EN 60601-2-30:2000
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
01-09-2010
18-05-2000
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 THE 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, and
compatibility
45 Pressure vessels and parts subject to PRESSURES OUTPUTS
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 lay-out
Annex L (normative) References - Publications mentioned in
this standard
Annex AA (informative) General guidance and rationale
Annex BB (informative) Alarm diagrams
Annex ZA (normative) Normative references to international
publications with their corresponding
European publications
Annex ZB (informative) Other international publications
mentioned in this standard with the
references of the relevant European
publications
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 |
CLC/TC 62
|
DevelopmentNote |
To be read in conjunction with EN 60601-1:1990, EN 60601-1-2:1993, and EN 60601-1-4:1996 (05/2001)
|
DocumentType |
Standard
|
PublisherName |
European Committee for Standards - Electrical
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
I.S. EN 60601-2-30:2000 | Identical |
IEC 60601-2-30:1999 | Identical |
VDE 0750-2-30 : 2016 | Identical |
NF EN 60601-2-30 : 2002 | Identical |
NBN EN 60601 2-30 : 2001 | Identical |
PN EN 60601-2-30 : 2006 | Identical |
NEN EN IEC 60601-2-30 : 2000 | Identical |
SN EN 60601-2-30 : 2000 | Identical |
UNE-EN 60601-2-30:2001 | Identical |
DIN EN 60601-2-30 : 2000 | Identical |
NEN 10601-2-30 : 1995 | Identical |
BS 5724-2.130(1995) : 1995 | Identical |
BS EN 60601-2-30:2000 | Identical |
CEI EN 60601-2-30 : 2001 | Identical |
I.S. EN ISO 11073-00103:2017 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015) |
I.S. EN 740:1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
DIN EN 1060-3:2010-03 | NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS |
ISO/IEEE 11073-00103:2015 | Health informatics — Personal health device communication — Part 00103: Overview |
EN 1060-3:1997+A2:2009 | Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
12/30266576 DC : 0 | BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES |
BS 5724-2.204(1999) : 1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
UNE-EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
I.S. EN 1060-3:1997 | NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS |
15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
UNE-EN 16372:2015 | Aesthetic surgery services |
UNI EN 13976-2 : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
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 |
PREN 13976-2 : DRAFT 2016 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
BS ISO/IEEE 11073-00103 : 2015 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW |
16/30333925 DC : 0 | BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
BS EN ISO 11073-00103:2017 | Health informatics. Personal health device communication Overview |
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 |
BS EN 740:1999 | Anaesthetic workstations and their modules. Particular requirements |
EN 16372:2014 | Aesthetic surgery services |
EN ISO 11073-00103:2017 | Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015) |
BS EN 16372:2014 | Aesthetic surgery services |
IEEE 11073-00103-2012 | Health informatics - Personal health device communication Part 00103: Overview |
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 |
BS EN 1060-3 : 1997 | NON-INVASIVE SPHYGMOMANOMETERS - PART 3: SUPPLEMENTARY REQUIREMENTS FOR ELECTRO-MECHANICAL BLOOD PRESSURE MEASURING SYSTEMS |
DIN EN 13976-2:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
HD 395.2.2 : 200S1 | MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH FREQUENCY SURGICAL EQUIPMENT |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
IEC 61000-4-8:2009 | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
IEC 61000-4-6:2013 | Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields |
EN 61000-4-3 : 2006 AMD 2 2010 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST |
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 |
EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
IEC 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
EN 61000-4-8:2010 | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test |
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
CISPR 11:2015 RLV | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
EN 61000-4-6:2014/AC:2015 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS (IEC 61000-4-6:2013) |
EN 60601-1-4:1996/A1:1999 | MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
EN 60529:1991/AC:2016-12 | DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015) |
IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.