{"id":416250,"date":"2024-10-20T06:09:45","date_gmt":"2024-10-20T06:09:45","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-22-30447834-dc-2022\/"},"modified":"2024-10-26T11:26:41","modified_gmt":"2024-10-26T11:26:41","slug":"bsi-22-30447834-dc-2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-22-30447834-dc-2022\/","title":{"rendered":"BSI 22\/30447834 DC 2022"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 4 Requirements 4.1 Risk approach 4.2 Usability engineering 4.3 Sterilization 4.4 Shelf life 4.5 Detectability 4.6 Biocompatibility 4.7 Surface <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 4.8 Corrosion resistance 4.9 Peak tensile force <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 4.10 Freedom from leakage during pressurization 4.11 Freedom from leakage during aspiration <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 4.12 Hubs 4.13 Flowrate 4.14 Power injection burst pressure 4.15 Packaging system 4.16 Simulated use, kink and\/or torque testing to consider depending on\u20acdevice design, intended use, and risk analysis <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 4.17 Coating integrity and\/or particulate testing to consider depending on\u20acdevice design, intended use, and risk analysis 4.18 Distal tip stiffness testing to consider for neurovascular applications 5 Designation of nominal size 5.1 Nominal outside diameter 5.2 Nominal inside diameter 5.3 Nominal effective length <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 6 Information to be supplied with the catheter 6.1 General 6.2 Marking on the device and\/or primary packaging <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 6.3 Instructions for use 6.4 Marking on the secondary packaging <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | Annex\u20acA (normative) Test method for corrosion resistance <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | Annex\u20acB (normative) Method for determining peak tensile force <\/td>\n<\/tr>\n | ||||||
26<\/td>\n | Annex\u20acC (normative) Test method for liquid leakage under pressure <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | Annex\u20acD (normative) Test method for air leakage into hub assembly during aspiration <\/td>\n<\/tr>\n | ||||||
30<\/td>\n | Annex\u20acE (normative) Determination of flowrate through catheter <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | Annex\u20acF (normative) Test for burst pressure under static conditions <\/td>\n<\/tr>\n | ||||||
35<\/td>\n | Annex\u20acG (normative) Power injection tests for flowrate and device pressure (only for products indicated for power injection) <\/td>\n<\/tr>\n | ||||||
40<\/td>\n | Annex\u20acH (informative) Units of measurement systems other than those specified in this\u20acdocument, which may additionally be used <\/td>\n<\/tr>\n | ||||||
42<\/td>\n | Annex\u20acI (normative) Test method for air leakage under water <\/td>\n<\/tr>\n | ||||||
44<\/td>\n | Annex\u20acJ (informative) Rationale and guidance <\/td>\n<\/tr>\n | ||||||
50<\/td>\n | Annex\u20acK (informative) Test methods <\/td>\n<\/tr>\n | ||||||
51<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" BS EN ISO 10555-1. Intravascular catheters. Sterile and single-use catheters – Part 1. General requirements<\/b><\/p>\n |