YY/T 0615.1-2007 English PDFUS$134.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0615.1-2007: Requirements for medical devices to be designated “STERILE”. Part 1: Requirements for terminally sterilized medical devices Status: Valid
Basic dataStandard ID: YY/T 0615.1-2007 (YY/T0615.1-2007)Description (Translated English): Requirements for medical devices to be designated ��STERILE��. Part 1: Requirements for terminally sterilized medical devices Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C47 Classification of International Standard: 11.080.01 Word Count Estimation: 7,757 Date of Issue: 2007-07-02 Date of Implementation: 2008-03-01 Quoted Standard: YY/T 0287-2003 Adopted Standard: EN 556-1-2001, IDT Regulation (derived from): Chinese industry standard filing Notice 2007 No. 9 (No. 93 overall) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the labeled " sterile " Requirements for terminally sterilized medical devices. YY/T 0615 part 2 of the labeled " sterile " medical devices aseptic processing requirements. YY/T 0615.1-2007: Requirements for medical devices to be designated “STERILE”. Part 1: Requirements for terminally sterilized medical devices---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. Requirements for medical devices to be designated "STERILE" .Part 1. Requirements for terminally sterilized medical devices ICS 11.080.01 C47 People's Republic of China pharmaceutical industry standards Labeling requirements "sterile" medical devices Part 1. eventually require sterilization of medical devices (EN556-1.2001, IDT) Posted 2007-07-02 2008-03-01 implementation State Food and Drug Administration issued ForewordYY/T 0615 "marked" sterile "medical device requirements," consists of the following components. --- Part 1. eventually require sterilization of medical devices; --- Part 2. aseptic processing medical equipment requirements. YY/T 0615 is equivalent to using this part of EN556-1.2001 "marked" requires sterile "medical devices --- Part 1. Final It requires sterilization of medical devices. " This part of the National Standardization Technical Committee appliances medical infusion made. This part of the jurisdiction of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. This section is drafted. Shandong Medical Devices Product Quality Inspection Center. The main drafters of this section. Wu Ping by Shaohua.IntroductionSterile product item is no viable microorganisms products. Medical equipment standards, when it is necessary to provide a sterile product project, you need to take a Effective means to cut all sources of medical devices brought by foreign microbial contamination to a minimum. Even so, in line with the medical Under standard production conditions therapy device quality system requirements (see YY/T 0287-2003) the production of medical devices prior to sterilization or microorganism have Presence, though few in number. These items are non-sterile products. The purpose of sterilization is to inactivate microbial contamination, non-free Bacteria project became sterile items. Physical and/or chemical methods of inactivation of a pure culture of medical device sterilization, microorganisms often are approximately exponential relationship, which It means that, regardless of the degree of sterilization, there is always a finite probability of viable micro-organisms. For a given sterilization process is concerned, Microbial survival probability determined by the number of microorganisms, microbial resistance and sterilization of microorganisms in the environment in which to decide. This makes subjected sterilized All items in the process of each project can not guarantee absolute sterility. Sterility after sterilization program can only exist with the project stored in/on The probability of a viable microorganism such term is defined. Standard quality management system that some process can not be used subsequent product testing and commissioning To test fully confirmed, sterilization is an example of such a process. Sterilization process must be confirmed prior to use, the performance of the process must be conventional Monitoring, sterilization equipment must be maintained. So that a product is subjected to due recognition and precise control of the sterilization process is not provided for the sterility assurance products and projects suitable for the intended application The only factor. Must also pay attention to many other factors, which include the purchase of raw materials and/or components of microbial status (negative biological Load), storage and product manufacturing, assembly and packaging of the environmental control after the purchase. Labeling requirements "sterile" medical devices Part 1. eventually require sterilization of medical devices1 ScopeYY/T 0615 provisions of this part of the declaration of "sterile" terminally sterilized medical devices requirements. YY/T 0615 Part 2 sets out Labeled "sterile" medical instruments sterile processing requirements. Note. When using a medical device only confirmed a sterilization process, it may be declared "sterile." GB 18278, GB 18279, GB 18280, GB/T 19974, ISO 14160 provides for medical device sterilization validation and routine control.2 Normative referencesThe following documents contain provisions which, through YY/T 0615 reference in this text, constitute provisions of this part. For dated reference documents Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this section. YY/T 0287-2003 medical device quality management system for regulatory requirements (ISO 13485.2003, IDT)3 Terms and DefinitionsThe following terms and definitions apply YY/T 0615 of this section. 3.1 Product and/or packaging of the number of viable microorganisms. 3.2 Designed by the manufacturer to become the following purposes for the human body, whether used alone or in combination, including the use of the required software Any instrument within the apparatus, appliances, materials or other items, in order to. --- Diagnosis, prevention, monitoring, treatment or alleviation; --- Disability diagnosis, monitoring, treatment, mitigation or compensation; --- Body structure or physiological process of research, replace or repair; --- Pregnancy control. For the human body or its principal expected effect on the human body is not a pharmacological, immunological or metabolic means to obtain, but in these instruments It uses play a supporting role. 3.3 No viable microorganisms state. 3.4 A medical device no viable microorganisms situation. 3.5 Medical devices after packaging or assembly through a sterilization process and maintaining the device or which particular part in sterility ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0615.1-2007_English be delivered?Answer: Upon your order, we will start to translate YY/T 0615.1-2007_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0615.1-2007_English with my colleagues?Answer: Yes. 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