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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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