Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
YY 0285 Intravascular Catheters - Sterile and Single-use Catheters consists of the following four Parts under the general title:
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: Over-needle Peripheral Catheters
This part is Part 1 of YY 0285.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This Part replaces YY 0285.1-2004 Sterile, Single-Use Intravascular Catheters - Part 1: General Requirements and YY 0285.2-1999 Sterile Single-use Intravascular Catheters - Part 2: Angiographic Catheters.
Compared with YY 0285.1-2004 and YY 0285.2-1999, the main technical changes are as follows:
- the requirements and test methods of Angiographic catheters are modified;
- the requirements for flow are modified;
- some literal expressions are corrected.
This part has been redrafted and modified in relation to International Standard ISO 10555-1: 2013 Intravascular Catheters -- Sterile and Single-use Catheters - Part 1: General Requirements
Technical deviations between this standard and the International Standard ISO 10555-1: 2013 and their justifications are as follows:
- as for normative references, adjustments with technical deviations have been made in this part to adapt to Chinese technical conditions, and are concentratedly reflected in Chapter 2 “Normative References” , which are as follows in specific:
– replace ISO 594-1 with GB/T 1962.1 identical with the international standard;
– replace ISO 594-2 with GB/T 1962.2 identical with the international standard;
– replace ISO 7886-1 with GB 15810 identical with the international standard;
- replace ISO 3104 with GB/T 30515 modified from the international standard;
– replace ISO 15223-1 with GB/T 0466.1 identical with the international standard;
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this standard shall not be held responsible for identifying any or all such patent rights.
This part was proposed by China Food and Drug Administration
This part is under the jurisdiction of China Food and Drug Administration Jinan Medical Appliance Quality Supervision and Inspection Center.
The previous editions hereof replaced by this part are as:
—— YY 0285.1-1999,YY 0285.1-2004,YY 0285.2-1999.
Intravascular Catheters — Sterile and Single-use Catheters — Part 1: General Requirements
1 Scope
This part of YY 0285 specifies the general requirements of sterile, single-use intravascular catheters for various purposes.
This part is not applicable to accessory devices for intravascular catheters, e.g. YY 0450.1.
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.
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)
GB/T 1962.2 Conical Fittings with a 6% (Luer)Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2:Lock Fittings (GB/T 1962.2-2001, ISO 594-2: 1998, IDT)
GB 15810 Sterile Hypodermic Syringes for Single Use(GB 15810-2001, Eqv ISO 7886-1: 1993)
GB/T 30515 Petroleum Products - Transparent and Opaque Liquids-Determination of Kinematic Viscosity and Calculation of Dynamic Viscosity(GB/T 30515-2014, ISO 3104: 1994.MOD)
YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied - Part 1:General Requirements(YY/T 0466.1-2016, ISO 15223-1: 2012, IDT)
YY/T 0586 Medical Polymer Products - Test Methods of Radiopacity
ISO 3105: 1994
Glass Capillary Kinematic Viscometers - Specifications and Operating Instructions
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
intravascular catheter
tubular device, single or multilumen, designed to be partially or totally inserted or implanted into the cardiovascular system for diagnostic and/or therapeutic purposes
3.2
distal end
end of the catheter inserted furthest into the patient
3.3
distal end configuration
shape of the catheter which is designed to facilitate its manual manipulation through the cardiovascular system and the placement and anchoring of the distal tip in the chosen location
3.4
proximal end; access end
end of the catheter to which connection can be made
3.5
hub
connector(s) at the proximal end of the catheter which may either be integral with the catheter or be capable of being securely fitted to the proximal end of the catheter
3.6
effective length, l
length of the catheter, or pre- and post-hydration lengths of hydratable catheters that can be inserted into the body
See: Figure 1.
Keys:
1 - effective length;
1 - catheter hub;
2- catheter strain reinforcement;
3- length mark;
4 - junction;
5- pre-connected port
Figure 1 Examples of Effective Length of Catheters
3.7
outside diameter
largest diameter of the catheter or pre- and post-hydration largest diameters of hydratable catheters that can be inserted into the vessel
3.8
Junction
the joining of one tube or more tubes, where the assembly of the tubes provide mechanical support in tension/compression during clinical use
3.9
hydratable intravascular catheter
intravascular catheter consisting of a material that manifests clinically significant hydration when subjected to an aqueous medium
3.10
post-hydration
state of a hydratable intravascular catheter after immersion in aqueous medium at (37±2)°C for a clinically appropriate period of time
3.11
clinically significant hydration
hydrated state in which either the post-hydration effective length is greater than the pre-hydration effective length by more than 1 % of the effective length, or the post-hydration outside diameter is greater than the pre-hydration outside diameter by 10 % or more
3.12
power injection
rapid injection of fluid at high pressure
3.13
primary packaging
packaging which has direct contact with the device and/or maintains the sterility of the product
3.14
secondary packaging
packaging designed to contain one or more primary packages
3.15
angiographic catheter
intravascular catheter used for the injection of contrast media and/or fluids and which may be used for pressure measurements and to obtain blood samples or insertion of coaxial inner catheter, occlusion coils or other devices
4 Requirements
4.1 General
The catheter shall have been sterilized by an appropriate validated method, and shall comply with 4.2 to 4.8 in the sterile condition.
4.2 Radio-detectability
Parts of the catheter shall be radio-detectable if required as determined by the risk assessment.
Compliance should be demonstrated by an appropriate test method, such as YY/T 0586.
Note: it may also be evaluated according to DIN 13273-7.
4.3 Biocompatibility
The catheter shall be free from biological hazard.
Note: the biological evaluation is detailed in GB/T 16886.1.
4.4 External surface
When examined by normal or corrected to normal vision, with a minimum x 2,5 magnification the external surface of the effective length of the catheter shall appear free from extraneous matter.
The external surface of the effective length of the catheter, including the distal end, shall be free from process and surface defects which could cause trauma to vessels during use.
If the catheter is lubricated, the lubricant shall not be visible as drops of fluid on the external surface when the catheter is examined under normal or corrected to normal vision.
4.5 Corrosion resistance
When tested in accordance with the method given in Annex A, metallic components of the catheter intended for fluid path contact shall show no signs of corrosion.
4.6 Peak tensile force
When tested in accordance with the method given in Annex B, the peak tensile force of each test piece shall be as given in Table 1.
Foreword i
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Designation of Nominal Size
6 Information to be Supplied by the Manufacturer
Annex A (Normative) Test Method for Corrosion Resistance
Annex B (Normative) Method for Determining Peak Tensile Force
Annex C (Normative) Test Method for Liquid Leakage under Pressure
Annex D (Normative) Test Method for Air Leakage into Hub Assembly during Aspiration
Annex E (normative) Determination of Flowrate through Catheter
Annex F (Normative) Test for Burst Pressure under Static Conditions
Annex G (Normative) Power Injection Test for Flow-rate and Device Pressure (Only for Products Indicated for Power Injection)
Annex H (Informative) Units of Measurement Systems Other than Those Specified in This Part, Which May Additionally be Used
Bibliography
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
YY 0285 Intravascular Catheters - Sterile and Single-use Catheters consists of the following four Parts under the general title:
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: Over-needle Peripheral Catheters
This part is Part 1 of YY 0285.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This Part replaces YY 0285.1-2004 Sterile, Single-Use Intravascular Catheters - Part 1: General Requirements and YY 0285.2-1999 Sterile Single-use Intravascular Catheters - Part 2: Angiographic Catheters.
Compared with YY 0285.1-2004 and YY 0285.2-1999, the main technical changes are as follows:
- the requirements and test methods of Angiographic catheters are modified;
- the requirements for flow are modified;
- some literal expressions are corrected.
This part has been redrafted and modified in relation to International Standard ISO 10555-1: 2013 Intravascular Catheters -- Sterile and Single-use Catheters - Part 1: General Requirements
Technical deviations between this standard and the International Standard ISO 10555-1: 2013 and their justifications are as follows:
- as for normative references, adjustments with technical deviations have been made in this part to adapt to Chinese technical conditions, and are concentratedly reflected in Chapter 2 “Normative References” , which are as follows in specific:
– replace ISO 594-1 with GB/T 1962.1 identical with the international standard;
– replace ISO 594-2 with GB/T 1962.2 identical with the international standard;
– replace ISO 7886-1 with GB 15810 identical with the international standard;
- replace ISO 3104 with GB/T 30515 modified from the international standard;
– replace ISO 15223-1 with GB/T 0466.1 identical with the international standard;
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this standard shall not be held responsible for identifying any or all such patent rights.
This part was proposed by China Food and Drug Administration
This part is under the jurisdiction of China Food and Drug Administration Jinan Medical Appliance Quality Supervision and Inspection Center.
The previous editions hereof replaced by this part are as:
—— YY 0285.1-1999,YY 0285.1-2004,YY 0285.2-1999.
Intravascular Catheters — Sterile and Single-use Catheters — Part 1: General Requirements
1 Scope
This part of YY 0285 specifies the general requirements of sterile, single-use intravascular catheters for various purposes.
This part is not applicable to accessory devices for intravascular catheters, e.g. YY 0450.1.
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.
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)
GB/T 1962.2 Conical Fittings with a 6% (Luer)Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2:Lock Fittings (GB/T 1962.2-2001, ISO 594-2: 1998, IDT)
GB 15810 Sterile Hypodermic Syringes for Single Use(GB 15810-2001, Eqv ISO 7886-1: 1993)
GB/T 30515 Petroleum Products - Transparent and Opaque Liquids-Determination of Kinematic Viscosity and Calculation of Dynamic Viscosity(GB/T 30515-2014, ISO 3104: 1994.MOD)
YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied - Part 1:General Requirements(YY/T 0466.1-2016, ISO 15223-1: 2012, IDT)
YY/T 0586 Medical Polymer Products - Test Methods of Radiopacity
ISO 3105: 1994
Glass Capillary Kinematic Viscometers - Specifications and Operating Instructions
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
intravascular catheter
tubular device, single or multilumen, designed to be partially or totally inserted or implanted into the cardiovascular system for diagnostic and/or therapeutic purposes
3.2
distal end
end of the catheter inserted furthest into the patient
3.3
distal end configuration
shape of the catheter which is designed to facilitate its manual manipulation through the cardiovascular system and the placement and anchoring of the distal tip in the chosen location
3.4
proximal end; access end
end of the catheter to which connection can be made
3.5
hub
connector(s) at the proximal end of the catheter which may either be integral with the catheter or be capable of being securely fitted to the proximal end of the catheter
3.6
effective length, l
length of the catheter, or pre- and post-hydration lengths of hydratable catheters that can be inserted into the body
See: Figure 1.
Keys:
1 - effective length;
1 - catheter hub;
2- catheter strain reinforcement;
3- length mark;
4 - junction;
5- pre-connected port
Figure 1 Examples of Effective Length of Catheters
3.7
outside diameter
largest diameter of the catheter or pre- and post-hydration largest diameters of hydratable catheters that can be inserted into the vessel
3.8
Junction
the joining of one tube or more tubes, where the assembly of the tubes provide mechanical support in tension/compression during clinical use
3.9
hydratable intravascular catheter
intravascular catheter consisting of a material that manifests clinically significant hydration when subjected to an aqueous medium
3.10
post-hydration
state of a hydratable intravascular catheter after immersion in aqueous medium at (37±2)°C for a clinically appropriate period of time
3.11
clinically significant hydration
hydrated state in which either the post-hydration effective length is greater than the pre-hydration effective length by more than 1 % of the effective length, or the post-hydration outside diameter is greater than the pre-hydration outside diameter by 10 % or more
3.12
power injection
rapid injection of fluid at high pressure
3.13
primary packaging
packaging which has direct contact with the device and/or maintains the sterility of the product
3.14
secondary packaging
packaging designed to contain one or more primary packages
3.15
angiographic catheter
intravascular catheter used for the injection of contrast media and/or fluids and which may be used for pressure measurements and to obtain blood samples or insertion of coaxial inner catheter, occlusion coils or other devices
4 Requirements
4.1 General
The catheter shall have been sterilized by an appropriate validated method, and shall comply with 4.2 to 4.8 in the sterile condition.
4.2 Radio-detectability
Parts of the catheter shall be radio-detectable if required as determined by the risk assessment.
Compliance should be demonstrated by an appropriate test method, such as YY/T 0586.
Note: it may also be evaluated according to DIN 13273-7.
4.3 Biocompatibility
The catheter shall be free from biological hazard.
Note: the biological evaluation is detailed in GB/T 16886.1.
4.4 External surface
When examined by normal or corrected to normal vision, with a minimum x 2,5 magnification the external surface of the effective length of the catheter shall appear free from extraneous matter.
The external surface of the effective length of the catheter, including the distal end, shall be free from process and surface defects which could cause trauma to vessels during use.
If the catheter is lubricated, the lubricant shall not be visible as drops of fluid on the external surface when the catheter is examined under normal or corrected to normal vision.
4.5 Corrosion resistance
When tested in accordance with the method given in Annex A, metallic components of the catheter intended for fluid path contact shall show no signs of corrosion.
4.6 Peak tensile force
When tested in accordance with the method given in Annex B, the peak tensile force of each test piece shall be as given in Table 1.
Contents of YY 0285.1-2017
Foreword i
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Designation of Nominal Size
6 Information to be Supplied by the Manufacturer
Annex A (Normative) Test Method for Corrosion Resistance
Annex B (Normative) Method for Determining Peak Tensile Force
Annex C (Normative) Test Method for Liquid Leakage under Pressure
Annex D (Normative) Test Method for Air Leakage into Hub Assembly during Aspiration
Annex E (normative) Determination of Flowrate through Catheter
Annex F (Normative) Test for Burst Pressure under Static Conditions
Annex G (Normative) Power Injection Test for Flow-rate and Device Pressure (Only for Products Indicated for Power Injection)
Annex H (Informative) Units of Measurement Systems Other than Those Specified in This Part, Which May Additionally be Used
Bibliography
