CTF

Hologic Inc.

 
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Standards in Scope

Category
Standard
Tests/Clauses
Acceptance Date
Responsible National Certification Body(s)
MEDIEC 60601-1:2005
4.11 - POWER INPUT 5.7 - HUMIDITY PRECONDITIONING TREATEMENT 5.9.2 - DETERMINATION OF ACCESSIBLE PARTS 8.6.4 a - IMPEDANCE AND CURRENT CARRYING CAPABILITY 8.7 - LEAKAGE CURRENT TESTS 8.8.3 - DIELECTRIC VOLTAGE WITHSTAND 9.2.2.2 - MEASUREMENT OF GAP "A" ACCORDING TO TABLE 20 (ISO 13852: 1996) 9.2.3.2 - OVERTRAVEL END STOPS 9.6.2.1 - ACOUSTIC ENERGY MEASUREMENT 9.8.3.1 - MECHANICAL STRENGTH - PATIENT SUPPORT SYSTEM 9.8.3.2 - MECHANICAL STRENGTH - FOOT RESTS/SITTING 9.8.3.3 - MECHANICAL STRENGTH – DYNAMIC FORCES 11 - TEMPERATURE 11.6.1 - OVERFLOW, SPILLAGE, LEAKAGE, INGRESS OF WATER, CLEANING, DISINFECTION, STERILIZATION, COMPATIBILITY WITH SUBSTANCES 11.8 - INTERRUPTION OF POWER SUPPLY 13.2 - SINGLE FAULT CONDITIONS IN ACCORDANCE WITH 13.2.2 TO 13.2.13, INCLUSIVE 15.3 - ENCLOSURE MECHANICAL STRENGTH 16.6.1 - LEAKAGE CURRENTS IN ME SYSTEM _ TOUCH CURRENT MEASUREMENTS
2019-12-12
MEDIEC 60601-1:2005/AMD1:2012
4.11 - POWER INPUT 5.7 - HUMIDITY PRECONDITIONING TREATEMENT 5.9.2 - DETERMINATION OF ACCESSIBLE PARTS 8.6.4 a - IMPEDANCE AND CURRENT CARRYING CAPABILITY 8.7 - LEAKAGE CURRENT TESTS 8.8.3 - DIELECTRIC VOLTAGE WITHSTAND 9.2.2.2 - MEASUREMENT OF GAP "A" ACCORDING TO TABLE 20 (ISO 13852: 1996) 9.2.3.2 - OVERTRAVEL END STOPS 9.6.2.1 - ACOUSTIC ENERGY MEASUREMENT 9.8.3.1 - MECHANICAL STRENGTH - PATIENT SUPPORT SYSTEM 9.8.3.2 - MECHANICAL STRENGTH - FOOT RESTS/SITTING 9.8.3.3 - MECHANICAL STRENGTH – DYNAMIC FORCES 11 - TEMPERATURE 11.6.1 - OVERFLOW, SPILLAGE, LEAKAGE, INGRESS OF WATER, CLEANING, DISINFECTION, STERILIZATION, COMPATIBILITY WITH SUBSTANCES 11.8 - INTERRUPTION OF POWER SUPPLY 13.2 - SINGLE FAULT CONDITIONS IN ACCORDANCE WITH 13.2.2 TO 13.2.13, INCLUSIVE 15.3 - ENCLOSURE MECHANICAL STRENGTH 16.6.1 - LEAKAGE CURRENTS IN ME SYSTEM _ TOUCH CURRENT MEASUREMENTS
2019-12-12
MEDIEC 60601-1:1988
IEC 60601-1:1988 + A1:1991 + A2:1995 7.1 - POWER INPUT TEST 0 IEC 60601-1:1988 + A1:1991 + A2:1995 15b - RESIDUAL VOLTAGE IN ATTACHMENT PLUG 0 IEC 60601-1:1988 + A1:1991 + A2:1995 15c - RESIDUAL VOLTAGE OR ENERGY IN CAPACITORS 0 IEC 60601-1:1988 + A1:1991 + A2:1995 18 - EARTHING AND POTENTIAL EQUALIZATION TEST 0 IEC 60601-1:1988 + A1:1991 + A2:1995 19 - LEAKAGE CURRENT TEST 0 IEC 60601-1:1988 + A1:1991 + A2:1995 20.4 - DIELECTRIC VOLTAGE WITHSTAND 0 IEC 60601-1:1988 + A1:1991 + A2:1995 21 - MECHANICAL STRENGTH IEC 60601-1:1988 + A1:1991 + A2:1995 22DV - IMPACT ON END STOPS IEC 60601-1:1988 + A1:1991 + A2:1995 28.4 - SUSPENSION SYSTEMS WITHOUT SAFETY DEVICES LOADING TEST IEC 60601-1:1988 + A1:1991 + A2:1995 42 - TEMPERATURE IEC 60601-1:1988 + A1:1991 + A2:1995 44 - CLEANING TEST, HUMIDITY IEC 60601-1:1988 + A1:1991 + A2:1995 49 - INTERRUPTION OF POWER IEC 60601-1:1988 + A1:1991 + A2:1995 52 - ABNORMAL OPERATION AND FAULT CONDITIONS IEC 60601-1:1988 + A1:1991 + A2:1995 57.9.2 - TRANSFORMER DIELECTRIC STRENGTH IEC 60601-1:1988 + A1:1991 + A2:1995 19.201.1 - SYSTEM LEAKAGE CURRENT
2019-12-12
MEDIEC 60601-1:1988/AMD1:1991
IEC 60601-1:1988 + A1:1991 + A2:1995 7.1 - POWER INPUT TEST 0 IEC 60601-1:1988 + A1:1991 + A2:1995 15b - RESIDUAL VOLTAGE IN ATTACHMENT PLUG 0 IEC 60601-1:1988 + A1:1991 + A2:1995 15c - RESIDUAL VOLTAGE OR ENERGY IN CAPACITORS 0 IEC 60601-1:1988 + A1:1991 + A2:1995 18 - EARTHING AND POTENTIAL EQUALIZATION TEST 0 IEC 60601-1:1988 + A1:1991 + A2:1995 19 - LEAKAGE CURRENT TEST 0 IEC 60601-1:1988 + A1:1991 + A2:1995 20.4 - DIELECTRIC VOLTAGE WITHSTAND 0 IEC 60601-1:1988 + A1:1991 + A2:1995 21 - MECHANICAL STRENGTH IEC 60601-1:1988 + A1:1991 + A2:1995 22DV - IMPACT ON END STOPS IEC 60601-1:1988 + A1:1991 + A2:1995 28.4 - SUSPENSION SYSTEMS WITHOUT SAFETY DEVICES LOADING TEST IEC 60601-1:1988 + A1:1991 + A2:1995 42 - TEMPERATURE IEC 60601-1:1988 + A1:1991 + A2:1995 44 - CLEANING TEST, HUMIDITY IEC 60601-1:1988 + A1:1991 + A2:1995 49 - INTERRUPTION OF POWER IEC 60601-1:1988 + A1:1991 + A2:1995 52 - ABNORMAL OPERATION AND FAULT CONDITIONS IEC 60601-1:1988 + A1:1991 + A2:1995 57.9.2 - TRANSFORMER DIELECTRIC STRENGTH IEC 60601-1:1988 + A1:1991 + A2:1995 19.201.1 - SYSTEM LEAKAGE CURRENT
2019-12-12
MEDIEC 60601-1:1988/AMD2:1995
IEC 60601-1:1988 + A1:1991 + A2:1995 7.1 - POWER INPUT TEST 0 IEC 60601-1:1988 + A1:1991 + A2:1995 15b - RESIDUAL VOLTAGE IN ATTACHMENT PLUG 0 IEC 60601-1:1988 + A1:1991 + A2:1995 15c - RESIDUAL VOLTAGE OR ENERGY IN CAPACITORS 0 IEC 60601-1:1988 + A1:1991 + A2:1995 18 - EARTHING AND POTENTIAL EQUALIZATION TEST 0 IEC 60601-1:1988 + A1:1991 + A2:1995 19 - LEAKAGE CURRENT TEST 0 IEC 60601-1:1988 + A1:1991 + A2:1995 20.4 - DIELECTRIC VOLTAGE WITHSTAND 0 IEC 60601-1:1988 + A1:1991 + A2:1995 21 - MECHANICAL STRENGTH IEC 60601-1:1988 + A1:1991 + A2:1995 22DV - IMPACT ON END STOPS IEC 60601-1:1988 + A1:1991 + A2:1995 28.4 - SUSPENSION SYSTEMS WITHOUT SAFETY DEVICES LOADING TEST IEC 60601-1:1988 + A1:1991 + A2:1995 42 - TEMPERATURE IEC 60601-1:1988 + A1:1991 + A2:1995 44 - CLEANING TEST, HUMIDITY IEC 60601-1:1988 + A1:1991 + A2:1995 49 - INTERRUPTION OF POWER IEC 60601-1:1988 + A1:1991 + A2:1995 52 - ABNORMAL OPERATION AND FAULT CONDITIONS IEC 60601-1:1988 + A1:1991 + A2:1995 57.9.2 - TRANSFORMER DIELECTRIC STRENGTH IEC 60601-1:1988 + A1:1991 + A2:1995 19.201.1 - SYSTEM LEAKAGE CURRENT
2019-12-12
MEDIEC 60601-1-3:2008
IEC 60601-1-3:2008 and IEC 60601 1 3:2008 (Second Edition) + A1:2013 7.6 - MINIMUM PERMISSIBLE FIRST HALF-VALUE-LAYER IEC 60601-1-3:2008 and IEC 60601 1 3:2008 (Second Edition) + A1:2013 12.4 - LEAKAGE RADIATION DURING LOADING IEC 60601-1-3:2008 and IEC 60601 1 3:2008 (Second Edition) + A1:2013 12.5 - LEAKAGE RADIATION DURING when not in the LOADING STATE
2019-12-12
MEDIEC 60601-1-3:2008/AMD1:2013
IEC 60601-1-3:2008 and IEC 60601 1 3:2008 (Second Edition) + A1:2013 7.6 - MINIMUM PERMISSIBLE FIRST HALF-VALUE-LAYER IEC 60601-1-3:2008 and IEC 60601 1 3:2008 (Second Edition) + A1:2013 12.4 - LEAKAGE RADIATION DURING LOADING IEC 60601-1-3:2008 and IEC 60601 1 3:2008 (Second Edition) + A1:2013 12.5 - LEAKAGE RADIATION DURING when not in the LOADING STATE
2019-12-12
MEDIEC 60601-1-3:1994
IEC 60601 1 3: 1994 29.201.2, 29.201.9 - MINIMUM PERMISSIBLE FIRST HALF-VALUE-LAYER IEC 60601 1 3: 1994 29.204.3 - LEAKAGE RADIATION DURING LOADING IEC 60601 1 3: 1994 29.204.5 - LEAKAGE RADIATION DURING when not in the LOADING STATE IEC 60601 1 3: 1994 29.205.1 - FOCAL SPOT TO SKIN DISTANCE
2019-12-12
MEDIEC 60601-2-28:2017
IEC 60601-2-28:2010 and IEC 60601-2-28:2017 201.8.7 - LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS IEC 60601-2-28:2010 and IEC 60601-2-28:2017 201.8.8.3 - DIELECTRIC STRENGTH IEC 60601-2-28:2010 and IEC 60601-2-28:2017 201.11.1 - EXCESSIVE TEMPERATURES IEC 60601-2-28:2010 and IEC 60601-2-28:2017 Annex AA - TEST OF X-RAY TUBE ASSEMBLIES FOR PRESSURE-RELATED RISKS
2019-12-12
MEDIEC 60601-2-28:2010
IEC 60601-2-28:2010 and IEC 60601-2-28:2017 201.8.7 - LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS IEC 60601-2-28:2010 and IEC 60601-2-28:2017 201.8.8.3 - DIELECTRIC STRENGTH IEC 60601-2-28:2010 and IEC 60601-2-28:2017 201.11.1 - EXCESSIVE TEMPERATURES IEC 60601-2-28:2010 and IEC 60601-2-28:2017 Annex AA - TEST OF X-RAY TUBE ASSEMBLIES FOR PRESSURE-RELATED RISKS
2019-12-12
MEDIEC 60601-2-28:1993
IEC 60601-2-28:1993 19 - CONTINUOUS LEAKAGE CURRENTS AND PATIENT AUXILIARY CURRENTS IEC 60601-2-28:1993 20 - DIELECTRIC STRENGTH IEC 60601-2-28:1993 42 - EXCESSIVE TEMPERATURES IEC 60601-2-28:1993 45.2 - DESTRUCTION OF X-RAY TUBE TEST
2019-12-12
MEDIEC 60601-2-32:1994
IEC 60601-2-32: 1994 21 - MECHANICAL STRENGTH IEC 60601-2-32: 1994 22 - MOVING PARTS IEC 60601-2-32: 1994 28 - SUSPENDED MASSES
2019-01-12
MEDIEC 60601-2-45:2011
201.4.10.2 201.9.2.101.3 a, b, c 203.6.3.1.2 203.6.3.2 203.6.4.3.102.2 203.6.4.3.102.5 203.6.5.3.2 203.6.5.3.3 203.6.7.103 203.6.7.104.2 203.7.1 203.8.5.4 203.8.5.4.101 203.9 203.11.101 203.13.101
2018-06-21
MEDIEC 60601-2-45:2011/AMD1:2015
IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 201.4.10.2 - SUPPLY MAINS FOR ME EQUIPMENT AND ME SYSTEMS IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 201.9.2.101.3 a, b, c - BIOPSY NEEDLE POSITIONING ACCURACY OF MAMMOGRAPHIC STEREOTACTIC DEVICES IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 203.6.3.1.2 - TESTS FOR VERIFYING LINEARITY OF AIR KERMA OVER LIMITED INTERVALS OF LOADING FACTORS IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 203.6.3.2 - TESTS FOR VERIFYING REPRODUCIBILITY OF THE X-RADIATION OUTPUT IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 203.6.4.3.102.2 - ACCURACY AND REPRODUCIBILITY OF X-RAY TUBE VOLTAGE IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 203.6.4.3.102.5 - ACCURACY OF CURRENT TIME PRODUCT IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 203.6.5.3.2 - AEC REPRODUCIBILITY IEC 60601-2-45: 2011 + AMD 1:2015 203.6.5.3.3 - AEC THICKNESS RESPONSE IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 203.6.7.103 - ARTEFACTS FROM GRID LINES IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 203.6.7.104.2 - MAXIMUM LOADING TIME using a typical MODE OF OPERATION IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 203.7.1 - TOTAL FILTRATION IN X-RAY EQUIPMENT IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 203.8.5.4 - POSITIONING OF THE PATIENT AND RESTRICTION OF THE IRRADIATED AREA IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 203.8.5.4.101 - MISSED TISSUE AT CHEST WALL SIDE IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 203.9 - FOCAL SPOT TO SKIN DISTANCE IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 203.11.101 - PRIMARY PROTECTIVE SHIELDING IEC 60601-2-45: 2011 and IEC 60601-2-45: 2011 + AMD 1:2015 203.13.101 - PROTECTIVE BARRIER
2019-12-12
MEDIEC 60601-2-45:2001
IEC 60601-2-45:2001 10.2.2 - POWER SUPPLY IEC 60601-2-45:2001 20.4A - DIELECTRIC VOLTAGE WITHSTANDS IEC 60601-2-45:2001 21.101.1A, B - MOTION OF THE ANTI-SCATTER GRID IEC 60601-2-45:2001 21.101.2A, B, C - STRENGTH OF COMPRESSION PLATES IEC 60601-2-45:2001 22.101 - MOTION OF X-RAY TUBE – IMAGE RECEPTOR ASSEMBLY IEC 60601-2-45:2001 22.102.2 - CONTROL OF COMPRESSION MOVEMENTS IEC 60601-2-45:2001 22.102.5 - COMPRESSION FORCE IEC 60601-2-45:2001 22.102.3 - RANGE OF MOVEMENT IEC 60601-2-45:2001 22.103.1 - POSITIONING OF X-RAY SOURCE ASSEMBLY FOR STEREOTACTIC IMAGING IEC 60601-2-45:2001 22.103.2 - MOTION OF APPLIED PARTS DURING IMAGING AND BIOPSY OR MARKED PLACING IEC 60601-2-45:2001 22.103.3A, B, C - BIOPSY NEEDLE POSITIONING ACCURACY OF MAMMOGRAPHIC STEREOTATIC DEVICES IEC 60601-2-45:2001 24.101 - STABILITY IN NORMAL USE IEC 60601-2-45:2001 29.1.101 - COMPLIANCE WITH IEC 60601-1-3 IEC 60601-2-45:2001 29.1.104C - SAFETY MEASURES AGAINST EXCESSIVE RADIATION OUTPUT IEC 60601-2-45:2001 29.1.105 - RADIATION OUTPUT IEC 60601-2-45:2001 29.207.1 - PRIMARY PROTECTIVE SHIELDING IEC 60601-2-45:2001 29.208.101 - PROTECTIVE BARRIER IEC 60601-2-45:2001 50.103.1, 50.104.1 - ACCURACY AND REPRODUCIBILITY OF X-RAY TUBE VOLTAGE IEC 60601-2-45:2001 50.103.4, 50.104.4 - ACCURACY OF CURRENT TIME PRODUCT IEC 60601-2-45:2001 50.105.3 - TESTS FOR VERIFYING REPRODUCIBILITY OF THE X-RADIATION OUTPUT IEC 60601-2-45:2001 50.105.4 - TESTS FOR VERIFYING LINEARITY OF AIR KERMA OVER LIMITED INTERVALS OF LOADING FACTORS
2019-12-12
MEDIEC 60601-2-46:2010
applicable clauses
2015-01-12