11.100.10 标准查询与下载
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This International Standard specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in histology and cytology including bacteriology, haematology, histochemistry, as performed in medical laboratories, both routine and research bacteriology. The requirements for information supplied by the manufacturer specified in this International Standard are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
- ICS
- 11.100.10
- CCS
- C30
- 发布
- 2013-03
- 实施
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
- ICS
- 11.100.10
- CCS
- C47
- 发布
- 2013-02-02
- 实施
- 2013-02-02
Diese Internationale Norm gilt fur die Haltbarkeitsprufung von In-vitro-Diagnostika, einschlieslich Reagenzien, Kalibriermaterialien, Kontrollmaterialien, Verdunnungsmitteln, Pufferlosungen und Reagens-Kits, nachstehend IVD-Reagenzien genannt. Diese Internationale Norm kann auch fur Primarprobensammler gelten, die Substanzen enthalten, die der Haltbarmachung von Proben dienen oder mit denen Reaktionen zur weiteren Behandlung der Probe in dem Sammler angeregt werden. Diese Internationale Norm legt allgemeine Anforderungen an die Haltbarkeitsprufung fest und enthalt spezielle Anforderungen an die Echtzeit- und beschleunigte Haltbarkeitsprufung fur die Gewinnung von Daten: zur Festlegung der Haltbarkeitsdauer von IVD-Reagenzien, einschlieslich geeigneter Transportbedingungen, um sicherzustellen, dass die Produktspezifikationen erhalten bleiben; zur Festlegung der Haltbarkeit des in Gebrauch befindlichen IVD-Reagens nach dem ersten Offnen des Primarbehalters; BEISPIEL Haltbarkeit im Analysengerat, Haltbarkeit nach Wiederherstellung, Haltbarkeit der geoffneten Ampulle/Flasche; zur Uberwachung der Haltbarkeit von bereits in Verkehr gebrachten IVD-Reagenzien; zur Bestatigung der Haltbarkeitsangaben nach Anderungen des IVD-Reagens, die Einfluss auf dessen Haltbarkeit haben konnten. Diese Internationale Norm gilt nicht fur Instrumente, Apparate, Ausrustung, Systeme oder Probengefase oder die zur Untersuchung vorgelegte Probe.
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2013-02-01
- 实施
- 2013-02-01
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 (ISO 18113-2:2009); German version EN ISO 18113-2:2011
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-01
- 实施
- 2013-01-01
This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to a)IVD devices for performance evaluation (e.g., for investigational use only), b)instrument marking, c)material safety data sheets.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-01
- 实施
- 2013-01-01
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 suoplied 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 (ISO 18113-4:2009); German version EN ISO 18113-4:2011
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-01
- 实施
- 2013-01-01
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 (ISO 18113-3:2009); German version EN ISO 18113-3:2011
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-01
- 实施
- 2013-01-01
This part of ISO 18113 specifies requirements for infornation 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 (ISO 18113-5:2009); German version EN ISO 18113-5:2011
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-01
- 实施
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
Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101. Particular requirements for in vitro diagnostic (IVD) medical equipment
- ICS
- 11.100.10
- CCS
- 发布
- 2013
- 实施
- 2015-09-01
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
- 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 instruments for professional use
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2011-11-30
- 实施
- 2011-11-30
