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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
| 분야 | ISO/TC 212 : Clinical laboratory testing and in vitro diagnostic test systems |
|---|---|
| 적용범위 | ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use. ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. ISO 18113-2:2009 can also be applied to accessories. ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use. |
| 국제분류(ICS)코드 | 11.100.10 : 체외진단용 시험 시스템 |
| 페이지수 | 10 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 18113-2:2022 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use | 2022-10-06 | 표준 |
| 2 | ISO 18113-2:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use | 2009-12-09 | 구판 |
ISO 18113-1:2022 - In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements 상세보기
ISO 18113-2:2022 - In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use 상세보기
ISO 18113-3:2022 - In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use 상세보기
ISO 18113-4:2022 - In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing 상세보기
ISO 18113-5:2022 - In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing 상세보기
ISO 18113-1:2009 - In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements 상세보기
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ISO 14971:2019 - Medical devices — Application of risk management to medical devices 상세보기
ISO 18113-3:2009 - In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use 상세보기
ISO/TS 10993-19:2006 - Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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