{"id":371783,"date":"2024-10-20T02:26:19","date_gmt":"2024-10-20T02:26:19","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10993-232021\/"},"modified":"2024-10-26T04:14:32","modified_gmt":"2024-10-26T04:14:32","slug":"bs-en-iso-10993-232021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10993-232021\/","title":{"rendered":"BS EN ISO 10993-23:2021"},"content":{"rendered":"<p>This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to <span class=\"std\"><span class=\"std-ref\">ISO&nbsp;10993-1<\/span><\/span> and <span class=\"std\"><span class=\"std-ref\">ISO&nbsp;10993-2<\/span><\/span>.<\/p>\n<p>This document includes:<\/p>\n<ul>\n<li>\n<p>pre-test considerations for irritation, including <i>in silico<\/i> and <i>in vitro<\/i> methods for dermal exposure;<\/p>\n<\/li>\n<li>\n<p>details of <i>in vitro<\/i> and <i>in vivo<\/i> irritation test procedures;<\/p>\n<\/li>\n<li>\n<p>key factors for the interpretation of the results.<\/p>\n<\/li>\n<\/ul>\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>2<b><\/td>\n<td>National foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>6<b><\/td>\n<td>European foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>8<b><\/td>\n<td>Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93\/42\/EEC [OJ L 169] aimed to be covered  <\/td>\n<\/tr>\n<tr>\n<td><b>10<b><\/td>\n<td>Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 90\/385\/EEC [OJ L 189] aimed to be covered  <\/td>\n<\/tr>\n<tr>\n<td><b>12<b><\/td>\n<td>Annex ZC (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>16<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>Introduction  <\/td>\n<\/tr>\n<tr>\n<td><b>19<b><\/td>\n<td>1 Scope <br \/> 2 Normative references  <\/td>\n<\/tr>\n<tr>\n<td><b>20<b><\/td>\n<td>3 Terms and definitions  <\/td>\n<\/tr>\n<tr>\n<td><b>21<b><\/td>\n<td>4 General principles \u2014 Step-wise approach  <\/td>\n<\/tr>\n<tr>\n<td><b>22<b><\/td>\n<td>5 Pre-test considerations <br \/> 5.1 General  <\/td>\n<\/tr>\n<tr>\n<td><b>23<b><\/td>\n<td>5.2 Types of material <br \/> 5.2.1 Initial considerations <br \/> 5.2.2 Ceramics, metals and alloys <br \/> 5.2.3 Polymers <br \/> 5.2.4 Biologically derived materials <br \/> 5.3 Information on chemical composition <br \/> 5.3.1 General <br \/> 5.3.2 Existing data sources  <\/td>\n<\/tr>\n<tr>\n<td><b>24<b><\/td>\n<td>6 In vitro irritation tests <br \/> 6.1 General <br \/> 6.2 In vitro reconstructed human epidermis model <br \/> 6.2.1 Test system \u2014 Reconstructed human epidermis model <br \/> 6.2.2 Principle of the method  <\/td>\n<\/tr>\n<tr>\n<td><b>25<b><\/td>\n<td>6.2.3 Prediction model  <\/td>\n<\/tr>\n<tr>\n<td><b>26<b><\/td>\n<td>6.3 Materials <br \/> 6.3.1 Reconstructed human epidermis models \u2014 Product description <br \/> 6.3.2 Preparation of medical device extracts  <\/td>\n<\/tr>\n<tr>\n<td><b>27<b><\/td>\n<td>6.4 Methods <br \/> 6.4.1 General <br \/> 6.4.2 Test procedure  <\/td>\n<\/tr>\n<tr>\n<td><b>28<b><\/td>\n<td>6.4.3 Media and end point solutions <br \/> 6.4.4 Test sample and control preparation  <\/td>\n<\/tr>\n<tr>\n<td><b>29<b><\/td>\n<td>6.5 Considerations for test performance <br \/> 6.5.1 Receipt of the reconstructed human epidermis tissues <br \/> 6.5.2 Preparation and pre-incubation <br \/> 6.6 Application of the test sample and rinsing <br \/> 6.6.1 General  <\/td>\n<\/tr>\n<tr>\n<td><b>30<b><\/td>\n<td>6.6.2 Preparation <br \/> 6.6.3 Test extract and controls exposure  <\/td>\n<\/tr>\n<tr>\n<td><b>31<b><\/td>\n<td>6.7 MTT test for determination of RhE tissue viability after the exposure period <br \/> 6.7.1 MTT incubation and Isopropanol extraction <br \/> 6.7.2 Absorbance measurements  <\/td>\n<\/tr>\n<tr>\n<td><b>32<b><\/td>\n<td>6.8 Test acceptance criteria <br \/> 6.9 Data calculation steps <br \/> 6.9.1 General <br \/> 6.9.2 Isopropanol background control for OD in RhE assay <br \/> 6.9.3 Negative DPBS or PBS treated controls <br \/> 6.9.4 Positive control  <\/td>\n<\/tr>\n<tr>\n<td><b>33<b><\/td>\n<td>6.9.5 Tested extract and VC samples (TTs) <br \/> 6.10 Data interpretation \u2014 Prediction model <br \/> 6.11 Method documentation sheet  <\/td>\n<\/tr>\n<tr>\n<td><b>34<b><\/td>\n<td>6.12 Test report <br \/> 7 In vivo irritation tests <br \/> 7.1 General  <\/td>\n<\/tr>\n<tr>\n<td><b>35<b><\/td>\n<td>7.2 Animal irritation test by skin exposure <br \/> 7.2.1 Principle <br \/> 7.2.2 Test materials <br \/> 7.2.3 Animals and husbandry <br \/> 7.2.4 Test procedure  <\/td>\n<\/tr>\n<tr>\n<td><b>37<b><\/td>\n<td>7.2.5 Observation of animals <br \/> 7.2.6 Evaluation of results  <\/td>\n<\/tr>\n<tr>\n<td><b>39<b><\/td>\n<td>7.2.7 Test report <br \/> 7.3 Animal irritation test by intracutaneous (intradermal) administration <br \/> 7.3.1 Introduction <br \/> 7.3.2 Exclusion from test <br \/> 7.3.3 Test sample  <\/td>\n<\/tr>\n<tr>\n<td><b>40<b><\/td>\n<td>7.3.4 Animals and husbandry <br \/> 7.3.5 Test procedure  <\/td>\n<\/tr>\n<tr>\n<td><b>41<b><\/td>\n<td>7.3.6 Observation of animals <br \/> 7.3.7 Evaluation of results <br \/> 7.3.8 Test report  <\/td>\n<\/tr>\n<tr>\n<td><b>42<b><\/td>\n<td>8 Human skin irritation test <br \/> 8.1 Introduction <br \/> 8.2 Initial considerations  <\/td>\n<\/tr>\n<tr>\n<td><b>44<b><\/td>\n<td>Annex A (normative) Preparation of materials for irritation testing  <\/td>\n<\/tr>\n<tr>\n<td><b>46<b><\/td>\n<td>Annex B (informative) Test method check list for in vitro irritation testing using reconstructed human epidermis models  <\/td>\n<\/tr>\n<tr>\n<td><b>48<b><\/td>\n<td>Annex C (informative) Example of method documentation sheet for reconstructed human epidermis models  <\/td>\n<\/tr>\n<tr>\n<td><b>54<b><\/td>\n<td>Annex D (normative) Special irritation tests  <\/td>\n<\/tr>\n<tr>\n<td><b>70<b><\/td>\n<td>Annex E (normative) Human skin irritation test  <\/td>\n<\/tr>\n<tr>\n<td><b>74<b><\/td>\n<td>Annex F (informative) Background information on irritation tests  <\/td>\n<\/tr>\n<tr>\n<td><b>76<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Biological evaluation of medical devices &#8211; Tests for irritation<\/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>80<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":371791,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-371783","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\/371783","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\/371791"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=371783"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=371783"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=371783"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}