Single Use Intravenous Catheter Certification Test

The single-use intravenous catheter is typically made from polymer materials and medical-grade stainless steel, provided in a sterile form. The use of single-use intravenous catheters is considered one of the best methods for clinical infusion, offering ease of operation, suitability for punctures in any area, and reducing the pain of repeated punctures for patients, as well as the workload for healthcare workers.

1. Product Composition

The single-use intravenous catheter usually consists of the following components:

- Sheath

- Catheter assembly: Including the catheter, wedge, and catheter hub.

- Needle assembly: Including the needle and needle hub.

- Air-permeable stopper: May include a needle-stick protection device.

The catheter assembly is made up of the catheter, catheter hub, extension tube (if applicable), and any integrated connectors. The needle assembly is made up of the needle tube, needle hub, and/or any integrated attachments.

2. Scope of Application

Single-use intravenous catheters are used clinically for:

- Puncturing and introducing body fluids

- Blood collection

- Arterial blood pressure monitoring

- Continuous arterial blood gas monitoring

3. Risk Management Classification

In China, under the medical device registration classification catalog for "Infusion, Nursing, and Protective Devices" (Category 14), the single-use intravenous catheter falls under Class III risk management.

4. Registration Unit Division Principles and Examples

The registration unit for single-use intravenous catheters is generally based on factors such as the product's working principle, structure, and the materials of the primary components.

- If the materials of the main components (such as the catheter and extension tube, including plasticizers) differ, they should be divided into separate registration units. For example, straight-through and three-way catheters with different catheter materials should be assigned to different units.

- Products claiming to be light-resistant and those not claiming to be light-resistant should be placed in different registration units. For example, regular catheters and light-resistant catheters should belong to different units.

5. Common Product Standards

China Certification and Registration - Testing Program

- Special Standards

- YY/T 1282-2022: Single-Use Intravenous Catheter

- Sterile Medical Device Packaging Validation

- YY 0681.1-2018: Sterile Medical Device Packaging Test Methods - Accelerated Aging Test Guide

- YY/T 0681.2-2010: Seal Strength of Flexible Barrier Materials

- YY/T 0681.3-2010: Internal Pressure Resistance for Unconstrained Packaging

- YY/T 0681.4-2021: Dye Penetration Test for Sealed Permeable Packaging

- YY/T 0681.5-2010: Internal Pressure Test for Gross Leaks (Bubble Test)

- YY/T 0681.9-2011: Internal Air Pressure Test for Soft Packaging Seal Rupture

- YY/T 0681.11-2014: Visual Inspection of Medical Packaging Seal Integrity

- YY/T 0681.14-2018: Wet and Dry Microbial Barrier Tests for Permeable Packaging Materials

- GB/T 19633.1-2015: Final Sterilization Medical Device Packaging Materials and Sterile Barrier Systems Requirements

- GB/T 19633.2-2015: Confirmation of Sterilization Process - Forming, Sealing, and Assembly Requirements

- Chemical Characterization

- GB/T 16886.17-2005: Establishing Allowable Limits for Leachable Substances in Medical Devices

- GB/T 16886.18-2022: Chemical Characterization of Materials in Risk Management Process

- GB/T 14233.1-2022: Chemical Analysis Methods for Medical Infusion, Blood Transfusion, and Injection Devices

- Biocompatibility

- GB/T 16886.1-2022: Biological Evaluation of Medical Devices - Evaluation and Testing in Risk Management Process

- GB/T 16886.4-2022: Tests for Interaction with Blood

- GB/T 16886.5-2017: In Vitro cytotoxicity tests

- GB/T 16886.10-2024 (Effective Sept 1, 2025): Skin Sensitization Test

- GB/T 16886.11-2021: Systemic Toxicity Tests

- GB/T 16886.23-2023: Irritation Test

- Bacterial Endotoxin

- GB/T 14233.2-2005: Biological Testing Methods for Medical Infusion, Blood Transfusion, and Injection Devices

- Sterilization Effect Testing

- GB/T 19973.2-2018: Sterility Test for Confirming Sterilization Process

- GB/T 14233.1-2022: Chemical Analysis Methods for Medical Devices

- GB/T 16886.7-2015: Ethylene Oxide Residuals

- GB 18280 Series: Radiation Sterilization Requirements for Medical and Health Products

- Performance Standards

- GB/T 18457-2015: Manufacturing of Stainless Steel Needles for Medical Devices

- GB/T 1962.2-2001: Locking Connectors for Syringes, Injection Needles, and Other Medical Devices

- YY/T 0586-2016: X-Ray Impermeability Test for Medical Polymer Products

- GB 8368-2018: Single-Use Infusion Set - Gravity Infusion Type

- Packaging and Transport

- GB/T 4857 Series: Packaging Transport Packaging Basic Tests

International Certification Testing Program

- Sterile Medical Device Packaging

- ASTM F1980-21: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

- ISO 11607-1:2019: Final Sterilization Medical Device Packaging Part 1: Materials and Sterile Barrier Systems Requirements

- Chemical Characterization

- ISO 10993-17:2002: Establishing Allowable Limits for Leachable Substances in Medical Devices

- ISO 10993-18:2020: Chemical Characterization of Medical Device Materials in Risk Management Process

- Biocompatibility

- ISO 10993-1:2018: Biological Evaluation of Medical Devices - Evaluation and Testing in Risk Management Process

- ISO 10993-4:2017: Selection of Tests for Interaction with Blood

- ISO 10993-5:2009: In Vitro Cytotoxicity Tests

- iso 10993-10:2021: Skin Sensitization Test

- ISO 10993-11:2017: Systemic Toxicity Tests

- ISO 10993-23:2021: Irritation Test

- Sterilization Effect and Testing

- ISO 11737-1:2018: Microbiological Methods for Sterilization - Total Microbial Count Determination

- ISO 11737-2:2019: Sterility Test for Confirming Sterilization Process

- ISO 11137 Series: Radiation Sterilization Requirements for Health Care Products

Note:

The standards listed above are the most commonly referenced in product technical requirements. Enterprises should refer to other applicable standards based on the specific characteristics of the product.

China JJR Medical Device Laboratory has obtained CNAS and CMA authorization for the above testing standards, including biocompatibility testing, physicochemical tests, packaging, and transport. We can provide one-stop registration and testing services for global market entry of Single-Use Intravenous Catheters.