{"id":279547,"date":"2024-10-19T18:52:16","date_gmt":"2024-10-19T18:52:16","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-17-30344601-dc\/"},"modified":"2024-10-25T15:26:08","modified_gmt":"2024-10-25T15:26:08","slug":"bsi-17-30344601-dc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-17-30344601-dc\/","title":{"rendered":"BSI 17\/30344601 DC"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
6<\/td>\nForeword <\/td>\n<\/tr>\n
7<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
10<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
13<\/td>\n4 General principles applying to biological evaluation of medical devices <\/td>\n<\/tr>\n
17<\/td>\n5 Categorization of medical devices
5.1 General
5.2 Categorization by nature of body contact
5.2.1 Non-contacting devices <\/td>\n<\/tr>\n
18<\/td>\n5.2.2 Transient-contacting devices
5.2.3 Surface-contacting devices
5.2.4 External communicating devices <\/td>\n<\/tr>\n
19<\/td>\n5.2.5 Implant devices
5.3 Categorization by duration of contact <\/td>\n<\/tr>\n
20<\/td>\n6 Biocompatibility evaluation process
6.1 Biological risk assessment
6.1.1 Physical and chemical information
6.1.2 General: Gap analysis and selection of biological endpoints for assessment <\/td>\n<\/tr>\n
22<\/td>\n6.1.3 Biological testing <\/td>\n<\/tr>\n
26<\/td>\n7 Interpretation of biological evaluation data and overall biological safety assessment <\/td>\n<\/tr>\n
28<\/td>\nAnnex\u00a0A (informative) Endpoints to be addressed in a biological risk assessment <\/td>\n<\/tr>\n
33<\/td>\nAnnex\u00a0B (informative) Guidance on the conduct of biological evaluation within a risk management process <\/td>\n<\/tr>\n
46<\/td>\nAnnex\u00a0C (informative) Suggested procedure for literature review <\/td>\n<\/tr>\n
48<\/td>\nAnnex\u00a0ZA (informative) Relationship between this European Standard and the\u00a0essential requirements of Directive 93\/42\/EEC [OJ L 169] aimed to be covered <\/td>\n<\/tr>\n
50<\/td>\nAnnex\u00a0ZB (informative) Relationship between this European Standard and the\u00a0essential requirements of Directive 90\/385\/EEC [OJ L 189] aimed to be covered <\/td>\n<\/tr>\n
52<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

BS EN ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2017<\/td>\n53<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279551,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-279547","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\/279547","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\/279551"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279547"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279547"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279547"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}