YY/T 1265-2015Evaluation of materials of medical device subject to moist heat sterilization (English PDF)
适用于湿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 1265-2015 is the English-translated version of 适用于湿热灭菌的医疗器械的材料评价.
YY/T 1265-2015 is the Chinese pharmaceutical industry standard that guides the evaluation of the materials of a medical device that is to be sterilized by moist 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 steam sterilization can be judged: the temperature, the pressure and the moisture of the process, the changes they may cause in the material 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 1265-2015
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 Material Selection
- 5 product design and processing
- 6 Material Testing
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 material to provide heat sterilized evaluation guidelines adaptability.
This standard applies to the use of heat 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 properly evaluated.
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 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 does not expose the instrument unhealthy consequences.
3.2 The glass transition
glasstransition Amorphous polymers or polymers having partially crystalline transition from one state to viscous or elastic hardness and brittle state Reversible change.
3.3 The glass transition temperature
The intermediate temperature range when the value of glass transition.
3.4 Melting temperature
Melting temperature or melting temperature of the plastic.
3.5 F value
Heat sterilization of microbial inactivation metric.
3.6 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.
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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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