{"id":464724,"date":"2024-10-20T10:36:32","date_gmt":"2024-10-20T10:36:32","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-11979-102018-2\/"},"modified":"2024-10-26T19:33:31","modified_gmt":"2024-10-26T19:33:31","slug":"bs-en-iso-11979-102018-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-11979-102018-2\/","title":{"rendered":"BS EN ISO 11979-10:2018"},"content":{"rendered":"

This document specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power.<\/p>\n

There are three main categories of phakic intraocular lenses depending on the optical design:<\/p>\n

    \n
  1. \n

    Phakic monofocal (PIOL);<\/p>\n<\/li>\n

  2. \n

    Phakic multifocal (PMIOL); and<\/p>\n<\/li>\n

  3. \n

    Phakic toric (PTIOL).<\/p>\n<\/li>\n<\/ol>\n

    Each of these categories is further designated for implantation in either the anterior or posterior chamber of the anterior segment of the eye.<\/p>\n

    The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and PTIOL designs.<\/p>\n

    This document addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.<\/p>\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
    2<\/td>\nNational foreword <\/td>\n<\/tr>\n
    4<\/td>\nEuropean foreword <\/td>\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, 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
    11<\/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
    12<\/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
    13<\/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
    14<\/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
    17<\/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
    18<\/td>\nAnnex A (informative) Elements in a phakic IOL clinical investigation <\/td>\n<\/tr>\n
    24<\/td>\nAnnex B (informative) Statistical methods and sample size calculations <\/td>\n<\/tr>\n
    25<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

    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>\n2018<\/td>\n26<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":464734,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[145,2641],"product_tag":[],"class_list":{"0":"post-464724","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\/464724","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\/464734"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=464724"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=464724"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=464724"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}