UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

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

active, Most Current
Buy Now
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

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...
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...
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...
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...
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...

References

Advertisement