{"id":426664,"date":"2024-10-20T07:03:08","date_gmt":"2024-10-20T07:03:08","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-23-30471829-dc\/"},"modified":"2024-10-26T13:20:18","modified_gmt":"2024-10-26T13:20:18","slug":"bsi-23-30471829-dc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-23-30471829-dc\/","title":{"rendered":"BSI 23\/30471829 DC"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
1<\/td>\n | 30471829.PDF <\/td>\n<\/tr>\n | ||||||
3<\/td>\n | ISO_DIS 23217.2 ed.1 – id.74899 Enquiry.2 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 <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 4 Considerations for design inputs 4.1 General 4.2 Risk assessment and usability engineering 4.2.1 Risk assessment 4.2.2 Usability engineering 4.3 Determination of the intended demographic population <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 4.4 Considerations for the determination of requirements for the design of medical devices specific to paediatric users 4.4.1 Considerations in relation to risk (risk-based approach to design) 4.4.2 Considerations in relation to human factors <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 4.4.3 Considerations for accompanying documentation 5 Development of the design <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | 6 Design verification and validation 6.1 General 6.2 Design verification 6.3 Design validation 6.3.1 General 6.3.2 Usability evaluations (also known as usability tests or user studies) <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | 6.3.3 Clinical evaluation <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | Annex\u20acA (informative) Additional considerations for the “paediatric population” <\/td>\n<\/tr>\n | ||||||
47<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" BS ISO 23217.2. Injection systems for self-administration by paediatric patients. Guidelines for design<\/b><\/p>\n |