{"id":279364,"date":"2024-10-19T18:50:58","date_gmt":"2024-10-19T18:50:58","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10993-102010\/"},"modified":"2024-10-25T15:24:58","modified_gmt":"2024-10-25T15:24:58","slug":"bs-en-iso-10993-102010","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10993-102010\/","title":{"rendered":"BS EN ISO 10993-10:2010"},"content":{"rendered":"

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.<\/p>\n

This part of ISO 10993 includes:<\/p>\n

    \n
  1. \n

    pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;<\/p>\n<\/li>\n

  2. \n

    details of in vivo (irritation and sensitization) test procedures;<\/p>\n<\/li>\n

  3. \n

    key factors for the interpretation of the results.<\/p>\n<\/li>\n<\/ol>\n

    Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.<\/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
    PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
    8<\/td>\nScope
    Normative references
    Scope
    Normative references <\/td>\n<\/tr>\n
    9<\/td>\nTerms and definitions
    Terms and definitions <\/td>\n<\/tr>\n
    11<\/td>\nGeneral principles\u00a0\u2014 Step-wise approach
    Pretest considerations
    General
    General principles\u00a0\u2014 Step-wise approach
    Pretest considerations
    General <\/td>\n<\/tr>\n
    12<\/td>\nTypes of material
    Initial considerations
    Ceramics, metals and alloys
    Polymers
    Biologically derived materials
    Information on chemical composition
    General
    Existing data sources
    Types of material
    Initial considerations
    Ceramics, metals and alloys
    Polymers
    Biologically derived materials
    Information on chemical composition
    General
    Existing data sources <\/td>\n<\/tr>\n
    13<\/td>\nIrritation tests
    In\u00a0vitro irritation tests
    In\u00a0vivo irritation tests\u00a0\u2014 Factors to be considered in desig
    Irritation tests
    In\u00a0vitro irritation tests
    In\u00a0vivo irritation tests\u00a0\u2014 Factors to be considered in desig <\/td>\n<\/tr>\n
    14<\/td>\nAnimal irritation test
    Principle
    Test material
    Animals and husbandry
    Animal irritation test
    Principle
    Test material
    Animals and husbandry <\/td>\n<\/tr>\n
    15<\/td>\nTest procedure
    Preparation of animals
    Application of test sample
    Application of powder or liquid sample
    Test procedure
    Preparation of animals
    Application of test sample
    Application of powder or liquid sample <\/td>\n<\/tr>\n
    16<\/td>\nApplication of extracts and extract vehicle
    Application of solid sample
    Application of extracts and extract vehicle
    Application of solid sample <\/td>\n<\/tr>\n
    17<\/td>\nObservation of animals
    General
    Single-exposure test
    Repeated-exposure test
    Evaluation of results
    Observation of animals
    General
    Single-exposure test
    Repeated-exposure test
    Evaluation of results <\/td>\n<\/tr>\n
    18<\/td>\nTest report
    Animal intracutaneous (intradermal) reactivity test
    Introduction
    Exclusion from test
    Test sample
    Test report
    Animal intracutaneous (intradermal) reactivity test
    Introduction
    Exclusion from test
    Test sample <\/td>\n<\/tr>\n
    19<\/td>\nAnimals and husbandry
    Test procedure
    Animals and husbandry
    Test procedure <\/td>\n<\/tr>\n
    20<\/td>\nObservation of animals
    Evaluation of results
    Observation of animals
    Evaluation of results <\/td>\n<\/tr>\n
    21<\/td>\nTest report
    Human skin irritation test
    Introduction
    Initial considerations
    Test report
    Human skin irritation test
    Introduction
    Initial considerations <\/td>\n<\/tr>\n
    22<\/td>\nSkin sensitization tests
    Choice of test methods
    Murine Local Lymph Node Assay (LLNA)
    Principle
    Skin sensitization tests
    Choice of test methods
    Murine Local Lymph Node Assay (LLNA)
    Principle <\/td>\n<\/tr>\n
    23<\/td>\nTest sample preparation
    Animals and husbandry
    Test procedure
    Test sample preparation
    Animals and husbandry
    Test procedure <\/td>\n<\/tr>\n
    24<\/td>\nTreatment groups
    Determination of cellular proliferation and tissue preparati
    Treatment groups
    Determination of cellular proliferation and tissue preparati <\/td>\n<\/tr>\n
    25<\/td>\nResults and interpretation
    Test report
    Guinea pig assays for the detection of skin sensitization
    Principle
    Results and interpretation
    Test report
    Guinea pig assays for the detection of skin sensitization
    Principle <\/td>\n<\/tr>\n
    26<\/td>\nChoice of test sample concentrations
    Induction
    Challenge
    Important factors affecting the outcome of the test
    Choice of test sample concentrations
    Induction
    Challenge
    Important factors affecting the outcome of the test <\/td>\n<\/tr>\n
    27<\/td>\nGuinea pig maximization test (GPMT)
    Principle
    Test sample preparation
    Animals and husbandry
    Test procedure
    Preparation
    Guinea pig maximization test (GPMT)
    Principle
    Test sample preparation
    Animals and husbandry
    Test procedure
    Preparation <\/td>\n<\/tr>\n
    28<\/td>\nPreliminary tests
    Main test
    Intradermal induction phase
    Preliminary tests
    Main test
    Intradermal induction phase <\/td>\n<\/tr>\n
    29<\/td>\nTopical induction phase
    Challenge phase
    Observation of animals
    Topical induction phase
    Challenge phase
    Observation of animals <\/td>\n<\/tr>\n
    30<\/td>\nEvaluation of results
    Test report
    Closed-patch test (Buehler test)
    Principle
    Test sample preparation
    Animals and husbandry
    Evaluation of results
    Test report
    Closed-patch test (Buehler test)
    Principle
    Test sample preparation
    Animals and husbandry <\/td>\n<\/tr>\n
    31<\/td>\nTest procedure
    Preparation
    Preliminary tests
    Main test
    Induction phase
    Challenge phase
    Test procedure
    Preparation
    Preliminary tests
    Main test
    Induction phase
    Challenge phase <\/td>\n<\/tr>\n
    32<\/td>\nObservation of animals
    Evaluation of results
    Test report
    Observation of animals
    Evaluation of results
    Test report <\/td>\n<\/tr>\n
    33<\/td>\nKey factors in interpretation of test results
    Key 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>\n2012<\/td>\n76<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279371,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-279364","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\/279364","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\/279371"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279364"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279364"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279364"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}