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). 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 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). 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 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
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In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]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
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
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 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 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 3 : in vitro diagnostic instruments 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
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 2: In vitro diagnostic reagents for professional use
- ICS
- 11.100.10
- CCS
- C30
- 发布
- 2009-12
- 实施
