{"id":376246,"date":"2024-10-20T02:47:16","date_gmt":"2024-10-20T02:47:16","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-16140-32021-2\/"},"modified":"2024-10-26T04:54:45","modified_gmt":"2024-10-26T04:54:45","slug":"bs-en-iso-16140-32021-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-16140-32021-2\/","title":{"rendered":"BS EN ISO 16140-3:2021"},"content":{"rendered":"<p>This document specifies the protocol for the verification of reference methods and validated alternative methods for implementation in the user laboratory.<\/p>\n<p>This document is applicable to the verification of methods used for the analysis (detection and\/or quantification), confirmation and typing of microorganisms in:<\/p>\n<ul>\n<li>\n<p>products intended for human consumption;<\/p>\n<\/li>\n<li>\n<p>products intended for animal feeding;<\/p>\n<\/li>\n<li>\n<p>environmental samples in the area of food and feed production, handling;<\/p>\n<\/li>\n<li>\n<p>samples from the primary production stage.<\/p>\n<\/li>\n<\/ul>\n<p>This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case&nbsp;basis.<\/p>\n<p>The technical protocols for the verification of validated qualitative methods and validated quantitative methods are described in <span class=\"xref\">Clauses&nbsp;5<\/span> and&nbsp;<span class=\"xref\">6<\/span>. The technical protocol for the verification of validated alternative confirmation and typing methods is described in <span class=\"xref\">Clause&nbsp;7<\/span>. The protocols for the verification of non-validated reference methods are described in <span class=\"xref\">Annex&nbsp;F<\/span>.<\/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>2<b><\/td>\n<td>National foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>6<b><\/td>\n<td>European foreword <br \/> Endorsement notice  <\/td>\n<\/tr>\n<tr>\n<td><b>9<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>10<b><\/td>\n<td>Introduction  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>1 Scope <br \/> 2 Normative references <br \/> 3 Terms and definitions  <\/td>\n<\/tr>\n<tr>\n<td><b>21<b><\/td>\n<td>4 General principles of verification of qualitative (detection) methods and quantification methods <br \/> 4.1 General <br \/> 4.2 Implementation verification  <\/td>\n<\/tr>\n<tr>\n<td><b>22<b><\/td>\n<td>4.3 (Food) item verification <br \/> 4.4 Requirements for implementation verification and (food) item verification  <\/td>\n<\/tr>\n<tr>\n<td><b>25<b><\/td>\n<td>4.5 Performance characteristics <br \/> 5 Qualitative methods \u2014 Technical protocol for verification <br \/> 5.1 Estimated LOD50 (eLOD50) determination <br \/> 5.2 Experimental design  <\/td>\n<\/tr>\n<tr>\n<td><b>26<b><\/td>\n<td>5.3 Selection of (food) items <br \/> 5.4 Artificial contamination <br \/> 5.4.1 Selection of strains  <\/td>\n<\/tr>\n<tr>\n<td><b>27<b><\/td>\n<td>5.4.2 Inoculation of the test portions  <\/td>\n<\/tr>\n<tr>\n<td><b>29<b><\/td>\n<td>5.5 Evaluation of results <br \/> 5.5.1 Determination of eLOD50 using protocol 1  <\/td>\n<\/tr>\n<tr>\n<td><b>32<b><\/td>\n<td>5.5.2 Determination of eLOD50 using protocol 2  <\/td>\n<\/tr>\n<tr>\n<td><b>33<b><\/td>\n<td>5.5.3 Use of protocol 3  <\/td>\n<\/tr>\n<tr>\n<td><b>34<b><\/td>\n<td>5.6 Acceptability limits <br \/> 5.7 Root cause analysis  <\/td>\n<\/tr>\n<tr>\n<td><b>35<b><\/td>\n<td>6 Quantitative methods \u2014 Technical protocol for verification <br \/> 6.1 Intralaboratory reproducibility standard deviation determination <br \/> 6.1.1 General <br \/> 6.1.2 Experimental design  <\/td>\n<\/tr>\n<tr>\n<td><b>37<b><\/td>\n<td>6.1.3 Selection of the (food) item <br \/> 6.1.4 Natural contamination <br \/> 6.1.5 Artificial contamination  <\/td>\n<\/tr>\n<tr>\n<td><b>38<b><\/td>\n<td>6.1.6 Evaluation of results  <\/td>\n<\/tr>\n<tr>\n<td><b>39<b><\/td>\n<td>6.1.7 Acceptability limit  <\/td>\n<\/tr>\n<tr>\n<td><b>40<b><\/td>\n<td>6.1.8 Root cause analysis  <\/td>\n<\/tr>\n<tr>\n<td><b>41<b><\/td>\n<td>6.2 Estimated bias (eBias) determination <br \/> 6.2.1 General <br \/> 6.2.2 Experimental design <br \/> 6.2.3 Selection of (food) items <br \/> 6.2.4 Artificial contamination  <\/td>\n<\/tr>\n<tr>\n<td><b>43<b><\/td>\n<td>6.2.5 Evaluation of results <br \/> 6.2.6 Acceptability limit  <\/td>\n<\/tr>\n<tr>\n<td><b>44<b><\/td>\n<td>6.2.7 Root cause analysis <br \/> 7 Validated alternative confirmation and typing methods \u2014 Technical protocol for verification <br \/> 7.1 General <br \/> 7.2 Implementation verification <br \/> 7.3 Experimental design <br \/> 7.3.1 General  <\/td>\n<\/tr>\n<tr>\n<td><b>45<b><\/td>\n<td>7.3.2 Strain selection <br \/> 7.4 Evaluation of results  <\/td>\n<\/tr>\n<tr>\n<td><b>46<b><\/td>\n<td>7.5 Acceptability limit <br \/> 7.6 Root cause analysis <br \/> 8 Summary of acceptability limits for the verification of validated methods  <\/td>\n<\/tr>\n<tr>\n<td><b>47<b><\/td>\n<td>Annex\u00a0A (informative)  Classification of (food) categories and suggested target combinations for verification studies  <\/td>\n<\/tr>\n<tr>\n<td><b>61<b><\/td>\n<td>Annex\u00a0B (informative)  Guidance on how to choose challenging (food) item(s) for (food) item verification  <\/td>\n<\/tr>\n<tr>\n<td><b>63<b><\/td>\n<td>Annex\u00a0C (informative)  Qualitative method verification \u2014 Example  <\/td>\n<\/tr>\n<tr>\n<td><b>71<b><\/td>\n<td>Annex\u00a0D (informative)  Quantitative method verification \u2014 Example  <\/td>\n<\/tr>\n<tr>\n<td><b>76<b><\/td>\n<td>Annex\u00a0E (informative)  Validated alternative confirmation or typing method verification \u2014 Examples  <\/td>\n<\/tr>\n<tr>\n<td><b>79<b><\/td>\n<td>Annex\u00a0F (normative)  Protocol for the verification of non-validated reference methods in\u00a0a\u00a0single\u00a0laboratory  <\/td>\n<\/tr>\n<tr>\n<td><b>86<b><\/td>\n<td> Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Microbiology of the food chain. Method validation &#8211; Protocol for the verification of reference methods and validated alternative methods in a single laboratory<\/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>88<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":376256,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[124,2641],"product_tag":[],"class_list":{"0":"post-376246","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-07-100-30","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\/376246","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\/376256"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=376246"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=376246"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=376246"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}