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YY/T 0343-2002

Chinese Standard: 'YY/T 0343-2002'
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Detail Information of YY/T 0343-2002; YY/T0343-2002; YYT 0343-2002; YYT0343-2002
Description (Translated English): Liquid penetrant inspection of metallic surgical implants
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.40
Word Count Estimation: 12,000
Date of Issue: 2002-09-24
Date of Implementation: 2003-04-01
Adopted Standard: ISO 9583-1993, NEQ; ASTM F601-1992, IDT
Drafting Organization: State Drug Administration of Tianjin Medical Device Quality Supervision and Inspection Center
Administrative Organization: National standardization technical committee of Surgical characters and orthopedic implant device
Proposing organization: State Drug Administration
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the surgical metal implants liquid penetrant inspection methods, inspection level, acceptable limits, inspection records, porous material control, penetrant inspection personnel qualification examination. This standard applies to inspect the surface of the metal implant surgery discontinuities or defects.

YY/T 0343-2002
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 30
Liquid penetrant inspection of
metallic surgical implants
(ISO 9583.1993, NEQ)
外科金属植入物液体渗透检验
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.
3.1.1 Surface pre-cleaning1
1) choose suitable cleaning material and process to remove the grease on
the specimen surface;
1 6.2 in ISO 3452.
sensitivity, high sensitivity and super sensitivity. The sensitivity level is agreed
by the manufacturer and the buyer of penetrant material via negotiation.
3.3.2 Applicability6
The penetrant material used shall be applicable to the material of test specimen.
It shall consider the effect of long corrosion.
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.
a) determined inspection method and operation procedure;
b) inspection data;
c) determined personal qualification and signature;
d) penetration techniques, ambient temperature, used penetrant material
as well as manufacturer;
e) suitable used sketch or description to determine all displayed locations
and influential factors;
6 6.1.1 in ISO 3452.
7 11.1 in ISO 3452.
8 13 in ISO 3452.
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).
Table A.1 Limit levels of size, space and amount of recommended
single or group surface discontinuous defects
Defect type Maximum length mm
Minimum space
mm
Maximum defect amount of each 25 mm ×
25 mm of inspection area
A B C D E
Single defect
(pore inclusion)
0.25 ~ 0.5 1 0 2 3 4 6
> 0.5 ~ 1 2 0 1 2 3 4
> 1 ~ 1.5 3 0 0 1 2 3
> 1.5 ~ 2 4 0 0 0 1 2
> 2 ~ 3 6 0 0 0 0 1
Maximum defect amount of each area
Group defect
(loosening)
≥ 2 3 0 0 2 3 6
> 2 ~ 4 6 0 0 1 2 3
> 4 ~ 6 10 0 0 0 1 2
1) Linear defect size (length . width > 3.1) is not acceptable.
2) Size < 0.25 mm can be neglected.
3) In the inspection area, if there is no big defect, the sum of small defect size shall be accessed
according to the maximum amount of acceptable limit level. There are several defects in the
inspection area can be used for mechanical cutting. The size and space of defects cannot be
limited because they can be dealt with by the later mechanical cutting.
4) Indicate any surface area of 25 mm × 25 mm.
5) According to the size and depth of discontinuous defect, access the surface discontinuous
defect. It shall use the cleaning method for volatile solvent for clear recognizable defect size.
6) Group-shaped defect, i.e., single defect space is less than twice the maximum length of the
maximum defect; group defect size includes the sum of all single defect size.
Annex B 
(Normative) 
Penetrant inspection procedure 
B.1 Inspection procedure
B.1.1 Penetration
B.1.1.1 Applied temperature
The temperature of test specimen surface and penetrant material must be
within the range provided by the instruction on use of penetrant material
manufacturer.
B.1.1.2 Penetrant application
The inspection surface shall be totally wetted and covered by penetrant. The
penetrant can be applied by dipping, spraying (electrostatic spraying) and
brushing.
B.1.1.3 Penetration time
Penetration time shall be in accordance with penetrant’s characteristics,
temperature for use, material for inspection and defect type. The penetrant must
not be dried within the penetration time. In the penetration time, the complete
wetting time for test specimen surface shall not be less than the time
recommended by manufacturer. Longer penetration time shall display more
obvious discontinuous defect.
B.1.2 Application of emulsifier
B.1.2.1 According to the penetra......
Related standard:   YY/T 0340-2009  YY/T 0342-2002
   
 
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