YY 1298-2016Medical endoscopes—Capsule endoscopes (English PDF)
医用内窥镜胶囊式内窥镜
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
March 23, 2016
Implementation date
January 1, 2018
Scope
YY 1298-2016 is the English-translated version of 医用内窥镜胶囊式内窥镜.
YY 1298-2016 is the Chinese pharmaceutical industry standard for the capsule endoscope, the swallowed capsule that photographs the digestive tract as it passes through.
It gives the terms and definitions, the requirements, the test methods and the inspection rules, covering the field of view and the resolution of the image, the frame rate and the illumination, the working life of the battery and the transmission of the images, the dimensions and the tightness of the capsule shell, the materials and their biological evaluation and sterility.
The external image receiving and processing equipment is not part of the capsule as defined here. Issued on 23 March 2016, it applies from 1 January 2018.
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Document preview — YY 1298-2016
National Standard of the People's Republic of China
- ICS
- 11.040.55
- Classification
- C 40
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms and definitions
- 4 Requirements
Foreword
Chapter 5 of this standard is recommended and the remainder is mandatory.
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the requirements and definitions of capsular endoscopes, requirements, test methods, and inspection rules.
This standard applies to capsule endoscopes.
Note. The capsule endoscope does not contain an external image receiving and processing device or system.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
Medical electrical equipment - Part 1. General requirements for safety GB 9706.1 Medical electrical equipment - Part 2. Particular requirements for safety of endoscopic equipment GB 9706.19 A kind of capsule shape which is used in combination with an external image receiving and processing device or system for integrating illumination, imaging and wireless transmission. Endoscopy, mainly used to collect human digestive tract images.
GB/T 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis methods
GB/T 14233.2 Methods of test for medical infusion, blood transfusion, and injectable utensils - Part 2. Biological test methods
GB/T 16886 (all parts) Biological evaluation of medical devices
YY 0068.1-2008 Medical endoscopic rigid endoscopes - Part 1. Optical properties and test methods
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Capsule endoscope
A kind of capsule shape which is used in combination with an external image receiving and processing device or system for integrating illumination, imaging and wireless transmission. Endoscopy, mainly used to collect human digestive tract images.
3.2 Distal
The optical axis of the capsule endoscope intersects the outer surface of the imaging direction.
3.3 Working distance
The distance between the observed object and the end of the capsule endoscope.
4 Requirements
4.1 Materials used in contact with the patient
4.1.1 Chemical composition requirements
The material used in contact with the patient should be given in any form possible. Where the metallic material shall indicate the grade and / Or the code and the chemical composition of the material requirements, the chemical composition of the metal material should be tested to verify.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- YY 0068.1-2008Medical Endoscopes—Rigid Endoscope - Part 1: Optical properties and test methods
GB/T 16886
Similar standards
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Related Standards
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 14233.2-2005 — Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
GB/T 14233.2-2025 — Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
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YY 1298-2016
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