YY/T 1266-2015Evaluation of materials of medical device subject to hydrogen peroxide sterilization (English PDF)
适用于过氧化氢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 1266-2015 is the English-translated version of 适用于过氧化氢灭菌的医疗器械的材料评价.
YY/T 1266-2015 is the Chinese pharmaceutical industry standard that guides the evaluation of the materials of a medical device that is to be sterilized with hydrogen peroxide.
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 sterilant and to the plasma where used, the absorption and the residues, 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 1266-2015
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
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
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. For the selection of hydrogen peroxide sterilization of material suitability reviews guide.
This standard applies to the use of hydrogen peroxide through the material evaluation sterilized medical devices.
Note 1. The standard of all the "hydrogen peroxide (H2O2) sterilization" mean gaseous sterilization. Liquid hydrogen peroxide is also used as a chemical sterilization, but this application is not Within the scope of this standard.
Note 2. The standard of the content is general information designed to provide guidance for the successful implementation of material appraisal. This standard should not be grounds, in the use of material does not Proper identification of materials.
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 1616 Industrial hydrogen peroxide
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test 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 Biocompatible material
Constituent material or packaging material instrument does not produce substances harmful to human health after sterilization.
3.2 Surface alteration
Bring physical, chemical or biological activity characteristic change material to the surface.
3.3 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.
3.4 Shelf life
Before using the product under standard storage conditions, functional and biocompatibility without unacceptable impacts to maintain the length of time Select the length of time or failure.
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 1616-2014 — Hydrogen peroxide for industrial use
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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