CSA C22.2 NO 60601-1-6
Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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| Organization: | CSA |
| Publication Date: | 1 January 2015 |
| Status: | active |
| Page Count: | 17 |
| ICS Code (Medical equipment): | 11.040 |
scope:
INTRODUCTION
Amendment 1 removes the reference to the complete life-cycle process (including postproduction monitoring and surveillance). IEC 60601 (the series) is confined to performing a TYPE TEST of ME EQUIPMENT. It does not extend to the entire life cycle including postproduction monitoring and periodic maintenance of the USABILITY ENGINEERING PROCESS.
Document History
January 1, 2022
Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability
This Standard applies to ME EQUIPMENT and ME SYSTEMS that are intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.
January 1, 2021
Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability
This Standard applies to ME EQUIPMENT and ME SYSTEMS that are intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.
CSA C22.2 NO 60601-1-6
January 1, 2015
Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
INTRODUCTION
Amendment 1 removes the reference to the complete life-cycle process (including postproduction monitoring and surveillance). IEC 60601 (the series) is confined to performing a TYPE TEST...
January 1, 2015
Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability
A description is not available for this item.
January 1, 2015
Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
FOREWORD
This amendment has been prepared by subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical...
December 1, 2011
Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL...
January 1, 2011
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL...
January 1, 2011
Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral standard: Usability
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL...
December 1, 2008
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
This Collateral Standard specifies requirements for a PROCESS to analyse, design, verify and validate the USABILITY, as it relates to SAFETY of MEDICAL ELECTRICAL EQUIPMENT, hereinafter referred to...
November 1, 2005
Medical electrical equipment - Part 1-6: General requirements for safety - Collateral Standard: Usability
This Collateral Standard specifies requirements for a PROCESS to analyse, design, verify and validate the USABILITY, as it relates to SAFETY of MEDICAL ELECTRICAL EQUIPMENT, hereinafter referred to...