YY/T 0884-2013Evaluation of materials of health care product subject to radiation sterilization (English PDF)
适用于辐射灭菌的医疗保健产品的材料评价
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY/T 0884-2013 is the English-translated version of 适用于辐射灭菌的医疗保健产品的材料评价.
YY/T 0884-2013 is the Chinese pharmaceutical industry standard that guides the evaluation of the materials of a health care product, its packaging included, when the product is to be sterilized by radiation.
It covers polymers, metals, ceramics and glass and the other materials used, and it sets out what has to be considered and what information has to be gathered about the effect of the radiation on them, so that materials can be chosen and identified with that process in view. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY/T 0884-2013
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
- References
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The standard reference AAMITIR17.2008 Content "material and suitability for sterilization" (in English) about the radiating portion.
1 Scope
This standard provides the evaluation of health care products (including packaging) of the constituent materials, including polymers, metals, ceramics/glass and other Material suitability radiation sterilization procedures and information processing, and for the selection and identification of health-care products and packaging materials to provide guidance.
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.
Determination of GB/T 1040 (all parts) Tensile Properties of Plastics Measuring performance GB/T 1041-2008 plastic compression Determination of GB/T 2410-2008 transparent plastic light transmittance and haze
GB/T 2411-2008 plastic and hard rubber Shore hardness
GB/T 3398.2-2008 Plastics - Determination of hardness - Part 2. Rockwell hardness Determination of GB/T 9341-2008 plastic bending performance
GB/T 13525 plastic tensile impact performance test methods GB/T Determination of plastic film and sheet tear resistance of 16578.1-2008 Part 1. Trouser tear method
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing
HG/T 3862-2006 plastic yellow index test method
ISO 11137-1:2006 Sterilization of health care products developed radiation - Part 1 medical device sterilization process, validation and often Regulatory control requirements (Sterilizationofhealthcareproducts-Radiation-Part 1. Requirementsfordevelopment, validationandroutinecontrolofasterilizationprocessformedicaldevices)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Absorbed dose
Transfer to the dose of ionizing radiation on the substance of mass units.
Note 1. The unit of absorbed dose is Gy (Gy), 1Gy = 1J/kg (= 100rad).
Note 2. The standard dose refers absorbed dose. [ISO 11137-1:2006]
3.2 Health care products
Medical devices, including in vitro diagnostic medical devices or pharmaceutical products, including biopharmaceuticals.
Note: This standard is intended to illustrate the term health care products or product should refer to finished medical devices and/or additional components of the final package.
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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 2411-2008Plastics and ebonite -- Determination of indentation hardness by means of a durometer (shore hardness)
- GB/T 3398.2-2008Plastics -- Determination of hardness -- Part 2: Rockwell hardness
- GB/T 13525Test method for tensile-impact properties of plastics
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- HG/T 3862-2006Plastics - Test method for yellowness index
ISO 11137-1:2006
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Related Standards
GB/T 13525-1992 — Test method for tensile-impact property of plastics
GB/T 13525-2026 — Test method for tensile-impact properties of plastics
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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