{"id":371965,"date":"2024-10-20T02:27:07","date_gmt":"2024-10-20T02:27:07","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-iso-ts-224562021\/"},"modified":"2024-10-26T04:16:12","modified_gmt":"2024-10-26T04:16:12","slug":"bsi-pd-iso-ts-224562021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-iso-ts-224562021\/","title":{"rendered":"BSI PD ISO\/TS 22456:2021"},"content":{"rendered":"<p><b>1.1<\/b> Inclusions<\/p>\n<p><b>1.1.1<\/b><\/p>\n<p>This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization.<\/p>\n<blockquote>\n<p>NOTE This document is intended to be used in conjunction with ISO&nbsp;11737\u20111 and ISO&nbsp;11737\u20112.<\/p>\n<\/blockquote>\n<p><b>1.1.2<\/b><\/p>\n<p>Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.<\/p>\n<p><b>1.2<\/b> Exclusions<\/p>\n<p><b>1.2.1<\/b><\/p>\n<p>This document does not include guidance for validation requirements for testing, eliminating and\/or inactivating viruses and prions or sterilization of tissue-based products.<\/p>\n<blockquote>\n<p>NOTE Guidance on inactivating viruses and prions can be found in ISO&nbsp;22442\u20113.<\/p>\n<\/blockquote>\n<p><b>1.2.2<\/b><\/p>\n<p>This document does not include guidance for containment or biosafety issues for biologics and tissue-based products.<\/p>\n<p><b>1.2.3<\/b><\/p>\n<p>This document does not include guidance for testing biologics and tissue-based products for specific infectious agents as listed in relevant national or international guidance (e.g. viruses\/protozoa\/parasites, intracellular microorganisms or mycoplasma screening).<\/p>\n<p><b>1.2.4<\/b><\/p>\n<p>This document does not include guidance for the acceptance criteria for biologics and tissue-based products during procurement or tissue to be processed and\/or released for use.<\/p>\n<p><b>1.2.5<\/b><\/p>\n<p>This document does not include guidance for the testing associated with procurement and screening of biologics and tissue-based products.<\/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>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 Scope <br \/> 1.1 Inclusions <br \/> 1.2 Exclusions <br \/> 2 Normative references  <\/td>\n<\/tr>\n<tr>\n<td><b>10<b><\/td>\n<td>3 Terms and definitions  <\/td>\n<\/tr>\n<tr>\n<td><b>11<b><\/td>\n<td>4 Definition and maintenance of product families <br \/> 5 Selection and testing of product for bioburden and tests of sterility <br \/> 5.1 General  <\/td>\n<\/tr>\n<tr>\n<td><b>12<b><\/td>\n<td>5.2 Nature of product <br \/> 5.3 Sample Item Portion (SIP) <br \/> 5.4 Sampling conditions <br \/> 5.4.1 General <br \/> 5.4.2 Considerations for human tissue donor batches in sterilization  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>5.4.3 Use of multiple batches <br \/> 5.4.4 Considerations for packaging <br \/> 5.5 Microbiological testing <br \/> 5.5.1 Bioburden test considerations for biologics\/tissues  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>5.5.2 Test of sterility considerations for biologics\/tissues  <\/td>\n<\/tr>\n<tr>\n<td><b>18<b><\/td>\n<td>5.5.3 Verification of microbiological methods  <\/td>\n<\/tr>\n<tr>\n<td><b>19<b><\/td>\n<td>5.5.4 Rapid microbiology tests  <\/td>\n<\/tr>\n<tr>\n<td><b>20<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Sterilization of healthcare products. Microbiological methods. Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products<\/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>22<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":371973,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[122,2641],"product_tag":[],"class_list":{"0":"post-371965","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-07-100-10","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\/371965","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\/371973"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=371965"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=371965"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=371965"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}