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IEC TR 60513:1994

Current

Current

The latest, up-to-date edition.

Fundamental aspects of safety standards for medical electrical equipment

Available format(s)

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

Language(s)

English - French

Published date

08-01-1994

Foreword
Section 1. General
1 Scope
2 Concepts
Section 2. Safety and standards
3 Hazards
4 Factors affecting safety
5 Measures to achieve safety
6 Goal of standards
7 Types of standards
8 Acceptable risk levels
9 Developing safety and essential performance
     requirements
10 Equipment accessories
11 Standardization
12 Coordination of standards
13 Standards and the law
14 Role of standards
15 Accidents
16 Maintenance of standards
Section 3. Guide to the development of future product
            standards
17 Identification of problems
18 Priority
19 Format and structure
20 Specifying safety and essential performance
     requirements
21 Testing requirements
22 Design verification
23 Clinical trials and similar assessment
24 Performance requirements
Annexes
A Classification of applied parts
B The role of standards in the assessment and
     approval of medical electrical equipment
C Improving overall safety
D Safety factors
E History of IEC 513, 1st edition and IEC 601 series
Figures
1 Flow diagram for risk management
2 Structure of IEC 601 series under the third edition
     of IEC 601-1
C.1 Overall safety
Tables
1 Risk classification of accidents
2 Interpretation of risk level
3 Third edition of IEC 601-1 and its collateral
     standards
B.1 Hazards and causes
B.2 Role of standards in overall safety

This report identifies fundamental considerations to be taken into account in developing standards to ensure the safety of medical electrical equipment. It follows closely recommendations of ISO/IEC Guide 51 and expands on matters which are unique to, or critical in, the application of medical electrical equipment.

Committee
TC 62/SC 62A
DevelopmentNote
Also numbered as BS PD6573(1994). (08/2005) Stability Date: 2019. (09/2017)
DocumentType
Technical Report
Pages
125
PublisherName
International Electrotechnical Committee
Status
Current

Standards Relationship
UNE 20611:1979 Identical
VDE 0752 : 1983 Identical
VDE 0752 SUPP 1 : 2003 Identical
DIN VDE 0752 SUPP 1 : 2003 Identical
AS/NZS 4513:1995 Identical
CEI 62-93 : 1998 Identical
NEN NPR 10513 : 1977 Identical

CSA Z10651.6 : 2006 : R2015 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
IEC TR 62354:2014 General testing procedures for medical electrical equipment
AAMI ISO TIR 16142 : 2005 MEDICAL DEVICES - GUIDANCE ON THE SELECTION OF STANDARDS IN SUPPORT OF RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES
CSA ISO 14971 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
IEC TR 60930:2008 Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
AAMI ES60601-1 : 2005 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
PD IEC/TR 62354:2014 General testing procedures for medical electrical equipment
IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
BS 5724-1.4(1997) : 1997 MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - GENERAL REQUIREMENTS FOR PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
BS EN 60601-2-44 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009)
AAMI TIR32 : 2004 : R2016 MEDICAL DEVICE SOFTWARE RISK MANAGEMENT
PD ISO/TR 16142:2006 Medical devices. Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
BS EN 60601-1-8 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006)
EN 60601-1-8:2007/A11:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)
ISO 14971:2007 Medical devices Application of risk management to medical devices
CEI UNI EN ISO 14971 : 2013 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ANSI/AAMI/IEC TIR62354:2015 GENERAL TESTING PROCEDURES FOR MEDICAL ELECTRICAL EQUIPMENT
I.S. EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
AAMI ES60601-1 : 2005 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD)
DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
BS EN 1441:1998 Medical devices. Risk analysis
I.S. EN ISO 10651-6:2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
DIN EN ISO 10651-2:2011-06 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
NF EN 61076 4 107 : 2002 CONNECTORS FOR ELECTRONIC EQUIPMENT - PART 4-107: PRINTED BOARD CONNECTORS WITH ASSESSED QUALITY - DETAIL SPECIFICATION FOR SHIELDED TWO-PART CONNECTORS HAVING A BASIC GRID OF 2,0 MM, FIXED PART WITH SOLDER AND PRESS-IN TERMINATIONS FOR PRINTED BOARDS, FREE PART WITH NON-ACCESSIBLE INSULATION DISPLACEMENT AND CRIMP TERMINATIONS
BS 5724-2.16(1989) : 1989 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR HAEMODIALYSIS EQUIPMENT
BS EN 60601-1-4:1997 Medical electrical equipment. General requirements for safety Collateral standard. General requirements for programmable electrical medical systems
BS 5724-1:1979 Medical electrical equipment Specification for general safety requirements
03/103294 DC : DRAFT JAN 2003 BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES
CSA Z10651.6 : 2006 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
UNE-EN 60601-2-44:2010 Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
I.S. EN 60601-1-8:2007 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
I.S. EN 60601-1:2006&A1:2013&AC:2014&A12:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
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
DIN EN ISO 10651-6:2011-06 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
ISO 10651-2:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
04/30106146 DC : DRAFT MARCH 2004 BS EN 60601-1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
UNE-EN 60601-1:2008 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
UNI EN ISO 10651-2 : 2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR- DEPENDENT PATIENTS
05/30134824 DC : 0 EN 50447 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR HEART-LUNG MACHINES (HLM)
03/103293 DC : DRAFT JAN 2003 BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
CSA Z32 : 2015 ELECTRICAL SAFETY AND ESSENTIAL ELECTRICAL SYSTEMS IN HEALTH CARE FACILITIES
CSA Z10651.2: 2006 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
AAMI TIR32 :2004 MEDICAL DEVICE SOFTWARE RISK MANAGEMENT
CSA C22.2 No. 60601.1.4 : 2002 MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
AAMI ISO 14971 : 2007 : R2010 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN 60601-2-44:2009/A2:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009/A2:2016)
BS EN 60601-1 : 2006 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
BS EN ISO 10651-6:2009 Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home-care ventilatory support devices
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
BS EN ISO 10651-2:2004 Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home care ventilators for ventilator-dependent patients
ISO 10651-6:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
EN ISO 10651-2:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)
EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
I.S. EN ISO 10651-2:2009 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
00/560888 DC : APR 2000 IEC 60601-1-2 EDITION 2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS
CSA ISO 14971 : 2007 : R2017 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA ISO 14971 : 2007 : R2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
CSA Z10651.2 : 2006 : R2015 LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
I.S. EN 60601-2-44:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
ANSI/AAMI/IEC 60601-1-8:2006/A2:2021 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
CSA CEI/IEC 1258 : 1998 GUIDELINES FOR THE DEVELOPMENT AND USE OF MEDICAL ELECTRICAL EQUIPMENT EDUCATIONAL MATERIALS
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
CSA C22.2 No. 60601.1.8 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
CSA C22.2 No. 60601.1.8 : 2008 : R2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
CAN/CSA-C22.2 NO. 60601-1-8:08 (R2018) Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted IEC 60601-1-8:2006, second edition, 2006-10) | Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d\'alarme des appareils et des systèmes électromédicaux (norme IEC 60601-1-8:2006 adoptée, deuxième édition, 2006-10)

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