{"id":279949,"date":"2024-10-19T18:54:16","date_gmt":"2024-10-19T18:54:16","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-11138-12017-tc\/"},"modified":"2024-10-25T15:29:01","modified_gmt":"2024-10-25T15:29:01","slug":"bs-en-iso-11138-12017-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-11138-12017-tc\/","title":{"rendered":"BS EN ISO 11138-1:2017 – TC"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
67<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
68<\/td>\nEndorsement notice <\/td>\n<\/tr>\n
70<\/td>\nForeword <\/td>\n<\/tr>\n
71<\/td>\nIntroduction <\/td>\n<\/tr>\n
73<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
76<\/td>\n4 General manufacturing requirements
4.1 Manufacturing controls
4.1.1 Quality management systems
4.1.2 Traceability
4.1.3 Finished product requirements
4.1.4 Personnel
4.2 Test organism
4.2.1 Strain <\/td>\n<\/tr>\n
77<\/td>\n4.2.2 Originating inoculum for suspension
4.2.3 Test organism count
4.3 Information to be provided by the manufacturer (labelling) <\/td>\n<\/tr>\n
78<\/td>\n4.4 Storage and transport <\/td>\n<\/tr>\n
79<\/td>\n5 Specific manufacturing requirements
5.1 Suspensions
5.2 Carrier, primary and secondary packaging
5.3 Inoculated carrier <\/td>\n<\/tr>\n
80<\/td>\n5.4 Biological indicators
5.5 Self-contained biological indicators
6 Determination of population and resistance
6.1 General resistance requirements
6.2 Test organism
6.3 Population of test organisms <\/td>\n<\/tr>\n
81<\/td>\n6.4 Resistance characteristics
6.5 Test conditions <\/td>\n<\/tr>\n
82<\/td>\n7 Culture conditions
7.1 Incubator
7.2 Growth medium
7.3 Incubation <\/td>\n<\/tr>\n
83<\/td>\n7.4 Software validation
7.5 Incubation time using detection system <\/td>\n<\/tr>\n
84<\/td>\nAnnex\u00a0A (normative) Determination of viable count <\/td>\n<\/tr>\n
86<\/td>\nAnnex\u00a0B (normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes <\/td>\n<\/tr>\n
89<\/td>\nAnnex\u00a0C (normative) D value determination by survivor curve method <\/td>\n<\/tr>\n
93<\/td>\nAnnex\u00a0D (normative) D value determination by fraction negative method <\/td>\n<\/tr>\n
109<\/td>\nAnnex\u00a0E (normative) Survival-kill response characteristics <\/td>\n<\/tr>\n
111<\/td>\nAnnex\u00a0F (informative) Relationship between components of biological indicators <\/td>\n<\/tr>\n
112<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. Sterilization of health care products. Biological indicators – General requirements<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2020<\/td>\n115<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279954,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-279949","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","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\/279949","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\/279954"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279949"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279949"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279949"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}