ISO 10993-10:2002
2002-09
Abstract
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity.
This part of ISO 10993 includes pretest considerations, details of the test procedures, and key factors for the interpretation of the results.
Guidance is given in annex A for the preparation of materials specifically in relation to the above tests.
Guidance on the conduct of supplementary tests which are required specifically for devices used intradermally and in the ocular area is given in annex B.
Guidance on the conduct of supplementary tests which may be required for devices used for oral, rectal, penile and vaginal areas is given in annex C.
General information
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Status: WithdrawnPublication date: 2002-09Stage: Withdrawal of International Standard [95.99]
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Edition: 2Number of pages: 49
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Technical Committee :ISO/TC 194ICS :11.100.20
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Life cycle
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Previously
WithdrawnISO 10993-10:1995
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Now
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00
Preliminary
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10
Proposal
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20
Preparatory
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30
Committee
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40
Enquiry
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50
Approval
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60
Publication
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90
Review
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95
Withdrawal
Amendments
Provide additional content; available for purchase; not included in the text of the existing standard.WithdrawnISO 10993-10:2002/Amd 1:2006
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00
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Revised by
WithdrawnISO 10993-10:2010