1. <em id="jym1e"></em>

      <button id="jym1e"></button>

    2. <span id="jym1e"></span>
    3. <button id="jym1e"><acronym id="jym1e"></acronym></button>
      1. Hi,are you ready?
        準備好開始了嗎?
        那就與我們取得聯系吧
        有一個醫療器械項目想和我們談談嗎?您可以填寫右邊的表格,讓我們了解您的項目需求,這是一個良好的開始,我們將會盡快與你取得聯系。當然也歡迎您給我們寫信或是打電話,讓我們聽到你的聲音!

        格慧泰福(GHTF) | 高端醫療器械臨床注冊專家

        24小時免費咨詢熱線:

        400-9905-168

        填寫您的項目信息

        填寫完表單后,請點擊以下任意一種溝通方式:

        QQ咨詢 QQ咨詢 在線商橋

        我們的服務
        歐盟體外診斷器械指令IVDD98/79/EC相關標準
         

        歐盟體外診斷器械指令IVDD98/79/EC相關標準

        The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS (Harmonised standards) database. This IT application HAS automates the process of the publication of the references of harmonised standards in the Official Journal of the European Union.
        Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal affect.

        ESO (1)

        Reference and title of the harmonised standard
        (and reference document)

        First publication OJ

        Reference of superseded standard

        Date of cessation of presumption of conformity of superseded standard
        Note 1

        CEN

        EN 556-1:2001

        Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

        31/07/2002

        EN 556:1994 + A1:1998

        Note 2.1

        Date expired
        (30/04/2002)

        EN 556-1:2001/AC:2006

        15/11/2006

        CEN

        EN 556-2:2003

        Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

        09/08/2007

        CEN

        EN 980:2008

        Symbols for use in the labelling of medical devices

        23/07/2008

        EN 980:2003

        Note 2.1

        Date expired
        (31/05/2010)

        CEN

        EN ISO 11737-2:2009

        Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

        07/07/2010

        CEN

        EN 12322:1999

        In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

        09/10/1999

        EN 12322:1999/A1:2001

        31/07/2002

        Note 3

        Date expired
        (30/04/2002)

        CEN

        EN ISO 13485:2003

        Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

        02/04/2004

        EN ISO 13488:2000
        EN ISO 13485:2000


        Note 2.1

        Date expired
        (31/07/2009)

        EN ISO 13485:2003/AC:2009

        07/07/2010

        CEN

        EN 13532:2002

        General requirements for in vitro diagnostic medical devices for self-testing

        17/12/2002

        CEN

        EN 13612:2002

        Performance evaluation of in vitro diagnostic medical devices

        17/12/2002

        EN 13612:2002/AC:2002

        02/12/2009

        CEN

        EN 13640:2002

        Stability testing of in vitro diagnostic reagents

        17/12/2002

        CEN

        EN 13641:2002

        Elimination or reduction of risk of infection related to in vitro diagnostic reagents

        17/12/2002

        CEN

        EN 13975:2003

        Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

        21/11/2003

        CEN

        EN 14136:2004

        Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

        15/11/2006

        CEN

        EN 14254:2004

        In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

        28/04/2005

        CEN

        EN 14820:2004

        Single-use containers for human venous blood specimen collection

        28/04/2005

        CEN

        EN ISO 14937:2009

        Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

        07/07/2010

        EN ISO 14937:2000

        Note 2.1

        Date expired
        (30/04/2010)

        CEN

        EN ISO 14971:2009

        Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

        07/07/2010

        EN ISO 14971:2007

        Note 2.1

        Date expired
        (21/03/2010)

        CEN

        EN ISO 15193:2009

        In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)

        07/07/2010

        CEN

        EN ISO 15194:2009

        In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)

        07/07/2010

        CEN

        EN ISO 15197:2003

        In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)

        28/04/2005

        EN ISO 15197:2003/AC:2005

        02/12/2009

        CEN

        EN ISO 17511:2003

        In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

        28/04/2005

        CEN

        EN ISO 18113-1:2009

        In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

        07/07/2010

        CEN

        EN ISO 18113-2:2009

        In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

        07/07/2010

        EN 375:2001

        Note 2.1

        31/12/2012

        CEN

        EN ISO 18113-3:2009

        In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

        07/07/2010

        EN 591:2001

        Note 2.1

        31/12/2012

        CEN

        EN ISO 18113-4:2009

        In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

        07/07/2010

        EN 376:2002

        Note 2.1

        31/12/2012

        CEN

        EN ISO 18113-5:2009

        In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

        07/07/2010

        EN 592:2002

        Note 2.1

        31/12/2012

        CEN

        EN ISO 18153:2003

        In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

        21/11/2003

        CEN

        EN ISO 20776-1:2006

        Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)

        09/08/2007

        Cenelec

        EN 61010-2-101:2002

        Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
        IEC 61010-2-101:2002 (Modified)

        17/12/2002

        Cenelec

        EN 61326-2-6:2006

        Electrical equipment for measurement, control and laboratory use - EMC requirements -- Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
        IEC 61326-2-6:2005

        27/11/2008

        Cenelec

        EN 62304:2006

        Medical device software - Software life-cycle processes
        IEC 62304:2006

        27/11/2008

        EN 62304:2006/AC:2008 (new)

        This is the first publication

        Cenelec

        EN 62366:2008

        Medical devices - Application of usability engineering to medical devices
        IEC 62366:2007

        27/11/2008

        (1) ESO: European Standardisation Organisation:

        CEN: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)

        CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.org)

        ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

        Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal (“dow”), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

        Note 2.1: The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

        Note 2.2: The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

        Note 2.3: The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.

        Note 3: In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive.

        更多
        收起
          服務流程資料添加中....
          官方收費資料添加中....
          基礎法規資料添加中....
          相關服務資料添加中....

          歐盟體外診斷器械指令IVDD98/79/EC相關標準

          IVD歐盟主要CE指令依據

          體外診斷醫療器械指令 98/79/EC

          IVDD產品分類與相關標準

        全國服務熱線:

        400-9905-168

        關注我們

        粵ICP備13059948號 廣州格慧泰福(GHTF)生物科技有限公司 版權所有 

        ??

        日本一级婬片免费啪啪_暖暖直播免费观看视频琪琪_中国av一级天堂_亚洲中文字幕人成影院