根據(jù)98/79/ECC（IVDD）指令附錄2確定產(chǎn)品分類原則對(duì)有認(rèn)證需求的產(chǎn)品進(jìn)行分類。分類的依據(jù)是產(chǎn)品所診斷的疾病。常見產(chǎn)品的分類可參考下表：
與上述診斷試劑配套使用的校準(zhǔn)品、儀器、標(biāo)本采集保存用具均屬于體外診斷器械指令管理的范疇。
對(duì)界于IVDD、MDD和常規(guī)儀器之間的產(chǎn)品，可參考?xì)W盟委員會(huì)MEDDEV.2.14/1 rev1 “IVD Guidances: Borderline issues”進(jìn)行分類。
IVD產(chǎn)品歐洲協(xié)調(diào)標(biāo)準(zhǔn)：
標(biāo)準(zhǔn)號(hào) | 內(nèi) 容 |
EN375 | Information supplied by manufacturer with IVD for professional use |
EN376 | Information supplied by manufacturer with IVD for self-testing |
EN591 | Instruction for use for IVD instruments for professional use |
EN592 | Instruction for use for IVD instruments for self-testing |
EN12287 | IVD—measure of quantities—description of reference materials |
EN12286 | IVD—measure of quantities—presentation of reference measurement procedures |
EN13532 | General requirements for IVD medical devices for self-testing |
EN13612 | Performance evaluation of IVD medical devices |
EN13641 | Elimination or reduction of risk of infection related to IVD reagents |
DRAFT prEN13975 | Sampling procedures used for acceptance testing of IVD—Statistical aspects |
DRAFT prEN14136 | Use of external quality assessment schemes in the assessment of the performance of IVD procedures |
DRAFT prEN ISO18153 | IVD—measurement of quantities—metrological traceability of values for catalytic concentration of enzymes |
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