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BSI - BS EN 45502-1 - TC

Tracked Changes (Redline) - Implants for surgery - Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

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Organization: BSI
Publication Date: 25 February 2020
Status: active
Page Count: 145
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

BS EN 45502-1 - TC
February 25, 2020
Tracked Changes (Redline) - Implants for surgery - Active implantable medical devices Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
A description is not available for this item.

References

This document references:
AAMI TIR42 - Evaluation of particulate associated with vascular medical devices
Published by AAMI on January 1, 2021
General This document addresses particulate released from intravascular medical devices that have direct contact with circulating blood. It is intended to assist intravascular medical device...
This document references:
EN ISO 11137-1 - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Published by CEN on June 1, 2015
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO...
This document references:
EN 60601-1 - Medical electrical equipment Part 1: General requirements for basic safety and essential performance
Published by CENELEC on October 1, 2006
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:
EN ISO 14155 - Clinical investigation of medical devices for human subjects - Good clinical practice
Published by CEN on August 1, 2020
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or...
This document references:
EN 62304 - Medical device software - Software life-cycle processes
Published by CENELEC on July 1, 2006
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:
EN 62304 - Medical device software - Software life-cycle processes
Published by CENELEC on July 1, 2006
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...
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