IEC TR 60930:2008

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

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.