根據(ju)98/79/ECC（IVDD）指令附錄2確定產(chan)品分(fen)類原則對有認證(zheng)需求(qiu)的產(chan)品進行分(fen)類。分(fen)類的依(yi)據(ju)是產(chan)品所診(zhen)斷(duan)的疾病。常見產(chan)品的分(fen)類可(ke)參考下(xia)表：
與上述(shu)診(zhen)(zhen)斷(duan)試劑配(pei)套使用(yong)的校(xiao)準(zhun)品、儀器、標本采集保存(cun)用(yong)具均屬(shu)于體外診(zhen)(zhen)斷(duan)器械指令管理(li)的范疇。
對界于IVDD、MDD和(he)常規儀器之間的產品，可(ke)參考歐(ou)盟委員(yuan)會MEDDEV.2.14/1 rev1 “IVD Guidances: Borderline issues”進行分類。
IVD產(chan)品歐洲協調標準：
標準號 | 內 ; 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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