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BSI - 22/30419490 DC

Draft BS EN ISO 22523 External limb prostheses and external orthoses - Requirements and test methods

pending
Organization: BSI
Publication Date: 3 May 2022
Status: pending
Page Count: 79
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

22/30419490 DC
May 3, 2022
Draft BS EN ISO 22523 External limb prostheses and external orthoses - Requirements and test methods
A description is not available for this item.
BS EN ISO 22523
October 31, 2006
External limb prostheses and external orthoses - Requirements and test methods
A description is not available for this item.

References

This document references:
IEC 60601-1-2 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
Published by IEC on September 1, 2020
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 document references:
IEC 60601-1-6 - Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
Published by IEC on July 1, 2020
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL...
This document references:
IEC 62304 - Medical device software – Software life cycle processes
Published by IEC on June 1, 2015
Purpose This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for...
This document references:
IEC 62366-1 - Medical devices – Part 1: Application of usability engineering to medical devices
Published by IEC on June 1, 2020
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN...
This document references:
IEC 80601-2-35 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use
Published by IEC on April 1, 2016
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT....
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