CSA C22.2 No. 60601-2-66 : 2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
BS EN 60601-2-51:2003
|
Medical electrical equipment. Particular requirements for safety Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
04/30089749 DC : DRAFT DEC 2004
|
BS EN 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
ISO/TR 27809:2007
|
Health informatics Measures for ensuring patient safety of health software |
I.S. EN ISO 22523:2006
|
EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
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 60601-2-30:2000
|
Medical electrical equipment. Particular requirements for safety Particular requirements for safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
UNE-EN 60645-6:2010
|
Electroacoustics - Audiometric equipment -- Part 6: Instruments for the measurement of otoacoustic emissions |
03/311987 DC : DRAFT AUG 2003
|
BS EN 60601-2-27 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT |
AAMI ID26:2004
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
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 |
AAMI DF80 : 2003 : R2010
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS] |
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 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 |
CSA C22.2 No. 60601.2.12 : 2003
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
CSA C22.2 No. 60601.1.1 : 2002
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
IEC TR 62348:2012
|
Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition |
I.S. EN 60601-2-66:2015
|
MEDICAL ELECTRICAL EQUIPMENT - PART-2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
CSA C22.2 No. 60601.1.1 : 2002 : R2006
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
CSA C22.2 No. 60601.2.51 : 2004
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS |
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 |
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 ISO 22523:2006
|
External limb prostheses and external orthoses. Requirements and test methods |
EN 62304:2006/A1:2015
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
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 ISO 22523 : 2006
|
EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006) |
EN 60601-2-51:2003
|
Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
EN 60645-5:2005
|
Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance |
CEN/TS 15260:2006
|
Health informatics - Classification of safety risks from health informatics products |
DIN EN 60601-2-30 : 2000
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
BS EN ISO 80601-2-13:2012
|
Medical electrical equipment Particular requirements for basic safety and essential performance of an anaesthetic workstation |
BS EN 60601-2-38:1997
|
Medical electrical equipment. Particular requirements for safety Particular requirements for the safety of electrically operated hospital beds |
BS EN 60645-6:2010
|
Electroacoustics. Audiometric equipment Instruments for the measurement of otoacoustic emissions |
DD ISO/TS 25238:2007
|
Health informatics. Classification of safety risks from health software |
14/30315340 DC : 0
|
BS EN 60601-2-66 ED.2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-66: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEARING INSTRUMENTS AND HEARING INSTRUMENT SYSTEMS |
14/30287753 DC : 0
|
BS EN 62304 AMENDMENT 1 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES |
BS ISO 15378 : 2006 AMD 17315
|
PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
BS EN 60601-2-12:2006
|
Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
UNE-EN 60601-2-66:2016
|
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
02/564924 DC : DRAFT NOV 2002
|
ISO 21647 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS |
07/30173580 DC : 0
|
BS EN 60645-6 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS |
ANSI Z80.11:2012
|
OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
AAMI TIR32 : 2004 : R2016
|
MEDICAL DEVICE SOFTWARE RISK MANAGEMENT |
BS EN 60601-2-66:2015
|
Medical electrical equipment Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
BS 5724-2.38(1997) : 1997
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
CEI EN 60645-1 : 2016
|
ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: EQUIPMENT FOR PURE-TONE AUDIOMETRY |
CEI EN 62274 : 2005
|
MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
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 |
ISO 14708-2:2012
|
Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
CSA ISO/IEC TR 15942:2004
|
INFORMATION TECHNOLOGY - PROGRAMMING LANGUAGES - GUIDE FOR THE USE OF THE ADA PROGRAMMING LANGUAGE IN HIGH INTEGRITY SYSTEMS |
UNI EN ISO 7494-1 : 2011
|
DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
I.S. EN 60645-6:2010
|
ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS |
BIS IS/ISO 14708-1 : 2000
|
IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
ISO 7494-1:2011
|
Dentistry Dental units Part 1: General requirements and test methods |
CSA C22.2 No. 601.2.20 : 1992
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF TRANSPORT INCUBATORS |
CSA C22.2 No. 601.1.1 : 2000
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY - 1: COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
CSA C22.2 No. 601.2.29 : 0
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY SIMULATORS |
AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
I.S. EN ISO 14971:2012
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01) |
IEC TR 60788:2004
|
Medical electrical equipment - Glossary of defined terms |
AAMI ES60601-1 : 2005
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
DIN EN ISO 6875:2011-10
|
DENTISTRY - PATIENT CHAIR |
DIN EN 1640:2010-02
|
Dentistry - Medical devices for dentistry - Equipment |
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 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 1640:2009
|
Dentistry. Medical devices for dentistry. Equipment |
BS EN 1441:1998
|
Medical devices. Risk analysis |
DIN EN ISO 11608-4:2016-03 (Draft)
|
PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
I.S. EN ISO 6875:2011
|
DENTISTRY - PATIENT CHAIR |
I.S. EN ISO 17510-1:2009
|
SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
EN ISO 17510-1:2009
|
Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
I.S. EN 1640:2009
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
I.S. 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 |
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 |
CSA C22.2 No. 60601.1 : 2014
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
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 |
ANSI/AAMI/IEC TIR62348:2012
|
ASSESSMENT OF THE IMPACT OF THE MOST SIGNIFICANT CHANGES IN AMENDMENT 1 TO IEC 60601-1:2005 AND MAPPING OF THE CLAUSES OF IEC 60601-1:2005 TO THE PREVIOUS EDITION |
AAMI TIR72 : 2017
|
DIALYSIS FLUID CHEMICAL COMPOSITION |
11/30243761 DC : 0
|
BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS |
BS ISO/IEC TR 15942:2000
|
Information technology. Programming languages. Guide for the use of the Ada programming language in high integrity systems |
UNE-EN 62304:2007
|
Medical device software - Software life-cycle processes (IEC 62304:2006) |
CSA ISO/IEC TR 15942 : 2004 : R2014
|
INFORMATION TECHNOLOGY - PROGRAMMING LANGUAGES - GUIDE FOR THE USE OF THE ADA PROGRAMMING LANGUAGE IN HIGH INTEGRITY SYSTEMS |
02/564070 DC : DRAFT SEP 2002
|
BS EN 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE SAFETY OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
07/30136476 DC : DRAFT APR 2007
|
IEC 60601-2-44 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
BS EN 60601-1-1:2001
|
Medical electrical equipment. General requirements for safety Collateral standard. Safety requirements for medical electrical systems |
07/30173584 DC : 0
|
BS EN 60645-7 - ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 7: INSTRUMENTS FOR THE MEASUREMENT OF AUDITORY EVOKED POTENTIALS |
AAMI DF80:2003
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS] |
AAMI ID26 : 2004 : R2009
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND 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 |
CSA Z9919 :2007
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
AAMI IEC 62304 : 2006
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES |
CEI EN 60601-2-12 : 2007
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
UNE-EN ISO 7494-1:2012
|
Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) |
I.S. EN 60601-1-1:2001
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
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 80601-2-13:2012
|
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. 601.2.19 : 1992
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF BABY INCUBATORS |
CSA C22.2 No. 601.2.13 : 0
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF ANAESTHETIC MACHINES |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
BS EN ISO 14971:2012
|
Medical devices. Application of risk management to medical devices |
I.S. EN 60645-5:2005
|
ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 5: INSTRUMENTS FOR THE MEASUREMENT OF AURAL ACOUSTIC IMPEDANCE/ADMITTANCE |
I.S. EN 62304:2006
|
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
DIN EN ISO 22523:2007-04
|
External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
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 |
BS EN ISO 9919:2009
|
Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
IEC 60645-6:2009
|
Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions |
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 |
IEC 60601-2-66:2015
|
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
IEC 60645-5:2004
|
Electroacoustics - Audiometric equipment - Part 5: Instruments for the measurement of aural acoustic impedance/admittance |
UNE-EN 60601-1:2008
|
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance |
UNI EN ISO 6875 : 2011
|
DENTISTRY - PATIENT CHAIR |
UNI EN 1640 : 2010
|
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
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 |
I.S. EN ISO 11608-4:2007
|
PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
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 ISO 10651-6 : 2009
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES |
I.S. EN ISO 11073-00103:2017
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
BS ISO/IEEE 11073-00103 : 2015
|
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
PD ISO/TR 27809:2007
|
Health informatics. Measures for ensuring patient safety of health software |
I.S. EN 62274:2005
|
MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
EN 60601-1-1:2001
|
Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
ISO/TS 25238:2007
|
Health informatics Classification of safety risks from health software |
CEI UNI EN ISO 14971 : 2013
|
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
08/30176438 DC : DRAFT JAN 2008
|
BS EN 60645-1 - ELECTRO ACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 1: PURE-TONE AUDIOMETERS |
PD IEC TR 60788:2004
|
Medical electrical equipment. Glossary of defined terms |
BS 5724-2.44(1999) : 1999
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
BS EN 62274:2005
|
Medical electrical equipment. Safety of radiotherapy record and verify systems |
CSA C22.2 No. 60601.1.1 : 2002 : R2011
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
BS EN ISO 11073-00103:2017
|
Health informatics. Personal health device communication Overview |
12/30244415 DC : DRAFT APR 2012
|
BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
NF EN 60645-6 : 2010
|
ELECTROACOUSTICS - AUDIOMETRIC EQUIPMENT - PART 6: INSTRUMENTS FOR THE MEASUREMENT OF OTOACOUSTIC EMISSIONS |
CSA ISO 27427 : 2014
|
ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
BS 5724-2.18(1997) : 1997
|
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR ENDOSCOPIC EQUIPMENT |
BS EN 60645-5:2005
|
Electroacoustics. Audiometric equipment Instruments for the measurement of aural acoustic impedance/admittance |
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 |
07/30145258 DC : 0
|
BS ISO 20072 - AEROSOL DRUG DELIVERY DEVICES DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
01/561640 DC : DRAFT APR 2001
|
BS EN ISO 8835-4 - INHALATIONAL ANAESTHESIA SYSTEMS - PART 4: ANAESTHETIC VAPOUR DELIVERY DEVICES |
DD CEN/TS 15260:2006
|
Health informatics. Classification of safety risks from health informatics products |
CSA Z10651.2 : 2006 : R2015
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
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 |
ANSI Z80.11 : 2012 : R2017
|
OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
AAMI TIR32 :2004
|
MEDICAL DEVICE SOFTWARE RISK MANAGEMENT |
EN ISO 7494-1:2011
|
Dentistry - Dental units - Part 1: General requirements and test methods (ISO 7494-1:2011) |
CEI EN 60601-1-1 : 2003
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS |
I.S. CEN TS 15260:2006
|
HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH INFORMATICS PRODUCTS |
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 |
IEEE 730-2014 REDLINE
|
IEEE Standard for Software Quality Assurance Processes |
I.S. EN ISO 7494-1:2011
|
DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS |
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) |
UNI EN ISO 17510-1 : 2009
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SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
BS EN ISO 7494-1:2011
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Dentistry. Dental units General requirements and test methods |
I.S. EN 60601-2-12:2006
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
I.S. EN 60601-2-38:1998
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MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
DIN EN ISO 8835-5:2009-07
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INHALATIONAL ANAESTHESIA SYSTEMS - PART 5: ANAESTHESIA VENTILATORS |
UNE-EN ISO 6875:2012
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Dentistry - Patient chair (ISO 6875:2011) |
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 |
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 ISO 11608-4:2007
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Pen-injectors for medical use Requirements and test methods for electronic and electromechanical pen-injectors |
ISO 11608-4:2006
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Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
IEC 60601-1-1:2000
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Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
ISO 6875:2011
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Dentistry Patient chair |
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 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 |
BS EN ISO 6875:2011
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Dentistry. Patient chair |
ISO 22523:2006
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External limb prostheses and external orthoses — Requirements and test methods |
IEC 60601-2-30:1999
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Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
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 |
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 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) |
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 1640:2009
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Dentistry - Medical devices for dentistry - Equipment |
EN 1441 : 1997
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MEDICAL DEVICES - RISK ANALYSIS |
EN ISO 11608-4:2007
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Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006) |
EN ISO 6875:2011
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Dentistry - Patient chair (ISO 6875:2011) |
BS 5724-2.39(1999) : 1999
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MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR PERITONEAL DIALYSIS EQUIPMENT |
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 |
14/30287226 DC : 0
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BS EN ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2008, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
ISO/TR 16142:2006
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Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
00/560888 DC : APR 2000
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IEC 60601-1-2 EDITION 2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS |
AAMI RD5 : 2003
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HEMODIALYSIS SYSTEMS |
04/30079743 DC : DRAFT APR 2004
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ISO 15378 - PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2000 WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) |
03/111613 DC : DRAFT AUG 2003
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BS EN ISO 9919 - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE |
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 |
AAMI ID26 : 2004 : R2013
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MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
CSA Z17510.1 : 2010
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SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
07/30166162 DC : 0
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BS IEC 60601-2-44 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY |
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 |
I.S. EN 60601-2-30:2000
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
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 62304 : 2006
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MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES |
CEI 65-186 : 2010
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GUIDELINE ON THE APPLICATION OF THE STANDARD SERIES CEI EN 61511 FUNCTIONAL SAFETY - SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR |
CSA ISO/IEC TR 15942:04 (R2019)
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Information Technology - Programming Languages - Guide for the Use of the Ada Programming Language in High Integrity Systems (Adopted ISO/IEC TR 15942:2000, first edition, 2000-03-01) |
DIN EN ISO 7494-1:2011-11
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DENTISTRY - DENTAL UNITS - PART 1: GENERAL REQUIREMENTS AND TEST METHODS (ISO 7494-1:2011) |
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) |
ISO 27427:2013
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Anaesthetic and respiratory equipment — Nebulizing systems and components |
I.S. EN 60601-2-51:2003
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-51: PARTICULAR REQUIREMENTS FOR SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS |
IEC 62304:2006+AMD1:2015 CSV
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Medical device software - Software life cycle processes |
EN 60601-2-66:2015
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Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |
ISO 17510-1:2007
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Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |
BS EN ISO 8835-5:2009
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Inhalational anaesthesia systems Anaesthesia ventilators |
IEC 60601-2-51:2003
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Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs |
IEC 60601-1:2005+AMD1:2012 CSV
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Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
EN 62274:2005
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Medical electrical equipment - Safety of radiotherapy record and verify systems |
EN 60601-2-38:1996/A1:2000
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MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS |
EN 60601-2-30:2000
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Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
EN 60601-2-12:2006
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Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
EN 60645-6:2010
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Electroacoustics - Audiometric equipment - Part 6: Instruments for the measurement of otoacoustic emissions |