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  • REGULATION (EU) 2017 745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL . . .
    5 5 2017 EN Official Jour nal of the European Union L 117 1 (1) Opinion of 14 Febr uar y 2013 (OJ C 133, 9 5 2013, p 52) (2) Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Journal) and position of the Council at first reading of 7 March 2017 (not yet published in the Official Jour nal)
  • MDR - Article 2 - Definitions - Medical Device Regulation
    Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, […]
  • Medical Device Regulation (MDR) 2017 745 Quick Reference
    Medical Device Regulation (MDR) 2017 745 Quick Reference Chapter I Scope and definitions Article 1 Subject matter and scope Article 2 Definitions Article 3 Amendment of certain definitions Article 4 Regulatory status of products (MDD) • 2017 745 (MDR) Author: Mark Durivage Created Date: 2 11 2021 7:55:56 AM
  • Using the Classification rules in Annex VIII - Institute of Physics and . . .
    EU Regulation 2017 745 regarding Medical Devices Definitions You must read carefully the definitions of medical devicea [Article 2(1)] and an accessory for a medical device [Article 2(2)] attached below from the main body of the RegulationClick on the term to go to the definition Click on the definition text to go back
  • MDCG 2023-1 Guidance on the health institution exemption under Article . . .
    (MDCG) established by Article 103 of Regulation (EU) 2017 745 The MDCG is the definition in Article 2(1) MDR or 2(2) IVDR in view of its use in the health institution, then Article 5(5) applies National legislation on quality of care may also apply In‐house devices may include RUO products as components, provided that the
  • 2017 745 - EN - Medical Device Regulation - EUR-Lex
    Regulation (EU) 2017 745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001 83 EC, Regulation (EC) No 178 2002 and Regulation (EC) No 1223 2009 and repealing Council Directives 90 385 EEC and 93 42 EEC (Text with EEA relevance PDF EN Toggle Dropdown BG The definitions in this
  • Regulation (EU) 2017 745 of the European Parliament and of the Council
    Regulation (EU) 2017 745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001 83 EC, Regulation (EC) No 178 2002 and Regulation (EC) No 1223 2009 and repealing Council Directives 90 385 EEC and 93 42 EEC (Text with EEA relevance) Article 2 Definitions Article 3 Amendment of certain
  • A. I. S. E. IHO GUIDELINES ON REGULATION (EU) 2017 745 ON MEDICAL DEVICES
    The European Regulation on Medical Devices (EU) 2017 745 contains amendments to Directive 2001 83 EC, Regulation (EC) No 178 2002 and Regulation (EC) No 1223 2009 and repeals Council Directives 90 385 EEC and 93 42 EEC The guidance is specifically targeted to industrial and institutional cleaning and disinfectant products
  • A GUIDE TO THE NEW EUROPEAN UNION MEDICAL DEVICE REGULATION (MDR) - Ansell
    2017 2019 2021 May 27 2017 eire 2023 2025 2018 2020 2022 2024 EU MEDICAL DEVICE REGULATION (MDR) The final MDR document was published in May 2017, and the regulations will come into force in May 2021 During the transition period, devices may be placed on the market under either AIMDD MDD or EU MDR Medical device companies can receive compliance
  • Regulation (EU) 2017 745 of the European Parliament and of t. . . - EUR-Lex
    MAIN DOCUMENT Regulation (EU) 2017 745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001 83 EC, Regulation (EC) No 178 2002 and Regulation (EC) No 1223 2009 and repealing Council Directives 90 385 EEC and 93 42 EEC (OJ L 117, 5 5 2017, pp 1–175) Successive amendments to Regulation (EU) 2017 745 have been incorporated into the original
  • B REGULATION (EU) 2017 745 OF THE EUROPEAN PARLIAMENT AND OF THE . . .
    02017R0745 — EN — 24 04 2020 — 001 001 — 2 REGULATION (EU) 2017 745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001 83 EC, Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘medical device’ means any instrument, apparatus
  • Commission Factsheet for Class I Medical Devices - Public Health
    What You Need to Know About Regulation (EU) 2017 745 Changes in the classification of devices The MDR introduces new classification rules, based on which manufacturers must determine the risk class of their devices In doing so, manufacturers should be aware that these risk classes may differ from the class assigned under the MDD, e g , devices may





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