IEC TR 60930:2008
(Main)Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
IEC/TR 60930:2008(E) is intended to lessen the risk to patients, operators, and their surroundings by providing a code of safe application. This reduction of risk is in addition to that brought about by the risk control measures incorporated in the medical electrical equipment, the medical electrical system, and the electrical installation in medical locations, hereafter referred to as me equipment, me system and installation respectively. Not all existing me equipment, me systems or installations meet the requirements of the relevant IEC standards. From time to time, operators and responsible organizations will encounter me equipment and me systems complying with older safety standards. However, the guidelines for safe application given in this technical report should nevertheless be followed in so far as this is possible. The guidelines in this technical report can be used with me equipment or me systems for the home healthcare environment provided the manufacturer has included home use in the intended use or the clinical engineering department has checked that the electrical installation and the physical environment will not result in any unacceptable risks. These guidelines can also be applied to equipment used for compensation or alleviation of disease, injury or disability. If the me equipment, an me system or the installation does not comply with the relevant IEC standards, the responsible organization should consult with the clinical engineering department or the manufacturer for instructions on how to achieve an adequate level of safety. This second edition cancels and replaces the first edition published in 1988. This edition constitutes a technical revision. This edition has been aligned with IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-8:2006 and IEC 62353:2007. This edition includes medical electrical systems within its scope.
General Information
Standards Content (Sample)
IEC/TR 60930
Edition 2.0 2008-09
TECHNICAL
REPORT
Guidelines for administrative, medical, and nursing staff concerned with the safe
use of medical electrical equipment and medical electrical systems
IEC/TR 60930:2008(E)
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IEC/TR 60930
Edition 2.0 2008-09
TECHNICAL
REPORT
Guidelines for administrative, medical, and nursing staff concerned with the
safe use of medical electrical equipment and medical electrical systems
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
U
ICS 11.040 ISBN 978-2-88910-333-1
– 2 – TR 60930 © IEC:2008(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
1 Scope.7
2 Normative references .7
3 Terms and definitions .8
4 Nature of HAZARDS .8
5 BASIC SAFETY provisions of and symbols on ME EQUIPMENT.8
5.1 General .8
5.2 ACCOMPANYING DOCUMENTS.8
5.3 Colours of indicator lights.9
5.4 Markings on ME EQUIPMENT .9
5.5 Protection against electric shock .9
5.5.1 Method of protection for ME EQUIPMENT .9
5.5.2 Degree of protection of APPLIED PARTS .10
5.5.3 ME EQUIPMENT not properly marked.11
5.6 Protection against mechanical HAZARDS.11
5.6.1 Protection of PATIENTS, OPERATORS and others from suspended or
moving masses.11
5.6.2 Stability .11
5.6.3 Protection against rough handling.11
6 Protection against thermal HAZARDS and fire prevention.12
6.1 APPLIED PARTS not intended to supply heat to the PATIENT.12
6.2 Protection against ignition in medical locations.12
7 Protection against unwanted or excessive radiation.12
8 ALARM SYSTEMS.12
8.1 General .12
8.2 ALARM CONDITION priorities.13
8.3 Visual ALARM SIGNALS .14
8.4 Auditory ALARM SIGNALS .14
9 BASIC SAFETY provisions for ME SYSTEMS .14
9.1 General .14
9.2 ACCOMPANYING DOCUMENTS.15
9.3 PATIENT ENVIRONMENT .15
9.4 MULTIPLE SOCKET-OUTLET (MSO).15
10 Protection against ingress of water or particulate matter.16
11 Cleaning, disinfection and sterilization.17
12 Electromagnetic phenomena .17
12.1 General recommendations.17
12.2 Identification, marking and documents.18
12.2.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts .18
12.2.2 ACCOMPANYING DOCUMENTS .18
13 Electrical installations in medical locations .19
14 Purchasing and MAINTENANCE of equipment, training of personnel .19
14.1 Accountability.19
14.2 Purchasing .19
TR 60930 © IEC:2008(E) – 3 –
14.3 Delivery and commissioning .20
14.4 Training.20
14.5 MAINTENANCE.21
14.5.1 Concepts .21
14.5.2 MAINTENANCE programme .21
14.6 Checking of the installation and selection of the ME EQUIPMENT or ME SYSTEM .22
14.6.1 Installation.22
14.6.2 Verification of equipment safety.22
14.6.3 Single items of ME EQUIPMENT .22
14.6.4 Combinations of ME EQUIPMENT .22
14.6.5 Connection of ME EQUIPMENT or an ME SYSTEM to the health care
facilities’ data network .22
15 Recommended practice .23
Annex A (informative) PATIENT ENVIRONMENT .25
Bibliography.26
Index of defined terms used in this technical report.27
Figure 1 – Symbols indicating the degree of protection provided by an APPLIED PART .10
Figure 2 – Symbols indicating the degree of protection against the effects of a
discharge of a cardiac defibrillator .10
Figure 3 – Safety signs indicating a RISK from a person pushing, sitting or stepping on
ME EQUIPMENT .11
Figure 4 – Symbols indicating the ME EQUIPMENT is designed to avoid ignition of
FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, or FLAMMABLE ANAESTHETIC MIXTURE WITH
OXYGEN OR NITROUS OXIDE .12
Figure 5 – Example of the construction of a MULTIPLE SOCKET-OUTLET (MSO) .16
Figure A.1 – Example of PATIENT ENVIRONMENT.25
Table 1 – Colours of indicator lights and their meaning for ME EQUIPMENT .9
Table 2 – ALARM CONDITION priorities from IEC 60601-1-8:2006 .14
Table 3 – Characteristics of alarm indicator lights from IEC 60601-1-8:2006.14
– 4 – TR 60930 © IEC:2008(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
GUIDELINES FOR ADMINISTRATIVE, MEDICAL, AND NURSING STAFF
CONCERNED WITH THE SAFE USE OF MEDICAL ELECTRICAL
EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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