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

Standard No.

ISO 16061:2015

Release Date

2015

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 16061:2021

Latest

ISO 16061:2021

ISO 16061:2015 Referenced Document

• EN 2127:1992 Aluminium Alloy AL-P7075-T73511 Extruded Bars and Sections a or D Less Than or Equal to 100 mm
• EN 2128:1992 Aluminium Alloy AL-P7075-T7351 Drawn Bars 6 mm Less Than or Equal to a or D Less Than or Equal to 75 mm
• EN 2318:1992 Aluminium Alloy AL-P2024-T3511 Extruded Bars and Sections 1,2 mm Less Than or Equal to a or D Less Than or Equal to 150 mm
• EN 2326:1992 Aluminium Alloy AL-P6082-T6 Extruded Bars and Sections a or D Less Than or Equal to 200 mm
• EN 2384:1992 Aluminium Alloy AL-P2014A T6511 Extruded Bars and Sections a or D Less Than or Equal to 150 mm
• IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
• IEC 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
• ISO 4957:1999 Tool steels
• ISO 5832 Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel*， 2019-02-08 Update
• ISO 5832-1:2007 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
• ISO 5832-2:1999 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
• ISO 5832-3:1996 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
• ISO 5832-4:2014 Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy
• ISO 5832-5:2005 Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
• ISO 5832-6:1997 Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
• ISO 5832-7:1994 Implants for surgery; metallic materials; part 7: forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
• ISO 5832-8:1997 Implants for surgery - Metallic materials - Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy

ISO 16061:2015 history

• 2021 ISO 16061:2021 Instruments for use in association with non-active surgical implants - General requirements
• 2015 ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements
• 2008 ISO 16061:2008 Instrumentation for use in association with non-active surgical implants - General requirements
• 2000 ISO 16061:2000 Instrumentation for use in association with non-active surgical implants - General requirements