YY/T 1565-2017Implants for surgery-Non-destructive testing-Radiographic examination of cast metallic surgical implants (English PDF)
外科植入物无损检验铸造金属外科植入物射线照相检验
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 28, 2017
Implementation date
April 1, 2018
Scope
YY/T 1565-2017 is the English-translated version of 外科植入物无损检验铸造金属外科植入物射线照相检验.
YY/T 1565-2017 is the Chinese pharmaceutical industry standard that gives the method for detecting and evaluating defects in cast metal surgical implants.
It sets out the non-destructive examination to be used, the reference standards against which an indication is judged, the classification of the defects by size and position and the acceptance criteria, so that a casting fit for implantation can be told from one that is not. Issued on 28 March 2017, it has applied since 1 April 2018.
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Document preview — YY/T 1565-2017
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 35
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions GB/T 12604.2-2005
- 4 Procedures
- 5 Test level
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses redrafted law revision using ISO 9584:1993 "surgical implant non-destructive testing cast metal surgical implants Radiographic test. " This standard compared with ISO 9584:1993, there are the following technical differences.
--- Normative references with "GB/T 19943-2005 (ISO 5579:1998, IDT)" instead of "ISO 5579:1985";
--- Personnel qualifications by the non-destructive testing in accordance with the relevant laws and regulations of the United States to modify the requirements to comply with the relevant laws and regulations in China;
--- Added references.
1 Scope
This standard specifies a method for the detection and evaluation of defects in cast metal surgical implants.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 12604.2-2005 Non-destructive testing terms radiographic testing (ISO 5576:1997, IDT)
GB/T 19802-2005 Non-destructive testing - Minimum requirements for industrial radiography spot lamps (ISO 5580:1985, IDT)
GB/T 19803-2005 Non-destructive testing radiographic quality indicators and identification (ISO 1027:1983, IDT)
GB/T 19943-2005 Nondestructive testing of metallic materials X and gamma radiographic testing of the basic rules (ISO 5579:1998, IDT)
3 Terms and definitions GB/T 12604.2-2005
Terms and definitions apply to this document.
4 Procedures
4.1 Radiographic methods
Radiographic methods shall comply with the requirements of GB/T 19803-2005 and GB/T 19943-2005.
4.2 Ray image lighting
Radiographic examination of the image should be in line with GB/T 19802-2005 lighting requirements. Cast metal surgical implant radiography As a test, radiographic techniques should be used to ensure that the diffraction pattern is distinguishable from the actual defect because the pattern of grain diffraction resembles a false defect.
4.3 Image quality
For X-ray energy less than 500kV, ray image quality levels are divided into the following two categories.
--- consistent with the method in ASTM E142, at least 2% (2-2T);
--- Equalized image quality (IQN) consistent with GB/T 19803-2005.
For high energy X-rays (greater than 500 kV), an image quality of (2-4T) or equivalent to meet the requirements of GB/T 19803-2005 Image Quality (IQN).
5 Test level
Unless the manufacturer or purchaser of implants otherwise requires, each lot shall be 100% inspected.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 12604.2-2005Non-destructive testing -- Terminology -- Terms used in radiographic testing
- GB/T 19802-2005Non-destructive testing - Industrial radiographic illuminators - Minimum requirements
- GB/T 19803-2005Non-destructive testing -- Radiographic image quality indicators -- Principles and identification
- GB/T 19943-2005Non-destructive testing - Radiographic testing of metallic materials using film and X-or gamma rays - Basic rules
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Related Standards
GB/T 12604.2-2005 — Non-destructive testing -- Terminology -- Terms used in radiographic testing
GB/T 19802-2005 — Non-destructive testing -- Industrial radiographic illuminators -- Minimum requirements
GB/T 19803-2005 — Non-destructive testing -- Radiographic image quality indicators -- Principles and identification
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