GUIDELINES FOR ADMINISTRATIVE, MEDICAL, AND NURSING STAFF CONCERNED WITH THE SAFE USE OF MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
International Electrotechnical Committee
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Nature of HAZARDS
5 BASIC SAFETY provisions of and symbols on ME EQUIPMENT
5.1 General
5.2 ACCOMPANYING DOCUMENTS
5.3 Colours of indicator lights
5.4 Markings on ME EQUIPMENT
5.5 Protection against electric shock
5.5.1 Method of protection for ME EQUIPMENT
5.5.2 Degree of protection of APPLIED PARTS
5.5.3 ME EQUIPMENT not properly marked
5.6 Protection against mechanical HAZARDS
5.6.1 Protection of PATIENTS, OPERATORS and others
from suspended or moving masses
5.6.2 Stability
5.6.3 Protection against rough handling
6 Protection against thermal HAZARDS and fire prevention
6.1 APPLIED PARTS not intended to supply heat to the
PATIENT
6.2 Protection against ignition in medical locations
7 Protection against unwanted or excessive radiation
8 ALARM SYSTEMS
8.1 General
8.2 ALARM CONDITION priorities
8.3 Visual ALARM SIGNALS
8.4 Auditory ALARM SIGNALS
9 BASIC SAFETY provisions for ME SYSTEMS
9.1 General
9.2 ACCOMPANYING DOCUMENTS
9.3 PATIENT ENVIRONMENT
9.4 MULTIPLE SOCKET-OUTLET (MSO)
10 Protection against ingress of water or particulate matter
11 Cleaning, disinfection and sterilization
12 Electromagnetic phenomena
12.1 General recommendations
12.2 Identification, marking and documents
12.2.1 Marking on the outside of ME EQUIPMENT or
ME EQUIPMENT parts
12.2.2 ACCOMPANYING DOCUMENTS
13 Electrical installations in medical locations
14 Purchasing and MAINTENANCE of equipment, training
of personnel
14.1 Accountability
14.2 Purchasing
14.3 Delivery and commissioning
14.4 Training
14.5 MAINTENANCE
14.5.1 Concepts
14.5.2 MAINTENANCE programme
14.6 Checking of the installation and selection of the ME
EQUIPMENT or ME SYSTEM
14.6.1 Installation
14.6.2 Verification of equipment safety
14.6.3 Single items of ME EQUIPMENT
14.6.4 Combinations of ME EQUIPMENT
14.6.5 Connection of ME EQUIPMENT or an ME SYSTEM
to the health care facilities' data network
15 Recommended practice
Annex A (informative) PATIENT ENVIRONMENT
Bibliography
Index of defined terms used in this technical report
Provides a code of safe application to lessen the RISK to PATIENTS, OPERATORS, and their surroundings.
| Document Type | Standard |
| Status | Current |
| Publisher | International Electrotechnical Committee |
| Committee | TC 62 |
