SS-EN-ISO-16061 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)

SS-EN-ISO-16061 - 2015 EDITION - CURRENT
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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.

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

11.040.99 (Other medical equipment)


Medical devices

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Designation Name

SS-EN ISO 16061:2015

Revision Level

2015 EDITION

Status

Current

Publication Date

May 25, 2015

Language(s)

English

Page Count

36

International Equivalent

EN ISO 16061:2015(IDT); ISO 16061:2015(IDT)