C38 普通诊察器械 标准查询与下载
共找到 209 条与 普通诊察器械 相关的标准，共 14 页
Medical electrical equipment. Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ICS
- 17.200.20
- CCS
- C38
- 发布
- 2012-12-31
- 实施
- 2012-12-31
Medical electrical equipment - Part 2-56 : particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ICS
- 17.200.20
- CCS
- C38
- 发布
- 2012-12-01
- 实施
- 2012-12-28
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007); German version EN ISO 81060-1:2012
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2012-08
- 实施
- 2012-08-01
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
Developing human cells for clinical applications in the European Union and the United States of America. Guide
- ICS
- 11.040.60
- CCS
- C38
- 发布
- 2012-06-30
- 实施
- 2012-06-30
This Standard specifies general, performance and mechanical and electrical safety requirement for non-invasive mechanical sphygmomanometers and their accessories which by means of an inflatable cuff, are used for the non-invasive measurement of blood pressure.
Non-invasive mechanical sphygmomanometers
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2012-06-01
- 实施
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
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011); German version EN ISO 80601-2-61:2011
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2012-01
- 实施
- 2012-01-01
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 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 instruments 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 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 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
Subclause 1.1 of The general standard is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT. This includes any part necessary for NORMAL USE, including the PULSE OXIMETER MONITOR, PULSE OXIMETER PROBE, and PROBE CABLE EXTENDER. These requirements also apply to PULSE OXIMETER EQUIPMENT, including PULSE OXIMETER MONITORS, PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS, which have been REPROCESSED. The intended use of PULSE OXIMETER EQUIPMENT includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of PATIENTS in professional healthcare institutions as well as PATIENTS in the HOME HEALTHCARE ENVIRONMENT. This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended for use in laboratory research applications nor to oximeters that require a blood sample from the PATIENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 201.11 and in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This standard can also be applied to PULSE OXIMETER EQUIPMENT and their ACCESSORIES used for compensation or alleviation of disease, injury or disability. This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended solely for foetal use. This International Standard is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the PATIENT ENVIRONMENT.
Medical electrical equipment. Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2011-08-31
- 实施
- 2011-08-31
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers (IEC 80601-2-30:2009 + Cor. :2010); German version EN 80601-2-30:2010
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2011-05
- 实施
- 2011-05-01
Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type; Technical Corrigendum 1
- ICS
- 11.040.10
- CCS
- C38
- 发布
- 2011-02
- 实施
이 한국산업표준은 모세혈관의 혈액 검체 내의 당 농도를 측정하는 체외 혈당 감시 시스템에
In vitro diagnostic test systems－Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
- ICS
- 11.100
- CCS
- C38
- 发布
- 2010-12-17
- 实施
- 2010-12-17
이 표준은 공장, 광산, 선박, 그 밖의 사업장에서 산소 결핍 공기, 가스, 증기 또는 공
Guidance for selection, use and maintenance of respiratory protective devices
- ICS
- 11.040.10
- CCS
- C38
- 发布
- 2010-12-17
- 实施
- 2010-12-17
이 표준은 체외진단용 의료기기 및 의학 시험 기관을 위한 표준 측정 절차의 작성에 대한 요
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
- 2010-12-17
- 实施
- 2010-12-17
