YY/T 1403-2017Requirements of contract sterilization using ethylene oxide (English PDF)
环氧乙烷分包灭菌的要求
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 28, 2017
Implementation date
April 1, 2018
Scope
YY/T 1403-2017 is the English-translated version of 环氧乙烷分包灭菌的要求.
YY/T 1403-2017 is the Chinese pharmaceutical industry standard that sets the requirements for contract sterilization with ethylene oxide, the case where a manufacturer has its devices sterilized by an outside plant.
It guides the implementation of GB 18279.1 in that arrangement: what the two parties must agree, the responsibilities of each, the information and the product data to be exchanged, the qualification and the routine control of the process and the release of the product, with further guidance in GB/T 18279.2.
It does not cover ethylene oxide sterilization contracted by a healthcare institution. Issued on 28 March 2017, it has applied since 1 April 2018.
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Document preview — YY/T 1403-2017
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
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Subcontractor sterilization options
- 5 Written agreement between the product manufacturer and the subcontractor
- 6 confirm the program
- 7 Biological Indicators, Process Challenge Devices and Sample Disposal
- 8 sterilization process documents
- 9 routine sterilization process control
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Introduction
ISO 11135-1-2007 Sterilization of health products - Ethylene oxide - Part 1. Development, validation and routine maintenance of medical device sterilization processes Requirements for regulatory control (English version) and ISO /T S11135-2.2008 Sterilization of health products - Ethylene oxide - Part 2. ISO 11135-1 Application Guide (English version) is being translated into SAC/TC200 equivalent to China's national standards GB 18279.1 and GB/T 18279.2.
AAMI (The Association for the Advancement of Medical Instrumentation) has four standard aims
ISO 11135-1-2007 Guide to the use of, respectively. AAMITIR14.2009 ethylene oxide subcontracting sterilization; AAMITIR15.2009 Ethylene oxide sterilization physical requirements; AAMITIR16.2000 Ethylene Oxide Sterilization Requirements; AAMITIR28.2009 Ethylene Oxide Sterilization Product Addition and Process Equivalent.
For the better implementation of GB 18279.1, SAC/TC200 has made reference to the above four AAMI standards, According to our national conditions of the industry standards.
Among them, the standard reference AAMITIR14.2009 developed, the choice of sub-sterilization sterilization, product manufacturers and sub-sterilization sterilization book Surface protocols, validation procedures, biological indicators, disposal of process challenge devices and samples, sterilization process documentation, routine sterilization process control, etc. Give guidance to facilitate the better implementation of GB 18279.1. Ethylene oxide subcontracting sterilization requirements
1 Scope
This standard specifies the requirements for subcontracting sterilization of ethylene oxide, designed for the implementation of subcontracting sterilization of medical device manufacturers
GB 18279.1 provide guidance. Other guidance information can refer to GB/T 18279.2.
This standard does not include the medical institutions using ethylene oxide subcontracting sterilization requirements.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
Sterilization of ethylene oxide by GB 18279.1 Healthcare products - Part 1. Development, validation and routine control of sterilization of medical devices (GB 18279.1-2015, ISO 11135-1:2007, IDT)
GB/T 18279.2 Sterilization of Healthcare Products - Ethylene Oxide - Part 2. Application Guidance GB 18279.1 (GB/T 18279.2- 2015, ISO 11135-2:2008, IDT)
YY/T 1302.2-2015 Physical and microbiological requirements for ethylene oxide sterilization - Part 2. Requirements for microorganisms
3 Terms and definitions
GB 18279.1 and GB/T 18279.2 as defined in the following terms and definitions apply to this document.
3.1 Bacteriostatic/fungistatic test
Experiments with the selected microorganisms demonstrate whether there are substances that inhibit the multiplication of the microorganisms.
3.2 Subcontractor sterilizer contractterilizer
The subcontracting facility is designed to provide subcontracting services for medical devices manufactured by medical device manufacturers.
Note. This definition applies to all facilities that provide medical device sterilization services and also to internal sterilization of medical device manufacturers (ie manufacturing and sterilization integration Factory).
3.3 Manufacturer
Manufacturing, Manufacturing, Assembly and Finished Products, including any form of repackaging, relabeling.
3.4 Verification
An evaluation performed to ensure the current operation or suitability of the system.
4 Package sterilization business choice
4.1 Evaluation of sterilization sites
First, the manufacturer should determine whether to choose the subcontractor sterilization or internal sterilization. Manufacturers should fully understand the choice of sterilization field
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
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Related Standards
GB/T 18279.2-2015 — Sterilization of health care products -- Part 2: Guidance on the application of GB 18279.1
YY/T 1302.2-2015 — Physical requirements and microbiological performance of ethylene oxide sterilization - Part 2: Microbiological aspects
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 1403-2017
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