{"id":403509,"date":"2024-10-20T05:06:24","date_gmt":"2024-10-20T05:06:24","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10993-92021-tc\/"},"modified":"2024-10-26T09:06:45","modified_gmt":"2024-10-26T09:06:45","slug":"bs-en-iso-10993-92021-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10993-92021-tc\/","title":{"rendered":"BS EN ISO 10993-9:2021 – TC"},"content":{"rendered":"

This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro<\/i> degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series<\/span><\/span>.<\/p>\n

This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade.<\/p>\n

This document is not applicable to:<\/p>\n

    \n
  1. \n

    the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available;<\/p>\n

    \n
    \n NOTE\n <\/div>\n

    Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993<\/span><\/span> .<\/p>\n<\/p><\/div>\n<\/li>\n

  2. \n

    leachable components which are not degradation products;<\/p>\n<\/li>\n

  3. \n

    medical devices or components that do not contact the patient’s body directly or indirectly.<\/p>\n<\/li>\n<\/ol>\n

    PDF Catalog<\/h4>\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
    1<\/td>\n30455776 <\/td>\n<\/tr>\n
    31<\/td>\nA-30354690 <\/td>\n<\/tr>\n
    32<\/td>\nNational foreword <\/td>\n<\/tr>\n
    36<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
    38<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the general health and safety requirements of Regulation (EU) 2017\/745 on medical devices aimed to be covered <\/td>\n<\/tr>\n
    41<\/td>\nForeword <\/td>\n<\/tr>\n
    42<\/td>\nIntroduction <\/td>\n<\/tr>\n
    43<\/td>\n1 Scope
    2 Normative references
    3 Terms and definitions <\/td>\n<\/tr>\n
    44<\/td>\n4 Principles for design of degradation studies
    4.1 General <\/td>\n<\/tr>\n
    45<\/td>\n4.2 Preliminary considerations
    4.3 Study design <\/td>\n<\/tr>\n
    46<\/td>\n4.4 Characterization of degradation products from medical devices
    5 Study report <\/td>\n<\/tr>\n
    48<\/td>\nAnnex A (normative) Consideration of the need for degradation studies <\/td>\n<\/tr>\n
    50<\/td>\nAnnex B (informative) Degradation study considerations <\/td>\n<\/tr>\n
    52<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

    Tracked Changes. Biological evaluation of medical devices – Framework for identification and quantification of potential degradation products<\/b><\/p>\n\n\n\n\n
    Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
    BSI<\/b><\/a><\/td>\n2022<\/td>\n54<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":403515,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-403509","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\/403509","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\/403515"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=403509"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=403509"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=403509"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}