YY/T 0343-2002 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 0343-2002 | English | 105 |
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Liquid penetrant inspection of metallic surgical implants
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YY/T 0343-2002: Liquid penetrant inspection of metallic surgical implants---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0343-2002
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.40
C 30
Liquid penetrant inspection of
metallic surgical implants
(ISO 9583.1993, NEQ)
Issued on. SEPTEMBER 24, 2002
Implemented on. APRIL 1, 2003
Issued by. China Drug Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Inspection methods... 4
4 Inspection level... 6
5 Acceptable limit... 6
6 Inspection record... 6
7 Control of penetrant material... 7
8 Personnel qualification of penetrant inspection... 8
Annex A (Normative) Liquid penetrant inspection of metallic surgical implants -
Acceptable limit level of surface Discontinuous defects... 9
Annex B (Normative) Penetrant inspection procedure... 11
Foreword
This Standard non-equivalently uses the international standard ISO 9583.1993
Implants for surgery - Non-destructive testing - Liquid penetrant inspection of
metallic surgical implants (English version).
This Standard lists the content of ISO 3452.1984 Non-destructive testing -
Penetrant inspection - General principles which is in normative references of
the international standard; see adoption explanation.
Due to the use of porous material made in China, therefore, control of the
infiltration material in Clause 7 (except 7.4) quotes the corresponding provisions
of HB/Z 61-1998 Penetrant Inspection, an aviation standard of People's
Republic of China Ministry.
7.4 of this Standard identically uses 5.1.4 of ASTM F601-1992 Standard
Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants.
Annex A, Annex B of this Standard are normative.
Annex A provides the acceptable threshold level of discontinuities on the
surface of surgical metal implants.
Annex B provides penetration testing procedures.
This Standard was proposed by and approved by China Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee
on Surgical implants and Orthopedic Instruments of Standardization
Administration of China (CSBTS/TC 110).
The drafting organization of this Standard. Tianjin Medical Device Quality
Supervision and Inspection Center of China Drug Administration.
Main drafters of this Standard. Zhang Wenhui, Song Duo, Xing Jiaqiang.
Liquid penetrant inspection of
metallic surgical implants
1 Scope
This Standard specifies the inspection methods, inspection level, acceptable
limits, inspection records, penetrant material control, qualification examination
of penetrant inspection personnel of liquid penetrant inspection of metallic
surgical implants.
This Standard is applicable to inspect the discontinuities or defects on the
surface of metallic surgical implants.
NOTE See GB/T 12604.3-1990 Terminology for nondestructive testing - Penetrant testing
for terminology for nondestructive testing involved in this Standard.
2 Normative references
The following standards contain the provisions which, through reference in this
Standard, constitute the provisions of this Standard. At the time of publication
of this Standard, all editions indicated are effective. All standards shall be
revised; the parties who enter into agreement based on this Standard are
encouraged to investigate whether the latest versions of these documents are
applicable.
HB/Z 61-1998 Penetrant Inspection
3 Inspection methods
3.1 Inspection conditions
The surface of test specimen shall be clean without any substance to impede
liquid penetrant inspection or generate false penetrant indication.
3.1.2 Degreasing2
Before the specimen is added with penetrant, it shall degrease the surface of
test specimen. Choose suitable degreasing solvent.
3.1.3 Subsequent inspection3
If there are different penetrants used for subsequent inspection, it shall re-clean
the test specimen so as to completely remove the corrosion products in any
discontinuities and previously used penetrant residues. The chemical reaction
between residual dye-penetrant and fluorescent penetrant shall result in
complete or partial quenching of fluorescence.
3.2 Procedure
3.2.1 Penetrant inspection system classification4
3.2.2 Inspection procedures5
See Annex B of this Standard.
3.3 Penetrant materials
3.3.3 Cleaning after inspection7
After inspection, remove penetrant and developer. The residual of inspection
material shall make specimen react with other factor to generate corrosive
effect during use. In order not to interfere with subsequent processes or use
requirements, in-time cleaning must be conducted after inspection.
4 Inspection level
Unless there are special requirements from the manufacturer or buyer of
metallic surgical implants, 100% inspection shall be carried out for each batch
of products.
5 Acceptable limit
The reference for product being accepted or rejected shall be specified in the
given norm. See Annex A of this Standard for recommended acceptable limit.
6 Inspection record8
The inspection results shall be recorded so as to trace the metallic surgical
implants for the inspection.
7 Control of penetrant material
It shall carry out the following tests to evaluate the effectiveness of penetrant
material.
7.1 Penetrant
The gravity detection cycle and maintenance cycle shall be in accordance with
the requirements of manufacturer’s instructions on use. The fluorescence
intensity shall be inspected according to 5.10.5.1 of HB/Z 61-1998.
7.2 Emulsifier
7.2.1 Water content
The water content of oil-based emulsifier must not exceed 10%. Inspection
cycle. 30 days for open container; 3 months for closed container. Inspect
according to 5.10.5.2 of HB/Z 61-1998.
7.3 Photographic developer
Dry powdered photographic developer shall be dry, loose and non-caking.
Caked photographic developer must not be used.
7.4 Black light9
Black light is used for fluorescent penetrant inspection. It shall inspect the
output power of black light. Black light irradiance at the place 380 mm from
black light filter surface shall not be less than 800 µW/cm2.The measurement
is in the calibrated black light irradiance. The inspection cycle is one week.
9 5.1.4 in ASTM F601-1992.
8 Personnel qualification of penetrant inspection
The personnel for penetrant inspection shall be qualified and certified, with
professional and technical qualifications, who is engaged in the job which suits
his qualification.
Annex A
(Normative)
Liquid penetrant inspection of metallic surgical implants ‐
Acceptable limit level of surface Discontinuous defects
A.1 Recommended acceptable limit level
The acceptable and rejection limit level of manufacturer or buyer is related to
the shape, size and space of discontinuous defects in the inspection area.
The manufacturer and buyer shall indicate different inspection areas for metallic
surgical implants (see A.2).
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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