Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

Replaced Cited by 29

3Version History

ISO 10993-9:1999 older 1999-03

ISO 10993-9:2009 2009-12

ISO 10993-9:2019 newer 2019-11-26

4Standard Metadata

Standard Number: ISO 10993-9:2009
Status: Replaced
Publisher: International Organization for Standardization (ISO)
Publication Date: 2009-12
Adopted Standard: DIN EN ISO 10993-9-2010,IDT;ANSI/AAMI/ISO 10993-9-2009,IDT;BS EN ISO 10993-9-2010,IDT;EN ISO 10993-9-2009,IDT;NF S99-501-9-2010,IDT;SN EN ISO 10993-9-2010,IDT;OENORM EN ISO 10993-9-2010,IDT;OENORM EN ISO 10993-9-2009,IDT;PN-EN ISO 10993-9-2010,IDT;UNE-EN

5Citation Network

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Referenced herein

Standards that cite ISO 10993-9:2009

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials Ophthalmic implants - Ophthalmic viscosurgical devices Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015); German version EN ISO 22442-1:2015 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

Referenced by ISO 10993-9:2009

ISO 10993-13:1998 ISO 10993-14:2001 ISO 10993-15:2000 ISO 10993-1:2009 ISO 10993-2:2006

6Frequently Asked Questions

What is ISO 10993-9:2009?

ISO 10993-9:2009 — 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).

What does ISO 10993-9:2009 cover?

This standard covers:

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 10993-9:2009?

The current published version is ISO 10993-9:2009, published on 2009-12. Always check for amendments or pending revisions.

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