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IEC 60601-2-30:1999

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
Available format(s)

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

Superseded date

01-28-2009

Language(s)

English, Spanish, Castilian

Published date

12-22-1999

FOREWORD
INTRODUCTION
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
5 Classification
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK
                HAZARDS
14 Requirements related to classification
17 Separation
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY
   CURRENTS
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
22 Moving parts
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED
               OR EXCESSIVE RADIATION
36 ELECTROMAGNETIC COMPATIBILITY
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
              FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
                AND OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of
   liquids, cleaning, sterilization and disinfection
45 Pressure vessels and parts subject to PRESSURE
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND
                PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS,
               ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 MAINS PARTS, components and layout
Annexes
L (normative) References - Publications mentioned in
              this standard
AA (informative) General guidance and rationale
BB (informative) Alarm diagrams
Figure 101 - Test for protection against defibrillator
             discharge
Figure 102 - Safety means, SINGLE FAULT CONDITION, adult
             (neonatal) determination
Figure 103 - Safety means, SINGLE FAULT CONDITION, adult
             (neonatal) determination
Figure 104 - Maximum inflation time, NORMAL CONDITION and
             SINGLE FAULT CONDITION adult (neonatal)
             determination
Figure 105 - LONG TERM AUTOMATIC MODE NORMAL CONDITION,
             adult (neonatal) determination
Figure 106 - LONG TERM AUTOMATIC MODE SINGLE FAULT CONDITION,
             adult (neonatal) determination
Figure 107 - SHORT TERM AUTOMATIC MODE, adult (neonatal)
             determination
Figure 108 - Test layout
Figure 109 - ESU test layout
Figure 110 - Patient simulator

Specifies particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment, with special attention being paid to the avoidance of hazards due to the inflation process.

Committee
TC 62/SC 62D
DevelopmentNote
Also numbered as BS EN 60601-2.30 (09/2003)
DocumentType
Standard
Pages
45
PublisherName
International Electrotechnical Committee
Status
Superseded
SupersededBy
Supersedes

DIN EN ISO 81060-1:2012-08 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
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)
12/30266576 DC : 0 BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
I.S. EN 61219:1994 LIVE WORKING - EARTHING OR EARTHING AND SHORT-CIRCUITING EQUIPMENT USING LANCES AS A SHORT-CIRCUITING DEVICE - LANCE EARTHING
DIN EN 1060-3:2010-03 NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS
ISO 81060-1:2007 Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
EN 61219:1993 Live working - Earthing or earthing and short-circuiting equipment using lances as short-circuiting device - Lance earthing
AAMI ISO 81060-1 : 2007 NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
BS 5724-2.204(1999) : 1999 ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
BS ISO 81060-1 : 2007 COR 2012 NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
UNE-EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
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
I.S. EN 1060-3:1997 NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS
UNI EN ISO 81060-1 : 2012 NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
I.S. EN ISO 81060-1:2012 NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE (ISO 81060-1:2007)
BS EN ISO 81060-1:2012 Non-invasive sphygmomanometers Requirements and test methods for non-automated measurement type
AAMI ISO 81060-1:2007(R2013) NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
UNE-EN 16372:2015 Aesthetic surgery services
BS EN ISO 11073-10418:2014 Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
UNI EN 1060-3 : 2010 NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS
UNI EN 13976-2 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
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)
I.S. EN 13976-2:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
BS EN 13976-2:2011 Rescue systems. Transportation of incubators System requirements
ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
BS EN 740:1999 Anaesthetic workstations and their modules. Particular requirements
DIN EN 13976-2 E : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
EN 16372:2014 Aesthetic surgery services
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)
BS EN 16372:2014 Aesthetic surgery services
BS EN ISO 11073-10406:2012 Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
UNI EN ISO 11073-10406 : 2013 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements
DIN EN 13976-2:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS
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)
BS EN 1060-3 : 1997 NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS
AAMI SP10 : 2002 MANUAL, ELECTRONIC, OR AUTOMATED SPHYGMOMANOMETERS
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
DIN EN 13976-2:2011-08 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems

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