CTF

A-Dec, Inc.

 
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Standards in Scope

Category
Standard
Tests/Clauses
Acceptance Date
Responsible National Certification Body(s)
MEASIEC 61010-1:2010
10.1-10.4 NORMAL TEMPERATURE TEST 4.4.2.3 PROTECTIVE CONDUCTOR ABNORMAL 5.1.3 INPUT POWER/CURRENT MEASUREMENT 5.3 DURABILITY OF MARKINGS 6.2 DETERMINATION OF ACCESSIBLE PARTS 6.3 PERMISSIBLE LIMITS 6.5.2.4 AND 6.5.2.5 GROUNDING CONTINUITY TEST 6.7.2.1 CLEARANCES AND CREEPAGE DISTANCES 6.8 DIELECTRIC STRENGTH
2016-10-18
MEDIEC 60601-1:2005
11 TEMPERATURE 11.6.2 OVERFLOW IN ME EQUIPMENT 11.6.3 SPILLAGE 11.6.6 CLEANING AND DISINFECTION OF ME EQUIPMENT AND ME SYSTEMS 11.8 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER HAZARDS -INTERRUPTION OF THE POWER SUPPLY / SUPPLY MAINS TO ME EQUIPMENT 13.2.6 LEAKAGE OF LIQUID 13.2.7 IMPAIRMENT OF COOLING 13.2.8 LOCKING OF MOVING PARTS 13.2.9 INTERRUPTION AND SHORT CIRCUIT OF MOTOR CAPACITORS 15.3.2 ENCLOSURE MECHANICAL STRENGTH - PUSH TEST 15.3.3 ENCLOSURE MECHANICAL STRENGTH - IMPACT 15.3.4.1 DROP-HANDHELD 15.3.5 CONSTRUCTION OF ME EQUIPMENT - MECHANICAL STRENGTH -ROUGH HANDLING 15.3.6 CONSTRUCTION OF ME EQUIPMENT - MECHANICAL STRENGTH -MOULD STRESS RELIEF TEST 15.4.7.1 CORD CONNECTED FOOT OPERATED CONTROL DEVICE 15.4.7.2 ACCIDENTAL OPERATION OF ME EQUIPMENT 15.5.1 MAINS SUPPLY TRANSFORMERS OF ME EQUIPMENT AND TRANSFORMERS PROVIDING 15.5.2 TRANSFORMER DIELECTRIC VOLTAGE WITHSTAND 4.11 POWER INPUT 4.7 FAILURE OF COMPONENTS 5.7 HUMIDITY PRECONDITIONING TREATMENT 7.1.2 LEGIBILITY OF MARKINGS 7.1.3 DURABILITY OF MARKINGS 8.11.3.5 MAINS PARTS, COMPONENTS AND LAYOUT - POWER SUPPLY CORDS - CORD ANCHORAGE 8.4.2 AND 8.11.1 LOW VOLTAGE RELIABILITY 8.4.3 LIMITATION OF VOLTAGE, CURRENT OR ENERGY - ME EQUIPMENT INTENDED TO BE CONNECTED TO A POWER SOURCE BY A PLUG 8.4.4 VOLTAGE LIMITATION (PART 2) 8.6.4A EARTHING AND POTENTIAL EQUALIZATION 8.7.4.5 LEAKAGE CURRENTS AND PATIENT AUXILIARY CURRENTS -MEASUREMENTS -MEASUREMENT OF THE EARTH LEAKAGE CURRENT 8.7.4.6 TOUCH CURRENT 8.7.4.7 PATIENT LEAKAGE CURRENT 8.7.4.7H TOTAL PATIENT LEAKAGE CURRENT 8.7.4.8 PATIENT AUXILIARY CURRENT 8.8.3 DIELECTRIC STRENGTH 8.9.4 CREEPAGE DISTANCES AND AIR CLEARANCES 9.2.2.2 MEASUREMENT OF GAPS (TRAPPING ZONES) 9.4.2 PROTECTION AGAINST MECHANICAL HAZARDS OF ME EQUIPMENT AND ME SYSTEMS - INSTABILITY HAZARDS- INSTABILITY – OVERBALANCE 9.4.2.4.2 INSTABILITY HAZARDS- INSTABILITY – OVERBALANCE -CASTORS AND WHEELS -FORCE FOR PROPULSION 9.4.2.4.3 INSTABILITY HAZARDS - INSTABILITY – OVERBALANCE - CASTORS AND WHEELS -MOVEMENT OVER A THRESHOLD 9.8.3.1 HAZARDS ASSOCIATED WITH SUPPORT SYSTEMS- STRENGTH OF PATIENT OR OPERATOR SUPPORT OR SUSPENSION SYSTEMS -GENERAL 9.8.3.2 HAZARDS ASSOCIATED WITH SUPPORT SYSTEMS- STRENGTH OF PATIENT OR OPERATOR SUPPORT OR SUSPENSION SYSTEMS- STATIC FORCES DUE TO LOADING FROM PERSONS 9.8.3.3 HAZARDS ASSOCIATED WITH SUPPORT SYSTEMS - STRENGTH OF PATIENT OR OPERATOR SUPPORT OR SUSPENSION SYSTEMS - DYNAMIC FORCES DUE TO LOADING FROM PERSONS
2015-01-12
MEDIEC 60601-1:2005/AMD1:2012
11.1.1 MAXIMUM TEMPERATURE DURING NORMAL USE 11.6.2 OVERFLOW IN ME EQUIPMENT 11.6.3 SPILLAGE ON ME EQUIPMENT AND ME SYSTEMS 11.6.6 CLEANING AND DISINFECTION OF ME EQUIPMENT AND ME SYSTEMS 11.8 INTERRUPTION OF THE POWER SUPPLY / SUPPLY MAINS TO ME EQUIPMENT 13.2.6 LEAKAGE OF LIQUID 13.2.7 IMPAIRMENT OF COOLING THAT COULD RESULT IN A HAZARDOUS SITUATION 13.2.8 LOCKING OF MOVING PARTS 13.2.9 INTERRUPTION AND SHORT CIRCUIT OF MOTOR CAPACITORS 15.3.2 PUSH TEST 15.3.3 IMPACT TEST 15.3.4.1 HAND-HELD ME EQUIPMENT 15.3.5 ROUGH HANDLING TEST 15.3.6 MOULD STRESS RELIEF TEST 15.4.7.1 MECHANICAL STRENGTH 15.4.7.2 ACCIDENTAL OPERATION OF ME EQUIPMENT 15.5.1 OVERHEATING OF TRANSFORMERS IN ME EQUIPMENT 15.5.2 DIELECTRIC STRENGTH 4.11 POWER INPUT 4.7 SINGLE FAULT CONDITIONS FOR ME EQUIPMENT 5.7 HUMIDITY PRECONDITIONING TREATMENT 7.1.2 LEGIBILITY OF MARKINGS 7.1.3 DURABILITY OF MARKINGS 8.11.1 ISOLATION FROM THE SUPPLY MAINS 8.11.3.5 CORD ANCHORAGE 8.4.2.D ACCESSIBLE PARTS AND APPLIED PARTS 8.4.3 ME EQUIPMENT INTENDED TO BE CONNECTED TO A POWER SOURCE BY A PLUG 8.4.4 INTERNAL CAPACITIVE CIRCUITS 8.6.4.A IMPEDANCE AND CURRENT-CARRYING CAPACITY 8.7.4.5 MEASUREMENT OF THE EARTH LEAKGE CURRENT AND CURRENTS IN FUNCTIONAL EARTH CONNECTION 8.7.4.6 MEASUREMENT OF TOUCH CURRENT 8.7.4.7 MEASUREMENT OF PATIENT LEAKAGE CURRENT 8.7.4.8 MEASUREMENT OF PATIENT AUXILIARY CURRENT 8.8.3 DIELECTRIC STRENGTH 8.9.2 CREEPAGE DISTANCES AND AIR CLEARANCES 9.4.2.1 INSTABILITY IN TRANSPORT POSITION 9.4.2.2 INSTABILITY EXCLUDING TRANSPORT POSITION 9.4.2.3 INSTABILITY FROM HORIZONTAL AND VERTICAL FORCES 9.4.2.4.2 FORCE FOR PROPULSION 9.4.2.4.3 MOVEMENT OVER A THRESHOLD 9.8.3.1 GENERAL 9.8.3.2 STATIC FORCES DUE TO LOADING FROM PERSONS 9.8.3.3 DYNAMIC FORCES DUE TO LOADING FROM PERSONS
2015-01-12
MEDIEC 80601-2-60:2012
201.11.1.3 MEASUREMENTS
2015-01-12