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IEC TR 60930:2008

Current
Current

The latest, up-to-date edition.

Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

19-09-2008

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.

Committee
TC 62/SC 62A
DevelopmentNote
Stability Date: 2021. (09/2017)
DocumentType
Technical Report
Pages
28
PublisherName
International Electrotechnical Committee
Status
Current
Supersedes

Standards Relationship
BIS IS 11478 : 2018 Identical
NEN NPR IEC/TR 60930 : 2008 Identical
BS EN 60332-3-25:2009 Identical
SAC GB/T 17995 : 1999 Identical
NFC 74 005 : 89 FD Identical

AAMI/IEC TIR61289:2011 HIGH FREQUENCY SURGICAL EQUIPMENT - OPERATION AND MAINTENANCE
PD IEC/TR 62296:2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
IEC TR 62296:2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
IEC TR 61258:2008 Guidelines for the development and use of medical electrical equipment educational materials
AAMI/IEC TIR62296:2009
IEC TR 61289:2011 High frequency surgical equipment - Operation and maintenance
CSA CEI/IEC 1288.1 : 1998 CARDIAC DEFIBRILLATORS - CARDIAC DEFIBRILLATORS-MONITORS - PART 1: OPERATION

IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
IEC 62353:2014 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements

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