YY 0450.1-2020Accessory devices for sterile single-use intravascular catheters - Part 1: Introducers (English PDF)

Foreword

Some content of 6.2 in this Part is recommended, and the remaining is mandatory.

YY 0450 Accessory Devices for Sterile Single-use Intravascular Catheters is composed of the following parts.

---Part 1: Introducers;

---Part 2: Obturators for Over-needle Peripheral Catheters;

---Part 3: Inflation Devices for Balloon of Balloon Dilatation Catheters. This Part is Part 1 of YY 0450.

This Part was drafted in accordance with the rules provided in GB/T 1.1-2009.

This Part serves as a replacement of YY 0450.1-2003 Accessory Devices for Sterile Single-use Intravascular Catheters - Part 1: Introducers.

In comparison with YY 0450.1-2003, other than editorial modifications, the main technical changes are as follows.

---Some requirements and test methods of guidewires are modified (see Chapter 8; Chapter 8 of Version 2003);

---The requirements for size designation are modified (see 5.2, 6.5, 7.2, 8.2 and 9.2; see 5.2, 6.5, 7.2, 8.2 and 9.2 of Version 2003);

---Appendix I "Determination Method of Strength of Union of Needle Hub and Needle" is added (see Appendix I);

This Part adopts the re-drafting law to modify the adoption of ISO 11070:2014 Sterile Single-use Intravascular Introducers, Dilators and Guidewires.

In comparison with ISO 11070:2014, there are structural differences. The differences and the causes for these differences are shown below.

---Chapter 11 "Determination of Strength of Union of Needle Hub and Needle" is added, which quotes Appendix I; meanwhile, 5.4.2 is modified, which quotes Chapter 11, so as to comply with the requirements of GB/T 1.1 for the sequence of the appendix of volume in this Part. In comparison with ISO 11070:2014, there is no technical difference.

In comparison with ISO 11070:2014, there are technical differences. The differences and the causes for these differences are shown below.

---In terms of Normative References, this Part makes adjustments with technical differences, so as to adapt to the technical conditions of China. The adjustments are intensively reflected in Chapter 2 "Normative References". See the specific adjustments below.

lambda GB/T 1962.1, which equivalently adopts International Standard, is used to replace ISO 594-1;

lambda GB/T 1962.2, which equivalently adopts International Standard, is used to replace ISO 594-2;

lambda GB/T 7408, which equivalently adopts International Standard, is used to replace ISO 8601;

lambda GB 15810, which equivalently adopts International Standard, is used to replace ISO 7886-1;

lambda GB/T 16886.1, which equivalently adopts International Standard, is used to replace ISO 10993-1;

lambda YY/T 0466.1, which equivalently adopts International Standard, is used to replace ISO 15223-1;

lambda Use YY/T 0586-2016 to replace ASTM F640-12 and DIN 13273-7.

---In terms of footnote, this Part makes adjustments with technical differences. See the specific adjustments below.

Footnote 1) and Footnote 2) are modified, so as to adapt to the current international and national technical conditions.

Please be noted that certain content of this document might involve patents. The institution issuing this document does not undertake the responsibility of identifying these patents.

1 Scope

This Part of YY 0450 specifies the requirements for single-use introducer needles, introducer catheters, sheath introducers, guidewires and dilators supplied in the sterile condition and used in conjunction with intravascular catheters specified in YY 0285.

This Standard is applicable to single-use introducer needles, introducer catheters, sheath introducers, guidewires and dilators supplied in the sterile condition and used in conjunction with intravascular catheters specified in YY 0285.

2 Normative References

The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document.

GB/T 1962.11) 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 are applicable to this document.

Distal end refers to one end of a medical device that is inserted into patient's body.

4 General Requirements

When tested in accordance with the appropriate requirements in GB/T 16886.1, the medical device shall be free of biological hazards.

If the intravascular catheter introducer is coated with lubricant, when normal vision or corrected vision is adopted for the inspection, the outer surface of the effective length of the medical device shall not manifest concentrated lubricant droplets.

5 Additional Requirements for Introducer Needles

When inspected under 2.5 times magnification, the needle point shall be sharp and free of feather edges, burrs or hooks.

If a needle hub is provided, the needle hub shall have a 6% (Luer) taper internal conical fitting that complies with GB/T 1962.1 and / or GB/T 1962.2.

6 Additional Requirements for Introducer Catheters

When tested in accordance with the method provided in Appendix C, the peak tensile force of the introducer catheter and the junction between the introducer catheter and the hub shall comply with the stipulations of Table 2.

7 Additional Requirements for Sheath Introducers

If the sheath introducer is equipped with an integral hemostasis valve, when tested in accordance with Appendix E, the hemostasis valve shall not generate any leakage.

When tested in accordance with the method provided in Appendix C, the minimum peak tensile force of the sheath introducer and the junction between the sheath introducer and the hub shall comply with the stipulations of Table 2.

8 Additional Requirements for Guidewires

When tested in accordance with Appendix G, the guidewire shall not manifest fracture, loosening or failure in the following forms. The manufacturer shall provide the following information.

9 Additional Requirements for Dilators

When tested in accordance with the method provided in Appendix C, the peak tensile force of the dilator and the junction between the dilator and the hub shall comply with the requirements of Table 2.

The manufacturer shall provide the nominal sizes of dilators designated in 9.2.