YY 0285.1-2017 PDF English
US$185.00 · In stock · Download in 9 secondsYY 0285.1-2017: Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid YY 0285.1: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY 0285.1-2017 | English | 185 |
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Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
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| YY 0285.1-2004 | English | 70 |
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Sterile, single-use intravascular catheters. Part 1: General requirements
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| YY 0285.1-1999 | English | 359 |
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Sterile, single-use intravascular catheters. Part 1: General requirements
| Obsolete |
| YY 0285.1-1996 | English | 559 |
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(Disposable Sterile intravascular catheters and accessories - Part 1: General requirements)
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YY 0285.1-2017: Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
---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/YY0285.1-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.20
C 31
Replacing YY 0285.1-2004, YY 0285.2-1999
Intravascular catheters - Sterile and single-use catheters -
Part 1.General requirements
(ISO 10555-1.2013, MOD)
Issued on. JULY 17, 2017
Implemented on. JANUARY 1, 2019
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 6
4 Requirements... 9
5 Mark of nominal size... 11
6 Information provided by manufacturers... 11
Foreword
YY 0285 “Intravascular catheters - Sterile and single-use catheters” consists of four
parts.
- Part 1.Intravascular catheters - Sterile and single-use catheters - Part 1.General
requirements;
- Part 3.Intravascular catheters - Sterile and single-use catheters - Part 3.Central
venous catheters;
- Part 4.Intravascular catheters - Sterile and single-use catheters - Part 4.Balloon
dilatation catheters;
- Part 5.Intravascular catheters - Sterile and single-use catheters - Part 5.Trocar
peripheral catheter.
This part is the first part of YY 0285.
This part was drafted in accordance with the rules in GB/T 1.1-2009.
This part replaces YY 0285.1-2004 "Sterile, single-use intravascular catheters - Part 1.
General requirements" and YY 0285.2-9 "Sterile, single-use intravascular catheters -
Part 2.Angiographic catheter".
Compared with YY 0285.1-2004 and YY 0285.2-1999, the main technical changes in
this part are as follows.
- revise the requirements and test methods of angiographic catheter;
- revise flow requirements;
- modify some verbal expressions. This part uses the redrafted law revision using
IS0 10555-1.2013 "Intravascular catheters - Sterile and single-use catheters - Part
1.General requirements".
The technical differences and the reasons between this part and ISO 10555-1.2013
are as follows.
- With regard to the normative references, this part has made adjustments with
technical differences so as to adapt to the technical conditions in our country. The
adjustments are mainly reflected in Chapter 2 "Normative References". The
specific adjustments are as follows.
• Replace ISO 594-1 with GB/T 1962.1 that is identical to international standard;
• Replace ISO 594-2 with GB/T 1962.2 that is identical to international standard;
• Replace ISO 7886-1 with GB15810 that is identical to international standard;
• Replaced ISO 3104 with GB/T 30515 that is identical to international standard;
• Replace ISO 15223-1 with YY/T 0466.1 that is identical to international standard.
Please note that some of this document may involve patents. The issuing agencies of
this document do not bear the responsibility of identifying these patents.
This part was proposed by China Food and Drug Administration.
This part shall be under the jurisdiction of Jinan Medical Device Quality Supervision
and Inspection Center, State Food and Drug Administration.
The main drafting organizations of this part. Shanghai Medical Device Testing
Institute(CMTC), Beilang Medical (Shanghai) International Trade Co., Ltd., Shanghai
minimally invasive medical devices (Group) Co., Ltd.
The participating drafting organizations of this part. Shandong Province Medical
Device Quality Inspection Center, Johnson & Johnson (Shanghai) Medical Equipment
Co., Ltd., Cook (China) Medical Trade Co., Ltd., Medtronic (Shanghai) Management
Co., Ltd.
The main drafters of this part. Hua Songhe, Yang Xi, Li Yong, Chen Baoai, Mu Pengtao,
Li Yuanyu.
The previous released editions replaced by this part include.
- YY 0285.1-1999, YY 0285.1 - 2004, YY 0285.2-1999.
Intravascular catheters - Sterile and single-use catheters
- Part 1.General requirements
1 Scope
This part of YY 0285 specifies the general requirements for intravascular catheters of
various uses with sterile supply and single-use. This part does not apply to
intravascular catheter accessories, such as YY 0450.1.
2 Normative references
The following document for the application of this document is essential. For dated
references, only the dated version applies to this document. For undated references,
the latest edition (including all amendments) applies to this document.
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 1962.1-2015, ISO 594-
1.1986, IDT)
3 Terms and definitions
The following terms and definitions apply to this document.
The shape of the catheter end that is designed to facilitate manual insertion of the
catheter into the cardiovascular system and to place and secure the distal end of the
catheter to a selected location.
4 Requirements
With at least 25 times magnification, when using normal vision or corrected to normal
vision to check, the outer surface of the catheter at its effective length shall be clean
and free of impurities.
To reduce damage to the blood vessels during use, the distal end & head end of the
catheter shall be rounded, tapered or treated similarly.
5 Mark of nominal size
When effective length is less than 100 mm, it shall be expressed in millimeters; when
effective length is greater than or equal to 100 mm, it shall be expressed in millimeters
or centimeters.
6 Information provided by manufacturers
Instruments shall be accompanied by relevant safety and proper-use information. All
dimensions given shall be expressed in international units.
In addition to the units specified above, additional units of measurement may be
attached.
Appendix A
(Normative)
Corrosion resistance test method
Immerse the catheter in sodium chloride solution first, and then immerse it in boiling
distilled water, and then check the corrosive traces with the naked eye.
Appendix B
(Normative)
Peak tension test method
Select the test section of the catheter or entire catheter so that each connection
between each tubular portion, catheter adapter or connector and the pipeline, and
connections between each tubular portion are tested. Put tension on each test section
until the pipeline is broken or the connection is separated.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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