{"id":279953,"date":"2024-10-19T18:54:17","date_gmt":"2024-10-19T18:54:17","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-11979-102018-tc\/"},"modified":"2024-10-25T15:29:03","modified_gmt":"2024-10-25T15:29:03","slug":"bs-en-iso-11979-102018-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-11979-102018-tc\/","title":{"rendered":"BS EN ISO 11979-10:2018 – TC"},"content":{"rendered":"

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
47<\/td>\nNational foreword <\/td>\n<\/tr>\n
49<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
51<\/td>\nForeword <\/td>\n<\/tr>\n
52<\/td>\nIntroduction <\/td>\n<\/tr>\n
54<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
55<\/td>\n3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviated terms
4 Optical requirements
5 Mechanical requirements
6 Biocompatibility requirements
7 Shelf-life and transport stability requirements
8 Fundamental requirements <\/td>\n<\/tr>\n
56<\/td>\n9 Justification for a clinical investigation
10 General clinical requirements
10.1 General
10.2 Design of a clinical investigation
10.2.1 Requirements for all types of phakic IOLs
10.2.2 Additional requirements for PTIOLs <\/td>\n<\/tr>\n
57<\/td>\n10.2.3 Additional requirements for PMIOLs
10.3 Characteristics
10.3.1 General
10.3.2 Characteristics applying to the clinical evaluations for all types of phakic IOLs <\/td>\n<\/tr>\n
58<\/td>\n10.3.3 Additional characteristics applying to PTIOLs
10.3.4 Additional characteristics applying to PMIOLs
10.4 Duration of the investigation
10.5 Enrolment
10.6 Bilateral implantation <\/td>\n<\/tr>\n
59<\/td>\n10.7 Surgical technique
10.8 Examination and treatment of subjects
10.9 Adverse events reports
10.10 Inclusion and exclusion criteria
10.10.1 General criteria for all phakic IOLs <\/td>\n<\/tr>\n
62<\/td>\n10.10.2 Additional criteria for PTIOLs
10.10.3 Additional criteria for multifocal IOLs
11 Information supplied by the manufacturer <\/td>\n<\/tr>\n
63<\/td>\nAnnex A (informative) Elements in a phakic IOL clinical investigation <\/td>\n<\/tr>\n
69<\/td>\nAnnex B (informative) Statistical methods and sample size calculations <\/td>\n<\/tr>\n
70<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. Ophthalmic implants. Intraocular lenses – Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2020<\/td>\n71<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279960,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[145,2641],"product_tag":[],"class_list":{"0":"post-279953","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-70","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\/279953","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\/279960"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279953"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279953"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279953"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}