{"id":425024,"date":"2024-10-20T06:54:37","date_gmt":"2024-10-20T06:54:37","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10993-102023\/"},"modified":"2024-10-26T13:00:55","modified_gmt":"2024-10-26T13:00:55","slug":"bs-en-iso-10993-102023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10993-102023\/","title":{"rendered":"BS EN ISO 10993-10:2023"},"content":{"rendered":"

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: \u2014     details of in vivo skin sensitization test procedures; \u2014    key factors for the interpretation of the results. NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.<\/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\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
7<\/td>\nAnnex ZA (informative)Relationship between this European standard and the General Safety and Performance requirements of Regulation (EU) 2017\/745 aimed to be covered <\/td>\n<\/tr>\n
10<\/td>\nBlank Page <\/td>\n<\/tr>\n
13<\/td>\nForeword <\/td>\n<\/tr>\n
14<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n4 General principles \u2014 Step-wise approach <\/td>\n<\/tr>\n
18<\/td>\n5 Pretest considerations
5.1 General
5.2 Types of material
5.2.1 Initial considerations
5.2.2 Ceramics, metals and alloys
5.2.3 Polymers
5.2.4 Biologically derived materials
5.3 Information on chemical composition
5.3.1 General <\/td>\n<\/tr>\n
19<\/td>\n5.3.2 Existing data sources
6 Skin sensitization tests
6.1 Choice of test methods <\/td>\n<\/tr>\n
20<\/td>\n6.2 Murine local lymph node assay
6.2.1 Principle
6.2.2 Test sample preparation
6.2.3 Animals and husbandry <\/td>\n<\/tr>\n
21<\/td>\n6.2.4 Test procedure <\/td>\n<\/tr>\n
22<\/td>\n6.2.5 Treatment groups
6.2.6 Determination of cellular proliferation and tissue preparation <\/td>\n<\/tr>\n
23<\/td>\n6.2.7 Results and interpretation
6.2.8 Test report
6.3 Guinea pig assays for the detection of skin sensitization
6.3.1 Principle <\/td>\n<\/tr>\n
24<\/td>\n6.3.2 Choice of test sample concentrations
6.3.3 Induction
6.3.4 Challenge
6.4 Important factors affecting the outcome of the test <\/td>\n<\/tr>\n
25<\/td>\n6.5 Guinea pig maximization test
6.5.1 Principle
6.5.2 Test sample preparation
6.5.3 Animals and husbandry <\/td>\n<\/tr>\n
26<\/td>\n6.5.4 Test procedure <\/td>\n<\/tr>\n
28<\/td>\n6.5.5 Observation of animals
6.5.6 \u200bEvaluation of results <\/td>\n<\/tr>\n
29<\/td>\n6.5.7 Test report
6.6 Closed-patch test (Buehler test)
6.6.1 Principle
6.6.2 Test sample preparation
6.6.3 Animals and husbandry <\/td>\n<\/tr>\n
30<\/td>\n6.6.4 Test procedure <\/td>\n<\/tr>\n
31<\/td>\n6.6.5 Observation of animals
6.6.6 \u200bEvaluation of results
6.6.7 Test report <\/td>\n<\/tr>\n
32<\/td>\n7 Key factors in interpretation of test results <\/td>\n<\/tr>\n
33<\/td>\nAnnex A (normative) Preparation of materials for skin sensitization testing <\/td>\n<\/tr>\n
35<\/td>\nAnnex B (informative) Method for the preparation of extracts from polymeric test materials <\/td>\n<\/tr>\n
38<\/td>\nAnnex C (informative) Non-animal methods for skin sensitization <\/td>\n<\/tr>\n
51<\/td>\nAnnex D (informative) Background information on sensitization tests for skin sensitization <\/td>\n<\/tr>\n
54<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Biological evaluation of medical devices – Tests for skin sensitization<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2023<\/td>\n64<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":425033,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-425024","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\/425024","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\/425033"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=425024"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=425024"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=425024"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}