11.100.10 标准查询与下载
共找到 267 条与 相关的标准，共 18 页
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing.
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
- 2011
- 实施
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
- ICS
- 11.100.10
- CCS
- 发布
- 2011
- 实施
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
- C30
- 发布
- 2010-03-01
- 实施
- 2010-03-17
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
- C30
- 发布
- 2010-03-01
- 实施
- 2010-03-17
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
- C30
- 发布
- 2010-03-01
- 实施
- 2010-03-17
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1 : terms, definitions and general requirements.
- ICS
- 11.100.10
- CCS
- C37
- 发布
- 2010-03-01
- 实施
- 2010-03-17
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
- C30
- 发布
- 2010-03-01
- 实施
- 2010-03-17
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) - Terms, definitions and general requirements
- ICS
- 11.100.10
- CCS
- C37
- 发布
- 2010-02-28
- 实施
- 2010-02-28
이 기술 보고서는 전문가용 IVD 의료기기와 관련하여 제조업체가 제공하는 정보에 대한 규제
Clinical laboratory testing and in vitro diagnostic test systems-In vitro diagnostic medical devices for professional use-Summary of regulatory requirements for information supplied by the manufacturer
- ICS
- 11.100.10
- CCS
- C39
- 发布
- 2009-12-29
- 实施
- 2009-12-29
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
- C31
- 发布
- 2009-12
- 实施
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
- 2009-12
- 实施
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
- C30
- 发布
- 2009-12
- 实施
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
- C30
- 发布
- 2009-12
- 实施
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
- ICS
- 11.100.10
- CCS
- C30
- 发布
- 2009-12
- 实施
This International Standard specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. This International Standard also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty. This International Standard applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009); English version of DIN EN ISO 15194:2009-10
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2009-10
- 实施
This International Standard specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories. NOTE 1 It is intended that an experienced laboratory worker who follows a measurement procedure written in accordance with this International Standard can be expected to produce measurement results with a measurement uncertainty not exceeding the stipulated interval. This International Standard applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure. Full descriptions of measurement methods are usually published in scientific literature, in which methods are described in sufficient detail that they can be used as the basis of a documented measurement procedure. NOTE 2 In this International Standard, "international measurement standard" designates a material standard. The term "international standard" is used by WHO for reference materials.
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009); English version of DIN EN ISO 15193:2009-10
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2009-10
- 实施
This International Standard specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. This International Standard also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty. This International Standard applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.
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
- C38
- 发布
- 2009-05-31
- 实施
- 2009-05-31
This International Standard specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories. NOTE 1 It is intended that an experienced laboratory worker who follows a measurement procedure written in accordance with this International Standard can be expected to produce measurement results with a measurement uncertainty not exceeding the stipulated interval. This International Standard applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure. Full descriptions of measurement methods are usually published in scientific literature, in which methods are described in sufficient detail that they can be used as the basis of a documented measurement procedure. NOTE 2 In this International Standard, “international measurement standard” designates a material standard. The term “international standard” is used by WHO for reference materials.
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
- C38
- 发布
- 2009-05-31
- 实施
- 2009-05-31
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
- C38
- 发布
- 2009-05
- 实施
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
- C38
- 发布
- 2009-05
- 实施
