Dental chair
Dental chair
Safety :
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
EMC : -
Performance : -
Local Standard
USA
ANSI/AAMI ES60601-1:2005/A2:2021 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance - Amendment 2
IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
ISO 7494-1 Third edition 2018-06 Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
ANSI/AAMI ES60601-1-2:2005/A2:2021 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
ANSI/ADA 46-2016 Dental Patient Chair
MIL-D-42007A NOT 1 Dental Operating And Treatment Unit, Over Patient Type, Chair Mounted (No S/S Document)
Europe
EN 60601-1:2006(MAIN) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
EN ISO 5467-1:2022(MAIN) Dentistry - Mobile dental units and dental patient chairs - Part 1: General requirements (ISO 5467-1:2022)
EN ISO 5467-2:2022(MAIN) Dentistry - Mobile dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems (ISO 5467-2:2022)
EN ISO 7494-1:2018(MAIN) Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements (ISO 7494-1:2018)
EN IEC 80601-2-60:2020(MAIN) Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
China
GB 9706.1: General requirements for safety of medical electrical equipment
GB 4824.1: General requirements for electromagnetic compatibility of medical electrical equipment
GB/T 19469-2004 Minimum allowable values of energy efficiency and energy efficiency grades for electrical dental units and dental chairs
Japan
JIS T 0601-1: General requirements for safety of medical electrical equipment
JIS T 0601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
JIS T 5602-2014 Dental - patient chair
Korea
KS IEC 60601-1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
KS C 9811 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement KS C IEC 60601-1-2:2016 is Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
KS P ISO7494-1: Dentistry ─ Fixed dental units and dental chairs ─ Part 1: General requirements
Taiwan
CNS 60601:2015 Medical electrical equipment - Part 1: General requirements for safety
CNS 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
CNS 14907:2016 - Dental chairs
Brasil
ABNT NBR IEC 60601-1:2015 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
ABNT NBR IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
ABNT NBRISO6875 DE 03/2014 Dentistry - Patient chair
Mexico
NOM-IEC 60601-1:2014 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
NOM-IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
NOM-125-SSA1-2016 Goods and services. Dental chairs. Specifications and test methods for safety and efficacy.
Argentina
IRAM 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IRAM 60601-1-2:2012 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Australia
AS/NZS IEC 60601.1:2015 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
AS IEC 60601.1.2:2017 Medical electrical equipment, Part 1.2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
AS/NZS 3973:2015 Dental equipment - Dental chairs and stools
AS/NZS 3200.2.41:2008 Medical electrical equipment - Particular requirements for the safety of electrically powered medical, dental and electrosurgical equipment
South Africa
SANS 60601-1:2016 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SANS 60601-1-2:2022 (Ed. 4.01):Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Saudi Arabia
SASO IEC 60601-1:2015 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SASO IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Safety :
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
EMC : -
Performance : -
Local Standard
USA
ANSI/AAMI ES60601-1:2005/A2:2021 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance - Amendment 2
IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
ISO 7494-1 Third edition 2018-06 Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
ANSI/AAMI ES60601-1-2:2005/A2:2021 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
ANSI/ADA 46-2016 Dental Patient Chair
MIL-D-42007A NOT 1 Dental Operating And Treatment Unit, Over Patient Type, Chair Mounted (No S/S Document)
Europe
EN 60601-1:2006(MAIN) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
EN ISO 5467-1:2022(MAIN) Dentistry - Mobile dental units and dental patient chairs - Part 1: General requirements (ISO 5467-1:2022)
EN ISO 5467-2:2022(MAIN) Dentistry - Mobile dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems (ISO 5467-2:2022)
EN ISO 7494-1:2018(MAIN) Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements (ISO 7494-1:2018)
EN IEC 80601-2-60:2020(MAIN) Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
China
GB 9706.1: General requirements for safety of medical electrical equipment
GB 4824.1: General requirements for electromagnetic compatibility of medical electrical equipment
GB/T 19469-2004 Minimum allowable values of energy efficiency and energy efficiency grades for electrical dental units and dental chairs
Japan
JIS T 0601-1: General requirements for safety of medical electrical equipment
JIS T 0601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
JIS T 5602-2014 Dental - patient chair
Korea
KS IEC 60601-1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
KS C 9811 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement KS C IEC 60601-1-2:2016 is Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
KS P ISO7494-1: Dentistry ─ Fixed dental units and dental chairs ─ Part 1: General requirements
Taiwan
CNS 60601:2015 Medical electrical equipment - Part 1: General requirements for safety
CNS 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
CNS 14907:2016 - Dental chairs
Brasil
ABNT NBR IEC 60601-1:2015 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
ABNT NBR IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
ABNT NBRISO6875 DE 03/2014 Dentistry - Patient chair
Mexico
NOM-IEC 60601-1:2014 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
NOM-IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
NOM-125-SSA1-2016 Goods and services. Dental chairs. Specifications and test methods for safety and efficacy.
Argentina
IRAM 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IRAM 60601-1-2:2012 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
Australia
AS/NZS IEC 60601.1:2015 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
AS IEC 60601.1.2:2017 Medical electrical equipment, Part 1.2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
AS/NZS 3973:2015 Dental equipment - Dental chairs and stools
AS/NZS 3200.2.41:2008 Medical electrical equipment - Particular requirements for the safety of electrically powered medical, dental and electrosurgical equipment
South Africa
SANS 60601-1:2016 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SANS 60601-1-2:2022 (Ed. 4.01):Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Saudi Arabia
SASO IEC 60601-1:2015 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
SASO IEC 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
GSO ISO 6875:2016 ISO 6875:2011 Gulf Standard Dentistry -- Patient Chair
EAEU
GOST R IEC 60601-1:2017 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GOST R IEC 60601-1-2:2017 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
GOST 28131-89 Dental chair. General technical requirements and methods of tests
EAEU
GOST R IEC 60601-1:2017 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GOST R IEC 60601-1-2:2017 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
GOST 28131-89 Dental chair. General technical requirements and methods of tests
