{"id":425918,"date":"2024-10-20T06:59:20","date_gmt":"2024-10-20T06:59:20","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-23-30453001-dc\/"},"modified":"2024-10-26T13:11:58","modified_gmt":"2024-10-26T13:11:58","slug":"bsi-23-30453001-dc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-23-30453001-dc\/","title":{"rendered":"BSI 23\/30453001 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\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
3 Terms and definitions and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviated terms <\/td>\n<\/tr>\n
10<\/td>\n4 Justification for a clinical investigation
5 Ethical considerations
6 General requirements
6.1 General <\/td>\n<\/tr>\n
11<\/td>\n6.2 Design of a clinical investigation
6.2.1 Requirements for all types of IOL
6.2.2 Additional requirements for toric IOLs (TIOL)
6.2.3 Additional requirements for Simultaneous Vision IOL (SVIOL) including MIOL, EDF and FVR lenses <\/td>\n<\/tr>\n
14<\/td>\n6.2.4 Additional requirements for accommodating IOLs (AIOL)
6.2.5 Additional requirements for anterior chamber IOLs
6.3 Characteristics of clinical investigations
6.3.1 General
6.3.2 Characteristics to be studied for all types of IOL <\/td>\n<\/tr>\n
15<\/td>\n6.3.3 Additional characteristics to be studied for toric IOL
6.3.4 Additional characteristics to be studied for SVIOLs
6.3.5 Additional characteristics to be studied for accommodating IOL <\/td>\n<\/tr>\n
16<\/td>\n6.3.6 Additional characteristics applying to anterior chamber IOLs
6.3.7 Additional characteristics
6.4 Duration of the investigations
6.5 Enrolment <\/td>\n<\/tr>\n
17<\/td>\n6.6 Bilateral implantation
6.7 Surgical technique
6.8 Examination and treatment of subjects
6.9 Adverse events reports
6.10 Inclusion and exclusion criteria
6.10.1 General
6.10.2 General inclusion criteria <\/td>\n<\/tr>\n
18<\/td>\n6.10.3 Additional inclusion criteria for toric IOL
6.10.4 General exclusion criteria
6.10.5 Additional exclusion criteria for simultaneous vision IOL
6.10.6 Additional exclusion criteria for anterior chamber IOL <\/td>\n<\/tr>\n
20<\/td>\nAnnex\u20acA (normative) General elements in the clinical investigation of IOLs <\/td>\n<\/tr>\n
25<\/td>\nAnnex\u20acB (informative) Additional elements for the clinical investigation of toric IOLs <\/td>\n<\/tr>\n
30<\/td>\nAnnex\u20acC (informative) Additional elements for the clinical investigation of simultaneous vision (SVIOL) IOLs <\/td>\n<\/tr>\n
38<\/td>\nAnnex\u20acD (informative) Additional elements for the clinical investigation of accommodating IOLs <\/td>\n<\/tr>\n
43<\/td>\nAnnex\u20acE (informative) Evaluation of post operative adverse events and visual acuity rates <\/td>\n<\/tr>\n
47<\/td>\nAnnex\u20acF (informative) Clinical tests <\/td>\n<\/tr>\n
54<\/td>\nAnnex\u20acG (informative) Statistical methods and sample size calculations <\/td>\n<\/tr>\n
59<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

BS EN ISO 11979-7. Ophthalmic implants. Intraocular lenses – Part 7. Clinical investigations of intraocular lenses for the correction of aphakia<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2023<\/td>\n59<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":425927,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[145,2641],"product_tag":[],"class_list":{"0":"post-425918","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\/425918","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\/425927"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=425918"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=425918"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=425918"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}