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