09/30169318 DC : 0
Superseded
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BS EN 60601-2-34 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-34: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT
Hardcopy , PDF
31-07-2014
English
FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.1.1 *Scope
201.1.2 Object
201.1.3 Collateral standards
201.1.4 Particular standards
201.2 Normative references
201.3 Terminology and definitions
201.4 General requirements
201.4.3.101 ESSENTIAL PERFORMANCE
201.5 General requirements for testing of ME
EQUIPMENT
201.5.4 Other conditions
201.5.8 * Sequence of tests
201.6 Classification of ME EQUIPMENT and ME
SYSTEMS
201.6.2 * Protection against electric shock
201.6.6 Mode of operation
201.7 ME EQUIPMENT identification, marking
and documents
201.7.2 Marking on the outside of ME EQUIPMENT
or ME EQUIPMENT parts
201.7.2.17 * Protective packaging
201.8 Protection against electrical HAZARDS from
ME EQUIPMENT
201.8.3 Classification of APPLIED PARTS
201.8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS
201.9 Protection against MECHANICAL HAZARDS of
ME EQUIPMENT and ME SYSTEMS
201.9.7 Pressure vessels and parts subject to
pneumatic and hydraulic pressure
201.9.7.5 * Pressure vessels
201.10 Protection against unwanted and excessive
radiation HAZARDS
201.11 Protection against excessive temperatures
and other HAZARDS
201.11.6.5 * Ingress of water or particulate matter
into ME EQUIPMENT and ME SYSTEM
201.11.8 * Interruption of the power supply/SUPPLY
MAINS to ME EQUIPMENT
201.12 Accuracy of controls and instruments and
protection against hazardous outputs
201.12.1 Accuracy of controls and instruments
201.12.1.101 * ESSENTIAL PERFORMANCE
201.12.3 Alarm systems
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.15.1.101 * Constructive requirements
201.15.3 Mechanical strength
201.15.4 ME EQUIPMENT components and general assembly
201.15.4.4 Indicators
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and
ME SYSTEMS
202 Electromagnetic compatibility - Requirements and tests
202.5.2.2.2 Requirements applicable to ME EQUIPMENT and
ME SYSTEMS other than those specified for
use only in a shielded location
202.6 ELECTROMAGNETIC COMPATIBILITY
202.6.1 EMISSIONS
202.6.2 * IMMUNITY
202.6.2.3 Radiated RF electromagnetic fields
202.6.2.3.1 Requirements
202.6.2.3.2 Tests
202.6.2.6.2 Tests
203 General requirements for radiation protection in
diagnostic X-ray equipment
206 Usability
208 General requirements, tests and guidance for
alarm systems in medical electrical equipment and
medical electrical systems
208.3 Terms and Definitions
208.6 ALARM SYSTEM
208.6.6 ALARM LIMIT
208.6.6.1.101 Physiological ALARM CONDITIONS,
ALARM LIMITS and delay time of
physiological ALARM SIGNALS
208.6.6.1.102 Detection of TRANSDUCER and
TRANSDUCER cable fault
208.6.8 ALARM SIGNAL inactivation states
208.6.8.1.101 * Duration of ALARM PAUSED and
AUDIO PAUSED
208.6.9 * ALARM RESET
208.6.10 * NON-LATCHING and LATCHING ALARM SIGNALS
208.6.10.101 * NON-LATCHING ALARM SIGNAL for
TECHNICAL ALARM CONDITIONS
208.6.11 DISTRIBUTED ALARM SYSTEM
208.6.11.2.2 * Failure of remote communication
of ALARM CONDITIONS
209 Requirements for the reduction of environmental impacts
210 Process requirements for the development of therapeutic
closed-loop controllers
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Alarm diagrams 208/IEC 60601-1-8:2006
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