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YY/T 0343-2002Liquid penetrant inspection of metallic surgical implants (English PDF)

外科金属植入物液体渗透检验

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 24, 2002

Implementation date

April 1, 2003

Scope

YY/T 0343-2002 is the English-translated version of 外科金属植入物液体渗透检验.

YY/T 0343-2002 is the Chinese pharmaceutical industry standard for liquid penetrant inspection of metallic surgical implants, the dye method used to reveal cracks and other discontinuities open to the surface.

It sets the inspection methods, the inspection levels, the acceptable limits, the inspection record, the control of the penetrant materials themselves and the qualification required of the personnel who perform the inspection, with the normative appendix giving the procedure for metallic surgical implants.

It applies to the detection of discontinuities or defects on the surface of metallic implants, and takes its terminology from the Chinese standards on non-destructive testing. Issued on 24 September 2002, it has applied since 1 April 2003.

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Document preview — YY/T 0343-2002

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword3
  • 1 Scope4
  • 2 Normative references4
  • 3 Inspection methods4
  • 4 Inspection level6
  • 5 Acceptable limit6
  • 6 Inspection record6
  • 7 Control of penetrant material7
  • 8 Personnel qualification of penetrant inspection8
  • Annex A (Normative) Liquid penetrant inspection of metallic surgical implants - Acceptable limit level of surface Discontinuous defects9
  • Annex B (Normative) Penetrant inspection procedure11

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.

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

3.2.2 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).

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.

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