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IEC 60601-2-16 : 4.0
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English - French
08-03-2012
Pertains to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2018 does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems.
Committee |
TC 62
|
DevelopmentNote |
Stability Date: 2022. (04/2018)
|
DocumentType |
Standard
|
Pages |
138
|
PublisherName |
International Electrotechnical Committee
|
Status |
Current
|
SupersededBy | |
Supersedes |
17/30321193 DC : 0 | BS ISO 23500-1 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 1. GENERAL REQUIREMENTS |
BS EN ISO 13958:2015 | Concentrates for haemodialysis and related therapies |
IEC 80601-2-49:2018 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors |
CSA Z23500 : 2016 | GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES |
ISO 13958:2014 | Concentrates for haemodialysis and related therapies |
DIN EN 13867:2009-09 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
DIN EN 13867:2003-01 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
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 |
PD IEC/TR 60601-4-1:2017 | Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy |
16/30323461 DC : 0 | BS EN 60601-2-16 ED 5.0 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
BS EN ISO 23500:2015 | Guidance for the preparation and quality management of fluids for haemodialysis and related therapies |
DIN EN ISO 13958:2016-03 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
13/30270468 DC : 0 | BS ISO 13958 - CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
I.S. EN ISO 11073-10406:2012 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012) |
AAMI ISO 13958 : 2009 | CONCENTRATES FOR HEMODIALYSIS AND RELATED THERAPIES |
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 |
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 |
UNE-EN ISO 13958:2016 | Concentrates for haemodialysis and related therapies (ISO 13958:2014) |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
ISO/IEEE 11073-10418:2014 | Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor |
17/30321202 DC : DRAFT MAY 2017 | BS EN ISO 23500-4 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 4: CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
13/30270474 DC : 0 | BS ISO 23500 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES |
AAMI ISO 23500 : 2011 | GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HEMODIALYSIS AND RELATED THERAPIES |
BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
DIN EN ISO 13958 E : 2016 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
I.S. EN ISO 23500:2015 | GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 23500:2014) |
IEC TR 60601-4-1:2017 | Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy |
IEC TR 62653:2012 | Guideline for safe operation of medical equipment used for haemodialysis treatments |
BS EN 60601-2-16:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
UNI EN 13867 : 2009 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
I.S. EN ISO 13958:2015 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES (ISO 13958:2014) |
PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
AAMI 23500 : 2014 | GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HEMODIALYSIS AND RELATED THERAPIES |
AAMI 13958 : 2014 | CONCENTRATES FOR HEMODIALYSIS AND RELATED THERAPIES |
I.S. EN ISO 11073-10418:2014 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01) |
BS EN 13867 : 2002 | CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES |
ISO/IEEE 11073-10406:2012 | Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
ISO 23500:2014 | Guidance for the preparation and quality management of fluids for haemodialysis and related therapies |
EN 13867:2002+A1:2009 | Concentrates for haemodialysis and related therapies |
EN ISO 23500:2015 | Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014) |
EN ISO 13958:2015 | Concentrates for haemodialysis and related therapies (ISO 13958:2014) |
EN ISO 11073-10406:2012 | Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012) |
PD IEC/PAS 63023:2016 | Medical electrical system. Input interface for haemodialysis equipment for use of external alarming device |
BS EN ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
BS ISO 23500 : 2014 | GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES |
AAMI RD5 : 2003 | HEMODIALYSIS SYSTEMS |
UNE-EN ISO 23500:2016 | Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014) |
UNI EN ISO 11073-10406 : 2013 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) |
EN ISO 11073-10418:2014/AC:2016 | Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016) |
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 |
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