YY/T 1263-2015Evaluation of materials of medical device subject to dry heat sterilization (English PDF)
适用于干热灭菌的医疗器械的材料评价
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 2, 2015
Implementation date
January 1, 2016
Scope
YY/T 1263-2015 is the English-translated version of 适用于干热灭菌的医疗器械的材料评价.
YY/T 1263-2015 is the Chinese pharmaceutical industry standard that guides the evaluation of the materials of a medical device that is to be sterilized by dry heat.
It sets out what has to be considered in selecting the material, in designing and processing the device and in testing the material, so that the suitability of a material for dry heat sterilization can be judged: the temperatures and times of the process, the changes the heat may cause in the material and in the device and the tests by which those changes are looked for. Issued on 2 March 2015, it has applied since 1 January 2016.
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Document preview — YY/T 1263-2015
National Standard of the People's Republic of China
- ICS
- 11.080.01
- Classification
- C 47
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Select material
- 5 product design and processing
- 6 Material Testing
- Appendix A (informative) dry heat sterilization compatibility with a particular material Reference
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the material selection, design and processing, materials testing. Dry heat sterilization for the selection of material provides evaluation guidelines adaptability.
This standard applies to the use of materials Evaluation dry heat sterilized medical devices.
Note 1. This standard also applies to heat the material to the original.
Note 2. The standard of the content is general information designed to provide guidance for the successful implementation of material evaluation. When using this standard should not be material grounds, not Proper evaluation.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing Material Evaluation YY/T 0884-2013 suitable for radiation sterilization of health care products
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Dry heat sterilization dryheatstirilization
Sterilization process by convection, conduction, heat radiation, infrared and other ways of incineration is at least one process parameter, and no sterilizing agent residue Equipment needs a relatively simple and reliable sterilization process.
3.2 The glass transition
glasstransition In an amorphous polymer or amorphous region a partially crystalline polymer from (or to) the formation of a sticky or rubbery (Or from) a hard and brittle state of irreversible change.
3.3 Melting temperature
Melting temperature or melting temperature of the plastic.
3.4 Accelerated aging
Medical equipment stored at high temperature and/or other strengthening environmental conditions to simulate real-time within a short period of time the process of aging.
3.5 Real-time aging
Under normal environmental conditions to assess the medical equipment store features change over time.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
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