CE技术文档内容.docxVIP

PartA

1

2

3

3.1

3.2

3.3

3.4

3.5

3.6

3.7

4

ContentsofTechnicalFile

Contents

Name, Postal Address of Manufacturer /EURepresentive

Alistingofallmanufacturingsitescoveredbythequalitysystem

Productdescription

Productname,classificationofthedeviceandaccessories

Listofaccessories(ifapplicable)Specification,modelandarticlenumbersChosenconformityassessmentpathIntendeduse

Integralpartsofthesalesunit

A brief product history (including existingregulatoryapprovals)

Listofharmonizedstandards

Notes

SatisfytheAnnexI

thesolutionsadoptedtosatisfythe

Es