{"id":415965,"date":"2024-10-20T06:08:10","date_gmt":"2024-10-20T06:08:10","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-130042022-2\/"},"modified":"2024-10-26T11:24:09","modified_gmt":"2024-10-26T11:24:09","slug":"bs-iso-130042022-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-130042022-2\/","title":{"rendered":"BS ISO 13004:2022"},"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\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
13<\/td>\n4 Definition and maintenance of product families for sterilization dose substantiation and sterilization dose auditing
4.1 General
4.2 Defining product families <\/td>\n<\/tr>\n
14<\/td>\n4.3 Designation of product to represent a product family
4.3.1 Product to represent a product family <\/td>\n<\/tr>\n
15<\/td>\n4.3.2 Master product
4.3.3 Equivalent product
4.3.4 Simulated product
4.4 Maintaining product families
4.4.1 Periodic review <\/td>\n<\/tr>\n
16<\/td>\n4.4.2 Modification to either product or manufacturing process, or both
4.4.3 Records
4.5 Consequence of failure of sterilization dose substantiation or sterilization dose audit
5 Selection and testing of product for substantiating and auditing a selected sterilization dose
5.1 Nature of product <\/td>\n<\/tr>\n
17<\/td>\n5.2 Sample item portion (SIP) <\/td>\n<\/tr>\n
18<\/td>\n5.3 Manner of sampling <\/td>\n<\/tr>\n
19<\/td>\n5.4 Microbiological testing
5.5 Irradiation
6 Method \ufffc \u2014 Substantiation of a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy
6.1 Rationale <\/td>\n<\/tr>\n
20<\/td>\n6.2 Procedure for Method VDmaxSD for multiple production batches
6.2.1 General
6.2.2 Stage 1: Obtain samples of product
6.2.3 Stage 2: Determine average bioburden <\/td>\n<\/tr>\n
21<\/td>\n6.2.4 Stage 3: Obtain the selected sterilization dose <\/td>\n<\/tr>\n
22<\/td>\n6.2.5 Stage 4: Obtain \ufffc
6.2.6 Stage 5: Perform verification dose experiment <\/td>\n<\/tr>\n
23<\/td>\n6.2.7 Stage 6: Interpretation of results <\/td>\n<\/tr>\n
24<\/td>\n6.2.8 Confirmatory verification dose experiment <\/td>\n<\/tr>\n
25<\/td>\n6.3 Procedure for Method VDmaxSD for a single production batch
6.3.1 Rationale
6.3.2 General
6.3.3 Stage 1: Obtain samples of product
6.3.4 Stage 2: Determine average bioburden <\/td>\n<\/tr>\n
26<\/td>\n6.3.5 Stage 3: Obtain the selected sterilization dose
6.3.6 Stage 4: Obtain VDmaxSD <\/td>\n<\/tr>\n
27<\/td>\n6.3.7 Stage 5: Perform verification dose experiment
6.3.8 Stage 6: Interpretation of results <\/td>\n<\/tr>\n
28<\/td>\n6.3.9 Confirmatory verification dose experiment <\/td>\n<\/tr>\n
29<\/td>\n7 Maintaining process effectiveness
7.1 General
7.2 Frequency of determination of bioburden
7.3 Sterilization dose audit
7.3.1 Frequency
7.3.2 Outcome <\/td>\n<\/tr>\n
30<\/td>\n7.3.3 Procedure for auditing a sterilization dose substantiated using Method VDmaxSD <\/td>\n<\/tr>\n
33<\/td>\n7.3.4 Failure of a sterilization dose audit <\/td>\n<\/tr>\n
34<\/td>\n8 Tables of values for SIP <\/td>\n<\/tr>\n
58<\/td>\n9 Worked examples
9.1 Substantiation of a selected sterilization dose of 17,5 kGy (SIP less than 1,0) <\/td>\n<\/tr>\n
59<\/td>\n9.2 Substantiation of a selected sterilization dose of 30 kGy (SIP equal to 1,0) <\/td>\n<\/tr>\n
60<\/td>\n9.3 Sterilization dose audit for a sterilization dose substantiated using
9.4 Method VDmax22,5 <\/td>\n<\/tr>\n
62<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2022<\/td>\n64<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":415976,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-415965","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\/415965","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\/415976"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=415965"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=415965"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=415965"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}