YY/T 0614-2017 PDF English
US$150.00 · In stock · Download in 9 secondsYY/T 0614-2017: Single-use high-pressure angiographic syringes and accessories Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid YY/T 0614: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 0614-2017 | English | 150 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Single-use high-pressure angiographic syringes and accessories
| Valid |
| YY 0614-2007 | English | 479 |
Add to Cart
|
3 days
|
Single-use high-pressure angiographic syringes and accessories
| Obsolete |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: YY/T 0614-2017
YY/T 0614-2017: Single-use high-pressure angiographic syringes and accessories---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0614-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.20
C 31
Replacing YY/T 0614-2007
Single-use high-pressure
angiographic syringes and accessories
Issued on. FEBRUARY 28, 2017
Implemented on. JANUARY 01, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
Introduction... 5
1 Scope... 6
2 Normative references... 6
3 Product type... 7
4 Product marking... 8
5 Materials... 9
6 Physical requirements... 9
7 Chemical requirements... 12
8 Biological requirements... 12
9 Markings... 12
10 Packaging... 14
Appendix A (Normative) Adhesion test... 15
Appendix B (Normative) Chemical performance test solution preparation
method... 17
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0614-2007 “Single-use high-pressure
angiographic syringes and accessories”. As compared with YY/T 0614-2007, in
addition to editorial changes, the main technical changes of this standard are
as follows.
- ADD the 88 kPa negative pressure adhesion requirements of the
angiographic syringe;
- MODIFY the cork piercer requirements;
- MODIFY the air intake device requirements;
- ADD anti-reflux valve requirements and test methods;
- REVISE the adhesion test method;
- ADD a single package identifier;
- ADD a shelf package or multi-unit packaging identifier;
- DELETE the Appendix A Particle content determination method from the
original standard, the particle content determination method makes
reference to the test method as given in YY/T 1556-2017 Test methods for
particle contamination of infusion, transfusion and injection equipment for
medical use which is formulated at the period;
- MODIFY the chemical test solution preparation method.
Please note that some of the contents of this document may involve patents.
The issuing agency of this document does not assume responsibility for
identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard shall be under the jurisdiction of the National Standardization
Technical Committee for Medical Infusion Devices (SAC/TC 106).
Drafting organizations of this standard. Shandong Medical Device Product
Quality Inspection Center, Shenyang Xinzhiyuan Medical Products Co., Ltd.,
Wuxi Yushou Medical Devices Co., Ltd., Jiangsu Guoyu Ningtai Medical
Devices Co., Ltd.
Main drafters of this standard. Yao Xiujun, Gao Na, Liu Han, Feng Zhong, Han
Enxi, Xing Xijuan.
The previous versions of YY/T 0614 are.
- YY 0614-2007.
1 Scope
This standard specifies the requirements for the single-use high-pressure
angiographic syringes and accessories (hereinafter referred to as angiographic
syringes). The angiographic syringe is mainly used by the medical department
to perform digital subtraction angiography (DSA), computer-controlled
tomography (CT), magnetic resonance imaging (MRI), and ultrasound (US)
examinations, together with various types of high-pressure injection device.
This standard does not include requirements for endovascular catheters and
related guidance puncture devices.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) are applicable to this standard.
GB/T 1962.1 Conical fittings with a 6%(Luer) taper for syringes, needles and
certain other medical equipment - Part 1.General requirement
GB/T 1962.2 Conical fittings with a 6%(Luer) taper for syringes, needles and
certain other medical equipment - Part 2.Lock fittings
GB 15810 Sterile hypodermic syringes for single use
YY/T 0466.1-2009 Medical devices - Symbols to be used with medical
device labels, labelling and information to be supplied - Part 1.General
requirements
YY 0585.4-2009 Fluid lines for use with pressure infusion equipment and
accessories for single use - Part 4.Check valves
3 Product type
Figure 1 ~ Figure 3 show the schematic diagrams of the structures of common
angiographic syringes and accessories (inhalers, connecting lines, etc.).
4 Product marking
Products marking is composed of product literal expression, this standard
number, applicable angiographic imaging techniques code [such as computer-
controlled X-ray tomography (CT), digital subtraction angiography (DSA),
magnetic resonance imaging (MRI), ultrasound (US), etc.], injection equipment
5 Materials
The materials used for the angiographic syringe and the parts given in clause
3 shall comply with the requirements of clause 6.
6 Physical requirements
6.1 General requirements
6.1.4 6% Luer cone joint
The conical joint for angiographic syringes and accessories shall meet the
following requirements.
6.1.5 Particle contamination
Angiographic syringes and accessories shall be manufactured with minimal
particulate contamination.
6.2 Angiographic syringe additional requirements
6.2.1 Lubricants
The inner surface of the angiographic syringe jacket and the outer surface of
the plunger shall have no lubricant accumulation.
6.2.2 Transparency
The angiographic syringe jacket shall have sufficient transparency.
6.3 Additional requirements for inhaler
6.3.1 Puncture type inhaler
6.3.2 Tubular inhaler
Tubular inhaler shall be compatible with angiographic syringes, the wall
thickness shall not be less than 0.5 mm.
6.4 Additional requirements for connection pipelines
6.4.1 Size
The internal diameter of the connection pipelines shall not be less than 1.0 mm,
the length shall not be less than the nominal value.
6.4.4 Anti-backflow valve
6.4.4.1 Backflow pressure impedance
At 23 °C ± 2 °C, the anti-backflow valve shall be able to withstand the nominal
water pressure for 30 s along the backflow direction of the connection pipeline
without leakage.
6.4.4.2 Blocking performance
It shall meet the requirements of clause 6.7 of YY 0585.4-2009.
7 Chemical requirements
The provisions of GB 15810 apply to angiographic syringes and accessories,
but the preparation method of test liquids is in accordance with Appendix B.
8 Biological requirements
The provisions of GB 15810 apply to angiographic syringes and accessories.
9 Markings
9.1 Single package
The single package shall be marked with at least the following information.
9.2 Shelf packaging or multiple-unit packaging
The shelf packaging or multi-unit packaging (if used) shall have at least the
following information.
10 Packaging
10.1 Angiographic syringes and/or accessories shall be packaged in set or
individually packaged, the packaging shall ensure that the contents remain
sterile during the storage period. After opening the single package, there shall
be open signs.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Tips & Frequently Asked QuestionsQuestion 1: How long will the true-PDF of English version of YY/T 0614-2017 be delivered?Answer: The full copy PDF of English version of YY/T 0614-2017 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice. Question 2: Can I share the purchased PDF of YY/T 0614-2017_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0614-2017_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- YY/T 0614-2017 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds. Question 5: Should I purchase the latest version YY/T 0614-2017?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0614-2017 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. How to buy and download a true PDF of English version of YY/T 0614-2017?A step-by-step guide to download PDF of YY/T 0614-2017_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "YY/T 0614-2017".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9
|