Scope of Accreditation（Measurement Method）

Accreditation Number: VLAC-001-6
Expiration Date: April 30, 2026
〔Name of Laboratory〕

Japan Quality Assurance Organization〔Test site name〕

Kitakansai Testing Center, Medical Devices Testing Div.
〔Test site Address〕

1-7-7, Ishimaru, Minoh-shi, Osaka 562-0027, Japan〔Measurement Method〕

Safety test of medical electrical equipment
IEC 60601-1 series
IEC 62304
ISO 80601-2 series
EN 60601-1 series
EN IEC 60601-2 series
JIS T 0601-1 series
JIS T 1115
JIS T 5701

IEC 60601-2 series

IEC 80601-2 series

IEC 62366 series

ISO 6875EN 60601-2 series
EN 62304
JIS T 0601-2 series
JIS T 1140
JIS T 7209

ISO 7494-1
EN 80601-2 series

ISO 8359
EN 62366 series

JIS T 80601-2 series
JIS T 2304

JIS T 62366 series
JIS T 5602

Safety tests of electrical equipment for measurement, control, and laboratory use
IEC 61010-1 Series
EN 61010-1 Series
JIS C 1010-1 Series

IEC 61010-2 Series
EN 61010-2 Series
JIS C 1010-2 Series

EN IEC 61010-2 Series

Environment (Power consumption)
Standard power consumption level TEC method
Operation method OM method

Voluntary EMC Laboratory Accreditation Center Inc.

Scope of Accreditation（Test standards）

Accreditation Number: VLAC-001-6
Expiration Date: April 30, 2026
〔Name of Laboratory〕

Japan Quality Assurance Organization.
〔Test site name〕

Kitakansai Testing Center, Medical Devices Testing Div.
〔Test site Address〕

1-7-7, Ishimaru, Minoh-shi, Osaka 562-0027, Japan〔Test standards〕

Safety test of medical electrical equipment
IEC 60601-1:2005
IEC 60601-1:2005+A1:2012
IEC 60601-1:2005+A2:2020

EN 60601-1:2006
JIS T 0601-1:2012
EN 60601-1:2006+A11:2011+A1:2013+A12:2014
JIS T 0601-1:2017
EN 60601-1:2006+A11:2011+A1:2013+A12:2014+A2:2021
JIS T 0601-1:2023
EN 60601-1-6:2010
EN 60601-1-6:2010+A1:2015

IEC 60601-1-6:2010
IEC 60601-1-6:2010+A1:2013
IEC 60601-1-6:2010+A1:2013+A2:2020
IEC 60601-1-8:2006
EN 60601-1-8:2007
JIS T 60601-1-8:2012
IEC 60601-1-8:2006+A1:2012
EN 60601-1-8:2007+A1:2013+AC:2014
IEC 60601-1-8:2006+A1:2012+A2:2020 EN 60601-1-8:2007+A1:2013+AC:2014+A11:2017+A2:2021
IEC 60601-1-11:2010
IEC 60601-1-11:2015
IEC 60601-1-11:2015+A1:2020
EN 60601-1-11:2015+A1:2021
IEC 60601-2-2:2009
JIS T 0601-2-2:2014
IEC 60601-2-2:2017
JIS T 0601-2-2:2020
IEC 60601-2-10:2012
EN 60601-2-10:2015
JIS T 0601-2-10:2015
IEC 60601-2-10:2012+A1:2016
EN 60601-2-10:2015+A1:2016
IEC 60601-2-16:2012
EN 60601-2-16:2015
JIS T 0601-2-16:2014
IEC 60601-2-16:2018
JIS T 0601-2-16:2022
IEC 60601-2-18:2009
JIS T 0601-2-18:2013
IEC 60601-2-24:2012
JIS T 0601-2-24:2018
IEC 60601-2-25:2011
JIS T 0601-2-25:2014
IEC 60601-2-27:2011
IEC 60601-2-37:2007
JIS T 0601-2-37:2013
IEC 60601-2-37:2007+A1:2015
JIS T 0601-2-37:2018
IEC 60601-2-46:2016
JIS T 0601-2-204:2015
JIS T 0601-2-205:2015
JIS T 0601-2-206:2015
IEC 80601-2-30:2009
EN 80601-2-30:2010
IEC 80601-2-30:2009+A1:2013
EN 80601-2-30:2010+A1:2015
JIS T 1115:2018
IEC 80601-2-60:2012
JIS T 80601-2-60:2014
IEC 80601-2-60:2019
EN IEC 80601-2-60:2020
JIS T 80601-2-60:2021
IEC 80601-2-77:2019

IEC 62304:2006
IEC 62304:2006+A1:2015
ISO 6875:2011
ISO 7494-1:2011
IEC 62366:2007
IEC 62366:2007+A1:2014
IEC 62366-1:2015
IEC 62366-1:2015+A1:2020
ISO 80601-2-56:2009
ISO 80601-2-56:2017
ISO 80601-2-56:2017+A1:2018

EN 62304:2006

JIS T 2304:2012
JIS T 2304:2017
JIS T 5602:2014
JIS T 5701:2014

EN 62366:2008
EN 62366:2008+A1:2015
EN 62366-1:2015+AC:2015

JIS T 62366-1:2019

EN 62366-1:2015+AMD1:2020

JIS T 62366-1:2022

JIS T 1140:2014
JIS T 7209:2007
JIS T 7209:2018

ISO 8359:1996
ISO 80601-2-69:2014

Safety tests of electrical equipment for measurement, control, and laboratory use
IEC 61010-1:2010
IEC 61010-1:2010+A1:2016
IEC 61010-2-010:2014
IEC 61010-2-010:2019
IEC 61010-2-040:2015
IEC 61010-2-040:2020
IEC 61010-2-081:2015
IEC 61010-2-081:2019
IEC 61010-2-101:2015
IEC 61010-2-101:2018

EN 61010-1:2010
EN 61010-1:2010+A1:2019
EN 61010-2-010:2015
EN IEC 61010-2-010:2020

JIS C 1010-1:2014
JIS C 1010-1:2019

EN 61010-2-101:2017
EN IEC 61010-2-101:2022

JIS C 1010-2-101:2017

Environment (Power consumption)
IEC 62087-1:2015, IEC 62087-2:2015, IEC 62087-3:2015
IEC 62301:2011

Voluntary EMC Laboratory Accreditation Center Inc.

The laboratory is only accredited for testing activities outlined within the test methods listed above.
If test standards do not include the edition, it means the latest one at the date of renewal (5.1, 2024).