{"id":279476,"date":"2024-10-19T18:51:49","date_gmt":"2024-10-19T18:51:49","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-11138-12017\/"},"modified":"2024-10-25T15:25:42","modified_gmt":"2024-10-25T15:25:42","slug":"bs-en-iso-11138-12017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-11138-12017\/","title":{"rendered":"BS EN ISO 11138-1:2017"},"content":{"rendered":"

This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.<\/p>\n

This document specifies basic and common requirements that are applicable to all parts of ISO 11138 . Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138 . If no specific subsequent part is provided, this document applies.<\/p>\n

\n

NOTE National or regional regulations can apply.<\/p>\n<\/blockquote>\n

This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and\/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.<\/p>\n

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
4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
5<\/td>\nEndorsement notice <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
10<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
13<\/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
14<\/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
15<\/td>\n4.4 Storage and transport <\/td>\n<\/tr>\n
16<\/td>\n5 Specific manufacturing requirements
5.1 Suspensions
5.2 Carrier, primary and secondary packaging
5.3 Inoculated carrier <\/td>\n<\/tr>\n
17<\/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
18<\/td>\n6.4 Resistance characteristics
6.5 Test conditions <\/td>\n<\/tr>\n
19<\/td>\n7 Culture conditions
7.1 Incubator
7.2 Growth medium
7.3 Incubation <\/td>\n<\/tr>\n
20<\/td>\n7.4 Software validation
7.5 Incubation time using detection system <\/td>\n<\/tr>\n
21<\/td>\nAnnex\u00a0A (normative) Determination of viable count <\/td>\n<\/tr>\n
23<\/td>\nAnnex\u00a0B (normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes <\/td>\n<\/tr>\n
26<\/td>\nAnnex\u00a0C (normative) D value determination by survivor curve method <\/td>\n<\/tr>\n
30<\/td>\nAnnex\u00a0D (normative) D value determination by fraction negative method <\/td>\n<\/tr>\n
46<\/td>\nAnnex\u00a0E (normative) Survival-kill response characteristics <\/td>\n<\/tr>\n
48<\/td>\nAnnex\u00a0F (informative) Relationship between components of biological indicators <\/td>\n<\/tr>\n
49<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

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>\n2017<\/td>\n52<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279479,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-279476","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\/279476","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\/279479"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279476"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279476"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279476"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}