{"id":278115,"date":"2024-10-19T18:44:22","date_gmt":"2024-10-19T18:44:22","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-156752016a12020\/"},"modified":"2024-10-25T15:16:19","modified_gmt":"2024-10-25T15:16:19","slug":"bs-iso-156752016a12020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-156752016a12020\/","title":{"rendered":"BS ISO 15675:2016+A1:2020"},"content":{"rendered":"
This document specifies requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous material from the blood of humans during cardiopulmonary bypass surgery.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
2<\/td>\n | National foreword <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | 4 Requirements 4.1 Biological characteristics 4.1.1 Sterility and non-pyrogenicity 4.1.2 Biocompatibility 4.2 Physical characteristics 4.2.1 Blood pathway integrity 4.2.2 Blood volume 4.2.3 Connectors 4.3 Performance characteristics 4.3.1 Blood cell damage <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | 4.3.2 Filtration efficiency 4.3.3 Flow rate capacity 4.3.4 Shelf life 4.3.5 Air-handling capability 5 Tests and measurements to determine compliance with this document 5.1 General 5.2 Biological characteristics 5.2.1 Sterility and non-pyrogenicity 5.2.2 Biocompatibility <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 5.3 Physical characteristics 5.3.1 Blood pathway integrity (sterile final assembly) 5.3.2 Blood volume 5.3.3 Connectors 5.4 Performance characteristics 5.4.1 Blood cell damage <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | 5.4.2 Filtration efficiency 5.4.3 Filter flow rate 5.4.4 Shelf life <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 5.4.5 Air-handling capability 6 Information supplied by the manufacturer 6.1 Information on the arterial blood line filter 6.2 Information on the packaging 6.2.1 Information on the unit container <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 6.2.2 Information on the shipping container 6.3 Information in the accompanying documents 6.4 Information in the accompanying documents in a prominent form <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 7 Packaging <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | \uea01Annex A (informative) Examples of connectors and reference fittings <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters<\/b><\/p>\n |