C38 普通诊察器械 标准查询与下载
共找到 208 条与 普通诊察器械 相关的标准，共 14 页
"Medical Electronic Thermometer" National Standard No. 1 Amendment
- ICS
- 11.040
- CCS
- C38
- 发布
- 2008-09-01
- 实施
- 2008-09-01
GB/T 21417的本部分规定了耳腔式医用红外体温计的术语和定义、要求、试验方法、检验规则和标志、使用说明书、包装、运输、贮存。 本部分适用于通过探测器测量与被测对象耳腔之间的红外辐射交换和适当的修正值，输出显示身体某部位温度的耳腔式医用红外体温计（以下简称体温计）。该体温计通过测量耳腔的热辐射来显示被测对象的体温。
Clinical infrared thermometers.Part 1:Ear
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2008-01-22
- 实施
- 2008-09-01
本标准规定了医用电子体温计的术语和定义、要求、试验方法、检验规则和标志、使用说明书、包装、运输、贮存。 本标准适用于间歇监控人体体温的数显医用电子体温计（以下简称体温计），该体温计供医疗部门或家庭作测量人体体温使用，可用于人体的腋下、口腔、肛门等不同部位。
Clinical electronic thermometer
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2008-01-22
- 实施
- 2008-09-01
本标准规定了玻璃体温计(以下简称体温计)的分类与命名、要求、试验方法、检验规则、标志、使用说明书、包装、运输、贮存等要求。 本标准适用于具有测温留点结构、感温液为汞或其他金属液体的医用温度计；该产品供测量人体、动物(兽用)的体温用。
Clinical thermometer
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2001-12-04
- 实施
- 2002-04-01
本标准规定了血压计、血压表的产品分类、技术要求、试验方法、验收规则及标志、包装、运输、贮存等要求。 本标准适用于汞柱式血压计和机械弹性元件式血压表；不适用于电子血压计。该产品供测量人体血压用。
Sphygmomanometer
- ICS
- 71.060.20
- CCS
- C38
- 发布
- 1993-10-16
- 实施
- 1994-06-01
"Medical Electronic Thermometer" National Standard No. 1 Amendment
- ICS
- 11.040
- CCS
- C38
- 发布
- 实施
- 2008-09-01
Medical electrical equipment. Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
- ICS
- 11.040.10
- CCS
- C38
- 发布
- 2020-11-23
- 实施
- 2020-11-23
Le présent document spécifie les exigences applicables à la sécurité de base et aux performances essentielles d'un concentrateur d'oxygène en combinaison avec ses accessoires, désigné ci-après sous le terme d'appareil EM, visant à augmenter la concentration en oxygène du gaz dest
Medical electrical equipment - Part 2-69 : particular requirements for the basic safety and essential performance of oxygen concentrator equipment
- ICS
- 11.040.10
- CCS
- C38
- 发布
- 2020-11-18
- 实施
- 2020-12-25
Medical electrical equipment -- Medical image display systems -- Part 1: Evaluation methods
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2019-04-01
- 实施
ISO 11070:2014 specifies requirements for introducer needles, introducer catheters, sheath introducers, guidewires, and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters.
Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014 + Amd 1:2018); German version EN ISO 11070:2014 + A1:2018
- ICS
- 11.040.25
- CCS
- C38
- 发布
- 2018-10-00
- 实施
Clause 1 of the general standard2 applies@ except as follows: Replacement: This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS@ hereafter referred to as ME EQUIPMENT@ which by means of an inflatable CUFF@ are used for non-continuous indirect estimation of the BLOOD PRESSURE without arterial puncture. NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE. This document specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for this ME EQUIPMENT and its ACCESSORIES@ including the requirements for the accuracy of a DETERMINATION. This document covers automatic electrically-powered ME EQUIPMENT used for the intermittent@ indirect estimation of the BLOOD PRESSURE without arterial puncture@ including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT. Requirements for indirect estimation of the BLOOD PRESSURE without arterial puncture ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used in conjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE (NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1 [2]. 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 document are not covered by specific requirements in this document except in 201.11 and 201.105.3.3@ as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005. NOTE 2 See also 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012. 2 The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012@ Medical electrical equipment ?C Part 1: General requirements for basic safety and essential performance.
Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers
- ICS
- 11.040.10
- CCS
- C38
- 发布
- 2018-03-01
- 实施
- 2018-03-24
Non-invasive electro-mechanical sphygmomanometers
- ICS
- 11.040.01;11.040.55
- CCS
- C38
- 发布
- 2018-02-01
- 实施
This standard of DIN EN 80601-2-35/A1 (VDE 0750-2-35/A1) is the alignment of the amendment of DIN N 60601-1:2013 and the related collateral standards of DIN EN 60601-1-x series. By the introduction of undated references, if no technical change is needed in this standard, the simplification of further alignment will be provided in the DIN EN 60601-2-series. Additional technical changes may be also included for the alignment of IEC 60601-1-2(electromagnetic phenomena), IEC 60601-1-11(home use) and IEC 60601-1-12(emergency use).
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use (IEC 80601-2-35:2009 + Cor.:2012 + Cor.:2015 +
- ICS
- 11.140
- CCS
- C38
- 发布
- 2017-11-01
- 实施
- 2017-11-01
Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
- ICS
- 11.040.55;19.080
- CCS
- C38
- 发布
- 2017-11-01
- 实施
Medical electrical equipment. Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2017-09-28
- 实施
- 2017-09-30
This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions@ hereafter referred to as ME EQUIPMENT. This document sets laboratory characterization test limits for the SCREENING THERMOGRAPH. NOTE 101 A SCREENING THERMOGRAPH is intended for screening of a human subject and detection of SKIN TEMPERATURE elevated above normal. An elevated SKIN TEMPERATURE needs to be followed up by a subsequent temperature measurement using a clinical thermometer (see ISO 80601-2-56 [30]). NOTE 102 The main part of such equipment is commonly referred to as an infrared camera. 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.
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2017-09-00
- 实施
- 2017-09-21
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2017-03
- 实施
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers (IEC 80601-2-30:2009 + Corrigendum Jan. 2010 + A1:2013); German version EN 80601-2-30:2010 + A1:20
- ICS
- 11.040.55
- CCS
- C38
- 发布
- 2016-02
- 实施
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2015
- ICS
- 11.100.10
- CCS
- C38
- 发布
- 2015-12
- 实施
