3 Terms and definitions  <\/td>\n<\/tr>\n<tr>\n<td><b>65<b><\/td>\n<td>4 General requirements  <\/td>\n<\/tr>\n<tr>\n<td><b>66<b><\/td>\n<td>5 Reference materials (RMs) <br \/> 5.1 General <br \/> 5.2 Certification of RMs for biological safety testing <br \/> 6 Use of RMs as experimental controls  <\/td>\n<\/tr>\n<tr>\n<td><b>67<b><\/td>\n<td>7 Test sample selection <br \/> 8 Test sample and RM preparation  <\/td>\n<\/tr>\n<tr>\n<td><b>68<b><\/td>\n<td>9 Selection of representative portions from a medical device <br \/> 10 Preparation of extracts of samples <br \/> 10.1 General <br \/> 10.2 Containers for extraction  <\/td>\n<\/tr>\n<tr>\n<td><b>69<b><\/td>\n<td>10.3 Extraction conditions and methods  <\/td>\n<\/tr>\n<tr>\n<td><b>72<b><\/td>\n<td>10.4 Extraction conditions for materials that polymerize in situ <br \/> 11 Records  <\/td>\n<\/tr>\n<tr>\n<td><b>73<b><\/td>\n<td>Annex A (informative) Experimental controls  <\/td>\n<\/tr>\n<tr>\n<td><b>75<b><\/td>\n<td>Annex B (informative) General principles on, and practices of, test sample preparation and sample selection  <\/td>\n<\/tr>\n<tr>\n<td><b>77<b><\/td>\n<td>Annex C (informative) Principles of test sample extraction  <\/td>\n<\/tr>\n<tr>\n<td><b>80<b><\/td>\n<td>Annex D (informative) Exhaustive extraction of polymeric materials for biological evaluation  <\/td>\n<\/tr>\n<tr>\n<td><b>82<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Tracked Changes. Biological evaluation of medical devices &#8211; Sample preparation and reference materials<\/b><\/p>\n<table class=\"shortdes-table\" style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/bsi\/\"><b>BSI<\/b><\/a><\/td>\n<td>2021<\/td>\n<td>84<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":386787,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-386776","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-20","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/386776","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/386787"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=386776"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=386776"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=386776"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}