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CAN/CSA-C22.2 NO. 60601-1-8:08 (R2018)

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The latest, up-to-date edition.

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)
Available format(s)

PDF

Language(s)

English - French

Published date

01-01-2008

FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT identification marking and documents
6 ALARM SYSTEMS
Annex A (informative) - General guidance and rationale
Annex B (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME SYSTEMS
Annex C (normative) - Symbols on marking
ANNEX D (informative) - Guidance for auditory ALARM SIGNALS
ANNEX E (informative) - Verbal ALARM SIGNALS
ANNEX F (normative) - Reserved melodies for ALARM SIGNALS
Bibliography
Index of defined terms used in this collateral standard

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.

C SA Preface This is the second edition of CAN/CSA-C22.2 No. 60601-1-8, 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, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-8 (second edition, 2006-10). It supersedes the previous edition published in 2005 as CAN/CSA-C22.2 No. 60601-1-8, Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (adopted IEC 60601-1-8:2005). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code. Scope This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS. It also provides guidance for the application of ALARM SYSTEMS. -------------------------------------------------------------------------------------------------------------------------------- Préface CSA Ce document constitue la deuxième édition de la CAN/CSA-C22.2 nº 60601-1-8, 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. Il s\'agit de l\'adoption, sans modifications, de la norme CEI (Commission Électrotechnique Internationale) 60601-1-8 (deuxième édition, 2006-10), qui porte le même titre. Cette norme remplace l\'édition précédente publiée en 2005 et intitulée CAN/CSA-C22.2 nº 60601-1-8, Appareils électromédicaux - Partie 1-8 : Règles générales de sécurité - Norme collatérale : Règles générales, essais et recommendations pour les systèmes d\'alarme des appareils et des systèmes électromédicaux (norme CEI 60601-1-8:2005 adoptée). Cette norme fait partie d\'une série de normes publiées par CSA lesquelles constituent le Code canadien de l\'électricité, Deuxième partie. Domaine d\'application La présente Norme internationale s\'applique à la SÉCURITÉ DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS ÉLECTROMÉDICAUX et des SYSTÈMES ÉLECTROMÉDICAUX, désignés ci-après sous le terme APPAREILS EM et SYSTÈMES EM. La présente norme collatérale spécifie les exigences applicables aux SYSTÈMES D\'ALARME et aux SIGNAUX D\'ALARME des APPAREILS ET DES SYSTÈMES EM. Elle donne également des lignes directrices pour l\'application des SYSTÈMES D\'ALARME.

DevelopmentNote
Supersedes CSA ISO 9703-1 & CSA ISO 9703-2. (02/2008) Amendment 1 is available separately, see CSA C22.2.60601.1.8A. (01/2015)
DocumentType
Standard
Pages
0
ProductNote
Reconfirmed EN This standard refers to :CEI 60417,CEI 60601-1:2005,CEI 61672-1:2002,CEI 62366:2007.
PublisherName
Canadian Standards Association
Status
Current
SupersededBy
Supersedes

Standards Relationship
IEC 60601-1-8:2006+AMD1:2012 CSV Identical

AAMI HE48 : 1993 HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES
ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
AAMI EC57 : 2012 TESTING AND REPORTING PERFORMANCE RESULTS OF CARDIAC RHYTHM AND ST SEGMENT MEASUREMENT ALGORITHMS
IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 11429:1996 Ergonomics System of auditory and visual danger and information signals
ISO 11428:1996 Ergonomics Visual danger signals General requirements, design and testing
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals

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