11.100.10 标准查询与下载
共找到 257 条与 相关的标准，共 18 页
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
- C31
- 发布
- 2015
- 实施
- 2016-11-01
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
- C31
- 发布
- 2015
- 实施
- 2016-11-01
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 1. Terms, definitions and general requirements
- ICS
- 11.100.10
- CCS
- C31
- 发布
- 2015
- 实施
- 2016-11-01
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
- C31
- 发布
- 2015
- 实施
- 2016-11-01
ISO 15197:2013 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. ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.
In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- ICS
- 11.100.10
- CCS
- 发布
- 2014-12-25
- 实施
ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.
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
- 2014-12-25
- 实施
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
- 2014-12-12
- 实施
- 2014-12-02
In virto 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
- 2014-12-12
- 实施
- 2014-12-02
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-09
- 实施
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 15197:2013
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-09
- 实施
- 2013-09-01
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-07-19
- 实施
- 2013-07-19
In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013
- ICS
- 11.100.10
- CCS
- C31
- 发布
- 2013-07
- 实施
- 2013-07-01
In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2013-06-30
- 实施
- 2013-06-30
ISO 19001:2013 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 hist
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
- 2013-05-03
- 实施
- 2013-05-03
Die vorliegende Internationale Norm legt Anforderungen an In-vitro-Glukosemesssysteme zur Messung von Glukosekonzentrationen in Kapillarblutproben fur spezifische Design-Verifizierungsverfahren und zur Validierung der Leistungsfahigkeit durch die vorgesehenen Anwender fest. Diese Systeme sind fur die Selbstmessung durch Laien zur Fuhrung des Diabetes mellitus vorgesehen. Diese Internationale Norm gilt fur die Hersteller derartiger Systeme und fur diejenigen sonstigen Organisationen (z. B. Zulassungsbehorden und Institutionen zur Konformitatsbeurteilung), die fur die Beurteilung der Leistungsfahigkeit dieser Systeme verantwortlich sind. Diese Internationale Norm liefert keine umfassende Bewertung aller moglichen Faktoren, die die Leistungsfahigkeit dieser Systeme beeinflussen konnen; gilt nicht fur die Glukosekonzentrationsmessung zur Diagnose des Diabetes mellitus; behandelt nicht die medizinischen Aspekte der Fuhrung des Diabetes mellitus; gilt nicht fur Messverfahren, bei denen die Messwerte auf einer Ordinalskale dargestellt werden (z. B. visuelle, halbquantitative Messverfahren) oder fur kontinuierliche Glukosemesssysteme; gilt nicht fur Blutzuckermessgerate in medizinischen Applikationen, die nicht fur den Gebrauch der Selbstuberwachung zum Management von Diabetes mellitus gedacht sind.
In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus
- ICS
- 11.100.10
- CCS
- C44
- 发布
- 2013-05-01
- 实施
- 2013-05-01
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. 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
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
