【判断题】
从事医疗器械零售业务的企业,应当给消费者开具销售凭据。
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相关试题
【判断题】
医疗器械临床试验,是指在经资质认定的医疗器械临床试验机构中,对拟申请注册的医疗器械在正常使用条件下的安全性和有效性进行确认或者验证的过程。
【判断题】
研究者接到申办者或者伦理委员会需要暂停或者终止临床试验的通知时,应当及时通知受试者,并保证受试者得到适当治疗和随访。
【判断题】
对显著偏离临床试验方案或者在临床可接受范围以外的数据应当加以核实,不过,研究者无需说明。
【判断题】
多中心临床试验中,各分中心临床试验小结应当由该中心的研究者签名并注明日期,经该中心的医疗器械临床试验管理部门审核、注明日期并加盖临床试验机构印章后交牵头单位。
【判断题】
医疗器械临床试验应当在三个或者三个以上医疗器械临床试验机构中进行。
【判断题】
医疗器械临床试验质量管理规范不适用于按照医疗器械管理的体外诊断试剂。
【判断题】
验证是指通过提供客观证据表明规定要求已经满足的确认。(风险管理中)
【判断题】
《医疗器械生产质量管理办法》不适用于体外诊断试剂。
【判断题】
生产用细胞应当建立原始细胞库、主代细胞库、工作细胞库。
【判断题】
与血型、组织配型、血源筛查相关的试剂。
【判断题】
体外诊断试剂产品技术要求可以低于国家强制性标准。
【判断题】
变更体外诊断试剂的主要原材料供应商都属于许可事项变更。
【判断题】
体外诊断试剂可以分为定量检测和定性检测。
【判断题】
在医疗器械延续注册申报中,如医疗器械强制性标准没有变化,申请人无需递交产品检验报告。
【判断题】
产品技术要求中的性能指标较多时,可以以“见随附资料”等形式提供。
【判断题】
进口医疗器械在我国注册时需提供境外政府医疗器械主管部门批准该产品上市的证明文件,还需提供境外政府医疗器械主管部门批准该产品上市时的临床评价资料。
【判断题】
国内首创且具有显著临床应用价值的医疗器械可认定为创新医疗器械。
【判断题】
为了维护食品药品监管部门发布的政策、法规的权威性、严肃性和延续性,已注册的医疗器械,其管理类别由低类别调整为高类别的,在有效期内的医疗器械注册证继续有效。
【判断题】
已经注册的医疗器械,在医疗器械注册证中“结构及组成”栏内所载明的组合部件,在不改变预期用途的情况下可以单独销售,不用注册。
【判断题】
植入性医疗器械生产企业不得使用患有传染性疾病的人员。
【判断题】
在质量管理体系文件里,生产过程中使用的生产工艺规程属于技术文件。
【判断题】
监管机构对体外诊断试剂生产企业生产许可现场检查时,关键项目全部符合要求,仅一般项目中不符合要求的项目数<10%的检查结论为“整改后复查”。
【判断题】
无菌医疗器械生产用100级的洁净室(区)内不得设置地漏。
【判断题】
质量目标应是可测量的,并与质量方针保持一致。
【单选题】
《安规》关于“低[电]压”的定义是:用于配电的___的电压等级。
A. 直流系统中1000V以下;
B. 交流系统中1000V以下;
C. 交(直)流系统中1000V及其以下;
D. 交流系统中1000V及以下
【单选题】
为加强电力生产现场管理,规范各类工作人员的行为,保证___安全,依据国家有关法律、法规,结合电力生产的实际,制定《安规》。
A. 人身;
B. 设备;
C. 人身和设备;
D. 人身、电网和设备
【单选题】
作业现场的生产条件和安全设施等应符合有关标准、规范的要求,工作人员的___应合格、齐备。
A. 劳动防护用品;
B. 工作服;
C. 安全工器具;
D. 施工机具;
【单选题】
经常有人工作的场所及施工车辆上宜配备急救箱,存放___,并应指定专人经常检查、补充或更换。
A. 劳保用品;
B. 医用绷带;
C. 创可贴;
D. 急救用品
【单选题】
具有通高频、阻低频特性的电路器件是_______。
A. 电阻器
B. 电感器
C. 电容器
D. 不存在
【单选题】
某电容的标称值为 103,代表它的容值实际为_______ 。
A. 1μF
B. 0.1μF
C. 0.01μF
D. 0.001μF
【单选题】
通常电工术语“负载大小”是指_______大小。
A. 实际电压
B. 总电流
C. 消耗功率
D. 等效电阻
【单选题】
人们常说的交流电压 220V 是指交流电压的 。
A. 最大值
B. 平均值
C. 瞬时值
D. 有效值
【单选题】
家用自动空气开关具有_______保护功能。
A. 漏电
B. 欠压
C. 短路
D. 以上都有
【单选题】
三相四线制的电路中,中线_______ 。
A. 可以接熔断器
B. 可以接开关
C. 两个都可以接
D. 两个都不能接
【单选题】
发生 LC 串联谐振的条件是_______。
A. XL>XC
B. XL<XC
C. XL=XC
D. 以上都不对
【单选题】
叠加定理适用于_________。
A. 一切电路
B. 线性电路
C. 非线性电路
D. 直流电路
【单选题】
一理想变压器,原绕组接在 220V 的交流电源上,测得副绕组的端电压 11V,如果原绕组的匝数为 220 匝,则变压器的变压比、副绕组的匝数分别为_________
A. k=10,N2=210 匝
B. k=20,N2=11 匝
C. k=10,N2=1 匝
D. k=20,N2=210 匝
【单选题】
采用差分放大电路是为了_______
A. 加强电路对称性
B. 抑制零点漂移
C. 增强放大倍数
D. 以上都不对
【单选题】
阻值为 4Ω 的电阻和容抗为 3Ω 的电容串联,总复阻抗为_________。
A. Z=3+j4
B. Z=3-j4
C. Z=4+j3
D. Z=4-j3
推荐试题
【单选题】
A vSphere administrator needs to backup a virtual machine that has a Microsoft SQL Server Database installed. Which solution allows for an application quiesce to occur during backup?___
A. VMware vCenter Converter
B. VMware vCenter Site Recovery Manager
C. VMware vSphere Replication
D. VMware vSphere Data Protection Advanced
【单选题】
An administrator is migrating a virtual machine from a Test cluster to a Production cluster. The two environments do not have any shared storage. What is the easiest way to accomplish this task? ___
A. Perform a Storage vMotion.
B. Perform a regular vMotion.
C. Perform a Virtual to Virtual migration.
D. Perform a backup and restore using VMware Data Protection.
【单选题】
An administrator must determine an appropriate backup solution, given these conditions: 50 of the virtual machines are in a resource pool named Finance. 50 of the virtual machines are in a resource pool named QA. Which solution allows an administrator the ability to backup 100 virtual machines? ___
A. Use Snapshot Manager on the vCenter Server to backup the virtual machines.
B. Use the VMware Consolidated Backup (vcb) tool on the ESXi Host to backup the virtual machines.
C. Use the VMware Data Recovery (VDR) Appliance on the vCenter Server to backup the virtual machines.
D. Use the VMware Data Protection (VDP) Appliance on one of the
E. SXi Hosts to backup the virtual machines.
【单选题】
What is a benefit of using Enhanced vMotion Compatibility for an environment? ___
A. EVC masks CPU features to allow compatibility between hosts that are dissimilar.
B. EVC allows for cross platform vMotion to occur.
C. EVC enables Long
D. istance vMotion.
【单选题】
How many Link Aggregation Groups (LAGs) can be configured on a vSphere 6.x Distributed Switch? ___
A. 64
B. 96
C. 128
D. 256
【单选题】
How many Link Aggregation Groups (LAGs) can be configured on a vSphere 6.x Distributed Switch? ___
A. 64
B. 96
C. 128
D. 256
【单选题】
An administrator needs to verify that vMotion operations can be performed in a vSphere data center.What round trip time (RTT) latency is the maximum value that will allow vMotion operations to succeed? ___
A. 50ms RTT
B. 100ms RTT
C. 150ms RTT
D. 200ms RTT
【单选题】
A storage administrator has reported that full utilization of all bandwidth from an ESXi 6.x host is not being seen. In troubleshooting the issue, the Adapter details are shown in the Exhibit. Based on the exhibit, what is cause of the issue? ___
A. The array is not setup to use the correct multipathing policy.
B. There are no virtual machines on the ESXi host.
C. Not all links are used because a path is disabled.
D. Another path needs to be configured.
【单选题】
An administrator is migrating a powered-on virtual machine, as shown in the exhibit. Which option should be selected to perform a Storage vMotion of the VM? ___
A. Change storage only
B. Change VM compute resource only
C. Change both compute resource and storage, changing the compute resource first.
D. Change both compute resource and storage, changing the storage resource first.
【单选题】
An administrator is attempting to enable Storage I/O Control on a datastore, but it is failing. What is the likely reason for this failure? ___
A. The host is connected to a datastore is running on ESX 4.0.
B. The host is connected to a Fibre Channel storage array.
C. The datastore has multiple extents.
D. The datastore is managed by a single vCenter Server.
【单选题】
A mission-critical virtual machine built on vSphere 4.1 needs to be moved to an ESXi 6.x host.Which virtual hardware version is needed to move the virtual machine without upgrading? ___
【单选题】
An administrator is analyzing a virtual machine as shown in the Exhibit. What is the current long term risk for this virtual machine? ___
A. The virtual machine may run out of memory before April 27.
B. The virtual machine may continue to function after April 27.
C. The virtual machine has adequate memory configured for operation for the next 120 days.
D. The virtual machine has adequate memory reservation configured for operation for the next 120 days.
【单选题】
An administrator is monitoring a High Availability (HA) and Distributed Resource Scheduler (DRS) enabled cluster and has noticed that virtual machines in the cluster are being migrated without user intervention. Why is this happening? ___
A. The DRS Automation level is set to Fully Automated.
B. The Automation level is set to Automatic.
C. The
D. PM Threshold is set to Aggressive.
【单选题】
An administrator attempts to migrate a suspended virtual machine to a newly deployed vSphere 6.x cluster. The compatibility check fails. What condition could cause this behavior?___
A. The new vSphere 6.x cluster is running Intel CPUs instead of AMD CPUs.
B. A suspended virtual machine cannot be migrated.
C. The hardware virtualization feature of the CPU is not enabled on the new hosts.
D. A vSphere Distributed Switch is required to migrate a suspended virtual machine.
【单选题】
A vSphere administrator has been using vSphere in evaluation mode and now wants to deploy an environment that provides the same features. Which edition of vSphere provides similar functionality to evaluation mode? ___
A. Enterprise Plus
B. Enterprise
C. Standard
D. Essentials
【单选题】
A vSphere administrator has been using vSphere in evaluation mode and now wants to deploy an environment that provides the same features. Which edition of vSphere provides similar functionality to evaluation mode? ___
A. Enterprise Plus
B. Enterprise
C. Standard
D. Essentials
【单选题】
An administrator has just configured the IP address on an ESXi host from the Direct Console User Interface. How can the configuration be validated as correct without any additional tools?___
A. Add the host to vCenter Server and if it works, then all networking settings are ok.
B. Select the Test Management Network option from the DCUI.
C. Connect to the host with the vSphere Client and click the Test Network option.
D. Use PowerCLI to connect to the host and initiate a network test.
【单选题】
An administrator is installing vCenter Server for an environment that has 40 ESXi 6.x Hosts and 150 virtual machines. Which database would meet the minimal requirements needed for this task? ___
A. vFabric Postgres
B. Microsoft SQL Express 2008
C. Microsoft SQL Server 2014
D. Oracle 11g
【单选题】
What is a requirement when enabling a Virtual SAN cluster in an existing High Availability (HA) and Distributed Resource Scheduler (DRS) Cluster? ___
A. Disable DRS and HA before enabling Virtual SAN
B. Enable DRS before enabling Virtual SAN
C. Disable HA before enabling Virtual SAN
D. Enable Storage DRS before enabling Virtual SAN
【单选题】
The vSphere administrator attempts to connect to an ESXi host via an SSH client and receives the following security alert: The vSphere administrator needs to determine whether the RSA key fingerprint shown in the security alert is the fingerprint of the intended ESXi host. Which tool should the vSphere administrator use? ___
A. Direct Console User Interface
B. vSphere Client
C. vSphere Web Client
D. vSphere Management Assistant
【单选题】
An administrator needs to monitor traffic on vSwitches in a vSphere 6.x environment. Which option, if configured, would accomplish this task? ___
A. Forged Transmits
B. MAC Address Changes
C. Promiscuous Mode
D. Notify Switches
【单选题】
What is true regarding datastores on ESXi 6.x? ___
A. NFS 4.1 datastore does not support Fault Tolerance (FT)
B. VMFS3 and VMFS5 datastores can be newly created
C. NFS datastore can be concurrently mounted using NFS 4.1 on one host and NFS on another
D. NFS 3.0 datastore does not support Fault Tolerance (FT)
【单选题】
An administrator is cloning and configuring five new web server virtual machines. What would be the benefit of configuring resource shares for the new VMs? ___
A. To prioritize access to a resource during contention.
B. To guarantee access to a resource during contention.
C. To prioritize access to a resource before contention occurs.
D. To guarantee access to a resource before contention occurs.
【单选题】
An administrator logs into the vSphere Web Client and sees the warning shown in the Exhibit. During a change control window, the warning was addressed. What should be done to verify that the host is no longer showing the warning? ___
A. Run a Remediate host operation.
B. Recheck the compliance of the host.
C. Restart the host to get rid of the warning.
D. Install VMware tools to clear the warning.
【单选题】
A vApp named Sales has a Memory Limit of 32 GB and a CPU Limit of 12,000 MHz. There are three virtual machines within the vApp: <Sales-DB -- Has a memory reservation of 20 GB. > <Sales-DC -- Has a memory reservation of 8 GB. > <Sales-Web -- Has a memory reservation of 8 GB.> Which statement is correct? ___
A. All three virtual machines can power on, but will have memory contention.
B. All three virtual machines can power on without memory contention.
C. Only two of the three virtual machines can power on.
D. Only one of the virtual machines can power on.
【单选题】
You are editing the management network configuration of an ESXi 6.x Host from the vSphere Web Client. You mistakenly put the incorrect VLAN in place for the management network. What action do you need to take to correct this? ___
A. You need to manually edit the configuration on the host with command line utilities.
B. No action is required. By default ESXi rolls back configuration changes that disconnect the host.
C. The ESXi host system configuration will need to be restored to the factory configuration to fix the issue.
D. The change can be reverted in the vSphere Web Client by simply editing the switch again.
【单选题】
What is true about resource pools created on a Distributed Resource Scheduler (DRS) cluster?___
A. A root resource pool is created with the specified values.
B. A root resource pool is automatically created using the aggregate total of the ESXi host resources in the cluster.
C. A root resource pool is automatically created using the aggregate total of all resources in the datacenter.
D. A root resource pool is not needed when creating resource pools on a DRS cluster.
【单选题】
An administrator attempts to enable Enhanced vMotion Compatibility (EVC) on a cluster. The operation results in a compatibility error, as shown in the exhibit. What is the likely cause of this error? ___
A. The CPUs in the ESXi host are not AMD CPUs.
B. The CPUs in the ESXi host do not support hardware virtualization capabilities.
C. The XD/NX CPU features have not been enabled in the BIOS of the server.
D. There is no shared storage between the hosts in the cluster.
【单选题】
What condition would prevent an administrator from creating a new VMFS3 datastore on an ESXi 6.x host using the vSphere Web Client? ___
A. A VMFS3 datastore cannot be created on an ESXi 6.x host.
B. The VMFS3 kernel module is not loaded.
C. A VMFS3 datastore cannot be mounted on an ESXi 6.x host.
D. VMFS3 datastores are not compatible with virtual machines created on an
E. SXi 6.x host.
【单选题】
During a new vSphere Distributed Switch configuration, where does the Maximum Transmission Unit (MTU) value get modified? ___
A. Uplink Settings
B. Switch Settings
C. Portgroup Settings
D. NIC Teaming Settings
【单选题】
A small company wants to use VMware products for its production systems. The system administrator needs to recommend a solution that will deliver High Availability to the company's production applications. What is minimum vSphere offering that will support this requirement? ___
A. vSphere Essentials
B. vSphere Essentials Plus
C. vSphere Hypervisor
D. vSphere Standard
【单选题】
Which scenario shows a reason for VMware Tools failing to install? ___
A. Virtual machine has a CD-ROM configured.
B. Guest OS Antivirus is blocking the VMware Tools installation.
C. Guest OS has 64-bit ldd (list dynamic dependencies) utility installed.
D. Virtual machine is powered on.
【单选题】
An administrator is configuring an ESXi 6.x host to use multiple NICs to resolve a management network redundancy error. After configuring a second NIC, the server is not able to communicate when the primary connection is taken down. The administrator analyzes the Exhibit shown here. Based on the exhibit, what is the likely cause of the issue? ___
A. vmnic4 is not attached to a vSwitch.
B. vmnic2 is not connected to a physical switch.
C. E1000 is the incorrect NIC
D. river for this card.
【单选题】
What information is required as part of an interactive ESXi 6.x installation? ___
A. Keyboard layout
B. IP Address
C. Root password
D. DNS information
【单选题】
What is the default load balancing policy for a newly created VMkernel port on a vSphere Distributed Switch? ___
A. Route based on orginating virtual port ID
B. Route based on IP Hash
C. Route based on source mac address
D. Route based on physical NIC load
【单选题】
An administrator deploys vCenter Server using the embedded Platform Services Controller. After testing the deployment for a couple of months, it is determined that the environment would be better served with an external Platform Services Controller. What should the administrator do to meet this new requirement? ___
A. Deploy a fresh instance of vCenter Server with an external Platform Services Controller.
B. Perform a fresh install of an external Platform Services Controller.
C. Migrate the embedded Platform Services Controller to an external Platform Services Controller.
D. Upgrade the embedded Platform Services Controller to an external Platform Services Controller.
【单选题】
Why are some virtual machines orphaned after rebooting a High Availability (HA) enabled host? ___
A. The Orphaned virtual machines have HA restart disabled.
B. The Orphaned virtual machines moved recently and the change did not persist.
C. The host is attached to failed storage.
D. The host just came out of maintenance mode.
【单选题】
Which vSphere 6 Standard Edition feature will allow an organization to ensure that critical multi-threaded applications have the maximum possible uptime? ___
A. Fault Tolerance
B. High Availability
C. Distributed Resource Scheduler
D. App HA
【多选题】
An application running in a virtual machine is experiencing performance issues. When utilizing performance monitoring utilities, it is noted that the CPU Utilization of the application is at 100%. Which two scenarios are probable causes of the CPU contention for the application? (Choose two.)___
A. There is a network I/O constraint.
B. There is a storage I/O constraint.
C. There is insufficient disk space assigned to the virtual machine.
D. The application is not virtualization aware.
【多选题】
A Fault Tolerance (FT) virtual machine with four vCPUs is experiencing high latency when performing ICMP and Application tests. What are three potential causes that may be attributing to this latency? (Choose three.)___
A. The FT network has insufficient bandwidth and is running on a 1GB Link.
B. The FT network is on a particularly high latency link.
C. The FT network has been configured with Network I/O Control.
D. The FT virtual machine is running an e1000 network adapter.
E. The
F. T virtual machine is running on poor performing network-based storage.