Some standard content:
rcs_11.040.40
Pharmaceutical Industry Standard of the People's Republic of China
YY/T 0343--2002
Liguid penetrant iaspcction of metallic surgical implants (IS()9583:1993.NEQ)
200209-24 Issued
State Food and Drug Administration Issued
2003-04-01 Implementation
YY/I03432002
This standard is not equivalent to the national standard ISOS553, 1993 Implants-Non-destructive testing-Surgical metal implants (English version)
This standard lists the relevant clauses of 1503-52:14 Non-destructive testing-Fitness testing-General principles cited in the national standard. For details, please refer to the adoption instructions.
Because domestic implant materials are used, the first one is outstanding! Except for 7.4, the preparation of the dense material is based on the relevant clauses of the People's Republic of China Aviation Standard HB/7.61-99 penetration test. The requirements of the A5TM-19924 standard are all normative records, and Appendix A provides the acceptable limit level of the continuous defect rate of surgical metal parts. Appendix 15 provides the test sequence of penetration rate:
This standard is proposed by the National Drug Administration. This standard is jointly managed by the National Technical Committee for Standardization of Orthopedic Implants (CSBIS/1110), and the National Drug Administration's Medical Device Testing Center drafted this standard: Zhang Wenhui, Song Duo, and Xing Jiama. 1 Scope
Liquid immersion test for surgical metal implants
YY/T343—2002
This standard specifies the test methods, test levels, test limits, test records, air conditioning of the sample, and qualification of the test personnel. This standard is not applicable to the test of non-continuous deformation defects of surgical metal implants. For the test technology of this standard, see R/T1262.3139, the non-standard test technology of this standard. 2 Referenced standards
The following standards contain standard documents, which shall become the provisions of this standard through citation in this standard. At the time of publication of this standard, the versions indicated are valid. All standards will be considered by the parties using this standard to explore the advantages of the latest versions of the following standards. 11B/261-1998 Pre-test Method 3.1 Test Conditions The test piece should be clean and level without any material such as paint or paint residue that could cause false indications. 3.1.1 Surface Pre-cleaning 1) Use a suitable cleaning material to remove any oil on the surface of the test piece. 2) The inspected specimens shall be cleaned by the following cleaning methods and shall be tested for any defects that are not continuous and shall not be contaminated by any contamination sources. 3.1.2 Degreasing the specimens: Apply a porcelain penetrant to the specimens to remove contamination from the surface of the inspected specimens. Select an appropriate degreasing solvent. 3.1.3 Subsequent inspection: If different penetrants are used in subsequent inspections, the inspected specimens shall be cleaned immediately to completely remove any discontinuity defects, the products of disease and the residual paint penetrants previously applied. The general color of the penetrants and the fire penetrants left in the environment The penetrant undergoes a chemical reaction which may lead to complete or partial extinguishing of the flame.
3.2 Procedures
3.2.1 Classification of penetration test systems
3.2.1 Classification by test method
) Lightless penetrant test:
) Color penetrant test:
) Color penetrant test:
) Light penetrant test (light/color penetrant test) 3.2.2 Penetrant removal (method for removing excess penetrant):
1) t51 2.62 + 5. 2.
2) 151 326.3
3 JS 4F4 1?
23 7911:4F2 5.5,
YY/T 0343 2002
. Post-emulsifier,
c) Exfoliant.
3.2.2 Test procedure
Appendix 3 of this standard..
3.3 Penetrant material
3.3.1 Sensitivity
According to the external dimensions of surgical implants, different materials are selected from different production stages. The sensitivity levels are divided into: general sensitivity; medium sensitivity; ultra-high sensitivity. The manufacturer of the exfoliant material and the buyer negotiate to select 3.3.2 Suitability\
The material to be tested should be the same as the material of the test piece. The corrosion resistance should be reduced. 3.3 .3 Cleaning after inspection
After inspection, remove the penetrant and developer. The residue of the inspection material will cause the test piece to react with other factors during use. In order to avoid the subsequent use requirements, the cleaning condition must be studied after inspection. 4 Inspection level
For non-surgical metal implants, the parties or purchasers have special requirements, otherwise 1% of each batch of products should be inspected. 5 Acceptable loss limit
The acceptance or rejection of the product shall be determined according to the given specification. The recommended maximum acceptable limit is given in the appendix of the technical standard. 6 Inspection record"
The inspection results should be recorded to indicate the number of surgical metal implants involved in the inspection. (Day) Determine the inspection method and operation procedure! 1. Test data:
Personal qualification chain name:
Seepage point technology, bad flow rate, virtual materials and manufacturers: appropriate single diagram or description, determine the location of the public to know the impact of the internal separation; e
f according to the advertising period.
7 Liao Tong material control
should be carried out, a series of tests to determine the effectiveness of the cleaning material. Responsibility: The use of aging makes the concentration of the science of the dynamic effect of the reduction. 1. Push kneading agent
The inspection period and maintenance cycle shall be in accordance with the requirements of the manufacturer's instructions for the speed-up agent, and the light is completely in accordance with the standard HB/Z51-1!515.10.5.1. 7.2 Emulsifier 7.2.1 Water content The water content of the base emulsifier shall not exceed 10%. The test cycle is: 30 days for open container and 3 months for closed container. Check according to Table 8, 9, F 152 34 +2 i.1. 1. 8 [5 3432 13. HB/Z 6:-19813.10.5.2. 7.2.2 Pollution of transparent materials 03432002
Emulsifier (Shantou-based or water-based) can be more than 10 times the penetrating agent. Once the emulsifier is unchanged, it can only be used according to the calibration. The inspection period is before use or before use. The two provinces or provinces shall choose the inspection of the source or the longer the inspection. 7.3 Developer
The developer must be dried, loosened and not agglomerated. The developer must not be used. The inspection period is every day or before use. For liquid developers, the inspection period is according to the manufacturer's instructions. For roller developers, the inspection period is every week or before use. According to 5.1U.5.3 of HB61-1, 7.4 Black light lamp is used for the fluorescent paint penetration test. The output power of the black light lamp should be checked, and the black light should be no less than 800m away from the black light lamp surface. The black light auxiliary pressure gauge with calibration should be used to measure the power of the penetration tester. The penetration tester should be qualified and recognized from among them. The professional technical qualification should be obtained and engaged in the work related to his qualification. 9) ASIMF6011932. 4.
YYT0343—2002
Appendix A
(Normative information:
Manufacturer's and supplier's inspection of surgical implants - Acceptable limits of surface discontinuities 4.1 Recommended acceptable limit levels The manufacturer or purchaser's acceptance and rejection limits are related to the color, size and spacing of the discontinuities in the inspection area. The manufacturer and purchaser shall specify the acceptable limit levels for the size, spacing and number of single or grouped surface discontinuities (4.2) Table A, 1 Recommended acceptable limit levels for the size, spacing and number of single or grouped surface discontinuities Defects Approval Defects (1) 0.25 --, 5
·2·-·3
1 effective sensitivity trap scale (hospital: degree>3 test connection
2 feet 2 can be ignoredbzxz.net
small same distance
: L? . .
long area material defects are more exciting
in the inspection area test, if the student says there is a school defect.The total amount of acceptable technical defects and the maximum effective estimation of the main inspection results within the inspection period are the limits of the effective size of the non-defective parts of the machine. They must be completely machined. The surface area of 25mm×mm can be measured without adding any sink marks and heavy defects. The two non-contiguous defects can be evaluated by rubbing the attached size with a volatile chemical. A.2 Inspection area A, B, E, etc. can be made or purchased as follows: B.1 Inspection procedure B.1.1 Penetration R. 1.1.1 Applied temperature
Appendix B
(Normative appendix)
Qualified inspection procedure
YY/TQ343-2302
The temperature of the surface material of the inspected specimen must be within the specified pressure range. B.1.1.2 Application of penetrant
The surface to be inspected should be lubricated and placed by the penetrant. The penetrant can be applied by staining, coating (electrostatic spraying), washing, etc. 1.\.1.3 Pre-penetration time
The penetration time shall be based on the temperature, the inspected material and the defect shape, and the source of the The dosage form should not be used for any reason. For example, if a new dosage form is to be added to the inspected surface, the time for complete wetting of the inspected surface should not be longer than that of the manufacturer within the penetration time. A longer penetration time may indicate a small defect in the product. 1.2 Addition of emulsions. 1.2.1 After penetration, apply the emulsified emulsion to the inspected surface by dripping it with water or other methods. B.1.2.2 The emulsification time should be determined based on the structure and non-normality of the inspected surface. The emulsification time should be sufficient to allow the inspected surface to be fully wetted. However, the inspected surface should not be exposed to the replacement of the dosage form during the penetration. B.1.3 Removal of excess material
B.1.3.1 General requirements
After the permeation time and emulsification time are completed, the surface penetrant and emulsifier should be removed and the inappropriate interference of the surface should be effectively removed to avoid false indications. The continuous cleaning of the filter system should be avoided. The filter system should be tested under a fluorescent lamp to observe the traces of the dye on the surface. H.1.3.2 Solvent removal type penetrant
Remove excess penetrant (tt||) Remove with a clean, wet gauze or paper. b) Use a small amount of water or some other material to clean up the excess penetrant, and avoid removing the concentrated penetrant to reduce the risk of irreversible defects.
B..3.3 For water-washable and post-emulsified type penetrants, use water. The water temperature should be within the temperature range recommended by the penetrant manufacturer. Emulsifier application, the removal of excess light must be done, the surface of the black light should be inspected and cleaned, the old taste should be completely cleaned, if the scene is too much, the test piece should be freshly cleaned, penetrated and emulsified B.1.4 Drying
R..4.1 Before imaging, the surface of the test piece should be thoroughly cleaned according to the following: 2) Use a clean cloth to make a paper cloth: b) Clean and dry the bottom of the filter air for 1 second:
> Hot air frost ring 1
: Dry in a hot air circulation box.
B.1.4.2 When using dry powder imaging agent or non-water-wet developer, the surface of the test piece should be wetted and moistened to meet the requirements of correction. B.1.4.3 Avoid too long time or high air pressure to prevent continuous defects in the developer.
YY/T 0343—2002
H.1.5 Application of developer
A.1.5.1 Dry powder developer
After the surface of the test is dried, a developer suitable for the developer shall be applied to the test surface. Such as spraying, manual application, etc. E.1.5.2 Liquid developer
After the surface of the test is dried, a developer suitable for the developer shall be applied to the test surface evenly. The developer shall be applied by spraying, electrostatic spraying, etc. When applying the developer, the particles in the test surface shall be evenly distributed. The excess liquid developer may come into contact with the product. After drying, the product shall show a thin layer of active agent on the surface of the test. B.1.6 Imaging time
After the imaging process is applied, the surface of the structure should be kept for a long time: the imaging time point depends on the test material used, the test material and the type of defects. In some cases, the bottom is transparent. The small discontinuity is fast, and the penetration time can be reached. The effect is long. The long imaging time can cause the large-scale penetration of the wide and deep discontinuity defects to be reflected. The traces of the over-penetration caused by the wetness are caused by the slow penetration. .2 Inspection
H.7.1. Fluorescence transparency inspection
When using fluorescent transparency inspection, the dark area or area should be clear. It can be illuminated by a slightly yellow lamp. The inspection should be carried out under a black light. The wavelength of the black light is generally 35nm at the peak of 20am~10n. Before the test, the inspector should be adapted for no more than 5min.
H.2.2 General color inspection
Use color penetration test. The test area should be artificially passively illuminated. The light intensity should not be less than 1x. The surface to be inspected should be inspected under a light source with a suitable defect. B.7.3 Auxiliary inspection
Inspection should be carried out with the aid of a magnifying lens. In the case of fluorescent latent inspection, the contrast between the material and the ultraviolet light is increased. When the surface of the test piece is found to be reflective, ultraviolet light can be removed. R.3 Interpretation and definition
B8.37 The surface of the image test film should be inspected under suitable conditions: if the background of the image has been weakened, it should be re-inspected. The position of the dust discontinuity defect shall be recorded and evaluated according to the acceptance criteria. B.3.2 As the imaging time increases, the size of the point-shaped and line-shaped discontinuity defects will increase. Therefore, their size should be recorded from time to time. The size of the discontinuity defect should be recorded from time to time.3. For water-washing type and emulsified type permeable test pieces, remove excess permeable agent with water. The water temperature should be within the temperature range recommended by the permeable agent manufacturer. For the application of emulsifier, the excess must be removed by light. The surface of the test piece should be completely cleaned under a black light. If the test piece has been tested, it should be cleaned again. B.1.4 Drying
R..4.1 Before imaging, the surface of the test piece should be thoroughly cleaned according to the following: 2) Use a clean cloth to dry in a paper cloth for 10 seconds: b) Clean and dry the filter bottom with air for 10 seconds:
> Hot air circulation box 1
: Dry in a hot air circulation box.
B.1.4.2 When using dry powder imaging agent or non-water-wet developer, the surface to be tested should be moistened and lubricated to meet the requirements of correction. B.1.4.3 Avoid too long time of opening or high air pressure in the chamber to prevent the occurrence of continuous defects.
YY/T 0343—2002
H.1.5 Application of developer
A.1.5.1 Dry powder developer
After the surface of the drug test is exposed, a dry and effective developer that is compatible with the developer is added to the surface to be tested. E.1.5.2 Liquid developer
After the surface is dried, the developer compatible with the penetrant should be evenly applied to the sensitive surface. The developer should be applied by spraying, electrostatic spraying, etc. The application should make the particles of the firmware evenly distributed. The over-cover layer of the fluid developer may come into contact with the product. After drying, the product should show a thin layer of active material on the surface. B.1.6 Imaging time
After the imaging process is applied, the surface of the structure should be kept for a long time: the imaging time point depends on the test material used, the test material and the type of defects. In some cases, the bottom is transparent. The small discontinuity is fast, and the penetration time can be reached. The effect is long. The long imaging time can cause the large-scale penetration of the paint in the wide and deep discontinuity defects. The traces of the over-penetration caused by the paint are caused by the slow penetration. .2 Inspection
H.7.1. Fluorescence transparency inspection
When using fluorescent transparency inspection, the dark area or area should be clear. It can be illuminated by a slightly yellow lamp. The inspection should be carried out under a black light. The wavelength of the black light is generally 35nm at the peak of 20am~10n. Before the test, the inspector should be adapted for no more than 5min.
H.2.2 General color inspection
Use color penetration test. The test area should be artificially passively illuminated. The light intensity should not be less than 1x. The surface to be inspected should be inspected under a light source with a suitable defect. B.7.3 Auxiliary inspection
Inspection should be carried out with the aid of a magnifying lens. In the case of fluorescent latent inspection, the contrast between the material and the ultraviolet light is increased. When the surface of the test piece is found to be reflective, ultraviolet light can be removed. R.3 Interpretation and definition
B8.37 The surface of the image test film should be inspected under suitable conditions: if the background of the image has been weakened, it should be re-inspected. The position of the dust discontinuity defect shall be recorded and evaluated according to the acceptance criteria. B.3.2 As the imaging time increases, the size of the point-shaped and line-shaped discontinuity defects will increase. Therefore, their size should be recorded from time to time. The size of the discontinuity defect should be recorded from time to time.3. For water-washing type and emulsified type permeable materials, remove excess permeable agent by water. The water temperature should be within the temperature range recommended by the permeable agent manufacturer. For the application of emulsifier, the excess must be removed by light. The surface of the washed sample should be inspected under a black light. The old sample should be completely clean. If the sample has been tested, the sample should be cleaned again. B.1.4 Drying
R..4.1 Before imaging, the surface of the tested sample should be thoroughly cleaned according to the following: 2) Use a clean cloth to dry in a paper towel for 10 seconds: b) Clean and dry the filter bottom with air for 10 seconds:
> Hot air circulation box 1
: Dry in a hot air circulation box.
B.1.4.2 When using dry powder imaging agent or non-water-wet developer, the surface to be tested should be moistened and lubricated to meet the requirements of correction. B.1.4.3 Avoid too long time of opening or high air pressure in the chamber to prevent the occurrence of continuous defects.
YY/T 0343—2002
H.1.5 Application of developer
A.1.5.1 Dry powder developer
After the surface of the drug test is exposed, a dry and effective developer that is compatible with the developer is added to the surface to be tested. E.1.5.2 Liquid developer
After the surface is dried, the developer compatible with the penetrant should be evenly applied to the sensitive surface. The developer should be applied by spraying, electrostatic spraying, etc. The application should make the particles of the firmware evenly distributed. The over-cover layer of the fluid developer may come into contact with the product. After drying, the product should show a thin layer of active material on the surface. B.1.6 Imaging time
After the imaging process is applied, the surface of the structure should be kept for a long time: the imaging time point depends on the test material used, the test material and the type of defects. In some cases, the bottom is transparent. The small discontinuity is fast, and the penetration time can be reached. The effect is long. The long imaging time can cause the large-scale penetration of the wide and deep discontinuity defects to be reflected. The traces of the over-penetration caused by the wetness are caused by the slow penetration. .2 Inspection
H.7.1. Fluorescence transparency inspection
When using fluorescent transparency inspection, the dark area or area should be clear. It can be illuminated by a slightly yellow lamp. The inspection should be carried out under a black light. The wavelength of the black light is generally 35nm at the peak of 20am~10n. Before the test, the inspector should be adapted for no more than 5min.
H.2.2 General color inspection
Use color penetration test. The test area should be artificially passively illuminated. The light intensity should not be less than 1x. The surface to be inspected should be inspected under a light source with a suitable defect. B.7.3 Auxiliary inspection
Inspection should be carried out with the aid of a magnifying lens. In the case of fluorescent latent inspection, the contrast between the material and the ultraviolet light is increased. When the surface of the test piece is found to be reflective, ultraviolet light can be removed. R.3 Interpretation and definition
B8.37 The surface to be inspected should be inspected under suitable conditions: if the background of the display has weakened, it should be re-inspected. The position of the dust discontinuity defect shall be recorded and evaluated according to the acceptance criteria. B.3.2 As the imaging time increases, the size of the point-shaped and line-shaped discontinuity defects will increase. Therefore, their size should be recorded from time to time. The size of the discontinuity defect should be recorded from time to time.
Tip: This standard content only shows part of the intercepted content of the complete standard. If you need the complete standard, please go to the top to download the complete standard document for free.