{"id":279263,"date":"2024-10-19T18:50:19","date_gmt":"2024-10-19T18:50:19","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10993-32014\/"},"modified":"2024-10-25T15:24:15","modified_gmt":"2024-10-25T15:24:15","slug":"bs-en-iso-10993-32014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10993-32014\/","title":{"rendered":"BS EN ISO 10993-3:2014"},"content":{"rendered":"<p>This part of ISO&nbsp;10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:<\/p>\n<ul>\n<li>\n<p>genotoxicity;<\/p>\n<\/li>\n<li>\n<p>carcinogenicity;<\/p>\n<\/li>\n<li>\n<p>reproductive and developmental toxicity.<\/p>\n<\/li>\n<\/ul>\n<p>This part of ISO&nbsp;10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.<\/p>\n<blockquote>\n<p>NOTE Guidance on selection of tests is provided in ISO&nbsp;10993-1.<\/p>\n<\/blockquote>\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>4<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>5<b><\/td>\n<td>Annex ZA  (informative)  Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42 EEC on medical devices <br \/> Table ZA.1 \u2014 Correspondence between this European Standard and Directive 93\/42\/EEC on medical devices  <\/td>\n<\/tr>\n<tr>\n<td><b>7<b><\/td>\n<td>Annex ZB  (informative)  Relationship between this European Standard and the Essential Requirements of EU Directive 90\/385\/EEC on active implantable medical devices <br \/> Table ZB.1 \u2014 Correspondence between this European Standard and Directive 90\/385\/EEC on active implantable medical devices  <\/td>\n<\/tr>\n<tr>\n<td><b>9<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>11<b><\/td>\n<td>Introduction  <\/td>\n<\/tr>\n<tr>\n<td><b>12<b><\/td>\n<td>Section sec_1 <br \/> Section sec_2 <br \/> 1\tScope <br \/> 2\tNormative references  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>Section sec_3 <br \/> Section sec_3.1 <br \/> Section sec_3.2 <br \/> Section sec_3.3 <br \/> Section sec_3.4 <br \/> Section sec_3.5 <br \/> Section sec_3.6 <br \/> Section sec_4 <br \/> Section sec_4.1 <br \/> 3\tTerms and definitions <br \/> 4\tRequirements for test strategies <br \/> 4.1\tGeneral  <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>Section sec_4.2 <br \/> Section sec_4.3 <br \/> 4.2\tAdditional requirements for carcinogenicity testing <br \/> 4.3\tAdditional requirements for reproductive toxicity testing  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>Section sec_5 <br \/> Section sec_5.1 <br \/> Section sec_5.2 <br \/> Section sec_5.2.1 <br \/> Section sec_5.2.2 <br \/> 5\tGenotoxicity tests <br \/> 5.1\tGeneral <br \/> 5.2\tTest strategy  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>Section sec_5.2.3  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>Section sec_5.3 <br \/> 5.3\tSample preparation  <\/td>\n<\/tr>\n<tr>\n<td><b>18<b><\/td>\n<td>Section sec_6 <br \/> Section sec_6.1 <br \/> Section sec_6.2 <br \/> 6\tCarcinogenicity tests <br \/> 6.1\tGeneral <br \/> 6.2\tEvaluation strategy  <\/td>\n<\/tr>\n<tr>\n<td><b>19<b><\/td>\n<td>Section sec_6.3 <br \/> Section sec_6.4 <br \/> 6.3\tSample preparation <br \/> 6.4\tTest methods  <\/td>\n<\/tr>\n<tr>\n<td><b>20<b><\/td>\n<td>Section sec_7 <br \/> Section sec_7.1 <br \/> Section sec_7.2 <br \/> 7\tReproductive and developmental toxicity tests <br \/> 7.1\tGeneral <br \/> 7.2\tTest strategy  <\/td>\n<\/tr>\n<tr>\n<td><b>21<b><\/td>\n<td>Section sec_7.3 <br \/> Section sec_7.4 <br \/> 7.3\tSample preparation <br \/> 7.4\tTest methods  <\/td>\n<\/tr>\n<tr>\n<td><b>22<b><\/td>\n<td>Section sec_8 <br \/> 8\tTest report  <\/td>\n<\/tr>\n<tr>\n<td><b>23<b><\/td>\n<td>Annex sec_A <br \/> Annex sec_A.1 <br \/> Annex\u00a0A<br \/>\n(informative)<\/p>\n<p>Guidance on selecting an appropriate sample preparation procedure in genotoxicity testing  <\/td>\n<\/tr>\n<tr>\n<td><b>24<b><\/td>\n<td>Annex sec_A.2 <br \/> Annex sec_A.2.1 <br \/> Annex sec_A.2.2 <br \/> Annex sec_A.2.2.1 <br \/> Annex sec_A.2.2.2  <\/td>\n<\/tr>\n<tr>\n<td><b>25<b><\/td>\n<td>Annex sec_A.2.2.3 <br \/> Annex sec_A.2.3 <br \/> Annex sec_A.3 <br \/> Annex sec_A.3.1  <\/td>\n<\/tr>\n<tr>\n<td><b>26<b><\/td>\n<td>Figure fig_A.1  <\/td>\n<\/tr>\n<tr>\n<td><b>27<b><\/td>\n<td>Table tab_A.1 <br \/> Annex sec_A.3.2 <br \/> Annex sec_A.3.3 <br \/> Annex sec_A.3.3.1  <\/td>\n<\/tr>\n<tr>\n<td><b>28<b><\/td>\n<td>Annex sec_A.3.3.2 <br \/> Annex sec_A.3.3.3  <\/td>\n<\/tr>\n<tr>\n<td><b>29<b><\/td>\n<td>Annex sec_A.3.3.4 <br \/> Annex sec_A.3.4 <br \/> Annex sec_A.3.4.1 <br \/> Annex sec_A.3.4.2 <br \/> Annex sec_A.3.4.2.1 <br \/> Annex sec_A.3.4.2.2 <br \/> Annex sec_A.3.4.2.3  <\/td>\n<\/tr>\n<tr>\n<td><b>30<b><\/td>\n<td>Annex sec_A.3.4.2.4 <br \/> Annex sec_A.3.4.2.5 <br \/> Annex sec_A.4 <br \/> Annex sec_A.4.1 <br \/> Annex sec_A.4.2 <br \/> Annex sec_A.4.3  <\/td>\n<\/tr>\n<tr>\n<td><b>31<b><\/td>\n<td>Annex sec_B <br \/> Figure fig_B.1 <br \/> Annex\u00a0B<br \/>\n(informative)<\/p>\n<p>Flowchart for follow-up evaluation  <\/td>\n<\/tr>\n<tr>\n<td><b>32<b><\/td>\n<td>Annex sec_C <br \/> Annex sec_C.1 <br \/> Annex\u00a0C<br \/>\n(informative)<\/p>\n<p>Rationale of test systems  <\/td>\n<\/tr>\n<tr>\n<td><b>33<b><\/td>\n<td>Annex sec_C.2 <br \/> Annex sec_C.3  <\/td>\n<\/tr>\n<tr>\n<td><b>34<b><\/td>\n<td>Annex sec_D <br \/> Annex\u00a0D<br \/>\n(informative)<\/p>\n<p>Cell transformation test systems  <\/td>\n<\/tr>\n<tr>\n<td><b>35<b><\/td>\n<td>Annex sec_E <br \/> Annex sec_E.1 <br \/> Annex sec_E.2 <br \/> Annex\u00a0E<br \/>\n(normative)<\/p>\n<p>Considerations for carcinogenicity studies performed as implantation studies  <\/td>\n<\/tr>\n<tr>\n<td><b>36<b><\/td>\n<td>Annex sec_F <br \/> Table tab_F.1 <br \/> Annex\u00a0F<br \/>\n(informative)<\/p>\n<p>In\u00a0vitro tests for embryo toxicity  <\/td>\n<\/tr>\n<tr>\n<td><b>37<b><\/td>\n<td>Table tab_F.2  <\/td>\n<\/tr>\n<tr>\n<td><b>38<b><\/td>\n<td>Reference ref_1 <br \/> Reference ref_2 <br \/> Reference ref_3 <br \/> Reference ref_4 <br \/> Reference ref_5 <br \/> Reference ref_6 <br \/> Reference ref_7 <br \/> Reference ref_8 <br \/> Reference ref_9 <br \/> Reference ref_10 <br \/> Reference ref_11 <br \/> Reference ref_12 <br \/> Reference ref_13 <br \/> Reference ref_14 <br \/> Reference ref_15 <br \/> Reference ref_16 <br \/> Reference ref_17 <br \/> Reference ref_18 <br \/> Reference ref_19 <br \/> Reference ref_20 <br \/> Bibliography <br \/> Bibliography  <\/td>\n<\/tr>\n<tr>\n<td><b>39<b><\/td>\n<td>Reference ref_21 <br \/> Reference ref_22 <br \/> Reference ref_23 <br \/> Reference ref_24 <br \/> Reference ref_25 <br \/> Reference ref_26 <br \/> Reference ref_27 <br \/> Reference ref_28 <br \/> Reference ref_29 <br \/> Reference ref_30 <br \/> Reference ref_31 <br \/> Reference ref_32 <br \/> Reference ref_33 <br \/> Reference ref_34 <br \/> Reference ref_35  <\/td>\n<\/tr>\n<tr>\n<td><b>40<b><\/td>\n<td>Reference ref_36 <br \/> Reference ref_37 <br \/> Reference ref_38 <br \/> Reference ref_39 <br \/> Reference ref_40 <br \/> Reference ref_41 <br \/> Reference ref_42 <br \/> Reference ref_43 <br \/> Reference ref_44 <br \/> Reference ref_45 <br \/> Reference ref_46 <br \/> Reference ref_47 <br \/> Reference ref_48 <br \/> Reference ref_49 <br \/> Reference ref_50 <br \/> Reference ref_51 <br \/> Reference ref_52  <\/td>\n<\/tr>\n<tr>\n<td><b>41<b><\/td>\n<td>Reference ref_53 <br \/> Reference ref_54 <br \/> Reference ref_55 <br \/> Reference ref_56 <br \/> Reference ref_57 <br \/> Reference ref_58 <br \/> Reference ref_59 <br \/> Reference ref_60 <br \/> Reference ref_61 <br \/> Reference ref_62 <br \/> Reference ref_63 <br \/> Reference ref_64 <br \/> Reference ref_65 <br \/> Reference ref_66 <br \/> Reference ref_67 <br \/> Reference ref_68 <br \/> Reference ref_69 <br \/> Reference ref_70 <br \/> Reference ref_71  <\/td>\n<\/tr>\n<tr>\n<td><b>42<b><\/td>\n<td>Reference ref_72 <br \/> Reference ref_73 <br \/> Reference ref_74 <br \/> Reference ref_75 <br \/> Reference ref_76 <br \/> Reference ref_77 <br \/> Reference ref_78 <br \/> Reference ref_79 <br \/> Reference ref_80 <br \/> Reference ref_81 <br \/> Reference ref_82 <br \/> Reference ref_83 <br \/> Reference ref_84 <br \/> Reference ref_85 <br \/> Reference ref_86 <br \/> Reference ref_87  <\/td>\n<\/tr>\n<tr>\n<td><b>43<b><\/td>\n<td>Reference ref_88 <br \/> Reference ref_89 <br \/> Reference ref_90 <br \/> Reference ref_91 <br \/> Reference ref_92 <br \/> Reference ref_93 <br \/> Reference ref_94 <br \/> Reference ref_95 <br \/> Reference ref_96 <br \/> Reference ref_97 <br \/> Reference ref_98 <br \/> Reference ref_99 <br \/> Reference ref_100 <br \/> Reference ref_101 <br \/> Reference ref_102 <br \/> Reference ref_103  <\/td>\n<\/tr>\n<tr>\n<td><b>44<b><\/td>\n<td>Reference ref_104 <br \/> Reference ref_105 <br \/> Reference ref_106 <br \/> Reference ref_107 <br \/> Reference ref_108 <br \/> Reference ref_109 <br \/> Reference ref_110 <br \/> Reference ref_111 <br \/> Reference ref_112 <br \/> Reference ref_113 <br \/> Reference ref_114 <br \/> Reference ref_115 <br \/> Reference ref_116 <br \/> Reference ref_117 <br \/> Reference ref_118 <br \/> Reference ref_119 <br \/> Reference ref_120 <br \/> Reference ref_121  <\/td>\n<\/tr>\n<tr>\n<td><b>45<b><\/td>\n<td>Reference ref_122 <br \/> Reference ref_123  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Biological evaluation of medical devices &#8211; Tests for genotoxicity, carcinogenicity and reproductive toxicity<\/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>2014<\/td>\n<td>48<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279267,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-279263","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\/279263","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\/279267"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279263"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279263"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279263"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}