YY/T 0567.7-2016 English PDF

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YY/T 0567.7-2016: Aseptic processing of health care products--Part 7: Alternative processes for medical devices and combination products
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Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0567.7-2016	394	Add to Cart	3 days	Aseptic processing of health care products--Part 7: Alternative processes for medical devices and combination products	Valid

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Basic data

Standard ID: YY/T 0567.7-2016 (YY/T0567.7-2016)
Description (Translated English): Aseptic processing of health care products--Part 7: Alternative processes for medical devices and combination products
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C47
Word Count Estimation: 21,280
Date of Issue: 2016-07-29
Date of Implementation: 2017-06-01
Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129)
Issuing agency(ies): State Food and Drug Administration

YY/T 0567.7-2016: Aseptic processing of health care products--Part 7: Alternative processes for medical devices and combination products

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Aseptic processing of health care products - Part 7. Alternative processes for medical devices and combination products ICS 11.080.01 C47 People's Republic of China Pharmaceutical Industry Standard Sterile processing of health care products - Part 7. Alternative processing of medical devices and combined products Asepticprocessingofhealthcareproducts-Part 7. (ISO 13408-7..2012, IDT) 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued Directory Preface III Introduction IV 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 quality system elements 1 Definition of aseptic processing 6 production environment 2 7 Equipment 3 8 people 3 9 production 3 Simulation Production 3 11 Sterility test 6 Appendix A (informative) Risk assessment of aseptic processing - Quality risk management approach 7 Appendix B (informative) Selection of microbiological contamination test samples 14 Appendix C (informative) Simulation Production Test Options 15 Reference 17

Foreword

YY/T 0567 "Sterile processing of health care products" is divided into the following sections. - Part 1. General requirements; Part 2. Filtering; - Part 3. freeze - drying method; - Part 4. Online cleaning technology; - Part 5. Online sterilization; - Part 6. Isolator systems; - Part 7. Alternative processing of medical devices and combined products. This part is part 7 of YY/T 0567. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This part is equivalent to ISO 13408-7..2012 "Sterile processing of health care products Part 7. Medical devices and their combination products Alternative Processing ". Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This section is proposed by the State Food and Drug Administration. This part of the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200) centralized. This part of the drafting unit. Hangzhou Tailin Biotechnology Equipment Co., Ltd., the State Food and Drug Administration Guangzhou Medical Equipment Quality Supervision Supervisory center. This part of the main drafters. Ke Jun, Zhou Wen, Xia Xinqun, Huang Hongxin.

Introduction

YY/T 0567 is an industry standard for aseptic processing of health care products. Historically, sterile medical products are usually liquid, Powder or suspension, usually not finally sterilized. Recently, medical devices and medical products have evolved into combination with drug-containing products, including organisms Active cells, these products can not be finally sterilized. YY/T 0567.1-2013 requirements for the production of simulated medical equipment and combination of products to provide. And this part of the content to YY/T 0567.1-2013, based on the development of alternative methods to simulate the sterile processing of medical devices and combinations of products and make it meet The quality standards set out the requirements and provide guidance. YY/T 0567.1-2013 10.1.2 Medical devices or combinations that can not be evaluated using conventional liquid culture filling methods Type products, should be used to simulate alternative production methods. Generally require sterile processing of medical devices and their combination products may include the following, for example. a) Medical devices that can not be used in accordance with YY/T 0567.1-2013 using simulated production methods and for final sterilization. --- biological prostheses (such as heart valves, vascular stents, etc.); Biodegradable implanted material (eg hernia patch); - artificial and/or non-bioactive substrates; - in vitro treatment equipment (eg immunosorbette); --- Implantable osmotic pump; --- Fully enclosed electromechanical facilities and partially enclosed electronic facilities (eg invasive and non-invasive diagnostic equipment). b) Combination products (including active cell matrix products). - implants covered with drugs and/or biologically derived substances (eg drug scaffolds, carrier-carrying substances, Long factor bone graft material, biodegradable drug scaffold); - wound dressings (eg dressings containing hemostatic agents, tissue sealants or biological agents); - percutaneous or injectable release systems (eg drug patch containing drug coating or biologics); A kit consisting of a biological agent or a pharmaceutical ingredient (e.g., a decalcified bone matrix). The entire product life/production cycle, the use of risk management strategies and methods to identify the risk of pollution, assessment and quantification, and the use of the environment Monitoring and microbiology research to evaluate the effectiveness of pollution control and risk control. Design simulation production based on risk analysis results, such as simulation Production results are acceptable, indicating that the aseptic processing in the pollution control state (that is, in the aseptic processing process did not introduce foreign micro Substance/microbial contaminants). This part can be used in conjunction with YY/T 0567.1-2013. Sterile processing of health care products - Part 7. Alternative processing of medical devices and combined products

1 Scope

This standard specifies a medical device that can not be final sterilized and is not suitable for YY/T 0567.1-2013 simulated production methods Equipment and combinations of products, aseptic processing performance confirmation of the simulation production alternative requirements, and provide guidance. This standard is applicable to the development of aseptic processing during the development of sterile processing, when the processing is not allowed to use the media directly substitute products, or the media can not replace On the basis of practical aseptic processing, the use of risk assessment to design medical equipment and combinatorial products simulation production research.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. YY/T 0567.1-2013 Sterile processing of health care products - Part 1. General requirements (ISO 13408-1..2008, IDT)

3 terms and definitions

YY/T 0567.1-2013 and the following terms and definitions apply to this document. 3.1 Foreign pollution Production process, into the foreign material. 3.2 Simulation production processsimulation By simulating the entire production process or part of the production process, demonstrate the ability to prevent microbial contamination during aseptic processing. 3.3 Risk management riskmanagement The system uses quality management policies, procedures and practices to analyze, assess, control and monitor risk. [YY/T 0316-2008, definition 2.22] 3.4 Alternative products surrogateproduct Simulated production, the design is very similar to the real product on behalf of the product.

4 quality system elements

YY/T 0567.1-2013 Chapter 4 applies.

5 definition of aseptic processing

5.1 Overview YY/T 0567.1-2013 5.1 Applicable. ......

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