{"id":279436,"date":"2024-10-19T18:51:32","date_gmt":"2024-10-19T18:51:32","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10993-102013\/"},"modified":"2024-10-25T15:25:26","modified_gmt":"2024-10-25T15:25:26","slug":"bs-en-iso-10993-102013","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10993-102013\/","title":{"rendered":"BS EN ISO 10993-10:2013"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
5<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC on Medical Devices <\/td>\n<\/tr>\n
6<\/td>\nAnnex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90\/385\/EEC on Active Implantable Medical Devices <\/td>\n<\/tr>\n
11<\/td>\nScope
Normative references <\/td>\n<\/tr>\n
12<\/td>\nTerms and definitions <\/td>\n<\/tr>\n
14<\/td>\nGeneral principles\u00a0\u2014 Step-wise approach
Pretest considerations
General <\/td>\n<\/tr>\n
15<\/td>\nTypes of material
Initial considerations
Ceramics, metals and alloys
Polymers
Biologically derived materials
Information on chemical composition
General
Existing data sources <\/td>\n<\/tr>\n
16<\/td>\nIrritation tests
In\u00a0vitro irritation tests
In\u00a0vivo irritation tests\u00a0\u2014 Factors to be considered in desig <\/td>\n<\/tr>\n
17<\/td>\nAnimal irritation test
Principle
Test material
Animals and husbandry <\/td>\n<\/tr>\n
18<\/td>\nTest procedure
Preparation of animals
Application of test sample
Application of powder or liquid sample <\/td>\n<\/tr>\n
19<\/td>\nApplication of extracts and extract vehicle
Application of solid sample <\/td>\n<\/tr>\n
20<\/td>\nObservation of animals
General
Single-exposure test
Repeated-exposure test
Evaluation of results <\/td>\n<\/tr>\n
21<\/td>\nTest report
Animal intracutaneous (intradermal) reactivity test
Introduction
Exclusion from test
Test sample <\/td>\n<\/tr>\n
22<\/td>\nAnimals and husbandry
Test procedure <\/td>\n<\/tr>\n
23<\/td>\nObservation of animals
Evaluation of results <\/td>\n<\/tr>\n
24<\/td>\nTest report
Human skin irritation test
Introduction
Initial considerations <\/td>\n<\/tr>\n
25<\/td>\nSkin sensitization tests
Choice of test methods
Murine Local Lymph Node Assay (LLNA)
Principle <\/td>\n<\/tr>\n
26<\/td>\nTest sample preparation
Animals and husbandry
Test procedure <\/td>\n<\/tr>\n
27<\/td>\nTreatment groups
Determination of cellular proliferation and tissue preparati <\/td>\n<\/tr>\n
28<\/td>\nResults and interpretation
Test report
Guinea pig assays for the detection of skin sensitization
Principle <\/td>\n<\/tr>\n
29<\/td>\nChoice of test sample concentrations
Induction
Challenge
Important factors affecting the outcome of the test <\/td>\n<\/tr>\n
30<\/td>\nGuinea pig maximization test (GPMT)
Principle
Test sample preparation
Animals and husbandry
Test procedure
Preparation <\/td>\n<\/tr>\n
31<\/td>\nPreliminary tests
Main test
Intradermal induction phase <\/td>\n<\/tr>\n
32<\/td>\nTopical induction phase
Challenge phase
Observation of animals <\/td>\n<\/tr>\n
33<\/td>\nEvaluation of results
Test report
Closed-patch test (Buehler test)
Principle
Test sample preparation
Animals and husbandry <\/td>\n<\/tr>\n
34<\/td>\nTest procedure
Preparation
Preliminary tests
Main test
Induction phase
Challenge phase <\/td>\n<\/tr>\n
35<\/td>\nObservation of animals
Evaluation of results
Test report <\/td>\n<\/tr>\n
36<\/td>\nKey factors in interpretation of test results <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Biological evaluation of medical devices – Tests for irritation and 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>\n2014<\/td>\n80<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279439,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-279436","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\/279436","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\/279439"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279436"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279436"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279436"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}