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www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY/T 1565-2017 English PDF

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YY/T 1565-2017: Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic surgical implants
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 1565-2017	English	119	Add to Cart	3 days [Need to translate]	Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic surgical implants	Valid	YY/T 1565-2017

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Basic data

Standard ID	YY/T 1565-2017 (YY/T1565-2017)
Description (Translated English)	Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic surgical implants
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C35
Classification of International Standard	11.040.40
Word Count Estimation	6,623
Date of Issue	2017-03-28
Date of Implementation	2018-04-01
Issuing agency(ies)	State Food and Drug Administration

YY/T 1565-2017: Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic surgical implants

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Implants for surgery-Non-destructive testing-Radiographic examination of cast metallic surgical implants ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Non-destructive examination of surgical implants Cast metal surgical implants radiographic examination (ISO 9584.1993, MOD) 2017-03-28 Posted 2018-04-01 implementation State Food and Drug Administration released

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. Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Surgical Implants and Orthopedic Instruments Standardization Technical Committee (SAC/TC110) centralized. This standard was drafted unit. Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Medical Device Inspection Institute. The main drafters of this standard. An Junbo, Zhang Chen, Li Libin, Su Jian, Chen Yu. Non-destructive examination of surgical implants Cast metal surgical implants radiographic examination

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 article Pieces. 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 ASTME142, 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.

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