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YY/T 0343-2002

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YY/T 0343-2002 英文版 380 购买 现货,9秒内自动发货PDF,有增值税发票。 外科金属植入物液体渗透检验 有效

   
标准编号: YY/T 0343-2002 (YY/T0343-2002)
中文名称: 外科金属植入物液体渗透检验
英文名称: Liquid penetrant inspection of metallic surgical implants
行业: 医药行业标准 (推荐)
中标分类: C30
国际标准分类: 11.040.40
字数估计: 9,961
发布日期: 2002-09-24
实施日期: 2003-04-01
采用标准: ISO 9583-1993, NEQ; ASTM F601-1992, IDT
起草单位: 国家药品监督管理局天津医疗器械质量监督检验中心
归口单位: 全国外科植入物和矫形器械标准化技术委员会(CSBTS/TC110)
提出机构: 国家药品监督管理局
发布机构: 国家药品监督管理局


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
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
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
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;
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 ‐ 
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
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
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
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) 
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
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 penetrant type, after penetration, use dipping or
B.1.2.2 Emulsification time is critical. It shall determine according to the
structure of inspection surface and discontinuous defect type. Emulsification
time shall be sufficient for water washing of inspection surface. However, it must
not filter out the penetrant through over emulsification in discontinuous defect.
B.1.3 Removal of excess penetrant materials
B.1.3.1 General requirements
B.1.5 Application of photographic developer
B.1.5.1 Dry powder photographic developer
After the surface to be inspected is dried, apply the dry, loosening photographic
manual spreading, etc.
B.1.5.2 Liquid photographic developer
After the surface to be inspected is dried, it shall evenly apply the photographic
developer...
   
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