YY/T 0595-2020 Translated English of Chinese Standard. (YYT 0595-2020, YY/T0595-2020, YYT0595-2020)

YY/T 0595-2020 Translated English of Chinese Standard. (YYT 0595-2020, YY/T0595-2020, YYT0595-2020) PDF

Author: https://www.chinesestandard.net

Publisher: https://www.chinesestandard.net

Published: 2021-03-20

Total Pages: 174

ISBN-13:

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This standard provides guidelines for the application of medical device quality management system requirements in YY/T 0287-2017. This standard applies to organizations of various sizes and types, as well as suppliers or other external parties that provide products and services for them, which involves one or more stages of the life cycle of medical devices.

YY/T 1268-2015 Translated English of Chinese Standard. (YYT 1268-2015, YY/T1268-2015, YYT1268-2015)

YY/T 1268-2015 Translated English of Chinese Standard. (YYT 1268-2015, YY/T1268-2015, YYT1268-2015) PDF

Author: https://www.chinesestandard.net

Publisher: https://www.chinesestandard.net

Published: 2018-10-27

Total Pages: 21

ISBN-13:

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This standard specifies the equivalence of the sterilization process when using new equipment in the process of adopting new product or changed product into the originally validated ethylene oxide sterilization process. This standard applies to medical devices that have been treated by ethylene oxide (EO) sterilization and that use conventional release or parametric release.

YY/T 0313-1998 Translated English of Chinese Standard. (YYT 0313-1998, YY/T0313-1998, YYT0313-1998)

YY/T 0313-1998 Translated English of Chinese Standard. (YYT 0313-1998, YY/T0313-1998, YYT0313-1998) PDF

Author: https://www.chinesestandard.net

Publisher: https://www.chinesestandard.net

Published: 2019-04-07

Total Pages: 17

ISBN-13:

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This Standard specifies the package, label, transport and storage for medical polymer products. This Standard is applicable to the package, label, transport and storage for medical polymer products (hereinafter referred to as the products). Special products are regulated by product standards.

YY/T 1498-2016 Translated English of Chinese Standard. (YYT 1498-2016, YY/T1498-2016, YYT1498-2016)

YY/T 1498-2016 Translated English of Chinese Standard. (YYT 1498-2016, YY/T1498-2016, YYT1498-2016) PDF

Author: https://www.chinesestandard.net

Publisher: https://www.chinesestandard.net

Published: 2020-04-11

Total Pages: 33

ISBN-13:

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This Standard provides information on the types, safety and performance indicators of protective clothing materials; evaluation and selection of protective clothing products; guiding principles for the selection of protection levels based on specific medical procedures; guidelines for the maintenance and handling of protective clothing. It is impossible for this Standard to cover all the technical information necessary for medical institutions to select protective clothing products. Moreover, it should not be used as an evaluation standard for medical protective clothing products.

YY/T 1499-2016 Translated English of Chinese Standard. (YYT 1499-2016, YY/T1499-2016, YYT1499-2016)

YY/T 1499-2016 Translated English of Chinese Standard. (YYT 1499-2016, YY/T1499-2016, YYT1499-2016) PDF

Author: https://www.chinesestandard.net

Publisher: https://www.chinesestandard.net

Published: 2020-04-11

Total Pages: 16

ISBN-13:

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This Standard stipulates the classification and relevant identification requirements for liquid barrier performance of protective apparel intended for use in health care facilities. This Standard is applicable to protective apparel identified with liquid barrier performance or liquid microorganism barrier performance. This Standard is inapplicable to other protective equipment used by medical personnel, such as: (1) protective equipment (for example, radiation protective apparel) that is not identified or not used for liquid or microbial barriers; (2) utensils or equipment for handling hazardous chemicals, chemotherapy drugs or hazardous wastes.

YY/T 0586-2016 Translated English of Chinese Standard (YYT 0586-2016, YY/T0586-2016, YYT0586-2016)

YY/T 0586-2016 Translated English of Chinese Standard (YYT 0586-2016, YY/T0586-2016, YYT0586-2016) PDF

Author: https://www.chinesestandard.net

Publisher: https://www.chinesestandard.net

Published: 2017-02-11

Total Pages: 13

ISBN-13:

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The test methods in this Standard cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography) and DEXA (dual energy X-ray absorptiometry), also known as DXA. The results of these measurements are an indication of the likelihood of locating the product within the human body.