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BSI - BS ISO 19227

Implants for surgery — Cleanliness of orthopedic implants — General requirements

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Organization: BSI
Publication Date: 30 April 2018
Status: active
Page Count: 26
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

BS ISO 19227
April 30, 2018
Implants for surgery — Cleanliness of orthopedic implants — General requirements
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:
AAMI ST72 - Bacterial endotoxins— Test methods, routine monitoring, and alternatives to batch testing
Published by AAMI on January 1, 2019
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials employing bacterial endotoxins test (BET)...
This document references:
F3127 - Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
October 1, 2022
This guide provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly prior to initial use. Validated cleaning processes are important for...
This document references:
AAMI ST72 - Bacterial endotoxins— Test methods, routine monitoring, and alternatives to batch testing
Published by AAMI on January 1, 2019
This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials employing bacterial endotoxins test (BET)...
This document references:
F3127 - Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
October 1, 2022
This guide provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly prior to initial use. Validated cleaning processes are important for...
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