1Key Takeaways
Specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by materials used in medical devices whose clinical accep…
2Scope / Description
Specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by materials used in medical devices whose clinical acceptability has been established. The test methods for local effects after implantation are used to assess subchronic effects (short-term, up to 12 weeks), or chronic effects (long-term, longer than 12 weeks).
5Citation Network
Standards that cite ISO 10993-6:1994
6Frequently Asked Questions
What is ISO 10993-6:1994?
ISO 10993-6:1994 — Biological evaluation of medical devices - Part 6: Tests for local effects after implantation is an international standard developed by International Organization for Standardization (ISO). Specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level. The local effects are evaluated by a comparison of the tissue response caused by a test specimen...
What does ISO 10993-6:1994 cover?
This standard covers: Specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by materials used in medical devices...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of ISO 10993-6:1994?
The current published version is ISO 10993-6:1994, published on 1994-07. Always check for amendments or pending revisions.
How do I purchase ISO 10993-6:1994?
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