EARNTZ EZKZP2, Техническая документация инструкция

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No.
Revision:
Effective:
Page:
EZKZ01
V2.0
2020-03-28
Page 3 of 28
SHANGHAI EARNTZ NONWOVEN.,LTD
Technical File of Earntz Protective Face Mask
Page 3 of 28
Table of Contents
TABLE OF CONTENTS .................................................................................................
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CHAPTER 1 DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS
AND ACCESSIRIES ......................................................................................................
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1.1 Device description and specification .................................................................... 5
1.1.1 Name and address of the manufacturer ........................................................................... 5
1.1.2 Device name and general description of the device ..................................................... 5
1.1.3 Intended use ............................................................................................................................... 6
1.1.4 Intended users ........................................................................................................................... 6
1.1.5 Basic UDI-DI ............................................................................................................................... 6
1.1.6 The disease status to be diagnosed/targeted/monitored ........................................... 6
1.1.7 Contraindications ...................................................................................................................... 7
1.1.8 Waring and Cautions ............................................................................................................... 7
1.1.9 Description of the principle ................................................................................................... 7
1.1.10 Rationale for the qualification of the product ............................................................... 7
1.1.11 Classification rule(s) ............................................................................................................... 7
1.1.12 Explanation for novel features ............................................................................................ 8
1.1.13 Description of the accessories ............................................................................................ 8
1.1.14 Description of the Variant configurations/ variants ..................................................... 8
1.1.15 Description of the key functional elements .................................................................... 9
1.1.16 Raw materials and packaging materials ....................................................................... 10
1.1.17 Product Specifications ........................................................................................................ 10
1.2 Previous and similar generation of the device .................................................... 11
1.3 EC Authorized Representative ........................................................................... 12
1.4 CND code ........................................................................................................... 13
1.5 Declaration of conformity .................................................................................... 13
CHAPTER 2 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER ...........
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CHAPTER 3 DESIGN AND MANUFACTURING INFORMATION ...............................
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3.1 Design Information ............................................................................................. 15
3.1.1 Design and Development flow chart ............................................................................... 15
3.1.2 Design and Development inputs ...................................................................................... 16
3.1.3 Design and Development Outputs................................................................................... 17
3.2 Manufacturing information .................................................................................. 21
3.2.1 Production Process Flow Chart .......................................................................................... 21
3.2.2 Special processing validation ............................................................................................. 21
3.2.3 Inspects and controls the environment .......................................................................... 21
CHAPTER 4 GENERAL SAFETY AND PERFORMANCE REQUIREMENTS ............
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4.1 General safety and performance requirements .................................................. 22
4.2 Applicable standards lists ................................................................................... 22
CHAPTER 5 BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT .......................
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