Intravascular Catheters — Sterile and Single-use Catheters — Part 3: Central Venous Catheters
1 Scope
This part of YY 0285 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
YY 0285.1-2017 Intravascular Catheters — Sterile and Single-use Catheters — Part 1: General Requirements (ISO 10555-1:2013, IDT)
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in YY 0285.1-2017 and the following apply.
3.1
central venous catheter
intravascular catheter, single- or multilumen, designed for introduction into, or withdrawal of liquids from, the central venous system and/or for pressure or other measurements
Note: The catheter can have a fixation system which is part of the device.
4 Requirements
4.1 General
Catheters shall comply with YY 0285.1-2017, except for the peak tensile force (see YY 0285.1-2017, 4.6), for which the requirements of 4.4 shall apply.
4.2 Distance markings
If the catheter is provided with distance markings, the marking system shall indicate distance from the distal end. From the first mark, the distance between marks shall not exceed 5 cm.
It is recommended that the distance marks be 1 cm apart on that portion of the catheter likely to be of importance to the user in positioning the catheter and monitoring catheter migration.
4.3 Lumen markings
Foreword II 1 Scope 2 Normative References 3 Terms and Definitions 4 Requirements
Intravascular Catheters — Sterile and Single-use Catheters — Part 3: Central Venous Catheters
1 Scope
This part of YY 0285 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
YY 0285.1-2017 Intravascular Catheters — Sterile and Single-use Catheters — Part 1: General Requirements (ISO 10555-1:2013, IDT)
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in YY 0285.1-2017 and the following apply.
3.1
central venous catheter
intravascular catheter, single- or multilumen, designed for introduction into, or withdrawal of liquids from, the central venous system and/or for pressure or other measurements
Note: The catheter can have a fixation system which is part of the device.
4 Requirements
4.1 General
Catheters shall comply with YY 0285.1-2017, except for the peak tensile force (see YY 0285.1-2017, 4.6), for which the requirements of 4.4 shall apply.
4.2 Distance markings
If the catheter is provided with distance markings, the marking system shall indicate distance from the distal end. From the first mark, the distance between marks shall not exceed 5 cm.
It is recommended that the distance marks be 1 cm apart on that portion of the catheter likely to be of importance to the user in positioning the catheter and monitoring catheter migration.
4.3 Lumen markings
Contents of YY 0285.3-2017
Foreword II
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
