{"id":386681,"date":"2024-10-20T03:36:33","date_gmt":"2024-10-20T03:36:33","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-166722021-tc\/"},"modified":"2024-10-26T06:35:30","modified_gmt":"2024-10-26T06:35:30","slug":"bs-en-iso-166722021-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-166722021-tc\/","title":{"rendered":"BS EN ISO 16672:2021 – TC"},"content":{"rendered":"

This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.<\/p>\n

With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.<\/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
36<\/td>\nNational foreword <\/td>\n<\/tr>\n
38<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
40<\/td>\nForeword <\/td>\n<\/tr>\n
41<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
43<\/td>\n4 Intended performance
5 Design attributes
5.1 General
5.2 Chemical description and contaminants <\/td>\n<\/tr>\n
44<\/td>\n5.3 Density
5.4 Gaseous expansion
5.5 Interfacial tension
5.6 Kinematic viscosity
5.7 Dynamic viscosity
5.8 Molecular mass distribution <\/td>\n<\/tr>\n
45<\/td>\n5.9 Particulates
5.10 Refractive index
5.11 Spectral transmittance
5.12 Surface tension
5.13 Vapour pressure
6 Design evaluation
6.1 General <\/td>\n<\/tr>\n
46<\/td>\n6.2 Evaluation of biological safety
6.2.1 General
6.2.2 Bacterial endotoxins test
6.2.3 Intraocular implantation test
6.2.4 Ethylene oxide <\/td>\n<\/tr>\n
47<\/td>\n6.3 Clinical investigation
7 Sterilization
8 Product stability
9 Integrity and performance of the delivery system <\/td>\n<\/tr>\n
48<\/td>\n10 Packaging
10.1 Protection from damage during storage and transport
10.2 Maintenance of sterility in transit
11 Information supplied by the manufacturer <\/td>\n<\/tr>\n
50<\/td>\nAnnex A (normative) Intraocular implantation test <\/td>\n<\/tr>\n
51<\/td>\nAnnex B (informative) Clinical investigation <\/td>\n<\/tr>\n
54<\/td>\nAnnex C (informative) Method for quantifying incompletely fluorinated contaminants in perfluorocarbon liquids <\/td>\n<\/tr>\n
56<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. Ophthalmic implants. Ocular endotamponades<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2021<\/td>\n58<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":386689,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[145,2641],"product_tag":[],"class_list":{"0":"post-386681","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\/386681","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\/386689"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=386681"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=386681"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=386681"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}