{"id":408641,"date":"2024-10-20T05:31:41","date_gmt":"2024-10-20T05:31:41","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-22-30399894-dc-2022\/"},"modified":"2024-10-26T10:04:54","modified_gmt":"2024-10-26T10:04:54","slug":"bsi-22-30399894-dc-2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-22-30399894-dc-2022\/","title":{"rendered":"BSI 22\/30399894 DC 2022"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
1<\/td>\n | 30399894-NC.pdf <\/td>\n<\/tr>\n | ||||||
3<\/td>\n | ISO_DIS 14630 ed.5 – id.76810 Enquiry PDF (en).pdf <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 4 Intended performance 5 Design attributes <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 6 Selection of materials 7 Design evaluation 7.1 General <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 7.2 Pre-clinical evaluation <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 7.3 Clinical evaluation and clinical investigation <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 7.4 Post-market surveillance 8 Manufacture <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 9 Sterilization 9.1 Implants supplied sterile 9.2 Implants supplied non-sterile 9.3 Implants that are resterilizable <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 9.4 Sterilization residuals 10 Packaging 10.1 Protection from damage in transport, storage and handling 10.2 Maintenance of sterility in transport, storage and handling 11 Information supplied by the manufacturer 11.1 General <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | 11.2 Marking on implants 11.3 Label <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | 11.4 Instructions for use <\/td>\n<\/tr>\n | ||||||
26<\/td>\n | 11.5 Patient record label(s) 11.6 Implant card <\/td>\n<\/tr>\n | ||||||
27<\/td>\n | 11.7 Implants for special purposes <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | Annex\u20acZA (informative) Relationship between this European Standard the General Safety and Performance Requirements of Regulation (EU) 2017\/745 aimed to be covered <\/td>\n<\/tr>\n | ||||||
33<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" BS EN ISO 14630. Non-active surgical implants. General requirements<\/b><\/p>\n |