1Key Takeaways
This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies.
This part of ISO 10993 is not applicable to:
a) viable-tissue engineered products;
b) methodologies for the g…
2Scope / Description
This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies.
This part of ISO 10993 is not applicable to:
a) viable-tissue engineered products;
b) methodologies for the generation of degradation products by mechanical processes. Methodologies for the production of this type of degradation product are described in specific product standards, where available;
c) leachable components which are not degradation products.
Where product standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards shall be considered as alternatives.
5Citation Network
Standards that cite ISO 10993-9:1999
Referenced by ISO 10993-9:1999
ISO 10993-1:1997
ISO 10993-2:1992
6Frequently Asked Questions
What is ISO 10993-9:1999?
ISO 10993-9:1999 — Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products is an international standard developed by International Organization for Standardization (ISO). This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. This part of ISO 10993 is not applicable...
What does ISO 10993-9:1999 cover?
This standard covers: This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. This part of ISO 10993 is not applicable to: a) viable-tissue engineered products; b)...
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 10993-9:1999?
The current published version is ISO 10993-9:1999, published on 1999-03. Always check for amendments or pending revisions.
How do I purchase ISO 10993-9:1999?
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