ISO 16061:2008
Withdrawn
View Superseded by
Instrumentation for use in association with non-active surgical implants — General requirements
Hardcopy , PDF
English, French
11-25-2008
04-09-2025
ISO 16061:2008 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.
ISO 16061:2008 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, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.
| Committee |
ISO/TC 150
|
| DocumentType |
Standard
|
| Pages |
19
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| BS EN ISO 16061:2008 | Equivalent |
| I.S. EN ISO 16061:2008 | Equivalent |
| UNE-EN ISO 16061:2010 | Identical |
| BS EN ISO 16061:2009 | Identical |
| BS EN ISO 16061:2008 | Identical |
| UNE-EN ISO 16061:2009 | Identical |
A newer version of this standard is available.
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