{"id":279504,"date":"2024-10-19T18:52:01","date_gmt":"2024-10-19T18:52:01","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10993-112018\/"},"modified":"2024-10-25T15:25:53","modified_gmt":"2024-10-25T15:25:53","slug":"bs-en-iso-10993-112018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10993-112018\/","title":{"rendered":"BS EN ISO 10993-11:2018"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
4<\/td>\nEuropean 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
11<\/td>\n4 General considerations
4.1 General
4.2 Selection of animal species
4.3 Animal status
4.4 Animal care and husbandry <\/td>\n<\/tr>\n
12<\/td>\n4.5 Size and number of groups
4.5.1 Size of groups
4.5.2 Number of groups
4.5.3 Treatment controls <\/td>\n<\/tr>\n
13<\/td>\n4.6 Route of exposure
4.7 Sample preparation
4.8 Dosing
4.8.1 Test sample administration
4.8.2 Dosage volumes <\/td>\n<\/tr>\n
14<\/td>\n4.8.3 Dosage frequency
4.9 Body weight and food\/water consumption
4.10 Clinical observations
4.11 Clinical pathology <\/td>\n<\/tr>\n
15<\/td>\n4.12 Anatomic pathology
4.13 Study designs
4.14 Quality of investigation
5 Acute systemic toxicity
5.1 General <\/td>\n<\/tr>\n
16<\/td>\n5.2 Study design
5.2.1 Preparations
5.2.2 Experimental animals
5.2.3 Test conditions <\/td>\n<\/tr>\n
17<\/td>\n5.2.4 Body weights
5.2.5 Clinical observations
5.2.6 Pathology <\/td>\n<\/tr>\n
18<\/td>\n5.3 Evaluation criteria
5.3.1 General
5.3.2 Evaluation of results
5.4 Final report <\/td>\n<\/tr>\n
20<\/td>\n6 Repeated exposure systemic toxicity (subacute, subchronic and chronic systemic toxicity)
6.1 General
6.2 Study design
6.2.1 Preparations
6.2.2 Experimental animals <\/td>\n<\/tr>\n
21<\/td>\n6.2.3 Test conditions
6.2.4 Body weights
6.2.5 Clinical observations
6.2.6 Pathology <\/td>\n<\/tr>\n
22<\/td>\n6.3 Evaluation criteria
6.3.1 General <\/td>\n<\/tr>\n
23<\/td>\n6.3.2 \u200bEvaluation of results
6.4 Final report <\/td>\n<\/tr>\n
24<\/td>\nAnnex A (informative) Routes of administration <\/td>\n<\/tr>\n
26<\/td>\nAnnex B (informative) Dosage volumes <\/td>\n<\/tr>\n
27<\/td>\nAnnex C (informative) Common clinical signs and observations <\/td>\n<\/tr>\n
28<\/td>\nAnnex D (informative) Suggested haematology, clinical chemistry and urinalysis measurements <\/td>\n<\/tr>\n
30<\/td>\nAnnex E (informative) Suggested organ list for histopathological evaluation <\/td>\n<\/tr>\n
32<\/td>\nAnnex F (informative) Organ list for limited histopathology for medical devices subjected to systemic toxicity testing <\/td>\n<\/tr>\n
33<\/td>\nAnnex G (informative) Information on material-mediated pyrogens <\/td>\n<\/tr>\n
34<\/td>\nAnnex H (informative) Subchronic rat \u2014 Dual routes of parenteral administration <\/td>\n<\/tr>\n
36<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Biological evaluation of medical devices – Tests for systemic toxicity<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2018<\/td>\n46<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279510,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-279504","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-20","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\/279504","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\/279510"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279504"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279504"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279504"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}