营口医疗器械检测报告在哪办理（附最新检测机构）

一、营口市医疗器械第三方检测机构

（一）营口世纪检测科技有限公司

1. 注册时间2021年05月21日。

2. 机构地址中国（辽宁）自由贸易试验区营口片区智胜街西92号4号厂房。

3. 机构负责人张桐玮。

（二）辽宁中检检验有限公司

1. 注册时间2022年07月18日。

2. 机构地址营口市鲅鱼圈区盐场09-天鸿小区1号楼。

3. 机构负责人李娜。

（三）营口皓泰医学检验有限公司

1. 注册时间2022年07月12日。

2. 机构地址营口市大石桥市经济开发区循环产业园。

3. 机构负责人刘阳。

（四）营口拓诚商品检验有限公司

1. 注册时间2021年08月09日。

2. 机构地址营口市鲅鱼圈区02-铁小商住楼-43号。

3. 机构负责人陈明。

（五）康特(辽宁)医学检验有限公司

1. 注册时间2019年08月13日。

2. 机构地址营口市站前区新地号里1号。

3. 机构负责人赵峰。

二、医疗器械检测服务类型及办理相关介绍

（一）医疗器械检测项目

医疗器械检测项目主要依据YY/T 0664、GB/T 25000.51等标准执行。核心项目包括安全性检测，排查电气安全、生物相容性及无菌性指标。性能检测测定产品功能精度、稳定性及使用寿命。还包括生物安全性检测，评估细胞毒性、致敏性等风险。同时覆盖软件类医疗器械的功能、信息安全检测，适配Ⅰ类、Ⅱ类、Ⅲ类各类医疗器械，满足注册审批、生产管控及市场准入需求。

（二）医疗器械检测费用

医疗器械检测费用按产品类别、检测项目及风险等级核算。Ⅰ类医疗器械基础检测每套3000至5000元，含安全性及基础性能指标。Ⅱ类医疗器械检测每套8000至15000元，增加生物相容性等项目。Ⅲ类高风险器械全项检测费用20000至50000元。软件类医疗器械检测按复杂程度收费，费用5000至20000元。加急检测额外收取50%至100%服务费，常规周期7至15个工作日，费用不含样品寄送及整改复测费。

（三）医疗器械检测流程

医疗器械检测流程分五个步骤执行。第一步委托对接，企业说明产品类别、型号及检测需求，确定检测方案并签订合同。第二步资料提交，提供产品技术文档、说明书及生产工艺资料。第三步样品送检，按标准提交代表性样品，做好标识与密封。第四步实验室检测，执行安全性、性能等项目测试，记录原始数据。第五步报告出具，对照标准判定结果，报告可用于产品注册、备案及市场流通审批。

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