ISO 9583:1993 pdf download – Implants for surgery一Non-destructive testing一Liquid penetrant inspection of metallic surgical implants.
This International Standard establishes a method for detecting and evaluating impertections revealed by liquid penetrant on the surfaces of metallic surgical implants.
Guidance on the acceptance limits ftor imperfections on metalic surgical implants in the raw and finally treated and finished conditions is given in annex A.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties agreements based on this International Standard are encouraged to investigate the possbility of applying the most re
cent editions of the standards indicated below.
Members of IEC and ISO maintain registers of currently valid International Standards.
ISO 3059:1974,Non-destructive testing 一Method for indirect assessment of black light sources.
ISO 3452:1984. Non-destructive testing 一Penetrant inspection一General principles.
ISO 3453:1984,Non-destructive testing 一Liquid penetrant inspection一Means of venification.
ASTM D 95:1983. Test method for Water in Petroleum Products and Bituminous Materials by Disti-
ASNT-SNT-TC-1A” Personnel qualification and certfication in non-destructive testing.
3 Inspection method
3.1 Inspection condition
The surfaces shall be cleaned in accordance with ISO 3452:1984, subclauses 6.2. 6.3 and 10.2 so that they are free of any material which would interfere with the penetration of the inspection fluid or would in itself retain the penetrant and result ifl false iridi cations.
3.2 Procedure
the liquid panetrant inspection of metMlic surgical implants shall be performed in accordance with ISO 3452 using the penetrarrt systems classified therein.
3.3 Penetrant materials
3.3.1 S.nsltlvity
According to type, strec category. malenal and rnanufactunng stage of the irnp4drlt, IJenetidni ITld terial systems of normal. high o very high 5ensitrity shall be used. The sensitivity level shell be established by the manufacturer or pucheser
3,3.2 Compatibility
In accordance with ISO 3452:1984. clause 6. all peneirant materials shall be compatible with each other
4 Inspection level
Unless otherwise requested by the manufacturer or purchasar of tha implant, the inspection shail be 100% of the lot.