YY/T 1264-2015Evaluation of materials of medical device subject to ozone sterilization (English PDF)
适用于臭氧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 1264-2015 is the English-translated version of 适用于臭氧灭菌的医疗器械的材料评价.
YY/T 1264-2015 is the Chinese pharmaceutical industry standard that guides the evaluation of the materials of a medical device that will be sterilized with ozone.
Ozone is a strong oxidant, so the standard sets out what to consider in selecting the material, in the design and processing of the part and in testing the material itself, and gives the criteria by which its suitability for repeated ozone exposure is judged.
It applies to the evaluation of materials for medical devices sterilized by ozone, and can also be used for products that are disinfected rather than sterilized; it is general guidance, and is not a ground for leaving a material untested. Issued on 2 March 2015, it has applied since 1 January 2016.
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Document preview — YY/T 1264-2015
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. Ozone sterilization process for the selection of material provides evaluation guidelines adaptability.
This standard applies to the use of ozone sterilization of medical devices for material evaluation.
Note 1. the content of this standard is general information designed to provide guidance for the successful implementation of material evaluation. In the selection of materials should not be present standard grounds, not Proper evaluation of the material.
Note 2. This standard also applies to material evaluation disinfection products.
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 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 Ozone ozone
At normal temperature and pressure, it is a light blue stench of gas (formula O3), has strong oxidation ability and bactericidal properties.
3.2 Ozone concentration ozoneoncentration
Unit volume ozone levels.
NOTE. Common mg/L, mg/m3 expressed.
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 Real-time aging
Under normal environmental conditions to assess the medical equipment store features change over time.
3.5 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.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 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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