11.100.10 标准查询与下载
共找到 257 条与 相关的标准，共 18 页
What is ISO 20916 - Clinical performance studies of In vitro diagnostic (IVD) medical devices about? ISO 20916 discusses In vitro diagnostic (IVD) medical devices. ISO 20916 is an international standard on clinical performance studies of In vitro diagnostic medical devices. ISO 20916 outlines good study practice for the planning, design, conduct, recording, and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. ISO 20916 identifies the principles that underpin clinical performance studies and specifies general requirements intended to: Ensure the conduct of the clinical performance study that led to reliable and robust study results Define the responsibilities of the sponsor and principal investigator Assist sponsors, clinical research organizations, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of In-vitro medical devices Protect the rights, safety, dignity, and well-being of...
In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
- ICS
- 11.100.10
- CCS
- 发布
- 2019-06-30
- 实施
- 2019-06-30
What is ISO 20186-1- Pre-examination processes for venous whole blood about? ISO 20186 discusses molecular in vitro diagnostic examinations. ISO 20186-1 is the first part of a multi-part series that lays out guidelines on the handling, storage, processing, and documentation of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular examination is performed. ISO 20186-1 covers specimens collected in venous whole blood collection tubes. ISO 20186-1 helps you to standardize the entire workflow from specimen collection to the cellular RNA examination and helps you to determine important influencing factors. Note 1: Different dedicated measures are taken for stabilizing blood cell-free circulating RNA and RNA in exosomes circulating in the blood. These are not described in ISO 20186-1 . Note 2: 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 ...
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood - Isolated cellular RNA
- ICS
- 11.100.10
- CCS
- 发布
- 2019-04-30
- 实施
- 2019-04-30
What is ISO 20184-2- Isolated protein for pre-examination processes for frozen tissue about? ISO 20184 is an international standard that discusses pre-examination processes for frozen tissue for molecular in vitro diagnostic examinations. ISO 20184-2 provides the best industry guidance on Isolated protein to ensure reliable results are produced that are comparable to other laboratories. ISO 20184-2 is the second part of a multi-part series that layouts guidelines on the handling, documentation, storage, and processing of frozen tissue specimens intended for protein examination during the pre-examination phase before a molecular assay is performed.
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue - Isolated proteins
- ICS
- 11.100.10
- CCS
- 发布
- 2019-02-28
- 实施
- 2019-02-28
What is ISO 20166‑1- Isolated RNA for pre-examination processes about? ISO 20166 is an international standard that discusses molecular in vitro diagnostic examinations. ISO 20166‑1 provides the best industry guidance on Isolated RNA examination during the pre-examination phase to produce reliable results that are comparable to other laboratories. ISO 20166‑1 is the first part of a multi-part series that layouts guidelines on the handling, documentation, storage, and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed.
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Isolated RNA
- ICS
- 11.100.10
- CCS
- 发布
- 2019-02-28
- 实施
- 2019-02-28
What is ISO 20166-2- Isolated protein for pre-examination processes about? ISO 20166 is an international standard that discusses molecular in vitro diagnostic examinations. ISO 20166‑2 provides the best industry guidance on Isolated protein examination during the pre-examination phase to produce reliable results that are comparable to other laboratories. ISO 20166-2 is the second part of a multi-part series that layouts 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.
Molecular in vitro diagnostic examinations. Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Isolated proteins
- ICS
- 11.100.10
- CCS
- 发布
- 2019-01-31
- 实施
- 2019-01-31
What is ISO 20166-3- In- vitro diagnostic examinations on Isolated DNA about? ISO 20166 discusses molecular in vitro diagnostic examinations. ISO 20166-3 is the third part of a multi-part standard that layouts guidelines on the handling, documentation, storage, and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed. ISO 20166-3 assists to improve the pre-examination phase of Isolated DNA Molecular in vitro diagnostics, including molecular pathology, has enabled significant progress in medicine. However, the profiles and/or integrity of these molecules can change drastically during specimen collection, transport, storage, and processing. Therefore, it is essential to take special measures to minimize the DNA changes and modifications for subsequent examination. Note: International, national, or regional regulations or requirements can also apply to specific topics covered in this document. Who is ISO 20166-3-
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Isolated DNA
- ICS
- 11.100.10
- CCS
- 发布
- 2019-01-31
- 实施
- 2019-01-31
What is ISO 20184-1- Isolated RNA for pre-examination processes about? ISO 20184 is an international standard that discusses pre-examination processes for frozen tissue for molecular in vitro diagnostic examinations. ISO 20184-1 provides the best industry guidance on Isolated RNA to ensure reliable results are produced that are comparable to other laboratories. ISO 20184-1 is the first part of a multi-part series that layouts guidelines on the handling, documentation, storage, and processing of frozen tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed.
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue - Isolated RNA
- ICS
- 11.100.10
- CCS
- 发布
- 2018-12-31
- 实施
- 2018-12-31
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to: a) instructions for instrument servicing or repair, b) IVD reagents, including calibrators and control materials for use in control of the reagent, c) IVD instruments for self-testing.
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
- ICS
- 11.100.10
- CCS
- 发布
- 2016-12-22
- 实施
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to: a) IVD instruments or equipment, b) IVD reagents for professional use.
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing
- ICS
- 11.100.10
- CCS
- 发布
- 2016-12-22
- 实施
This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. The following subjects are outside the scope of this standard: a) requirements for the design or selection of a reference measurement procedure; b) quantities involving mass of enzyme or immunoreactivity of enzymes; c) control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility (precision control materials); d) control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; e) metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; f) properties involving nominal and ordinal scales.
In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
- ICS
- 11.100.10
- CCS
- 发布
- 2016-12-22
- 实施
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to a) instructions for instrument servicing or repair, b) IVD reagents, including calibrators and control materials for use in control of the reagent, c) IVD instruments for professional use.
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing
- ICS
- 11.100.10
- CCS
- 发布
- 2016-12-22
- 实施
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to a) IVD instruments or equipment, b) IVD reagents for self-testing.
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
- ICS
- 11.100.10
- CCS
- 发布
- 2016-12-22
- 实施
This Technical Specification covers the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis. This Technical Specification is applicable to metabolomics examinations and is of importance to biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities. The adoption of the described procedures for the preanalytical phase make it possible to compare and evaluate the results obtained from metabolic profiling analysis.
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine@ venous blood serum and plasma
- ICS
- 11.100.10
- CCS
- C27
- 发布
- 2016-05
- 实施
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
- ICS
- 11.100.10
- CCS
- C31
- 发布
- 2016
- 实施
- 2017-03-01
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
- ICS
- 11.100.10
- CCS
- C31
- 发布
- 2016
- 实施
- 2017-03-01
Scope is not provided for this standard
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for certified reference materials and the content of supporting documentation
- ICS
- 11.100.10
- CCS
- 发布
- 2015-12-21
- 实施
Scope is not provided for this standard
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures
- ICS
- 11.100.10
- CCS
- 发布
- 2015-12-21
- 实施
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 1: Isolated RNA
- ICS
- 11.100.10
- CCS
- 发布
- 2015-12-16
- 实施
- 2015-12-16
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2015-12
- 实施
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2015-12
- 实施
