YY 0285.1-2017Intravascular catheters—Sterile and single-use catheters - Part 1: General requirements (English PDF)

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;

- 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 GB 15810 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.

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.

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.

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.