{"id":277620,"date":"2024-10-19T18:41:44","date_gmt":"2024-10-19T18:41:44","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-135042012\/"},"modified":"2024-10-25T15:12:33","modified_gmt":"2024-10-25T15:12:33","slug":"bs-en-iso-135042012","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-135042012\/","title":{"rendered":"BS EN ISO 13504:2012"},"content":{"rendered":"
This International Standard specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area.<\/p>\n
It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.<\/p>\n
It is not applicable to the power-driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant.<\/p>\n
With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be supplied by the manufacturer.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
6<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | 1\tScope 2\tNormative references <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | 3\tTerms and definitions 3.2\tInstruments 3.3\t\tStainless steel <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 4\tClassification 4.1\tIntended usage (application) 4.2\tTissue contact 4.3\tReprocessing 5\tIntended performance 6\tPerformance attributes <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | 7\tMaterial selection 8\tPerformance evaluation 8.1\tGeneral 8.2\tPre-clinical evaluation 8.3\tClinical evaluation <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 9\tManufacturing 9.1\tGeneral 9.2\tTechnical documentation 10\tReprocessing 10.1\tProducts supplied sterile 10.2\tProducts provided non-sterile 10.3\tReprocessing information 11\tInformation to be supplied by the manufacturer 11.1\tGeneral 11.2\tMarking on instruments <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 11.3\tLabelling on the package 11.4\tInstructions for use <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | Annex\u00a0A \n(normative)<\/p>\n Materials found acceptable for instrument manufacture <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | Annex\u00a0B \n(informative)<\/p>\n Cross-referencing of steel grades specified in international, regional | ||||||
23<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Dentistry. General requirements for instruments and related accessories used in dental implant placement and treatment<\/b><\/p>\n |