11.100.10 标准查询与下载
共找到 262 条与 相关的标准，共 18 页
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.
In vitro diagnostic test systems.Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- ICS
- 11.100.10
- CCS
- C39
- 发布
- 2013-05
- 实施
ISO 13079:2011 specifies requirements for single-use and re-usable glass and plastics tubes for measuring the erythrocyte sedimentation rate (ESR) by the Westergren method, and for a support to hold tubes during the performance of the test. These so-called "Westergren tubes" are also sometimes designated as "Westergren pipettes". A procedure for measuring the erythrocyte sedimentation rate by the Westergren method is given in an informative annex.
Laboratory glass and plastics ware -- Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method
- ICS
- 11.100.10
- CCS
- 发布
- 2013-04-01
- 实施
DIN EN ISO 16256:2013 临床实验室测试和体外诊断试验系统.检测体外抗菌剂抗传染病中酵母菌的活性的标准方法(ISO 16256-2012).德文版本EN ISO 16256-2012
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); German version EN ISO 16256:2012
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-04
- 实施
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-03-31
- 实施
- 2013-03-31
In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-03-31
- 实施
- 2013-03-31
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 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 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 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
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
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
