{"id":279903,"date":"2024-10-19T18:53:57","date_gmt":"2024-10-19T18:53:57","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-11138-72019-tc\/"},"modified":"2024-10-25T15:28:46","modified_gmt":"2024-10-25T15:28:46","slug":"bs-en-iso-11138-72019-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-11138-72019-tc\/","title":{"rendered":"BS EN ISO 11138-7:2019 – 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\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
101<\/td>\nundefined <\/td>\n<\/tr>\n
103<\/td>\nEuropean foreword
Endorsement notice <\/td>\n<\/tr>\n
106<\/td>\nForeword <\/td>\n<\/tr>\n
107<\/td>\nIntroduction <\/td>\n<\/tr>\n
108<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
111<\/td>\n4 General <\/td>\n<\/tr>\n
113<\/td>\n5 Characteristics of biological indicators
5.1 General <\/td>\n<\/tr>\n
114<\/td>\n5.2 Test organism suspension for direct inoculation of products
5.3 Inoculated carriers <\/td>\n<\/tr>\n
115<\/td>\n5.4 Self-contained biological indicators
6 Selection of supplier
6.1 General <\/td>\n<\/tr>\n
116<\/td>\n6.2 Documentation
6.2.1 General <\/td>\n<\/tr>\n
117<\/td>\n6.2.2 Manufacturer audit <\/td>\n<\/tr>\n
118<\/td>\n7 Biological indicators in process development
7.1 General
7.2 Overkill approach <\/td>\n<\/tr>\n
119<\/td>\n7.3 Combined biological indicator and bioburden method <\/td>\n<\/tr>\n
120<\/td>\n7.4 Bioburden method
8 Biological indicators in sterilization validation
8.1 General <\/td>\n<\/tr>\n
121<\/td>\n8.2 Placement and handling of biological indicators
8.3 Sterilizer qualification
8.4 Performance qualification <\/td>\n<\/tr>\n
122<\/td>\n8.5 Review and approval of validation
8.6 Requalification
9 Biological indicators in routine monitoring
9.1 General <\/td>\n<\/tr>\n
123<\/td>\n9.2 Placement and handling of biological indicators
9.3 Process challenge device <\/td>\n<\/tr>\n
124<\/td>\n10 Interpretation and acceptance criteria
10.1 General
10.2 Interpretation of results
11 Application of biological indicator standards
11.1 General assessment of biological indicator performance by the user <\/td>\n<\/tr>\n
125<\/td>\n11.2 Nominal population of test organism <\/td>\n<\/tr>\n
126<\/td>\n11.3 Resistance determination
11.3.1 General
11.3.2 Survivor curve method
11.3.3 Fraction-negative method <\/td>\n<\/tr>\n
127<\/td>\n11.3.4 Survival-kill response characteristics
11.4 z value determination
11.4.1 General
11.4.2 Graphically plotting the z value <\/td>\n<\/tr>\n
128<\/td>\n11.4.3 Mathematically calculating the z value <\/td>\n<\/tr>\n
129<\/td>\n11.4.4 Correlation coefficient, r, for the z value
11.5 F(T, z) equivalent sterilization value determination
11.6 Establishing spore-log-reduction <\/td>\n<\/tr>\n
130<\/td>\n11.7 Sterility assurance level calculation
11.8 Test equipment <\/td>\n<\/tr>\n
131<\/td>\n12 Culture conditions
12.1 General
12.2 Incubation temperature
12.3 Incubation period <\/td>\n<\/tr>\n
132<\/td>\n12.4 Choice of growth medium
13 Third-party considerations
13.1 General <\/td>\n<\/tr>\n
133<\/td>\n13.2 Minimum requirements from ISO 11138-1 for replicates and total number of biological indicators
13.3 Test equipment
14 Personnel training <\/td>\n<\/tr>\n
134<\/td>\n15 Storage and handling
16 Disposal of biological indicators <\/td>\n<\/tr>\n
135<\/td>\nAnnex A (informative) Microbiological inactivation kinetics and enumeration techniques <\/td>\n<\/tr>\n
140<\/td>\nAnnex B (informative) Process challenge devices <\/td>\n<\/tr>\n
141<\/td>\nAnnex C (informative) Formulae for D value determination by fraction-negative method <\/td>\n<\/tr>\n
157<\/td>\nAnnex D (informative) Examples of documentation for biological indicators prepared by the user <\/td>\n<\/tr>\n
161<\/td>\nAnnex E (informative) Calculation of z value <\/td>\n<\/tr>\n
164<\/td>\nAnnex F (informative) D value determination by survivor curve method <\/td>\n<\/tr>\n
168<\/td>\nAnnex G (informative) Survival-kill response characteristics <\/td>\n<\/tr>\n
170<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. Sterilization of health care products. Biological indicators – Guidance for the selection, use and interpretation of results<\/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>\n173<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279909,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-279903","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\/279903","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\/279909"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279903"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279903"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279903"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}