YY/T 1267-2015Evaluation of materials of medical device subject to ethylene oxide sterilization (English PDF)
适用于环氧乙烷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 1267-2015 is the English-translated version of 适用于环氧乙烷灭菌的医疗器械的材料评价.
YY/T 1267-2015 is the Chinese pharmaceutical industry standard that guides the evaluation of the materials of a medical device that is to be sterilized with ethylene oxide.
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 that process can be judged: the exposure to the gas and to the humidity and heat that accompany it, the absorption of the gas and the residues left in the device, and the changes the process may cause in the material. Issued on 2 March 2015, it has applied since 1 January 2016.
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Document preview — YY/T 1267-2015
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
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Material Selection
- 5 product design and processing
- 6 Material Testing
- Appendix A (informative) compatibility with the ethylene oxide sterilization 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. Ethylene oxide sterilization for the selection of material suitability reviews guide.
This standard applies to the use of ethylene oxide sterilization of medical devices for material evaluation.
Note: The contents of the standard general information designed to provide guidance for the successful implementation of material appraisal. This standard should not be grounds, in the use of materials not into Line suitable material identification.
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 of the risk management process and Test
GB 18279 ethylene oxide sterilization of medical devices Validation and routine control
YY 0503 ethylene oxide sterilizers
YY/T 0822 liquefied gas sterilization with ethylene oxide 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 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.
3.2 Biocompatible material
Constituent material or packaging material does not expose the instrument unhealthy consequences.
3.3 Shelf life
Under typical storage conditions, to ensure product functionality and biocompatibility no unacceptable effects or the length of selection time The length of time of the failure.
3.4 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.
Referenced standards
Normative references
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB 18279Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
- YY 0503Ethylene oxide sterilizer
- YY/T 0822Ethylene oxide liquefied gas for sterilization
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Related Standards
GB 18279.1-2015 — Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18279-2023 — Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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