YY/T 0285.5-2018 English PDFUS$289.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0285.5-2018: Intravascular catheters-Sterile and single-use catheters--Part 5: Over-needle peripheral catheters Status: Valid YY/T 0285.5: Historical versions
Basic dataStandard ID: YY/T 0285.5-2018 (YY/T0285.5-2018)Description (Translated English): Intravascular catheters-Sterile and single-use catheters--Part 5: Over-needle peripheral catheters Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C31 Classification of International Standard: 11.040.20 Word Count Estimation: 13,134 Date of Issue: 2018-02-28 Date of Implementation: 2019-03-01 Issuing agency(ies): State Food and Drug Administration Summary: This International Standard specifies requirements for trocar-type intravascular catheters supplied sterile and intended for single-use insertion into the peripheral vascular system. YY/T 0285.5-2018: Intravascular catheters-Sterile and single-use catheters--Part 5: Over-needle peripheral catheters---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. ICS 11:040:20 C31 Pharmaceutical Industry Standard of the People's Republic of China YY 0285:5-2018 Replace YY 0285:5-2004 Intravascular Catheters Disposable Sterile Catheters Part 5: Trocar peripheral catheters (ISO 10555-5:2013, MOD) According to the State Drug Administration medical device industry Standard Announcement (No: 76 of 2022), this standard is from From September 7, 2022, it will be converted into a recommended standard, no Enforce it again: Released on:2018-02-24 Implemented on:2019-03-01 Issued by China Food and Drug Administration forewordYY 0285 "Intravascular Catheter Disposable Sterile Catheter" is divided into the following parts: --- Part 1: General requirements; --- Part 3: Central venous catheters; --- Part 4: Balloon dilatation catheters; --- Part 5: Trocar peripheral catheter: This part is the fifth part of YY 0285: The following parts have been withdrawn and have been included in Part 1: --- Part 2: Contrast catheter: This section is drafted in accordance with the rules given in GB/T 1:1-2009: This Part replaces YY 0285:5-2004 "Single-use Sterile Intravascular Catheters Part 5: Trocar Peripheral Catheters", and Compared with YY 0285:5-2004, the main revisions are as follows: ---Modified the normative reference documents; --- Deleted Appendix A: This part uses the redrafted law to revise and adopt ISO 10555-5:2013 "Intravascular catheters for single-use sterile catheters Part 5 Subsection: Trocar Peripheral Catheters: The technical differences between this part and ISO 10555-5:2013 and the reasons are as follows: --- Regarding the normative reference documents, this standard has made adjustments with technical differences to adapt to the technical conditions of our country and the adjustment situation The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows: ● Replaced ISO 594-1 with GB/T 1962:1, which is equivalent to the international standard; ● Replaced ISO 9626 with GB/T 18457, which is equivalent to the international standard; ● Replacing ISO 10555-1 with YY 0285:1 which adopts the international standard: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents: This part is proposed by China Food and Drug Administration: This part is under the jurisdiction of the National Standardization Technical Committee of Medical Infusion Sets: This part is drafted by: Shandong Provincial Medical Device Product Quality Inspection Center, Shandong Xinhua Ande Medical Supplies Co:, Ltd: The main drafters of this section: Li Yuanyu, Liu Bin, Tian Xiaolei, Gao Ranran: The previous version releases replaced by this part are as follows: ---YY 0285:5-2004, YY 0285:5-1999: YY 0285:5-2018 Intravascular Catheters Disposable Sterile Catheters Part 5: Trocar peripheral catheters1 ScopeThis part of YY 0285 specifies the blood trocars supplied in a sterile state and used for single use for insertion into the peripheral vascular system In-line catheter requirements:2 Normative referencesThe following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document pieces: For undated references, the latest version (including all amendments) applies to this document: GB/T 1962:1 Syringes, injection needles and other medical devices 6% (Luer) conical fittings Part 1: General requirements (GB/T 1962:1-2015, ISO 594-1:1986, IDT) GB/T 18457 Manufacture of stainless steel needle tubes for medical devices (GB/T 18457-2015, ISO 9626:1991, MOD) YY 0285:1 Intravascular Catheters Sterile Disposable Catheters Part 1: General Requirements (YY 0285:1-2017, ISO 10555-1:2013, MOD)3 Terms and DefinitionsThe following terms and definitions defined in YY 0285:1 apply to this document: 3:1 A catheter used to introduce or remove fluids or devices from the peripheral vasculature: 3:2 needle needle An assembly including at least one needle tube and a hub that fixes it and communicates with it: see picture 1: 3:3 needle tube A rigid tube that is cut at one end to facilitate entry into body tissue: 3:4 needle hub The connector for fixing the needle tube, the inner hole of which communicates with the needle tube: 3:5 Exhaust joint ventfitting A fitting used to vent gas while restricting or preferably preventing the outflow of blood: Divided into two kinds of fixed or movable: 3:6 catheter assembly catheterunit An assembly consisting of catheter tubing, a catheter adapter, and any integral connectors: see picture 1: YY 0285:5-2018 ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0285.5-2018_English be delivered?Answer: Upon your order, we will start to translate YY/T 0285.5-2018_English as soon as possible, and keep you informed of the progress. 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Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY/T 0285.5-2018?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0285.5-2018 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
