Medical electrical equipment - Part 2-30: Particular requirements for the safety including essential performance of automatic cycling non-invasive blood pressure monitoring equipment
1.1 Scope
Addition:
This Particular Standard specifies requirements for the safety, including essential performance of Automatic Cycling Non-invasive Blood Pressure Monitoring Equipment as defined in 2.102, hereinafter referred to as Equipment. The Equipment may be attended or unattended.
This Particular Standard does not apply to blood pressure measuring equipment which uses finger transducers or to semi-automatic blood pressure measuring equipment, typically in which each determination needs to be initiated manually.
1.2 Object
Replacement:
The object of this Particular Standard is to establish 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.
Contents
Foreword III
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 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 Test
Section Ten Constructional Requirements
56 Components and General Assembly
57 Mains Part, Components and Lay-out
Appendix L (Normative) Normative References
Appendix AA (Informative) General Guidance and Rationale
Appendix BB (Informative) Alarm Diagrams
