准备无线共存的四个步骤

技术 trends continue to drive the rapid growth of wireless devices, 尤其是在医疗im体育平台app下载. These trends have created new challenges for product developers, especially when it comes to the safe operation of their products in increasingly crowded spaces.

根据FDA发布的指南, “potential risks that can affect consistent and timely wireless medical device functions include data corruption or loss and interference from simultaneous transmitters in a given location, which can increase latency and transmitted signal error rates.这些风险, FDA很早就发现了, 必须被量化, 减轻, and managed to stay at or below acceptable levels. One important method for doing so is wireless coexistence testing.

在成立之初, 无线共存测试方法差异很大, 但从那以后, established processes and standards were developed to provide more reliable test data and results.

Four steps for successful wireless coexistence testing

To ensure your products are prepared for successful wireless coexistence testing, you must define the product’s intended environment and determine the product’s risk level. 

Step 1: Define your product’s intended environment

To define your product’s risk level, you must first define its intended environment. You will need to decide where the product will be used, what other products and devices may be used in that area, 产品将如何使用, and which RF bands and wireless protocols the device will use.

ANSI C63.27 standard should be considered if equipment relies on wireless communication. ANSI C63.27 specifies methods for assessing the radio frequency (RF) wireless coexistence of equipment that incorporates RF communications and identifies key performance indicators (KPIs) that can be used to assess the ability of the equipment to coexist with other equipment. 蓝牙, 无线网络, LTE, and DECT are the principle technologies and bands that are addressed by the current standard. 

If the medical device is expected to operate in a healthcare environment near RFID readers, then the AIM 7351731 standard should be considered as well. The standard provides test methods and test levels for electromagnetic immunity of (non-implantable) medical electrical equipment and systems. AIM 7351731 is considered to be an immunity standard by the FDA, 类似于IEC 60601-1-2辐射抗扰度, so results should be evaluated against essential performance.

第二步:确定产品的风险等级

产品s fall under four risk-based tiers per AAMI TIR 69. The tiers listed below help determine what level of testing is necessary to ensure safe operation.

• Tier 1: Major risks, including those that can cause death or serious injury. Requires thorough testing with three competing devices.
• Tier 2: Moderate risks, including delayed or disrupted service. 需要在两个相互竞争的设备上测试.
• Tier 3: Minor risks that do not significantly impact health. Requires minimal testing with a single competing device.
• Tier 4: Negligible risks that provide minor inconvenience or discomfort. 无需测试.

ANSI C63.27第五节.4 provides details on the test levels required for each tier.

步骤3:确定性能参数

Once you have defined the products’ intended environment, you will also need to determine what optimum performance looks like for your device. 

Based on this information, what is acceptable failure? Are there times when some level of failure is acceptable, or does the product need to work perfectly every single use? These considerations help with the creation of your test plan.

第四步:聘请专家

一旦您完成了上面的步骤, it’s time to talk to our wireless coexistence testing experts. 与我们的实验室合作, you will be able to create a test plan that clearly describes what will be tested and the method of testing that is to be completed. After creating and receiving approval for your test plan, the testing may begin.

im体育APP offers all necessary wireless coexistence testing and provides full documentation of the test methods and results. The documentation provided is to be submitted along with your product’s other credentials to receive product approval.

问题? 

联系im体育APP的专家 to learn more about our services and how you can successfully prepare for wireless coexistence testing.