Biological evaluation of medical devices. Part 9, Framework for identification and quantification of potential degradation products / International Organization for Standardization.

Format:

• Book

Series:

• International standard ; ISO 10993-9.
• International standard ; ISO 10993-9

Language:

English

Subjects (All):

• Medical instruments and apparatus--Testing--Standards.
• Materials--Biodegradation--Testing--Standards.
• Biomedical materials--Biodegradation--Testing--Standards.
• Biomedical materials--Biodegradation.
• Testing.
• Materials--Biodegradation.
• Medical instruments and apparatus--Testing.

Physical Description:

vi, 9 pages ; 30 cm.

Edition:

Second edition.

Other Title:

Framework for identification and quantification of potential degradation products

Place of Publication:

Geneva : International Organization for Standardization, [2009]

Summary:

!SO 10993-9:2009 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. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. ISO 10993-9:2009 considers both non-resorbable and resorbable materials.

Notes:

• Cover title.
• "2009-12-15; reference number ISO 10993-0:2009(E)."
• Includes bibliographical references (page 9).

OCLC:

644433181