CTF

Hill-Rom, 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 Conditioning 5.9.2 Determination of Accessible Parts 7.1.3 Durability of Markings 8.4.3 Voltage or Charge Limitation 8.4.4 Voltage Limitation (Part 2) 8.5.4 Working Voltage Measurements 8.6.4 a Impedance and Current Carrying Capability 8.7 Leakage Current Tests 8.7.4.5 Earth Leakage Current 8.7.4.6 Touch Leakage Current 8.7.4.7 a) Patient Leakage Current 8.7.4.7 b) Patient Leakage Current, Mains on F-Type AP 8.7.4.7 c) Patient Leakage Current, Mains on I/O 8.7.4.7 d) Patient Leakage Current, Mains on Non-PE Enclosure 8.7.4.7 h) Total Patient Leakage Current 8.7.4.8 Patient Auxiliary Current 8.7.3 e) Non-Frequency-Weighted Leakage Current 8.8.3 Dielectric Voltage Withstand 8.8.4.1 Ball Pressure 8.9.2 Short Circuiting in Lieu of Spacings 8.11.3.5 Cord Anchorage 8.11.3.6 Cord Bending 9.2.2.2 Measurement of Gaps (Trapping Zones) 9.2.3.2 Overtravel End Stops (60601-1 AM 1 Only) 9.4.2 Stability and Transportability 9.4.2.4.2 Mobile Equipment Force for Propulsion 9.4.2.4.3 Mobile Equipment Over a Threshold 9.4.3.1 Instability from Unwanted Lateral Movement (Including Sliding) 9.4.3.2 Instability Excluding Transport 9.4.4 c Handle Loading 9.6.2.1 Acoustic Energy Measurement 9.8.3.1 Mechanical Strength - Patient Support System 11 Temperature 11.1.3 Change of Resistance Calculations 11.6.2 Overflow 11.6.3 Spillage 11.6.5 Leakage 11.6.5 Harmful Ingress (Water and Particulates) 11.6.6 Cleaning and Disinfection 11.8 Interruption of the Power Supply 13 Abnormal Operation Testing 13.1.2 Power Availability 13.2 Impairment of Cooling 13.2 Locking of Moving Parts 13.2 Interruption and Shorting of Motor Cap 13.2.13.3 b Overload, Motor 15.3.2 Enclosure Force 15.3.3 Enclosure Impact 15.3.4 Drop Impact 15.3.5 Rough Handling 15.3.6 Mold Stress Relief 15.4.7.1 Cord-Connected Foot Operated Control Devices 15.5.1.2 Transformer Short Circuit 15.5.1.3 Transformer Overload 15.5.2 Transformer Dielectric Voltage Withstand
2012-06-20
MEDIEC 60601-1:2005/AMD1:2012
4.11 Power Input 5.7 Humidity Conditioning 5.9.2 Determination of Accessible Parts 7.1.3 Durability of Markings 8.4.3 Voltage or Charge Limitation 8.4.4 Voltage Limitation (Part 2) 8.5.4 Working Voltage Measurements 8.6.4 a Impedance and Current Carrying Capability 8.7 Leakage Current Tests 8.7.4.5 Earth Leakage Current 8.7.4.6 Touch Leakage Current 8.7.4.7 a) Patient Leakage Current 8.7.4.7 b) Patient Leakage Current, Mains on F-Type AP 8.7.4.7 c) Patient Leakage Current, Mains on I/O 8.7.4.7 d) Patient Leakage Current, Mains on Non-PE Enclosure 8.7.4.7 h) Total Patient Leakage Current 8.7.4.8 Patient Auxiliary Current 8.7.3 e) Non-Frequency-Weighted Leakage Current 8.8.3 Dielectric Voltage Withstand 8.8.4.1 Ball Pressure 8.9.2 Short Circuiting in Lieu of Spacings 8.11.3.5 Cord Anchorage 8.11.3.6 Cord Bending 9.2.2.2 Measurement of Gaps (Trapping Zones) 9.2.3.2 Overtravel End Stops (60601-1 AM 1 Only) 9.4.2 Stability and Transportability 9.4.2.4.2 Mobile Equipment Force for Propulsion 9.4.2.4.3 Mobile Equipment Over a Threshold 9.4.3.1 Instability from Unwanted Lateral Movement (Including Sliding) 9.4.3.2 Instability Excluding Transport 9.4.4 c Handle Loading 9.6.2.1 Acoustic Energy Measurement 9.8.3.1 Mechanical Strength - Patient Support System 11 Temperature 11.1.3 Change of Resistance Calculations 11.6.2 Overflow 11.6.3 Spillage 11.6.5 Leakage 11.6.5 Harmful Ingress (Water and Particulates) 11.6.6 Cleaning and Disinfection 11.8 Interruption of the Power Supply 13 Abnormal Operation Testing 13.1.2 Power Availability 13.2 Impairment of Cooling 13.2 Locking of Moving Parts 13.2 Interruption and Shorting of Motor Cap 13.2.13.3 b Overload, Motor 15.3.2 Enclosure Force 15.3.3 Enclosure Impact 15.3.4 Drop Impact 15.3.5 Rough Handling 15.3.6 Mold Stress Relief 15.4.7.1 Cord-Connected Foot Operated Control Devices 15.5.1.2 Transformer Short Circuit 15.5.1.3 Transformer Overload 15.5.2 Transformer Dielectric Voltage Withstand
2014-07-02
MEDIEC 60601-2-38:1996N/A2017-06-28
MEDIEC 60601-2-38:1996/AMD1:1999
16E LOW VOLTAGE RELIABILITY 18 PROTECTIVE EARTHING, FUNCTIONAL EARTHING AND POTENTIAL EQUALIZATION 18.0 PROTECTIVE/FUNCTIONAL EARTHING AND POTENTIAL EQUALIZATION - E) 19 LEAKAGE CURRENT TEST 21.3 MECHANICAL STRENGTH - FIXINGS, MOUNTING, MASS SUPPORT 21.3.101 MECHANICAL STRENGTH - SAFE WORKING LOAD 21.3.102 MECHANICAL STRENGTH - SAFE WORKING LOAD OF LIFTING POLE 21.4 MECHANICAL STRENGTH - SIDE RAIL LOCK/LATCHING 21.6 MECHANICAL STRENGTH - WALL IMPACT 21.6.101 MECHANICAL STRENGTH - END PANEL STATIC FORCE 21.6.102 MECHANICAL STRENGTH - THRESHOLD 22.2.101 MOVING PARTS - EXPOSED SQUEEZING AND SHEARING POINTS - 200MM 22.2.101 MOVING PARTS - EXPOSED SQUEEZING AND SHEARING POINTS - 120MM 22.2.102 MOVING PARTS - BED FUNCTION DEACTIVATION CONTROL 22.4.101 MOVING PARTS - ELECTRIC POWERED MOVEMENT - MOMENTARY SWITCHES 22.5 MOVING PARTS - END STOPS / MOVEMENT LIMITATION 23.101 PATIENT ENTRAPMENT 24.3 STABILITY IN NORMAL USE - LIFTING POLE - BB) 24.3 STABILITY IN NORMAL USE - LATERAL/LONGITUDINAL - AA) 24.4 STABILITY IN NORMAL USE - CASTOR LOCKING 26.101 VIBRATION AND NOISE - BED 28.4 SUSPENDED MASSES - 2) AND 3) 28.4.101 SUSPENDED MASSES - ACCESSORIES 28.4.102 / 28.4.103 SUSPENDED MASSES - SIDE RAIL LATCH/LOCKS 44.6.102 INGRESS OF LIQUIDS - LEAKAGE CURRENT 52.4.101 ABNORMAL OPERATION AND FAULT CONDITIONS - UNINTENDED MOVEMENT 52.5.101 ABNORMAL OPERATION AND FAULT CONDITIONS - FAILURE OF LOCKOUT 52.5.102 / 54.101 ABNORMAL OPERATION AND FAULT CONDITIONS - TRENDELENBURG 52.5.103 ABNORMAL OPERATION AND FAULT CONDITIONS - FAILURE OF PROGRAMMABLE SYSTEM 52.5.9 ABNORMAL OPERATION AND FAULT CONDITIONS - MOVEMENT CONTROL OF APPLIED PARTS 56.1 COMPONENTS AND GENERAL ASSEMBLY - POWER SUPPLY CORD SUSPENSION - AA) 56.1.101 COMPONENTS AND GENERAL ASSEMBLY - HEAD PANEL REMOVAL 56.10 COMPONENTS AND GENERAL ASSEMBLY - LIMITATION OF MOVEMENT - DESIGNATED C ANGLE - AA) 57.3 MAINS PARTS, COMPONENTS AND LAYOUT - POWER SUPPLY CORD - A) 57.3.101 MAINS PARTS, COMPONENTS AND LAYOUT - POWER SUPPLY CORD - IPXX
2017-06-28
MEDIEC 60601-2-46:2010
21.101 SUPPORT LOADING TEST (PATIENT SUPPORT) 24 STABILITY IN NORMAL USE 24.1 OVERBALANCE 24.3.101 STABILITY - BRAKE HOLD (MOBILE AND TRANSPORT) 24.3A STABILITY (FIGURE 102) 44 OVERFLOW, SPILLAGE, LEAKAGE, HUMIDITY, INGRESS OF LIQUIDS, CLEANING, STERILIZATION, AND DISINFECTION 49 INTERRUPTION OF THE POWER SUPPLY 56.11 CORÚ-CONNECTED HAND-HELD AND FOOT-OPERATED CONTROL DEVICES - ACTUATING FORCE MEASUREMENT
2014-07-02
MEDIEC 60601-2-52:2009
201.11.6.5.101 INGRESS OF WATER 201.11.6.6.101 MACHINE WASHABLE MEDICAL BED 201.11.8 INTERRUPTION OF THE POWER SUPPLY TO THE ME EQUIPMENT 201.13.2.2.101 SINGLE FAULT CONDITION OF POWER-DRIVEN MEDICAL BED FOR TRANSPORTATION 201.15.3.4.1 HAND HELD PENDANT TEST 201.15.3.5, ITEM C ROUGH HANDLING TEST, DOOR FRAME SHOCK 201.15.4.6.2 LIMITATION OF MOVEMENT 201.15.4.7.1, ITEM B MECHANICAL STRENGTH OF FOOT OPERATED CONTROL 201.9.1.101 PROTECTION AGAINST PATIENT ENTRAPMENT 201.9.101 PROTECTION AGAINST INADVERTENT PATIENT FALLS 201.9.2.2.2 GAPS 201.9.4.2.2 INSTABILITY EXCLUDING TRANSPORT (LONGITUDINAL STABILITY TEST) 201.9.4.2.2 INSTABILITY EXCLUDING TRANSPORT (LATERAL STABILITY TEST) 201.9.4.2.3, ITEM B INSTABILITY FROM HORIZONTAL AND VERTICAL FORCES 201.9.4.2.4.3 MOVEMENT OVER A THRESHOLD 201.9.4.3.1, ITEM C INSTABILITY IN TRANSPORT 201.9.6.2.1 AUDIBLE ACOUSTIC ENERGY 201.9.8.3.1 STRENGTH OF SUPPORT SYSTEM 201.9.8.3.2 STATIC FORCES DUE TO LOADING FROM PERSONS 201.9.8.3.3.1 DYNAMIC FORCES DUE TO LOADING FROM PERSONS 201.9.8.3.3.2 DYNAMIC TESTING OF THE HEIGHT ADJUSTMENT MECHANISM 201.9.8.3.3.3 SIDE RAIL STRENGTH AND LATCH RELIABILITY 201.9.8.3.3.4 DYNAMIC TESTING OF LIFTING POLE BB.2.2 THE EFFECT OF IMPACTS TO THE MATTRESS SUPPORT PLATFORM (DROP TEST) BB.2.3 THE EFFECT OF LOADING ON THE EDGE OF THE MATTRESS SUPPORT PLATFORM (SIDE LOAD) BB.2.4 DURABILITY OF THE MOVEABLE SECTIONS (IF PROVIDED) OF THE MATTRESS SUPPORT PLATFORM (DECK CYCLE) BB.3.2 RANGE OF ADJUSTMENT OF THE HEIGHT OF THE MATTRESS SUPPORT PLATFORM BB.3.3.3 DIMENSIONS FOR HANDLES AND PEDALS (BUTTONS) BB.3.3.4 DIMENSIONS FOR HANDLES AND PEDALS (HANDLE) BB.3.3.5 DIMENSIONS FOR HANDLES AND PEDALS (PEDAL) BB.3.3.6 DIMENSIONS FOR HANDLES AND PEDALS (HANDLE) BB.3.3.7 DIMENSIONS FOR HANDLES AND PEDALS (PEDAL) BB.3.4.1 OPERATING FORCES FOR HANDLES AND PEDALS (BUTTON) BB.3.4.2 OPERATING FORCES FOR HANDLES AND PEDALS (MANUAL FUNCTIONS) BB.3.4.3 OPERATING FORCES FOR HANDLES AND PEDALS (PEDALS) BB.3.4.4 OPERATING FORCES FOR HANDLES AND PEDALS (MOVEMENT) BB.4.2 COMBINATION OF MEDICAL BED AND MOBILE HOISTS BB.4.3 COMBINATION OF MEDICAL BED AND MATTRESS BB.4.4 RANGE OF ADJUSTMENT OF MOVEABLE SECTIONS OF THE MATTRESS SUPPORT PLATFORM
2014-07-02
MEDIEC 60601-2-52:2009/AMD1:2015
201.11.6.5.101 INGRESS OF LIQUID 201.11.8 INTERRUPTION OF THE POWER SUPPLY/ SUPPLY MAINS TO ME EQUIPMENT 201.13.2.2.101 SINGLE FAULT CONDITION OF POWER-DRIVEN MEDICAL BED FOR TRANSPORTATION 201.15.3,5, ITEM C ROUGH HANDLING TEST, DOOR FRAME SHOCK 201.15.3.4.1 PENDANT CONTROL DROP TEST 201.15.4.6.2 LIMITATION OF MOVEMENT 201.15.4.7.1 MECHANICAL STRENGTH – FOOT-OPERATED CONTROL DEVICE 201.9.1.101 PATIENT ENTRAPMENT IN NON-MOVING PARTS 201.9.101 PROTECTION AGAINST INADVERTANT PATIENT FALLS 201.9.2.2.2 TRAPPING ZONE- GAPS 201.9.2.2.3 TRAPPING ZONE- GAPS 201.9.2.2.5.B CONTINUOUS ACTIVATION OF CONTROLS 201.9.2.3.1 UNINTENDED MOVEMENT 201.9.4.2 INSTABILITY - OVER BALANCE 201.9.4.2.3, ITEM B INSTABILITY FROM HORIZONTAL AND VERTICAL FORCES 201.9.4.2.4.3 MOVEMENT OVER A THRESHOLD 201.9.4.3.1 INSTABILITY IN TRANSPORT 201.9.6.2.1 AUDIBLE ACOUSTIC ENERGY 201.9.8.3.2 STATIC FORCES DUE TO LOADING FROM PERSONS 201.9.8.3.3 DYNAMIC FORCES DUE TO LOADING FROM PERSONS 201.9.8.3.3.2 DYNAMIC TESTING OF THE HEIGHT ADJUSTMENT MECHANISM 201.9.8.3.3.3 SIDE RAIL STRENGTH AND LATCH RELIABILITY 201.9.8.3.3.4 DYNAMIC TESTING OF THE LIFTING POLE BB.2.2 EFFECTS OF IMPACTS TO THE MATTRESS SUPPORT PLATFORM BB.2.3 THE EFFECT OF LOADING ON THE EDGE OF THE MATTRESS SUPPORT PLATFORM BB.2.4 DURABILITY OF THE MOVEABLE SECTIONS (IF PROVIDED) OF THE MATTRESS SUPPORT PLATFORM BB.3.2 RANGE OF ADJUSTMENT OF THE HEIGH OF THE MATTRESS SUPPORT PLATFORM BB.3.3.3 DIMENSIONS FOR HANDLES AND PEDALS (BUTTONS) BB.3.3.4 DIMENSIONS FOR HANDLES AND PEDALS (HANDLE) BB.3.3.5 DIMENSIONS FOR HANDLES AND PEDALS (PEDAL) BB.3.3.6 DIMENSIONS FOR HANDLES AND PEDALS (HANDLE) BB.3.3.7 DIMENSIONS FOR HANDLES AND PEDALS (PEDAL) BB.3.4.1 OPERATING FORCES FOR HANDLES AND PEDALS (BUTTON) BB.3.4.2 OPERATING FORCES FOR HANDLES AND PEDALS (MANUAL FUNCTIONS) BB.3.4.3 OPERATING FORCES FOR HANDLES AND PEDALS (PEDALS) BB.3.4.4 OPERATING FORCES FOR HANDLES AND PEDALS (MOVEMENT) BB.4.2 COMBINATON OF MEDICAL BED AND MOBILE HOISTS BB.4.3 COMBINATION OF MEDICAL BED AND MATTRESS BB.4.4 RANGE OF ADJUSTMENT OF MOVEABLE SECTIONS OF THE MATTRESS SUPPORT PLATFORM
2014-07-02
MEDIEC 80601-2-35:2009
201.15.4.1 CONSTRUCTION OF CONNECTORS 201.15.4.2.1.101 TEMPERATURE AND OVERLOAD CONTROLS DEVICES- ADDITIONAL REQUIREMENTS FOR APPLICATIONS 201.11.1.2.1.101.1 MAXIMUM CONTACT SURFACE TEMPERATURE IN NORMAL CONDITION 201.11.1.2.1.101.3 MAXIMUM CONTACT SURFACE TEMPERATURE IN SINGLE FAULT CONDITION 201.11.8.101 INTERRUPTION OF POWER SUPPLY/SUPPLY MAINS ALARM CONDITION 201.11.8.102 PRESET VALUES AFTER RESTORATION OF POWER SUPPLY/SUPPLY MAINS 201.12.3.101 OVERTEMPERATURE ALARM CONDITION 201.12.3.102 CONTACT SURFACE TEMPERATURE VARIATION ALARM CONDITION 201.12.3.103 VISUAL AND AUDITORY ALARM SIGNALS 201.12.3.104 DISCONNECTION OR SHORT-CIRCUITING OF SENSORS ALARM CONDITION 201.12.4.101 VARIATION OF TEMPERATURE ACROSS THE CONTACT SURFACE 201.12.4.102 VARIATION OF THE CONTACT SURFACE TEMPERATURE 201.12.4.103 TEMPERATURE OVERSHOOT WHEN THE TEMPERATURE CONTROL IS SET TO ITS MAXIMUM SETTING 201.12.4.104 ACCURACY OF THE CONTROL OF THE CONTACT SURFACE TEMPERATURE 201.12.4.105 TEMPERATURE INDICATOR 201.12.4.106 AVOIDANCE OF INCORRECT CONNECTION OF PARTS 201.12.4.107 INADVERTENT CHANGING OF CONTROL SETTINGS 201.12.4.108 MAXIMUM CONTACT SURFACE TEMPERATURE 201.13.1.2.101.1 ELECTRONIC COMPONENT FAILURE IN AN APPLIED PART 201.8.11.1.101 ISOLATION FROM THE SUPPLY MAINS 201.8.7.4.7.101 ADDITIONAL REQUIREMENTS FOR MEASUREMENT OF THE PATIENT LEAKAGE CURRENT 208.6.8.4.101 ADDITIONAL REQUIREMENTS FOR TERMINATION OF INACTIVATION OF ALARM SIGNALS
2019-07-16