ISO 9583:1993 download.Implants for surgery — Non-destructive testing — Liquid penetrant inspection of metallic surgical implants.
ISO 9583 establishes a method for detecting and evaluating imperfections revealed by liquid penetrant on the surfaces of metallic surgical implants.
Guidance on the acceptance limits for imperfections on metallic 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 ISO 9583. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on ISO 9583 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below Members of IEC and ISO maintain registers of curwntly valid International Standards.
ISO 3059:1974, Non-destructive testing — Method for indirect ascis.cment of hiack light sources.
ISO 3452:1984, Non-destructive testing — Penetrant inspection — General principles.
ISO 3453:1984, Non-destructive resting — Liquid penetrant inspection — Means of verification.
ASTM D 95:1983, Test method for Water in Petroleum Products and Bituminous Materials by Distil/a non.
ASNT-SNT-TC-1 A,1’ Personnel qualification and certification in non-dti.ctructive 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 in false mdi catio ns.
3.2 Procedure
The liquid penetrant inspection of metallic surgical implants shall be performed in accordance with ISO 3452 using the penetrant systems classified therein.
3.3 Penetrant materials
3.3.1 Sensitivity
According to type, stress category, material and manufacturing stage of the implant, piietrant material systems of normal, high or very high sensitivity shall bo ucd. The sensitivity level shall be established by the manufacturer or purchaser
3.3.2 Compatibility
In accordance with ISO 3452:1984, clause 6, all penetrant materials shall be compatible with each other.
4 Inspection level
Unless otherwise requested by the manufacturer or purchaser of the implant, the inspection shall be 100 % of the lot.
5 Acceptance limits
The product acceptance and rejection cr’teria shall be established by written specifications. Recommended acceptance limits are given in annex A.
6 Inspection documentation
Ihe inspection results shall be documented so that they are traceable to the examined implants.
7 Penetrant materials control
NOTE 1 The efficiency of penetrant materials deteriorates due to contamination and agcing.
The following tests shall be conducted to evaluate usefulness of the materials.
7.1 Penetrants
The density, visible dye intensity and fluorescent dye intensity shall be checked in ac-cnrdance with
ISO 3453.
7.2 Emulsifiers
7.2.1 Water content
The water content of oil-base emulsitiers shall be determined by ASTM D 95 and shall not exceed 10 %. The frequency of testing shall be 30 days for open containers and 3 months for closed containers.
7.2.2 Penetrant contamination
The contamination of the emulsifier (oil-base and water-base) by the penetrant shall not exceed 10 %. The concentration of the penetrant shall be checked by a refractometer. For each emulsifier and/or emulsifier concentration used, a calibration for determining the refractometer correction shall bc con(lucted
The frequency of testing shall be weekly or before use. whichever of the two alternatives is the more frequent.
7.3 Developer
Dry and liquid developers shall be checked in accordance with ISO 3453.
7.4 Ultraviolet radiation lamp
Ultraviolet radiation lamps used for fluorescent penetrant inspection shall be checked for ultraviolet radiation output in accordance with ISO 3059. The frequency of testing shall he weekly
8 Personnel certification
The personnel performing liquid penetrant inspection in accordance with ISO 9583 Shall be certified to level 2 as specified in ASNT-SNT-TC-1 A or recognized national equivalents, and shall be specifically trained for the product range of medical implants.