{"id":343945,"date":"2024-10-20T00:08:58","date_gmt":"2024-10-20T00:08:58","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-183852016\/"},"modified":"2024-10-25T23:29:00","modified_gmt":"2024-10-25T23:29:00","slug":"bs-iso-183852016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-183852016\/","title":{"rendered":"BS ISO 18385:2016"},"content":{"rendered":"<p>This International Standard specifies requirements for the production of products used in the collection, storage, and analysis of biological material for forensic DNA purposes, but not those consumables and reagents used in post-amplification analysis.<\/p>\n<p>The consumables and reagents covered by this International Standard include those used for evidence collection (sampling kits), such as swabs, containers, and packaging, and also products used in the analysis of DNA samples, such as tubes and other plasticware, disposable laboratory coats, gloves, and other consumables.<\/p>\n<p>This International Standard applies to the production of consumables and reagents which do not require cleaning for continued use. This International Standard does not cover technical product specifications (i.e. product design).<\/p>\n<p>This International Standard excludes microbiological testing.<\/p>\n<p>This International Standard specifies a requirement for manufacturers to minimize the risk of occurrence of detectable human nuclear DNA contamination in products used by the global forensic community.<\/p>\n<p>An overview of the International Standard is provided in Figure&nbsp;1.<\/p>\n<p><b>Figure&nbsp;1<\/b> Overview of the processes covered by this International Standard<\/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>6<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>7<b><\/td>\n<td>Introduction  <\/td>\n<\/tr>\n<tr>\n<td><b>9<b><\/td>\n<td>1\tScope  <\/td>\n<\/tr>\n<tr>\n<td><b>10<b><\/td>\n<td>2\tTerms and definitions  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>3\tAbbreviated terms <br \/> 4\tTypes of products <br \/> 4.1\tGeneral <br \/> 4.2\tProducts that come into direct contact with biological stains or material potentially containing human DNA  <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>4.3\tChemicals, reagents, solvents, and some disposables involved in the analysis of human DNA <br \/> 4.4\tProtective barrier products that are used during the collection and analysis of biological material <br \/> 5\tQuality management systems <br \/> 5.1\tGeneral <br \/> 5.2\tDocuments and records  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>5.3\tAuthorization <br \/> 5.4\tSubcontracting of work and purchase of components <br \/> 5.5\tControl of nonconforming product  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>5.6\tCorrective and preventive action <br \/> 5.7\tStaff contamination detection provision <br \/> 6\tHuman DNA contamination risk management <br \/> 6.1\tGeneral <br \/> 6.2\tRisk assessment  <\/td>\n<\/tr>\n<tr>\n<td><b>18<b><\/td>\n<td>6.3\tRisk mitigation <br \/> 6.4\tRisk control measures <br \/> 6.4.1\tEquipment <br \/> 6.4.2\tPersonnel <br \/> 6.4.3\tCleaning and maintenance  <\/td>\n<\/tr>\n<tr>\n<td><b>19<b><\/td>\n<td>7\tEnvironmental human DNA monitoring <br \/> 8\tRequirements for products subject to post-production treatment  <\/td>\n<\/tr>\n<tr>\n<td><b>20<b><\/td>\n<td>9\tRequirements for products not subject to post-production treatment <br \/> 9.1\tProduct testing <br \/> 9.2\tBatch records <br \/> 10\tProduct packaging, labelling, and documentation  <\/td>\n<\/tr>\n<tr>\n<td><b>21<b><\/td>\n<td>Annex\u00a0A (normative)  Compliance testing  <\/td>\n<\/tr>\n<tr>\n<td><b>23<b><\/td>\n<td>Annex\u00a0B (informative)  Guidance on the effectiveness of post-production treatments currently used in the manufacture of products  <\/td>\n<\/tr>\n<tr>\n<td><b>25<b><\/td>\n<td>Annex\u00a0C (informative)  Relevant markers for DNA profiling  <\/td>\n<\/tr>\n<tr>\n<td><b>26<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements<\/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>2016<\/td>\n<td>30<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":343950,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-343945","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bsi","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/343945","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\/343950"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=343945"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=343945"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=343945"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}