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IEC61000-4-11 最新版 CONTENTS 2 FOREWORD ........................................................................................................................... 3 3 INTRODUCTION ..................................................................................................................... 4 4 1 Scope .............................................................................................................................. 5 5 2 Normative references ....................................................................................................... 5 6 3 Terms and definitions ...................................................................................................... 5 7 4 General ........................................................................................................................... 7 8 5 Test levels ....................................................................................................................... 7 9 6 Test instrumentation ...................................................................................................... 12 10 7 Test set-up .................................................................................................................... 14 11 8 Test procedures ............................................................................................................. 15 12 9 Evaluation of test results ................................................................................................ 17 13 10 Test report ..................................................................................................................... 18

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DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Cooperating organizations The European Committee for Electrotechnical Standardization (CENELEC), under whose supeivision this European Standard was prepared, comprises the national committees of the following countries: Austria Belgium Denmark Finland France Germany Greece Iceland Ireland Italy Luxembourg Netherlands Norway Portugal Spain Sweden Switzerland United Kingdom

Deciding When to Submit a 510(k) for a Change to an Existing Device Guidance for Industry and Food and Drug Administration Staff Document issued on October 25, 2017. The draft of this document was issued on August 8, 2016. This document supersedes Deciding When to Submit a 510(k) for a Change to an Existing Device, dated January 10, 1997. For questions about this document regarding CDRH-regulated devices, contact the 510(k) Staff at 301-796-5640. For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010.

Deciding When to Submit a 510(k) for a Software Change to an Existing Device ______________________________________________________________________________ Guidance for Industry and Food and Drug Administration Staff Document issued on October 25, 2017. The draft of this document was issued on August 8, 2016.