11.100.10 标准查询与下载
共找到 267 条与 相关的标准，共 18 页
In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
- ICS
- 11.100.10
- CCS
- 发布
- 2013
- 实施
- 2014-08-01
Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
- ICS
- 11.100.10
- CCS
- C37
- 发布
- 2012-12
- 实施
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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
- 2012-09-17
- 实施
- 2012-09-17
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2012-06-30
- 实施
- 2012-06-30
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2011
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2012-03
- 实施
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
- ICS
- 11.100.10
- CCS
- 发布
- 2012-01-16
- 实施
- 2012-01-16
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
- ICS
- 11.100.10
- CCS
- 发布
- 2012-01-16
- 实施
- 2012-01-16
This International Standard describes a method for testing the susceptibility to antifungal agents of yeasts, including Candida spp. and Cryptococcus neoformans, that cause infections. The reference method described here has not been used in studies of the yeast forms of dimorphic fungi, such as B. dermatitidis and/or H. capsulatum variety capsulatum. Moreover, testing filamentous fungi (moulds) introduces several additional problems in standardization not addressed by the current procedure. Reference methods for broth dilution antifungal susceptibility testing of filamentous fungi have been developed and are now available as CLSI document M38 and EUCAST do
Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of fungi involved in infectious diseases (ISO 16256:2012)
- ICS
- 11.100.10
- CCS
- 发布
- 2012
- 实施
This International Standard is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. This International Standard can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device. This International Standard specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in: — the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained; — the establishment of stability of the IVD reagent in use after the first opening of the primary container; EXAMPLE On-board stability, stability after reconstitution, open vial/bottle stability. the monitoring of stability of IVD reagents already placed on the market; — the verification of stability specifications after modifications of the IVD reagent that might affect stability. — This International Standard is not applicable to instruments, apparatus, equipment, systems or specimen receptacles, or the sample subject to examination.
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2011-12
- 实施
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2011-11-30
- 实施
- 2011-11-30
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2011-11-30
- 实施
- 2011-11-30
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2011-11-30
- 实施
- 2011-11-30
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2011-11-30
- 实施
- 2011-11-30
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2011-10-31
- 实施
- 2011-10-31
In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials
- ICS
- 11.100.10
- CCS
- 发布
- 2011-01-01
- 实施
- 2013-01-01
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagentsfor professional use.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
- ICS
- 11.100.10
- CCS
- 发布
- 2011
- 实施
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
- ICS
- 11.100.10
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials
- ICS
- 11.100.10
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
This International Standard is applicable to the stability evaluation of in vitro diagnostic medical devices, includingreagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents.ThisInternational Standard can also be applied to specimen collection devices that contain substances u
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]
- ICS
- 11.100.10
- CCS
- 发布
- 2011
- 实施
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
- ICS
- 11.100.10
- CCS
- 发布
- 2011
- 实施
