YY 0285.4-2017Intravascular catheters—Sterile and single-use catheters - Part 4: Balloon dilatation catheters (English PDF)

Foreword

YY 0285 "Intravascular catheters - Sterile and single-use catheters" consists of four parts.

- Part 1: General requirements;

- Part 3: Central venous catheters;

- Part 4: Balloon dilatation catheters;

- Part 5: Over-needle peripheral catheters. This Part is Part 4 of YY 0285.

This Part is drafted in accordance with the rules given in GB/T 1.1-2009.

This Part replaces YY 0285.4-1999 "Sterile, single-use intravascular catheters - Part 4: Balloon dilatation catheters". Compared with YY 0285.4-1999, the main technical changes are as follows.

- UPDATE normative references;

- ADD the requirements and test methods for balloon rated burst pressure, balloon deflation time, and relationship between balloon diameter and inflation pressure.

This Part uses the redraft law to modify and adopt ISO 10555-4:2013 "Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters".

The technical differences between this Part and ISO 10555-1:2013 and their reasons are as follows.

- As for the normative references, this Standard has made adjustments with technical differences, to adapt to the technical conditions of China. The adjustments are mainly reflected in Clause 2 "Normative references". The specific adjustments are as follows.

lambda Replace ISO 594-1 with GB/T 1962.1, which is identical to the international standard;

lambda Replace ISO 594-2 with GB/T 1962.2, which is identical to the international standard;

lambda Replace ISO 10555-1 with YY 0285.1, which is identical to the international standard.

1 Scope

This Part of YY 0285 specifies requirements for balloon dilatation catheters supplied in the sterile condition, and intended for single use.

2 Normative references

The following documents are indispensable for the application of this document.

For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable 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 Definitions

For the purposes of this document, the terms and definitions given in YY 0285.1 and the following apply.

Intravascular catheter fitted with a balloon near the distal end, which is introduced into an artery or vein to dilate a part or parts of the vascular system.

4 Requirements

Determine the rated burst pressure with an appropriate safety margin when tested in accordance with Annex A. Longitudinal failure is the desirable balloon failure mode.

Annex A (Normative) Test for balloon rated burst pressure (RBP)

The purpose of this test is to determine the RBP of the balloon.

Annex B (Normative)

Balloon fatigue test for freedom from leakage and damage on inflation The catheter is inflated and deflated a number of times to simulate use in vivo.

The catheter in an inflated condition is examined for leakage, rupture or herniation.

Annex C (Normative)

Test for balloon deflation time The purpose of this test is to determine the time required to deflate the balloon from the rate burst pressure (RBP) level. This test provides information that might be clinically useful for treatment planning (e.g. potential occlusion time).

Annex D (Normative)

Test for balloon diameter to inflation pressure The purpose of this test is to determine the relationship between the balloon diameter and the inflation pressure.

Annex E (Informative)

Guidance on the selection of balloon materials The balloon, if it should fail during use, should burst longitudinally and without fragmentation. Consider the severity of other failure modes. Consideration should be given to this guideline in the selection of the balloon material and the manner of securing the balloon material to the shaft.