Medical Electrical Equipment - Part 1-1: General Requirements For Safety - Collateral Standard - Safety Requirements For Medical Electrical Systems
Japanese Standards Association
Introduction
1 Scope and object
1.201 Scope
2 Terminology and definitions
2.201 Coupling
2.202 Indirect contact
2.203 Medical electrical system
2.204 Patient environment
2.205 Separation device
2.206 Multiple portable socket-outlet
3 General requirements
3.201 General requirements for the system
4 General requirements for tests
4.201 General requirements for tests for the system
6 Identification, marking and documents
6.1.201 Marking
6.8.201 Accompanying documents
Section Two - Environmental conditions
Section Three - Protection against electric shock hazards
16 Enclosures and protective covers
16.201 Enclosures
17 Separation
17.201 Electrical separation
19 Continuous leakage currents and patient auxiliary currents
19.201 Leakage currents
19.201.1 Enclosure leakage current
19.201.2 Patient leakage current
19.201.3 Connection of signal input parts or signal output
parts
Section Four - Protection against mechanical hazards
22 Moving parts
22.7.201 Protective means
Section Five - Protection against hazards from unwanted or
excessive radiation
Section Six - Protection against hazards of ignition of flammable
anaesthetic mixtures
Section Seven - Protection against excessive temperatures
and other safety hazards
43.201 Fire prevention
44.7.201 Cleaning, sterilization and disinfection
49.201 Interruption of the power supply
Section Eight - Accuracy of operating data and protection
against hazardous output
Section Nine - Abnormal operation and fault conditions;
environmental tests
Section Ten - Constructional requirements
56.3.201 Connections
57.2 Mains connectors, appliance inlets and the like
57.2.201 Multiple portable socket-outlet
57.10 Creepage distances and air clearances
58.201 Protective earth conductor
59.201 Protection of wiring
Figures
201 Example of patient environment
202 Symbol 14, Table D1 of JIS T 0601-1
Annexes
AAA (informative) General guidance and rationale
BBB (informative) Examples of combinations of medical
electrical equipment and non-medical electrical equipment
CCC (normative) Normative references
DDD (informative) Bibliography
EEE (normative) Requirements for multiple portable
socket-outlets
FFF (informative) Examples of application of multiple
portable socket-outlets
Defines safety of medical electrical systems. It describes the safety requirements for medical electrical systems to provide protection for the patient, the operator and surroundings.
| Document Type | Standard |
| Status | Current |
| Publisher | Japanese Standards Association |
