CTF

VATECH Co., Ltd.

 
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Standards in Scope

Category
Standard
Tests/Clauses
Acceptance Date
Responsible National Certification Body(s)
MEDIEC 60601-1:2005
All clauses are applicable except for following clauses; Cl.10.2 to Cl.10.7 – Hazardous radiation Cl.11.4 to Cl.11.5 - MEE and MES intended for use in conjunction with flammable anaesthetics and agents Cl. 11.7 - Biocompatibility of ME Equipment and ME System Cl.17 – Electromagnetic compatibility of MEE and MES
MEDIEC 60601-1:2005/AMD1:2012
All clauses are applicable except for following clauses; Cl.10.2 to Cl.10.7 – Hazardous radiation Cl.11.4 to Cl.11.5 - MEE and MES intended for use in conjunction with flammable anaesthetics and agents Cl. 11.7 - Biocompatibility of ME Equipment and ME System Cl.17 – Electromagnetic compatibility of MEE and MES
MEDIEC 60601-1-3:2008
All clauses are applicable except for the related clauses excluded in Part 1
MEDIEC 60601-1-3:2008/AMD1:2013
All clauses are applicable except for the related clauses excluded in Part 1
MEDIEC 60601-2-63:2012
All clauses are applicable except for the related clauses excluded in Part 1.
MEDIEC 60601-2-63:2012/AMD1:2017
All clauses are applicable except for the related clauses excluded in Part 1.
MEDIEC 60601-2-65:2012
All clauses are applicable except for the related clauses excluded in Part 1.
MEDIEC 60601-2-65:2012/AMD1:2017
All clauses are applicable except for the related clauses excluded in Part 1.