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BSI - BS EN ISO 16061 - TC

Tracked Changes (Redline) - Instrumentation for use in association with non-active surgical implants - General requirements

active, Most Current
Organization: BSI
Publication Date: 25 February 2020
Status: active
Page Count: 66
ICS Code (Other medical equipment): 11.040.99
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

This International Standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.

This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.

With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer.

This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.

Document History

BS EN ISO 16061 - TC
February 25, 2020
Tracked Changes (Redline) - Instrumentation for use in association with non-active surgical implants - General requirements
This International Standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are...

References

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