Revision:
Effective:
V2.0
2020-03-28
SHANGHAI EARNTZ NONWOVEN.,LTD
Technical File of Earntz Protective Face Mask
Table of Contents
TABLE OF CONTENTS................................................................................................. 3
CHAPTER 1 DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS
AND ACCESSIRIES ...................................................................................................... 5
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 ofthe 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........... 14
CHAPTER 3 DESIGN AND MANUFACTURING INFORMATION............................... 15
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 ............ 22
4.1
General safety and performance requirements.................................................. 22
4.2
Applicable standards lists................................................................................... 22
CHAPTER 5 BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT....................... 23
