YY/T 1630-2018 Translated English of Chinese Standard. (YYT 1630-2018, YY/T1630-2018, YYT1630-2018) PDF Download
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Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Medical
Languages : en
Pages : 9
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Book Description
This Standard specifies relevant terms and definitions, and fundamental principle of unique device identifier, and requirements for device identifier and requirements for production identifier. This Standard is applicable to the management of unique device identifier.
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Medical
Languages : en
Pages : 9
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Book Description
This Standard specifies relevant terms and definitions, and fundamental principle of unique device identifier, and requirements for device identifier and requirements for production identifier. This Standard is applicable to the management of unique device identifier.
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Medical
Languages : en
Pages : 20
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Book Description
This Part of YY/T 0681 specifies the guide for designed accelerated aging solutions. This Part applies to the rapid determination of the sterile integrity of the sterile barrier system specified in GB/T 19633.1-2015 and the effects that physical properties of its packaging material components are affected by the elapsed time.
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Medical
Languages : en
Pages : 19
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Book Description
This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of colloidal gold immunochromatography analyzers. This standard is applicable to instruments that interpret the results of samples by measuring the reflectivity of the bands in the reaction zone of the colloidal gold reagent card. This standard does not apply to instruments that use fluorescent labels or other labeling methods for rapid immunoassay.
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Medical
Languages : en
Pages : 11
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Book Description
This standard specifies test methods of determining the effectiveness of sterilization process for reusable medical devices. This standard applies to tests that have established the effectiveness of the sterilization process, it does not apply to the validation of the sterilization process.
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Medical
Languages : en
Pages : 12
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Book Description
This Standard specifies the terms and definitions, classification, requirements and test methods of medical diagnostic X-ray tube assemblies. This Standard is applicable to medical diagnostic X-ray tube assemblies. This product is for use with medical diagnostic X-ray equipment.
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Medical
Languages : en
Pages : 12
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Book Description
This document specifies the method that uses threshold of toxicological concern (TTC) to assess the biocompatibility of constituents of a medical device. This document applies to: - Compare with the maximum concentration of identified or unidentified constituents in an extract (see GB/T 16886.18); - Toxicological equivalence studies; - Comparison with the estimated maximum exposure dose for an identified constituent (see GB/T 16886.17).
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Medical
Languages : en
Pages : 28
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Book Description
This Standard specifies the terms and definitions, system composition, requirements and test methods for digital X-ray radiography system. This Standard is applicable to the DR system for general X-ray photography. It includes but not limited to DR systems that use line scan or area scan detectors.
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Medical
Languages : en
Pages : 20
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Book Description
This Part specifies the methods for testing the microbial barrier for porous packaging materials under moist conditions and with passage of air. The test methods given in this Part apply to the packaging materials for terminally sterilized medical devices.
Author: https://www.chinesestandard.net
Publisher: https://www.chinesestandard.net
ISBN:
Category : Medical
Languages : en
Pages : 12
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Book Description
This document specifies the requirements for creation and placement of unique device identifier. This document is applicable to the implementation and application of the unique device identifier by all relevant parties.
Author: https://www.chinesestandard.net
Publisher: www.ChineseStandard.net
ISBN:
Category : Medical
Languages : en
Pages : 40
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Book Description
This standard specifies the terms and definitions, classification and composition, requirements and test methods of mobile C-arm X-ray equipments. This standard applies to mobile X-ray equipments with C-arm mechanical support devices, which are mainly used for positioning and inspection, in surgical operations in medical and health institutions. This standard does not apply to C-arm X-ray equipment, which has a maximum focus-image-receiver distance (SID) of less than 60 cm.
