{"id":381832,"date":"2024-10-20T03:13:20","date_gmt":"2024-10-20T03:13:20","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-217092020a12021\/"},"modified":"2024-10-26T05:51:15","modified_gmt":"2024-10-26T05:51:15","slug":"bs-iso-217092020a12021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-217092020a12021\/","title":{"rendered":"BS ISO 21709:2020+A1:2021"},"content":{"rendered":"<p>This document specifies process and quality requirements for the biobanking of mammalian (including human) cell lines. It describes requirements for the fundamental procedures of the biobank handling cell lines, such as establishment, reception, identification, propagation, preservation, storage, quality control, and distribution of cell lines.<\/p>\n<p>This document can be used by organizations performing biobanking activities with mammalian cell lines used for research and development, biobank users, organizations and schemes using peer-assessment and accreditation bodies.<\/p>\n<p>This document does not apply to biological material intended for therapeutic use.<\/p>\n<blockquote>\n<p>NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.<\/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>2<b><\/td>\n<td>National foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>7<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>8<b><\/td>\n<td>Introduction  <\/td>\n<\/tr>\n<tr>\n<td><b>9<b><\/td>\n<td>1 Scope <br \/> 2 Normative references <br \/> 3 Terms and definitions  <\/td>\n<\/tr>\n<tr>\n<td><b>11<b><\/td>\n<td>4 Requirements <br \/> 4.1 General <br \/> 4.2 Legal and ethical requirements <br \/> 4.3 Facilities <br \/> 4.3.1 General  <\/td>\n<\/tr>\n<tr>\n<td><b>12<b><\/td>\n<td>4.3.2 Cell culture facility <br \/> 4.4 Equipment <br \/> 4.4.1 General  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>4.4.2 Equipment inspection <br \/> 4.5 Reagents  <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>\uea014.6\uea02 Personnel <br \/> \uea014.6.1\uea02 General <br \/> \uea014.6.2\uea02 Personnel competence <br \/> \uea014.6.3\uea02 Personnel training <br \/> \uea014.6.4\uea02 Biorisk and biosafety of personnel  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>5 Process requirements <br \/> 5.1 Establishment of cell lines within the biobank <br \/> 5.1.1 General <br \/> 5.1.2 Isolation and purification of primary cells <br \/> 5.1.3 Primary cultures  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>5.1.4 Cell lines <br \/> 5.2 Reception of established cell lines <br \/> 5.2.1 General <br \/> 5.2.2 Review of the deposit request  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>5.2.3 Decision on the deposit request <br \/> 5.2.4 Transfer of material and associated data  <\/td>\n<\/tr>\n<tr>\n<td><b>18<b><\/td>\n<td>5.2.5 Characterization and authentication of the cell line  <\/td>\n<\/tr>\n<tr>\n<td><b>19<b><\/td>\n<td>5.2.6 Assignment of accession number <br \/> 5.3 Cell line management <br \/> 5.3.1 Planning for cell banking <br \/> 5.3.2 Accession <br \/> 5.3.3 Propagation of cell lines  <\/td>\n<\/tr>\n<tr>\n<td><b>20<b><\/td>\n<td>5.3.4 Preservation and storage <br \/> 5.3.5 Inventory management  <\/td>\n<\/tr>\n<tr>\n<td><b>21<b><\/td>\n<td>5.3.6 Disposal management <br \/> 5.4 Distribution <br \/> 5.4.1 General <br \/> 5.4.2 Acceptance of order request <br \/> 5.4.3 Distribution review <br \/> 5.4.4 Transport  <\/td>\n<\/tr>\n<tr>\n<td><b>22<b><\/td>\n<td>5.5 Quality control, validation and verification <br \/> 5.5.1 Quality control  <\/td>\n<\/tr>\n<tr>\n<td><b>23<b><\/td>\n<td>5.5.2 Validation and verification <br \/> 6 Performance evaluation and improvement  <\/td>\n<\/tr>\n<tr>\n<td><b>24<b><\/td>\n<td>Annex A (informative) Recommended units for biobanking of cell lines  <\/td>\n<\/tr>\n<tr>\n<td><b>25<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines<\/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>26<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":381842,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-381832","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\/381832","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\/381842"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=381832"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=381832"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=381832"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}