IEC 80601-2-30:2009+AMD1:2013 CSV

Superseded

View Superseded by

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Amended by

IEC 80601-2-30:2009/COR1:2010

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

09-12-2022

Language(s)

English - French

Published date

07-31-2013

Publisher

International Electrotechnical Committee

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.

Committee	TC 62/SC 62D
DocumentType	Standard
Pages	232
PublisherName	International Electrotechnical Committee
Status	Superseded
SupersededBy	IEC 80601-2-30:2018 IEC 80601-2-30 REDLINE : 2ED 2018 IEC 80601-2-30:2018 RLV
Supersedes	IEC 60601-2-30:1999

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
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
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)
DIN EN 80369-5 E : 2017	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)
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