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YY/T 0343-2002: Liquid penetrant inspection of metallic surgical implants Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYY/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/YYT0343-2002YY 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 ContentsForeword... 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... 11ForewordThis 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 implants1 ScopeThis 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 referencesThe 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 Inspection3 Inspection methods3.1 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 levelUnless 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 limitThe 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 materialIt 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 inspectionThe 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. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY/T 0343-2002 be delivered?Answer: The full copy PDF of English version of YY/T 0343-2002 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY/T 0343-2002_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0343-2002_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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