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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA
| 분야 | ISO/TC 212 : Clinical laboratory testing and in vitro diagnostic test systems |
|---|---|
| 적용범위 | This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination performed by medical 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. Different dedicated measures are taken for stabilizing blood cell free circulating DNA, which are not described in this document. NOTE Circulating cell free DNA in blood is covered in ISO 20186-3. Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document. This document does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom. DNA in pathogens present in blood is not covered by this document. |
| 국제분류(ICS)코드 | 11.100.10 : 체외진단용 시험 시스템 |
| 페이지수 | 20 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | CSA ISO 20186-2:22 | Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA (Adopted ISO 20186-2:2019, first edition, 2019-02) | 2022-01-01 | 표준 |
| 2 | ISO 20186-2:2019 | Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA | 2019-02-19 | 표준 |
ISO 20186-1:2019 - Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA 상세보기
ISO 20186-3:2019 - Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma 상세보기
CSA ISO 20186-1:22 - Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA (Adopted ISO 20186-1:2019, first edition, 2019-02) 상세보기
CSA ISO 20186-2:22 - Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA (Adopted ISO 20186-2:2019, first edition, 2019-02) 상세보기
CSA ISO 20186-3:22 - Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma (Adopted ISO 20186-3:2019, first edition, 2019-09) 상세보기
ISO 38200:2018 - Chain of custody of wood and wood-based products 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 20391-1:2018 - Biotechnology — Cell counting — Part 1: General guidance on cell counting methods 상세보기
ISO/TS 20658:2017 - Medical laboratories — Requirements for collection, transport, receipt, and handling of samples 상세보기
ISO 20391-2:2019 - Biotechnology — Cell counting — Part 2: Experimental design and statistical analysis to quantify counting method performance 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
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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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