IEC 80601-2-30:2009+AMD1:2013 CSV
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
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12-09-2022
English - French
31-07-2013
IEC 80601-2-30:2009+A1:2013 applies to the basic safety and essential performance of automated sphygmomanometers, which by means of an inflatable cuff are used for intermittent indirect measurement of the blood pressure without arterial puncture. It covers electrically-powered intermittent, indirect measurement of the blood pressure without arterial puncture, me equipment with automatic methods for estimating blood pressure, including blood pressure monitors for the home healthcare environment. This first edition of IEC 80601-2-30 cancels and replaces the second edition of IEC 60601-2-30, published in 1999. This edition constitutes a major technical revision as well as an alignment with the third edition of IEC 60601-1. Specific technical changes include: expansion of the scope to include all automated sphygmomanometers including those where the patient is the operator, identification of essential performance, new clinical accuracy requirements, additional mechanical strength requirements and prohibition of operator accessible 'Luer' connectors in the pneumatic system. The contents of the corrigendum of January 2010 have been included in this copy.This consolidated version consists of the first edition (2009) and its amendment 1 (2013). Therefore, no need to order amendment in addition to this publication.
DocumentType |
Standard
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Pages |
232
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PublisherName |
International Electrotechnical Committee
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Status |
Superseded
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SupersededBy | |
Supersedes |
Standards | Relationship |
NBN EN 80601-2-30 : 2010 AMD 1 2015 | Identical |
BS EN 80601-2-30 : 2010 | Identical |
VDE 0750-2-30 : 2016 | Identical |
DIN EN 80601-2-30 : 2016 | Identical |
NF EN 80601-2-30 : 2011 AMD 1 2015 | Identical |
EN 80601-2-30:2010/A1:2015 | Identical |
NEN EN IEC 80601-2-30 : 2010 AMD 1 2015 | Identical |
OVE/ONORM EN 80601-2-30 : 2016 | Identical |
AAMI IEC 80601-2-30 : 2009 | Identical |
I.S. EN 80369-5:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS |
I.S. EN 60601-2-34:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
EN 60601-2-34:2014 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
I.S. EN ISO 81060-2:2014 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE (ISO 81060-2:2013) |
17/30357644 DC : 0 | BS EN ISO 81060-2 - NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF INTERMITTENT AUTOMATED MEASUREMENT TYPE |
14/30292519 DC : 0 | BS EN 80369-5 ED 1.0 - SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS |
UNI EN ISO 81060-2 : 2014 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE |
CSA ISO 81060-2 : 2014 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE |
BS EN 60601-2-34:2014 | Medical electrical equipment Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring 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 |
AAMI ISO 81060-2 : 2013 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE |
I.S. EN ISO 11073-10407:2011 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10407: DEVICE SPECIALIZATION - BLOOD PRESSURE MONITOR |
BS EN ISO 81060-2:2014 | Non-invasive sphygmomanometers Clinical investigation of automated measurement type |
UNE-EN 80369-5:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
UNI EN ISO 11073-10407 : 2011 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10407: DEVICE SPECIALIZATION - BLOOD PRESSURE MONITOR |
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 |
ISO 81060-2:2013 | Non-invasive sphygmomanometers Part 2: Clinical investigation of automated measurement type |
DIN EN 13718-2:2015-05 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
UNE-EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
BS ISO 81060-2 : 2013 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF AUTOMATED MEASUREMENT TYPE |
DIN EN ISO 81060-2:2014-10 | NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVASTIGATION OF AUTOMATED MEASUREMENT TYPE (ISO 81060-2:2013) |
EN ISO 81060-2:2014 | Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013) |
BS EN 13718-2:2015 | Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances |
I.S. EN 13718-2:2015 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
I.S. EN 13718-2:2015+A1:2020 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
ISO/IEEE 11073-10407:2010 | Health informatics — Personal health device communication — Part 10407: Device specialization — Blood pressure monitor |
DIN EN 80369-5:2017-10 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS (IEC 80369-5:2016 + COR.1:2017) |
EN ISO 11073-10407:2011 | Health informatics - Personal health device communication - Part 10407: Device specialization - Blood pressure monitor (ISO/IEEE 11073-10407:2010) |
ANSI/AAMI/ISO 80369-5:2016 | SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS |
BS EN ISO 11073-10407:2011 | Health informatics. Personal health device communication Device specialization. Blood pressure monitor |
UNE-EN ISO 81060-2:2014 | Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013) |
IEC 60601-2-34:2011 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
CSA C22.2 No. 60601.2.34 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
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