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(042)Declaration of Conformity_Trinity_221215

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12 views3 pages

(042)Declaration of Conformity_Trinity_221215

Uploaded by

Rotaru Andrei
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Attachment #1.

Trinity

Rev
Certificate Table - Trinity 2020-10-09
Date.
1) Brand name : Trinity Rev No. 4

Model
No
Korea MFDS CE Marking
1 Trinity MBT022 #11 135-11-5 / 135-11-100
2 Trinity MBT022 #12 135-12-5 / 135-12-100
3 Trinity MBT022 #13H 135-13H-5 / 135-13H-100
4 Trinity MBT022 #21 135-21-5 / 135-21-100
5 Trinity MBT022 #22 135-22-5 / 135-22-100
6 Trinity MBT022 #23H 135-23H-5 / 135-23H-100
7 Trinity MBT022 #14H 135-14H-5 / 135-14H-100
8 Trinity MBT022 #24H 135-24H-5 / 135-24H-100
9 Trinity MBT022 #31 135-31-5 / 135-31-100
10 Trinity MBT022 #33 135-33-5 / 135-33-100
11 Trinity MBT022 #34 135-34-5 / 135-34-100
12 Trinity MBT022 #43 135-43-5 / 135-43-100
13 Trinity MBT022 #44 135-44-5 / 135-44-100

1 135-301 Trinity MBT022 Upper 3-3 135-301


2 135-030 Trinity MBT022 Lower 3-3 135-030
3 135-331 Trinity MBT022 Upper and Lower 3-3 135-331
4 135-503 Trinity MBT022 Upper 5-5 135-503
5 135-050 Trinity MBT022 Lower 5-5 135-050
6 135-553 Trinity MBT022 Upper and Lower 5-5 135-553
Attachment #2. Trinity

European Norms and Standards and other Documents supporting Technical Files;
Standard Number/Revision Harmonized Standard Description

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on
medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation
Regulation (EU) 2017/745 (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with
EEA relevance. )

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(OJ L 169 of 12 July
Directive 93/42/EEC
1993)

EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes

Medical devices - Application of risk management to medical devices (ISO/TR 24971:2020,


EN ISO 14971:2019 Medical devices-Guidance on the Application of ISO14971)

EN 1041:2008 Information supplied by the manufacturer of medical devices

Medical device-Symbols to be used with medical device labels, labelling and information to be
EN ISO 15223-1:2016 supplied – Part 1: General requirements

EN ISO 10993-1:2018 Biological evaluation of medical devices Part 1. : Evaluation and testing within a risk
Management Process
Biological evaluation of medical devices Part 3. : Tests for genotoxicity, carcinogenicity and
EN ISO 10993-3:2014 reproductive toxicity

EN ISO 10993-5:2009 Biological evaluation of medical devices Part 5. : Tests for in vitro cytotoxicity

EN ISO 10993-10:2010 Biological evaluation of medical devices Part 10. : Tests for irritation and skin sensitization

EN ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

EN 1641:2009 Dentistry - Medical devices for dentistry – Materials

ISO 27020:2019 Dentistry - Brackets and tubes for use in orthodontics

ISO 22674:2016 Dentistry - Metallic materials for fixed and removable restorations and appliances

IEC 62366:2015 Medical devices - Application of usability engineering to medical devices

ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems

MEDDEV 2.7.1 Clinical Evaluation Guide for manufacturers and notified bodies (June 2016) Rev. 4

MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies

MDCG 2020-13 Clinical evaluation assessment report template

MEDDEV 2.12-1 Medical devices vigilance system (January 2013) Rev. 8

MEDDEV 2.12-2 Post market clinical follow-up studies (January 2012) Rev. 2

MDCG 2020-7 MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for
manufacturers and notified bodies
MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template A guide for manufacturers
and notified bodies
NB-MED/2.12/Rec1 Post-Marketing Surveillance (PMS) Post market/production

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