{"id":278289,"date":"2024-10-19T18:45:15","date_gmt":"2024-10-19T18:45:15","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-160612015-tc\/"},"modified":"2024-10-25T15:17:40","modified_gmt":"2024-10-25T15:17:40","slug":"bs-en-iso-160612015-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-160612015-tc\/","title":{"rendered":"BS EN ISO 16061:2015 – TC"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
40<\/td>\nForeword
Endorsement notice <\/td>\n<\/tr>\n
41<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC on medical devices
Table ZA.1 \u2014 Correspondence between this International Standard and Directive 93\/42\/EEC <\/td>\n<\/tr>\n
44<\/td>\nForeword <\/td>\n<\/tr>\n
45<\/td>\n1\tScope
2\tNormative references <\/td>\n<\/tr>\n
46<\/td>\n3\tTerms and definitions
4\tIntended performance
5\tDesign attributes <\/td>\n<\/tr>\n
47<\/td>\n6\tSelection of materials
7\tDesign evaluation
7.1\tGeneral
7.2\tPre-clinical evaluation
7.3\tClinical evaluation
8\tManufacture <\/td>\n<\/tr>\n
48<\/td>\n9\tSterilization
9.1\tProducts supplied sterile
9.2\tProducts provided non-sterile
10\tPackaging
10.1\tProtection from damage in storage and transport
10.2\tMaintenance of sterility in transit
11\tInformation supplied by the manufacturer
11.1\tGeneral <\/td>\n<\/tr>\n
49<\/td>\n11.2\tLabelling <\/td>\n<\/tr>\n
50<\/td>\n11.3\tInstructions for use <\/td>\n<\/tr>\n
51<\/td>\n11.4\tInstruments with measuring function
11.5\tRestrictions in combinations
11.6\tMarking on instruments
11.7\tInstruments intended for single use <\/td>\n<\/tr>\n
52<\/td>\nAnnex\u00a0A (informative) Examples of typical instrument applications, together with materials found acceptable for instrument manufacture <\/td>\n<\/tr>\n
61<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. Instrumentation for use in association with non-active surgical implants. General requirements<\/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>\n66<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":278292,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[146,2641],"product_tag":[],"class_list":{"0":"post-278289","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-99","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\/278289","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\/278292"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=278289"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=278289"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=278289"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}