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Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins
| 분야 | ISO/TC 212 : Clinical laboratory testing and in vitro diagnostic test systems |
|---|---|
| 적용범위 | This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable for protein examination by immunohistochemistry. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document. |
| 국제분류(ICS)코드 | 11.100.10 : 체외진단용 시험 시스템 |
| 페이지수 | 19 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | CSA ISO 20166-2:22 | Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins (Adopted ISO 20166-2:2018, first edition, 2018-12) | 2022-01-01 | 표준 |
| 2 | ISO 20166-2:2018 | Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins | 2018-11-30 | 표준 |
ISO 20166-1:2018 - Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA 상세보기
ISO 20166-3:2018 - Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA 상세보기
ISO 20166-4:2021 - Molecular in vitro diagnostic examinations — Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 4: In situ detection techniques 상세보기
CSA ISO 20166-1:22 - Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA (Adopted ISO 20166-1:2018, first edition, 2018-12) 상세보기
CSA ISO 20166-2:22 - Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins (Adopted ISO 20166-2:2018, first edition, 2018-12) 상세보기
ISO 17511:2003 - In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials 상세보기
BS EN ISO 23640:2015 - In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents. 상세보기
BS EN ISO 18113-2:2011 - In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use. 상세보기
BS EN ISO 18113-1:2011 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements. 상세보기
BS EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices. 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
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