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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
| 분야 | ISO/TC 212 : Clinical laboratory testing and in vitro diagnostic test systems |
|---|---|
| 적용범위 | ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices. |
| 국제분류(ICS)코드 | 11.100.10 : 체외진단용 시험 시스템 |
| 페이지수 | 49 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 18113-1:2022 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements | 2022-10-06 | 표준 |
| 2 | ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements | 2009-12-09 | 구판 |
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