{"id":211924,"date":"2024-10-19T13:42:46","date_gmt":"2024-10-19T13:42:46","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/ieee-1708a-2019\/"},"modified":"2024-10-25T06:31:28","modified_gmt":"2024-10-25T06:31:28","slug":"ieee-1708a-2019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/ieee\/ieee-1708a-2019\/","title":{"rendered":"IEEE 1708a 2019"},"content":{"rendered":"
Amendment Standard – Active. Clarifying and furthering the subject selection of the sample size in the clinical study; looking into the results of the validation study with respect to the patient\u2019s body position and activity level for their applicability to ambulatory patients; and addressing the issues of motion artifact is covered in the amendment.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
1<\/td>\n | IEEE Std 1708a\u2122-2019 Front cover <\/td>\n<\/tr>\n | ||||||
2<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | Important Notices and Disclaimers Concerning IEEE Standards Documents <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | Participants <\/td>\n<\/tr>\n | ||||||
8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | 4. Performance evaluation 4.1 Summary <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | 4.2 Observer training and measurement 4.2.2 Observer measurement <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | 4.3 Subject selection 4.3.1 Subject selection requirements for normal adult population 4.3.2 Confounding factors <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 4.3.3 Special patient populations and confounding factors <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 4.4 Validation procedure 4.4.1 Introduction 4.4.2 Static test <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 4.5 Validation criteria 4.5.1 Introduction <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 4.5.3 Phase 2 4.5.3.2 Accuracy at different BP change levels <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 4.6 Data reporting 4.6.1 Subject information 4.6.2 Statistical report <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 4.6.3 Graphic representation 6. Device function and performance during ambulatory conditions and patient motion 6.1 Robustness to motion induced noise 6.2 Device design in relation to ambulatory conditions and motion <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 6.3 Performance during ambulatory and motion conditions <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | Annex C (informative) Posture of subject during validation test <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | Annex D (informative) Justification of sample size D.1 Introduction <\/td>\n<\/tr>\n | ||||||
26<\/td>\n | D.2 Experimental findings of estimation errors in cuffless BP measuring devices <\/td>\n<\/tr>\n | ||||||
27<\/td>\n | D.3 Sample size determination based on MAD <\/td>\n<\/tr>\n | ||||||
30<\/td>\n | D.4 Effect of repeated measurements from subjects <\/td>\n<\/tr>\n | ||||||
31<\/td>\n | D.5 Confounding factors and special patient conditions <\/td>\n<\/tr>\n | ||||||
33<\/td>\n | Annex E (informative) Bibliography <\/td>\n<\/tr>\n | ||||||
35<\/td>\n | Back cover <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" IEEE Standard for Wearable, Cuffless Blood Pressure Measuring Devices – Amendment 1<\/b><\/p>\n |