CSA C22.2 No. 80601-2-56 : 2012
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
AAMI IEC TIR 80001-2-2 : 2012
|
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS |
CEI EN 60601-1-11 : 2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
BS EN 60601-1-11:2015
|
Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
03/111582 DC : DRAFT JULY 2003
|
BS EN ISO 18779 - DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
I.S. EN ISO 8835-4:2009
|
INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
NF EN 60601-1-8 : 2007 AMD 11 2018
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
PD IEC/TR 62366-2:2016
|
Medical devices Guidance on the application of usability engineering to medical devices |
PREN ISO 80601-2-61 : DRAFT 2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
BS EN ISO 80601-2-56:2017
|
Medical electrical equipment Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
08/30176368 DC : 0
|
BS EN 60601-2-28 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS |
I.S. EN ISO 80601-2-61:2011
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
09/30203808 DC : 0
|
BS EN ISO 80601-2-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
13/30268585 DC : 0
|
BS EN ISO 10079-1 - MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT |
BS EN 60601-1-12:2015
|
Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
I.S. EN 60601-1-10:2008
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
DIN EN ISO 80601-2-69 E : 2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT (ISO 80601-2-69:2014) |
15/30312454 DC : 0
|
BS EN ISO 80601-2-56 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
CSA Z10651.6 : 2006 : R2015
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
IEC 80601-2-49:2018
|
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
AAMI ISO TIR 16142 : 2005
|
MEDICAL DEVICES - GUIDANCE ON THE SELECTION OF STANDARDS IN SUPPORT OF RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES |
CSA Z17510.1 : 2010
|
SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
CSA ISO 14971 : 2007
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA Z9919 : 2007 : R2012
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
UNE-EN ISO 80601-2-69:2015
|
Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
I.S. EN 60601-2-24:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS |
CSA C22.2 No. 80601-2-55 : 2014(R2019)
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
BS EN ISO 80601-2-12:2011
|
Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators |
AAMI IEC 62366-1 : 2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
CSA ISO TR 13154 : 2014
|
MEDICAL ELECTRICAL EQUIPMENT - DEPLOYMENT, IMPLEMENTATION AND OPERATIONAL GUIDELINES FOR IDENTIFYING FEBRILE HUMANS USING A SCREENING THERMOGRAPH |
ISO 16142-1:2016
|
Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
ISO 80601-2-74:2017
|
Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment |
AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
AAMI ES60601-1 : 2005 : R2012
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
BS EN ISO 80601-2-13:2012+A2:2019
|
Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
UNE-EN ISO 11197:2016
|
Medical supply units (ISO 11197:2016) |
BS EN 1782 : 1998
|
TRACHEAL TUBES AND CONNECTORS |
BS EN 13718-1:2014
|
Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances |
ISO 8835-5:2004
|
Inhalational anaesthesia systems Part 5: Anaesthetic ventilators |
ISO/IEEE 11073-00103:2015
|
Health informatics Personal health device communication Part 00103: Overview |
BS EN 12342 : 1998
|
BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
DIN EN 12342:1998-09
|
BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
DIN EN 12342:2010-01
|
BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
I.S. EN ISO 18777:2009
|
TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
NF EN ISO 10651-6 : 2009
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
EN 62304:2006/A1:2015
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
EN ISO 15002:2008
|
Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
EN ISO 80601-2-13:2012
|
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) |
EN 60601-2-16:2015
|
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
EN ISO 21647:2009
|
Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005) |
EN 13544-1:2007+A1:2009
|
Respiratory therapy equipment - Part 1: Nebulizing systems and their components |
BS EN ISO 15002:2008
|
Flow-metering devices for connection to terminal units of medical gas pipeline systems |
BS EN ISO 80601-2-13:2012
|
Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
17/30338753 DC : 0
|
BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT |
BS EN ISO 80601-2-72:2015
|
Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
BS EN ISO 5359 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES |
CEI EN 60601-2-24 : 2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS |
UNI EN ISO 5367 : 2015
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
11/30206856 DC : 0
|
BS EN 60601-1-8:2007/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS |
DIN EN ISO 80601-2-72:2016-04
|
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
AAMI IEC 80601-2-30 : 2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
14/30287753 DC : 0
|
BS EN 62304 AMENDMENT 1 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES |
14/30303965 DC : 0
|
BS EN 60601-2-33/A2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
16/30312315 DC : 0
|
BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
DIN EN ISO 15002:2008-11
|
FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
UNI EN ISO 80601-2-12 : 2011
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
15/30280904 DC : 0
|
BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT |
CAN/CSA-Z15002:12 (R2017)
|
Flow-metering devices for connection to terminal units of medical gas pipeline systems (Adopted ISO 15002:2008, second edition, 2008-07-01, with Canadian deviations) |
12/30271196 DC : 0
|
BS EN 60601-1-10:2007/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
BS EN 80601-2-30 : 2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
CSA Z1500:2012
|
FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
CEI EN 62274 : 2005
|
MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
CSA ISO 27427 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
IEC 80601-2-71:2015
|
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment |
I.S. EN ISO 80601-2-56:2017
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017) |
03/111581 DC : DRAFT JULY 2003
|
BS EN ISO 18778 - INFANT MONITORS - PARTICULAR REQUIREMENTS |
PD ISO/TR 16142:2006
|
Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
09/30181956 DC : DRAFT MAY 2009
|
BS ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
NF EN 60601-1-11 : 2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
CSA Z21647 : 2007 : R2012 : FR
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
CAN/CSA-C22.2 NO. 80601-2-72:17
|
Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations) |
ISO 11197:2016
|
Medical supply units |
UNE-EN ISO 10079-1:2016
|
Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015) |
I.S. EN 62366-1:2015&AC:2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
AAMI ISO 5367 : 2015
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
ISO/TS 19218:2005
|
Medical devices Coding structure for adverse event type and cause |
CSA ISO 10079-3:14 (R2019)
|
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (Adopted ISO 10079-3:2014, third edition, 2014-05-01) |
UNI EN ISO 80601-2-61 : 2011
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
ISO/TS 19218-1:2011
|
Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes |
AAMI IEC 60601-2-16 : 2012
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION EQUIPMENT |
DD ISO/TS 19218-1 : 2011
|
MEDICAL DEVICES - HIERARCHICAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 1: EVENT-TYPE CODES |
CSA IEC 62366-1 : 2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
CAN/CSA-ISO 10079-1:16
|
Medical suction equipment - Part 1: Electrically powered suction equipment (Adopted ISO 10079-1:2015, third edition, 2015-11-01) |
NF EN ISO 80601-2-13 : 2013 AMD 1 2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
I.S. EN 60601-2-16:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
BS EN ISO 5367:2014
|
Anaesthetic and respiratory equipment. Breathing sets and connectors |
UNE-EN ISO 5367:2015
|
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
UNE-EN ISO 18113-1:2012
|
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
CSA C22.2 No. 80601-2-61 : 2014(R2019)
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
CSA C22.2 No. 60601-1-10 : 2009 : R2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
NF EN 60601-1-12 : 2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
BS EN ISO 80601-2-61:2011
|
Medical electrical equipment Particular requirements for basic safety and essential performance of pulse oximeter equipment |
CEI UNI EN ISO 14971 : 2013
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
IEC 80601-2-30:2018
|
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
ISO 5367:2014
|
Anaesthetic and respiratory equipment — Breathing sets and connectors |
AAMI ES60601-1 : 2005
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
I.S. EN ISO 14971:2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01) |
DIN EN ISO 8835-4:2009-07
|
INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
DIN EN ISO 8835-2:2009-08
|
INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS |
DIN EN 1782:2009-12
|
TRACHEAL TUBES AND CONNECTORS |
DIN EN ISO 18778 E : 2009
|
RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
DIN EN ISO 17510-1:2009-07
|
Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
DIN EN ISO 18778:2009-08
|
Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) |
DIN EN ISO 18777:2009-07
|
TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
DIN EN ISO 14971:2013-04
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
UNE-EN ISO 80601-2-13:2013
|
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) |
BS EN ISO 8835-2:2009
|
Inhalational anaesthesia systems Anaesthetic breathing systems (ISO 8835-2:2007) |
I.S. EN ISO 17510-1:2009
|
SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
I.S. EN ISO 18778:2009
|
RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
EN ISO 17510-1:2009
|
Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
I.S. EN ISO 8185:2009
|
RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
UNI EN 13718-1 : 2014
|
MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
DIN EN ISO 10651-2:2011-06
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
I.S. EN 60601-2-33:2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
I.S. EN ISO 18779:2005
|
MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
I.S. EN ISO 10079-3:2014
|
MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014) |
NEMA XR 24-2008 (R2014)
|
PRIMARY USER CONTROLS FOR INTERVENTIONAL ANGIOGRAPHY X-RAY EQUIPMENT |
VDE 0750-2-64 : 2018
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
DIN EN 60601-2-64 : 2018
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-64: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LIGHT ION BEAM MEDICAL ELECTRICAL EQUIPMENT |
I.S. EN ISO 11073-00103:2017
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
02/562586 DC : DRAFT JUN 2002
|
BS EN 60601-1-8 - MEDICAL ELECTRICAL EQUIPMENT - PART 8-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - ALARM SYSTEMS - REQUIREMENTS, TEST AND GUIDELINES - GENERAL REQUIREMENTS AND GUIDELINES FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND IN MEDICAL ELECTRICAL SYSTEMS |
ISO 5359:2014
|
Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases |
13/30260084 DC : 0
|
BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS |
09/30197590 DC : 0
|
BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
14/30296572 DC : 0
|
BS EN 60601-1-11 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
I.S. EN ISO 9919:2009
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
ISO/TR 16142:2006
|
Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
DIN EN ISO 80601-2-72 E : 2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015) |
I.S. EN ISO 8835-2:2009
|
INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS |
AAMI ISO TIR 19218 : 2005
|
MEDICAL DEVICES - CODING STRUCTURE FOR ADVERSE EVENT TYPE AND CAUSE |
13/30268519 DC : 0
|
BS ISO 80601-2-13:2011/AMD 1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
BS ISO 18190:2016
|
Anaesthetic and respiratory equipment. General requirements for airways and related equipment |
UNI EN ISO 80601-2-69 : 2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT |
BS EN 60601-2-68:2015
|
Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
UNE-EN 62304:2007
|
Medical device software - Software life-cycle processes (IEC 62304:2006) |
14/30290166 DC : 0
|
BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
BS ISO 16142-1:2016
|
Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
16/30349981 DC : 0
|
BS EN 80601-2-59 ED 2.0 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-59: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SCREENING THERMOGRAPHS FOR HUMAN FEBRILE TEMPERATURE SCREENING |
NF EN 60601-1 : 2007-01
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
CSA Z18779 : 2008 : R2013
|
MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
03/103294 DC : DRAFT JAN 2003
|
BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES |
BS EN 60601-1-10 : 2008
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
CSA Z10651.6 : 2006
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
CAN/CSA-C22.2 NO. 80601-2-67:17
|
Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen conserving equipment (Adopted ISO 80601-2-67:2014, first edition, 2014-06-01, with Canadian deviations) |
CSA Z9919 :2007
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
UNE-EN ISO 80601-2-56:2013
|
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009) |
AAMI IEC 62304 : 2006
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES |
I.S. EN 62366-1:2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
ISO 10079-1:2015
|
Medical suction equipment Part 1: Electrically powered suction equipment |
I.S. EN 80601-2-30:2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
I.S. EN 60601-1-12:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
EN 60601-1-10:2008/A1:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS (IEC 60601-1-10:2007) |
I.S. EN 60601- 1:2006&A1:2013&AC:2014&A12:2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
I.S. EN ISO 80601-2-12:2011
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011) |
CSA ISO 10079-3 : 2014
|
MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE |
PD IEC/TR 60601-4-3:2015
|
Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements |
I.S. EN ISO 80601-2-13:2012
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION (ISO 80601-2-13:2011) |
CSA C22.2 No. 60601-2-68 : 2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
CSA Z8835.2 : 2008
|
INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS FOR ADULTS |
CSA C22.2 No. 60601-1-10:2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
EN ISO 80601-2-61:2011
|
Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011) |
NF EN ISO 80601-2-61 : 2011
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
EN ISO 80601-2-55:2018
|
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018) |
BS EN ISO 14971:2012
|
Medical devices. Application of risk management to medical devices |
ISO 15002:2008
|
Flow-metering devices for connection to terminal units of medical gas pipeline systems |
NF EN ISO 11197 : 2016
|
MEDICAL SUPPLY UNITS |
I.S. EN 62304:2006
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
DIN EN ISO 18777 E : 2009
|
TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
DIN EN ISO 10651-6:2011-06
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
DIN EN 13544-1:2009-12
|
RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
DIN EN 13718-1:2014-12
|
MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
DIN EN ISO 10079-3:2014-09
|
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
ISO 18779:2005
|
Medical devices for conserving oxygen and oxygen mixtures Particular requirements |
BS EN ISO 9919:2009
|
Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
ISO 8835-2:2007
|
Inhalational anaesthesia systems Part 2: Anaesthetic breathing systems |
BS EN 60601-2-16:2015
|
Medical electrical equipment Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
ISO 10651-2:2004
|
Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients |
ISO 80601-2-69:2014
|
Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
04/30106146 DC : DRAFT MARCH 2004
|
BS EN 60601-1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
UNE-EN 60601-1:2008
|
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance |
EN ISO 80601-2-69:2014
|
Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
I.S. EN 13544-1:2007
|
RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
EN 60601-1-12:2015
|
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
UNE-EN 1782:1998
|
TRACHEAL TUBES AND CONNECTORS. |
EN 62366-1:2015/AC:2015
|
MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015) |
EN ISO 8185:2009
|
Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) |
EN 1782:1998+A1:2009
|
Tracheal tubes and connectors |
EN ISO 18113-1:2011
|
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
UNI EN ISO 21647 : 2009
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
CSA Z8835.4 : 2006
|
INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
UNI EN ISO 10651-2 : 2009
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR- DEPENDENT PATIENTS |
UNI EN ISO 8835-5 : 2009
|
INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS |
UNI EN ISO 10079-3 : 2014
|
MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE |
UNI EN ISO 18777 : 2009
|
TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
EN ISO 9919:2009
|
Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) |
UNI EN ISO 9919 : 2009
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
UNI EN 13544-1 : 2009
|
RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
UNI EN 12342 : 2009
|
BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS |
UNI EN ISO 10651-6 : 2009
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
UNI EN ISO 18778 : 2009
|
RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS |
UNI EN ISO 8185 : 2009
|
RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
UNI EN ISO 8835-4 : 2009
|
INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
UNI EN 1782 : 2009
|
TRACHEAL TUBES AND CONNECTORS |
ANSI/AAMI HA60601-1-11:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
14/30281087 DC : 0
|
BS EN 80601-2-71 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-71: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF FUNCTIONAL NEAR-INFRARED SPECTROSCOPY (NIRS) EQUIPMENT |
EN ISO 5359:2014/A1:2017
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014/AMD 1:2017) |
NF EN ISO 80601-2-72 : 2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
06/30147232 DC : DRAFT OCT 2006
|
IEC 60601-1-10 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
I.S. EN ISO 21647:2009
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
14/30302072 DC : 0
|
BS EN 80601-2-71 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-71: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF FUNCTIONAL NEAR-INFRARED SPECTROSCOPY (NIRS) EQUIPMENT |
I.S. EN 62274:2005
|
MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
UNI EN ISO 8835-2 : 2009
|
INHALATIONAL ANAESTHESIA SYSTEMS - PART 2: ANAESTHETIC BREATHING SYSTEMS |
17/30338756 DC : 0
|
BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY |
13/30264413 DC : 0
|
BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
18/30356489 DC : DRAFT APR 2018
|
BS EN 60601-1-10:2008 AMENDMENT 2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
12/30245174 DC : 0
|
BS EN 60601-1-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
PD IEC/TR 80001-2-2:2012
|
Application of risk management for IT-networks incorporating medical devices Guidance for the disclosure and communication of medical device security needs, risks and controls |
BS EN ISO 80601-2-69:2014
|
Medical electrical equipment Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
IEC 60601-2-68:2014
|
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
BS EN 60601-2-24:2015
|
Medical electrical equipment Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
09/30155521 DC : 0
|
BS EN 60601-1-11 ED.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
DD ISO/TS 19218:2005
|
Medical devices. Coding structure for adverse event type and cause |
CAN/CSA-C22.2 NO. 80601-2-70:17
|
Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations) |
BS EN 62274:2005
|
Medical electrical equipment. Safety of radiotherapy record and verify systems |
I.S. EN ISO 18113-1:2011
|
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
08/30149952 DC : DRAFT MAY 2008
|
BS EN 60601-2-54 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY |
09/30189968 DC : DRAFT JAN 2009
|
BS EN 13544-1 AMD1 - RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
BS EN ISO 11073-00103:2017
|
Health informatics. Personal health device communication Overview |
PREN ISO 80601-2-55 : DRAFT 2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
12/30244415 DC : DRAFT APR 2012
|
BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
03/103293 DC : DRAFT JAN 2003
|
BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
UNI CEI EN ISO 14971 : 2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
01/561640 DC : DRAFT APR 2001
|
BS EN ISO 8835-4 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
CSA Z8185 : 2008
|
RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
NF EN ISO 80601-2-12 : 2011
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
CAN/CSA-Z18777-08 (R2018)
|
Transportable Liquid Oxygen Systems for Medical Use - Particular Requirements (Adopted ISO 18777:2005, first edition, 2005-02-15, with Canadian deviations) |
CSA Z21647:2007
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
CSA Z10651.2: 2006
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
CSA Z18777 : 2008
|
TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
ISO 80601-2-56:2017
|
Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
AAMI ISO 14971 : 2007 : R2010
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA Z8835.5 : 2006
|
INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHETIC VENTILATORS |
CSA C22.2 No. 60601.2.16 : 2014(R2019)
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
CEI EN 60601-2-16 : 2016
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
EN 60601-2-68:2015
|
Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
I.S. EN ISO 15002:2008
|
FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
I.S. EN ISO 80601-2-72:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS (ISO 80601-2-72:2015) |
CSA CEI/IEC 62304:14 (R2019)
|
Medical device software - Software life cycle processes (Adopted CEI/IEC 62304:2006, first edition, 2006-05) | Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel (norme CEI/IEC 62304:2006 adoptée, première édition, 2006-05) |
I.S. EN 60601-2-68:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
EN ISO 11197:2016
|
Medical supply units (ISO 11197:2016) |
UNI EN ISO 17510-1 : 2009
|
SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
CSA C22.2 No. 60601-1-12 : 2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
DIN EN ISO 5367:2015-02
|
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
I.S. EN 60601-1-11:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
DIN EN ISO 5359:2015-02
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
UNI EN ISO 80601-2-55 : 2012
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
CAN/CSA-C22.2 NO. 80601-2-71:17
|
Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment (Adopted IEC 80601-2-71:2015, first edition, 2015-06, with Canadian deviations) |
PD IEC/TR 62809:2013
|
Summary of requirements and tests for products in the scope of IEC 60601-2-66 |
CSA C22.2 No. 60601.1 : 2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
ISO 80601-2-70:2015
|
Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment |
IEC 80601-2-59:2017
|
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening |
IEC TR 80001-2-2:2012
|
Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls |
EN ISO 80601-2-12:2011/AC:2011
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011) |
ISO 80601-2-12:2011
|
Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
DIN EN ISO 8835-5:2009-07
|
INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS |
DIN EN ISO 10079-1:2016-05
|
MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015) |
BS EN ISO 8185:2007
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Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems |
BS EN 60601-1 : 2006
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MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
BS EN ISO 17510-1:2009
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Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment |
ISO 18778:2005
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Respiratory equipment — Infant monitors — Particular requirements |
UNE-EN ISO 10079-3:2014
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Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
IEC 62274:2005
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Medical electrical equipment - Safety of radiotherapy record and verify systems |
BS EN ISO 10651-6:2009
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Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home-care ventilatory support devices |
ISO 9919:2005
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Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
BS EN 13544-1 : 2007
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RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS |
BS EN ISO 10079-3:2014
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Medical suction equipment Suction equipment powered from a vacuum or positive pressure gas source |
ISO 80601-2-72:2015
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Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
BS EN ISO 18778:2009
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Respiratory equipment. Infant monitors. Particular requirements |
EN 13718-1:2014
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Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV
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Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
00/565497 DC : DRAFT DEC 2000
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BS IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY AND ESSENTIAL PERFORMANCE |
I.S. EN 13718-1:2014
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MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES |
BS EN ISO 10651-2:2004
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Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home care ventilators for ventilator-dependent patients |
ISO 18777:2005
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Transportable liquid oxygen systems for medical use — Particular requirements |
ISO 10651-6:2004
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Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices |
ISO 18113-1:2009
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
IEC 60601-2-24:2012
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Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
IEC 60601-1-10:2007+AMD1:2013 CSV
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Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
ISO 80601-2-13:2011
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Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
ISO 8835-4:2004
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Inhalational anaesthesia systems Part 4: Anaesthetic vapour delivery devices |
ISO 21647:2004
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Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors |
ISO 10079-3:2014
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Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
BS EN 60601-2-33 : 2010
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
NF EN ISO 17510-1 : 2009
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SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
UNI EN ISO 80601-2-13 : 2013
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-13: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AN ANAESTHETIC WORKSTATION |
EN ISO 11073-00103:2017
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Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015) |
EN ISO 80601-2-72:2015
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Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015) |
EN ISO 10651-2:2009
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Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004) |
IEC 80601-2-30:2018 RLV
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Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
EN 12342:1998+A1:2009
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Breathing tubes intended for use with anaesthetic apparatus and ventilators |
EN ISO 8835-4:2009
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Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004) |
EN ISO 10651-6:2009
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Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) |
EN ISO 8835-5:2009
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Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004) |
EN ISO 18779:2005
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Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005) |
EN ISO 18777:2009
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Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005) |
EN ISO 10079-3:2014
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Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014) |
EN ISO 18778:2009
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Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) |
EN ISO 5367:2014
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Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
EN ISO 8835-2:2009
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Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007) |
ISO 80601-2-61:2017
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Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
12/30210881 DC : DRAFT APR 2012
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BS EN ISO 5367 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
CSA C22.2 No. 60601.2.24 : 2015
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-24: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFUSION PUMPS AND CONTROLLERS |
BS ISO/IEEE 11073-00103 : 2015
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HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
I.S. EN ISO 8835-5:2009
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INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS |
I.S. EN ISO 10651-2:2009
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LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
BS ISO 27427:2013
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Anaesthetic and respiratory equipment. Nebulizing systems and components |
03/114562 DC : DRAFT SEP 2003
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BS EN ISO 18777 - TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
BS ISO 11197 : 2016
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MEDICAL SUPPLY UNITS |
DIN EN ISO 18113-1:2013-01
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
BS EN ISO 18113-1:2011
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In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
15/30300279 DC : 0
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BS ISO 80601-2-74 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT |
CSA C22.2 No. 60601-1-11 : 2015
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
16/30316718 DC : 0
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BS EN ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT |
BS EN 62366-1:2015
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Medical devices Application of usability engineering to medical devices |
CSA Z10651.6 :2006
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LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
I.S. EN ISO 5367:2014
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ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
NF EN 60601-1-10 : 2008 AMD 1 2015
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
AAMI ISO TIR 19218-1 : 2011
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MEDICAL DEVICES - HIERARCHAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 1: EVENT-TYPE CODES |
CSA Z8185 : 2008(R2013)
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RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
CSA Z18779 : 2008
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MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS |
CSA Z18777 : 2008 : R2013
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TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS |
IEC 80601-2-30 REDLINE : 2ED 2018
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS |
CSA ISO 14971 : 2007 : R2017
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
CSA ISO 14971 : 2007 : R2012
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
DIN EN ISO 80601-2-69:2014-12
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Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014) |
DIN EN ISO 5367 E : 2015
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ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014) |
ISO 11195:2018
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Gas mixers for medical use — Stand-alone gas mixers |
CSA Z10651.2 : 2006 : R2015
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LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
CSA Z21647 : 2007 : R2012
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MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
CSA C22.2 No. 60601-1-10 : 2009 : INC : AMD 1 : 2014 : R201400
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
IEEE 11073-00103-2012
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Health informatics - Personal health device communication Part 00103: Overview |
EN 60601-1-11:2015
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Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
I.S. EN ISO 80601-2-55:2018
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS (ISO 80601-2-55:2018) |
ISO 80601-2-67:2014
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Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment |
CSA Z5359 : 2016
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ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES, MEDICAL VACUUM, MEDICAL SUPPORT GASES, AND ANAESTHETIC GAS SCAVENGING SYSTEMS |
CEI 62-143 : 2007
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MAPPING BETWEEN THE CLAUSES OF THE THIRD EDITION OF IEC 60601-1 AND THE 1988 EDITION AS AMENDED |
BS EN ISO 10079-1:2015
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Medical suction equipment Electrically powered suction equipment |
BS EN 62304 : 2006
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MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
I.S. EN ISO 80601-2-69:2014
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-69: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OXYGEN CONCENTRATOR EQUIPMENT (ISO 80601-2-69:2014) |
ISO 18190:2016
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Anaesthetic and respiratory equipment — General requirements for airways and related equipment |
I.S. EN ISO 10079-1:2015
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MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015) |
I.S. EN ISO 11197:2016
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MEDICAL SUPPLY UNITS (ISO 11197:2016) |
NF EN 60601-2-68 : 2015
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
UNI EN ISO 18113-1 : 2012
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
CSA C22.2 No. 80601-2-56 : 2012 : R2016
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT |
13/30254355 DC : 0
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BS ISO 80601-2-70 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-70: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SLEEP APNEOA BREATHING THERAPY EQUIPMENT |
UNI EN ISO 15002 : 2008
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FLOW-METERING DEVICES FOR CONNECTION TO TERMINAL UNITS OF MEDICAL GAS PIPELINE SYSTEMS |
EN ISO 80601-2-56:2017
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Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2017) |
ISO 80601-2-55:2018
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Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
EN ISO 14971:2012
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Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
I.S. EN ISO 5359:2014
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ANAESTHETIC AND RESPIRATORY EQUIPMENT - LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES (ISO 5359:2014) |
ISO 27427:2013
|
Anaesthetic and respiratory equipment — Nebulizing systems and components |
IEC TR 62809:2013
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Summary of requirements and tests to products in the scope of IEC 60601-2-66 |
IEC 62304:2006+AMD1:2015 CSV
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Medical device software - Software life cycle processes |
EN 60601-2-33:2010/A12:2016
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS |
ISO 8185:2007
|
Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
ISO 17510-1:2007
|
Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |
BS EN ISO 21647:2009
|
Medical electrical equipment. Particular requirements for the basic safety and essential performance of respiratory gas monitors |
BS EN ISO 18779:2005
|
Medical devices for conserving oxygen and oxygen mixtures. Particular requirements |
BS EN ISO 8835-5:2009
|
Inhalational anaesthesia systems Anaesthesia ventilators |
BS EN ISO 18777:2009
|
Transportable liquid oxygen systems for medical use. Particular requirements |
BS EN ISO 8835-4:2009
|
Inhalational anaesthesia systems Anaesthetic vapour delivery devices |
IEC 60601-1:2005+AMD1:2012 CSV
|
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
EN 62274:2005
|
Medical electrical equipment - Safety of radiotherapy record and verify systems |
EN 60601-2-24:2015
|
Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
DIN EN ISO 8185:2009-07
|
RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS |
EN 80601-2-30:2010/A1:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS (IEC 80601-2-30:2009/A1:2013) |
DIN EN ISO 10079-3:2000-03
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MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014) |
UNE-EN 13544-1:2007
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Respiratory therapy equipment - Part 1: Nebulizing systems and their components |