Pediatric 中文可翻譯為小兒. 兒童. 但這個詞是指幾歲以下的人. 在不同地方有不同標準.
台灣兒科醫學會的公告 2007-09-12
行政院衛生署「兒童健康推展委員會」96年第2次會議討論我國兒科之就診年齡，建議醫療機構得參酌兒童及少年福利法之定義，將兒科就診年齡認定為未滿18歲之人乙案。
衛生署藥政處 中華民國九十一年七月公告的~~小兒族群的藥動學試驗基準 Guidance for Pediatric Pharmacokinetic Studies 年齡是指 16歲以下. 但後來衛生福利部於中華民國110年3月23日以衛授食字第1101401255號公告修訂「小兒族群的藥動學試驗基準」，已經將年齡修正為18歲
美國FDA Pediatric Medical Devices(更新至2024-04-18) 出生至21歲(滿22足歲之前)
Pediatric medical devices treat or diagnose diseases and conditions from birth through age 21. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients as persons aged 21 or younger at the time of their diagnosis or treatment. Pediatric subpopulations are further categorized as follows:
Neonates - from birth through the first 28 days of life
Infants - 29 days to less than 2 years
Children - 2 years to less than 12 years
Adolescents - aged 12 through 21 (up to but not including the 22nd birthday)
同樣是美國FDA~這裡是指出生至16歲(滿17歲之前)
Pediatric Drug Development: RegulatoryConsiderations — Complying With thePediatric Research Equity Act andQualifying for Pediatric Exclusivity Underthe Best Pharmaceuticals for Children ActGuidance for IndustryDRAFT GUIDANCE
For purposes of pediatric drug development, FDA generally considers the pediatric population to include those patients from birth to younger than 17 years (i.e., birth through 16 years of age), and to include the subpopulation age groups of neonates, infants, children, and adolescents. 11 Consistent with International Council for Harmonisation (ICH) guidelines, 12 FDA considers 67 these subpopulation age groups to be divided as follows:
• Neonates: birth through 27 days (corrected gestational age)
• Infants: 28 days to 23 months
• Children: 2 years to 11 years
• Adolescents: 12 years to younger than 17 years
11 See 21 CFR 201.57(c)(9)(iv)(A) (“the terms pediatric population(s) and pediatric patient(s) are defined as the pediatric age group, from birth to 16 years, including age groups often called neonates, infants, children, and adolescents”). FDA interprets “birth to 16 years” in 21 CFR 201.57(c)(9)(iv)(A) to mean from birth to younger than 17 years old. See, for example, the guidance for industry Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling (March 2019).
德國的慕尼黑兒科年齡分類標準定義為滿18歲以前
19歲第一天開始定義為成人 adult
Systemic review of age brackets in pediatric emergency medicine literature and the development of a universal age classification for pediatric emergency patients - the Munich Age Classification System (MACS)
The following classification is one of the most common used in Germany [7].
Newborn: up to the completed 28th day of life.
Infant: 29 days – 12 months.
Toddler: 2–3 years.
Child: 4–12 years.
Adolescent: 13–18 years.
Adult: from the beginning of the 19th year
