11.100.10 标准查询与下载
共找到 262 条与 相关的标准，共 18 页
Total bile acid determination kit (enzyme cycling method)
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-12-06
- 实施
- 2022-12-01
Human Leukocyte Antigen (HLA) Genotyping Test Kit
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-12-06
- 实施
- 2023-05-01
Calibrators for blood analyzers
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-12-06
- 实施
- 2023-05-01
Group B Streptococcus nucleic acid detection kit (fluorescence PCR method)
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-12-06
- 实施
- 2022-12-01
Fetal chromosomal aneuploidy trisomy 21, trisomy 18 and trisomy 13 detection kit (high-throughput sequencing method)
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-12-06
- 实施
- 2023-05-01
Carcinoembryonic Antigen (CEA) Assay Kit
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-12-06
- 实施
- 2022-12-01
Methods for performance evaluation of in vitro diagnostic test systems Part 2: Accuracy
- ICS
- 11.100.10
- CCS
- C30
- 发布
- 2021-12-06
- 实施
- 2023-05-01
Human chorionic gonadotropin (HCG) detection kit (colloidal gold immunochromatography)
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-12-06
- 实施
- 2022-12-01
Treponema pallidum antibody detection kit (immunochromatographic method)
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-12-06
- 实施
- 2023-05-01
Amino acid and carnitine detection kit (tandem mass spectrometry)
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2021-09-06
- 实施
- 2023-03-01
BS EN ISO 18113-5. 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
- 2021-08-11
- 实施
- 2021-08-11
BS EN ISO 18113-4. 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
- 2021-08-11
- 实施
- 2021-08-11
BS EN ISO 18113-2. 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
- 2021-08-11
- 实施
- 2021-08-11
BS EN ISO 18113-1. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 1. Terms, definitions, and general requirements
- ICS
- 11.100.10
- CCS
- 发布
- 2021-08-11
- 实施
- 2021-08-11
BS EN ISO 18113-3. 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
- 2021-08-11
- 实施
- 2021-08-11
This document defines 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. NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population. The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study. This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to — ensure the conduct of the clinical performance study will lead to reliable and robust study results, — define the responsibilities of the sponsor and principal investigator, — assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and — protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies. Analytical performance studies are out of the scope of this document. NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety. Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document. NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity. This document does not include safety information for laboratory workers or other personnel collecting the study specimens. NOTE 4 Such information is included in other publications[1][12][13]. NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.
In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
- ICS
- 11.100.10
- CCS
- 发布
- 2021-07-01
- 实施
What is ISO 23118 about? ISO 23118 addresses Molecular in vitro diagnostic examinations specifies requirements and gives recommendations for the handling, documentation, and processing of urine, venous blood plasma, and serum intended for metabolomics analysis in the pre-examination processes. ISO 23118 is applicable to metabolomics examinations and can be used by biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities. Who is ISO 23118 for?
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma
- ICS
- 11.100.10
- CCS
- 发布
- 2021-06-30
- 实施
- 2021-06-30
What is ISO 201843 about? ISO 201843 is one of a series of a document about molecular in vitro diagnostic examinations requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed . Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. Note: International, national, or regional regulations or requirements can also apply to specific topics covered in this document. Who is ISO 20184-3 for? ISO 20184-3
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue. Isolated DNA
- ICS
- 11.100.10
- CCS
- 发布
- 2021-06-30
- 实施
- 2021-06-30
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
- 20201230
- 实施
- 20201230
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
- 20201230
- 实施
- 20201230
