FDA医疗器械检测标准是什么?

为了确保产品可靠和用户安全,世界上主要经济体都制定了医疗器械市场准入的要求。纵观所有的市场准入程序的设置框架,可以肯定的说产品检验检测在其中都至关重要。今天我们就来说下美国FDA医疗器械检测标准是什么?

FDA医疗器械检测标准是什么?

医疗器械产品要进入美国市场,首先应确定产品对应的代码,依据代码找到其风险分类和合规路径。如下表所示,低风险的产品直接进行企业注册和产品列名,中风险先申请510(K),然后进行企业注册和产品列名,高风险则需要申请上市前批准。

产品分类确定,申报途径确定
510K豁免 510K(PMN) PMA
企业注册
产品列名
产品可以出口到美国市场
QSR医疗器械质量体系法规(含MDR)  
警告信    Import Alert DWPE
警告信解除,进口禁令解除


我们就以中风险申报510(K) 产品来分析产品检测的标准

众所周知,FDA的510(K) 的原则是证明申报器械和已经在美国合法上市的器械是实质等同。如果能够证明是实质等同,那么就可以确认其满足FDA 510(K)的要求。

实质等同包括了很多方面的内容,包括产品的预期用途,工作原理,结构和配件,很重要的一点是包括其安全性和功能性。不同的产品检测标题也不末产,下面我们通过两类产品来分析,一个是无源器械活检针,一个是有源器械电动轮椅。

电动轮椅

进行实质等同比对的项目包括:主体框架材料和设计,折叠机制,座椅设计,座椅附件,轮椅总体尺寸,座椅尺寸,折叠后尺寸,轮椅重量,电池重量,控制器,驱动模式,电机类别,电机功率,电池类型,电池数量,电池规格,充电模式,刹车类型,刹车距离,各部件材料。除了这些之外,还需要比对生物相容性、EMC、性能要求。分别涉及到如下的检测标准,需要提供全套测试报告:

Item Proposed Device
IS07176-1 The Static stability has been determineg after the testing ccording tO the ISO 7176-1,and test results meet its design specification.
IS07176-2 The dynamic stability has been determined after the testing according to the ISO 7176-2,and test resuts meetits design specification.
IS07176-3 The effectiveness of brakes has been determined after the testing according to the ISO 7176-3,and test results meet its design specification.
IS07176-4 The theoretical dista nce range has been determined after the testing according to the SO 7176-4,and test results meet its design specification.
ISO7176-5 The dimensions,mass has been determineg after the testing according to theISO 7176-5
ISO7176-6

The maxImum speed Acce eration and dece leration of scooter has been determined after the testing according to the ISO 7176-6

IS07176-7 The seating and whee dimensions have been determined after the testing according to the ISO 7176-7
IS07176-8 A test results meet the requirements In Clause of ISO 7176-8
ISO7176-9 The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified Clause of SO 7176-9
IS07176-10 The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10
IS0O7176-11
The test dummies used in the testing of ISO 7176 series are meet the requirements ofISO 7176-11
IS07176-13 The coefficient of friction oftestsurfaces has been determined which could be used in other 7176 series tests involved
IS07176-14 All test resdt5 meet the requirements In Clause 7,8,9,10,11,12,13,14,15,17 ofISO 7176-14
IS07176-15 The test results shown that information disclosure,documentation and label ling of device meet the requirements of SO 7176-15
IS07176-16
The performance ofresistance to ignition meets the requirements ofISO 7176-16
ISO 7176-21
The EMC performance results meet the requirements of SO 7176-21
IS07176-25 The performance of batteries and charger of device meet the Requirements Clause and of ISO 7176-25
Biocompatibil ity
All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.

 

活检针

进行实质等同比对的项目包括:预期用途、尺寸规格、作用机理、可用性、动力类型。还包括系列测试:

Characteristic Standard Content
Biocompatibility AAMI/ANSI/ISO10993-1 Biologica evaluation of Medica Devices Part1:Eva uation and Testing
Biocompatibility S010993-4 Biologica eV luation ofmedica devices--Part 4:selection of tests for interactions with blood
Biocompatibility ISO 10993-5 Biologica evauation of medical devices Part5: Tests tor in vitro cytotoxicity
Biocompatibility ISO 10993-10 Biologica evauation ofmedica devices Part 10:Tests for irritation and skin sensitization
Biocompatibility ISO 10993-11 Biologica evalauation of medica devices Part 11:Tests for svstemic toxicitv
Sterilization S011135 Medica Device Validation and Routine Control of Ethylene Oxide Sterilization
Residua IS010993-7 Bio logica evalauation of Medica Devices Part 7:Ethylene Oxide Sterilization Residuals
Sterilization ANSI/AAMI/ISO 11607 Packaging for Terminally Sterilizec Medica Devices
Sterilization ASTM F1980-07 Accelerateo Aging ofSterile Barrier Systems

 

性能测试和比对测试

Characteristic Standard Content
Performance ISO 9626:2016 Stainless Stee Needle Tubing tor the Manufacture of Medica Devices
Performance The test was conducted to the predicate device and  current device  to compare  to compare their performance Pressing parts, Pressing parts firing force, Cannula firing force, Safety switch, Sampling switch, Scale marks firmness,Total heavy metal content, Scale mark identification, Sampling structure,Sampling method,Penetration force-Comparison of testing result of predicate and proposed devices to prove eguivalency.
Performance Biopsy Sample Testing-Comparison of samples obtained by predicate and proposed devices to prove equivalency.
Performance Utrasound Visibility Testing-Verification of the proposed device ultrasouncd visibility to ensure safety and effectiveness

 

从上述两个案例来看,要证明产品实质等同就必须要提供详实的实验数据予以支撑,才能得到我们需要的结论。

那么对于510(K) 豁免的器械,产品检测同样重要,因为在上市后的QSR820合规抽查中,生产和检验控制模块同样要求制造商对于产品检测进行妥善的策划和实施。

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