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Respiratory Product
EZKZP2
EARNTZ EZKZP2 Manuals
Manuals and User Guides for EARNTZ EZKZP2. We have
1
EARNTZ EZKZP2 manual available for free PDF download: Technical Documentation Manual
EARNTZ EZKZP2 Technical Documentation Manual (25 pages)
Protective Face Mask
Brand:
EARNTZ
| Category:
Respiratory Product
| Size: 1 MB
Table of Contents
Table of Contents
3
And Accessiries
5
Device Description and Specification
5
Device Name and General Description of the Device
5
Name and Address of the Manufacturer
5
Basic UDI-DI
6
Intended Use
6
Intended Users
6
The Disease Status to be Diagnosed/Targeted/Monitored
6
Classification Rule(S)
7
Contraindications
7
Description of the Principle
7
Rationale for the Qualification of the Product
7
Waring and Cautions
7
Description of the Accessories
8
Description of the Variant Configurations/ Variants
8
Explanation for Novel Features
8
Description of the Key Functional Elements
9
Product Specifications
10
Raw Materials and Packaging Materials
10
CND Code
11
Declaration of Conformity
11
EC Authorized Representative
11
Previous and Similar Generation of the Device
11
Chapter 2 Information to be Supplied by the Manufacturer
12
Chapter 3 Design and Manufacturing Information
13
Design Information
13
Design and Development Flow Chart
13
Design and Development Inputs
14
Design and Development Outputs
15
Manufacturing Information
21
Production Process Flow Chart
21
Special Processing Validation
21
Inspects and Controls the Environment
21
Chapter 4 General Safety and Performance Requirements
22
General Safety and Performance Requirements
22
Applicable Standards Lists
22
Chapter 5 Benefit-Risk Analysis and Risk Management
23
Chapter 6 Product Verification and Validation
24
Biocompatibility Test Report
24
Product Performance Test Report
24
Usability Evaluation Report
25
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