ASTM F601-98

Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

SCOPE
1.1 This practice is intended as a guide for fluorescent penetrant inspection of metallic surgical implants.  
1.2 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 09-Oct-1998
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.12 - Metallurgical Materials

Relations

• Replaced By: ASTM F601-03 - Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
• Effective Date: 10-Sep-2003

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn. Contact
ASTM International (www.astm.org) for the latest information.
Designation: F 601 – 98
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Practice for
Fluorescent Penetrant Inspection of Metallic Surgical
1
Implants
This standard is issued under the fixed designation F 601; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 4.2 The penetrant system used shall conform to a minimum
of Sensitivity Level 3, in accordance with the latest revision of
1.1 This practice is intended as a guide for fluorescent
MIL-I-25135.
penetrant inspection of metallic surgical implants.
4.3 All penetrant materials shall be compatible with each
1.2 This standard does not purport to address all of the
other.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
5. Penetrant Method Materials Control
priate safety and health practices and determine the applica-
5.1 The penetrant method materials deteriorate in usefulness
bility of regulatory limitations prior to use.
through contamination and age. The following controls should
2. Referenced Documents be used to evaluate the materials’ usefulness unless the
supplier’s requirements are more stringent:
2.1 ASTM Standards:
5.1.1 Penetrants:
D 95 Test Method for Water in Petroleum Products and
2 5.1.1.1 Water Content—Where there is a possibility of
Bituminous Materials by Distillation
3
water contamination to penetrant materials, the water content
E 165 Test Method for Liquid Penetrant Examination
should be determined by Test Method D 95. The water content
E 433 Reference Photographs for Liquid Penetrant Inspec-
3
shall not exceed 10 %. The frequency of testing shall be at least
tion
4 once every 30 days for open containers.
2.2 ASNT Recommended Practice:
5.1.1.2 Fluorescent Brightness—Fluorescent brightness
Recommended Practice No. SNT-TC-1A
5
should be determined at least once every 30 days or before use
2.3 Military Standard:
by comparison of samples of the working penetrant to a sample
MIL-I-25135 Inspection Material, Penetrant
of new penetrant under black light. No visible difference shall
3. Significance and Use
be allowed.
5.1.2 Developer:
3.1 This practice is intended to confirm the method of
5.1.2.1 Dry—The developer should be dry and fluffy. De-
obtaining and evaluating the fluorescent penetrant indications
velopers showing evidence of fluorescence when compared to
on metallic surgical implants.
new developer shall not be used.
3.2 The product acceptance and rejection criteria will be as
5.1.2.2 Wet—A method should be employed to assure ad-
agreed upon between the purchaser and the supplier.
equate suspension of the wet developer prior to use. The
4. Fluorescent Penetrant Method
specific gravity of the developer should be from 1.018 to 1.034.
This method does not apply to nonaqueous solvent developer
4.1 Perform fluorescent penetrant inspection of metallic
due to the volatile nature of the product.
surgical implants in accordance with Practice E 165, Method
5.1.3 Black Lights—Black lights used for fluorescent pen-
A.
etrant inspection should be checked for black light output (with
2
a filter) for a minimum of 800 μW/cm at a distance of 381 mm
1
(15 in.) from the lamp face. This measurement could be
This practice is under the jurisdiction of ASTM Committee F-4 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee determined by using a calibrated black light meter. The
F04.12 on Metallurgical Materials.
Current edition approved October 10, 1998. Published March 1999. Originally
published as F 601 – 78. Last previous edition F 601 – 92.
2
Annual Book of ASTM Standards, Vol 05.01.
3
Annual Book of ASTM Standards, Vol 03.03.
4
Available from American Society for Non-Destructive Testing, 3200 Riverside
Dr., Columbus, OH 43221.
5
Available form Standardization Documents Order Desk, Bldg. 4 Section D, 700
Robbins Ave., Philadelphia, PA 19111–5094, Attn: NPODS.
1

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NOTICE:¬This¬standard¬has¬either¬been¬superceded¬and¬replaced¬by¬a¬new¬version¬or¬discontinued.¬
Contact¬ASTM¬International¬(www.astm.org)¬for¬the¬latest¬information.¬
F 601
frequency of testing shall be at least once every 7 days or tion under this practice shall be certified in accordance with
before use. ASNT Recommended Practice No. SNT-TC-1A or recognized
national equivalent.
6. Evaluation
6.1 A general method of evaluating fluorescent penetrant
8. Keywords
indications is encompassed in reference photo
...