PRODUCT PERFORMANCE QUALIFICATION - Euromedeuromed.com.eg/sites/default/files/pdf/PC-stop...

Issue Date: - 10/03/2019

code: TF-03

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performance claims of

EURO-3 WAY STOP COCK

PRODUCT PERFORMANCE QUALIFICATION

Issue Date: - 10/03/2019

code: TF-03

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➢ Intended Uses: • 3-Way Stop Cock- For infusion of more than one fluid at a single time. This device is lipid

resistant.

• 3-way stop cock used with infusion sit not blood transfusion and don’t use with

chemotherapy.

• 3 Way Stop Cock is an intended to be used for all patients. It is not to • be used in patients with known hypersensitivity to any of the materials.

• This is device is to be used ambient conditions and should be used by a qualified doctor or

a paramedic

• It has a two- fold function

• 1) To serve as a protective stopper for any standard female luer.

• 2) To provide two additional ports for administration of any fluid.

2-List of material

Composition/Information on Ingredients:

Material Ingredients/Construction Characteristics

COMPONENTS MATERIAL

1-Channel Polycarbonate- 1.225 gm.

2-Handle Polyethylene – 0.925 gm.

3-Screw Cap PVC TFG 100 B – 0.6587 gm.

3-Luer Lock Polyethylene – 0.3391 gm.

4-Cock Cap Polypropylene – 0.1568 gm.

# Product Ref. No. Device GMDN Code

1 EURSCB Euro-3 Way Stop Cock 32172

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3-Sample size

No maximum limit was set for number of samples to be tested, Destructive test results obtained from

testing according to our sampling plan.

4-Acceptance criteria

If exceeding relevant standard requirement minimal limit, the lowest result obtained during testing

considered being our minimal acceptance limit.

Inspection Items 1.1 Standard Requirement

【Chemical Requirements】

Extractable metal The extract shall not contain more than 1 µg/ml of Ba, Cr, Cu, Pb and Sn and 0.1 µg/ml of Cd.

Acidity-alkalinity 1.0max(the difference of PH value)

【Physical Requirements】

Flow Rate ml/min 130 ml/min ± 10%

Length 5 cm ± 10mm

Tube O.D. 4.0 mm ± 0.05mm

Tube I.D. 2.7 mm ± 0.05mm

Connection port Transparent having 6% Taper with luer lock facility

Leakage Test

• Leakage proof when tested by Leakage tester apply air with an internal excess pressure 3 bar, for time 15 seconds of underwater at (23 1) °C and (40 ±1) ˚С

Fill the accessory with distilled water and apply an internal excess pressure of 3 bar

for 15 min for any leakage of water

at (10 1) °C and (40 ±1) ˚С

• The accessory shall be so designed that no water/air leakage.

Leakage proof between its own components.

Leakage proof at connection points with another device.

No leakage at injection site. No leakage at check valve

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Leakage with I.V. cannula Ok No Leakage (leak proof ,complies as per ISO 80369-7:2016 ,ISO80369-1:2018)

Leakage with I.V. set Ok No Leakage (leak proof ,complies as per ISO 80369-7:2016,ISO80369-1:20183 )

Packaging The sets are individually packed in Pouch consists of PVC & Medical Paper which maintains the integrity of the sets

Tensile strength

The accessory to be tested in longitudinal direction to a static tensile force of 15 N for 15, In the case of stopcocks, connections between plug and housing shall withstand this tensile force when in any position. S

ISO 8536-10:2015 - INFUSION ACCESSORIES

packing

Each 50 sets are packed in inner box and each 10 Inner Boxes are packed in master

carton.

Blister Pack: - Medical Grade paper / Tyvek paper (Gsm-70 gm/m2) and Non – toxic

PVC Rigid Film.

Labeling The package labeling is complete and meets the requirements acc. to BS

EN ISO 15223-1. The content should meet the requirements

Color of handle Blue

Color channel Transparent and clear

Avoidance of air

bubbles

All components of accessories shall be designed such that no air bubbles are detected in flow channels when Tested Fill distilled water into the accessories to be tested as under usual practice conditions, Inspect visually the flow channels of transparent components for the presence of air bubbles. ISO 8536-10:2015 - INFUSION ACCESSORIES

particulate

contamination

The volume of rinse fluid shall be at least 50 times the inner volume of a test specimen. ISO 8536-10:2015 - INFUSION ACCESSORIES

Manipulation of stopcocks

Stopcocks and stopcock manifolds shall be so designed that when tested as specified in flow channels can be opened and closed without any adverse effect on the functionality of adjacent components. ISO 8536-10:2015 - INFUSION ACCESSORIES

Unit with injection site

Units with injection site shall enable injection. When tested no more than 10 drops per batch and no more than 2 drops per unit shall be lost


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Unit with check valve

When tested the valve shall close tightly to prevent any leakage of water.


Biological Tests

Sterility test Sterile according Sterility Test No. (TSM-001)

Endotoxin Pyrogen free according Pyrogen Test No. (TSM-002)

➢ 5-Technical Standard:

No. Standard Ref. No Standard Name

01 ISO 13485:2016

Medical devices quality management systems

requirements for regulatory purposes

02 93/42/EEC Council Directive concerning medical devices.

03

2007/47/EC

The European Parliament and of the Council of 5

September 2007amending Council Directive

93/42/EEC concerning medical devices

04 ISO 8536-10 :2015 - INFUSION ACCESSORIES

05 ISO 80369-1:2018

ISO80369-7:2016

For general requirement Connectors for intervascular or hypodermic needle

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➢ 6- Packaging Specification

6 -1 LABELLING AND PACKAGE MATERIAL

Standard: According to ISO 15223-1

The label contain below data and its symbol See attach 06 labeling and IFU

• Product name

• Manufacture name and address

• EU representative

• CE Mark with number 0120

• Kind of sterilization EO

• Lot number

• Expiry date

• Product Dimensions

• Storage Conditions

• Symbol for phthalate

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The package material

General Description : The sets are individually packed in Pouch consists of PVC &

Medical Paper which maintains the integrity of the sets, PVC sheet

and medical paper shall be sealed in such a way that the

accessory remain sterile.

Color : Transparent but its data printed with red color only.

Form : Pouch closed from all directions except one direction.

Width : 36 ± 1 mm

Length : 76± 1 mm (after sealing)

Post supplier sealing distance : 0.5 ± 0.1 mm

Thickness : 24 ± 5 mm

Special Req. : • It has thin holes.

• cut from header

Packing : Each unit packed in one bag.

Design : Attached

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Item: Non- Toxic PVC Rigid Film 0.25 Micron for Euro- 3Way Stop Cock

General Description : The sets are individually packed in Pouch

consists of PVC Rigid Film 0.25 Micron, PVC

sheet and medical paper shall be sealed in such

a way that the accessory remain sterile.

Thickness : 300 ±20 mm

Core diameter : 72±2 mm

Width (cm) : 25±0.5 mm

Heat forming : 80-120 °C

Special Req. : None

Packing : Individually packed with plastic attached with

label contains weight & description.

Design : Attached

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6.2 STORAGE REQUIREMENTS

Storage Condition

- Temperature: The Temperature limit from 10°C to 35°C

- Cool and dry place, not allowed to store direct sun light

- Humidity: Less than 45%

- Moisture: Dry place

- Shock: Aggressive mechanical shock is prevented.

- Ventilation: Controlled well-ventilated area

- Corrosion from fluids: Catheter package should be stored away from fluid.

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6.3 EXPIRY DATE/ RESULTS OF STABILITY STUDY

Inspection Items 1.1 Standard Requirement Results

【Chemical Requirements】

Extractable metal The extract shall not contain more than 1 µg/ml of Ba, Cr, Cu, Pb and Sn and 0.1 µg/ml of Cd.

Conform

Acidity-alkalinity 1.0max(the difference of PH value) 0.7

【Physical Requirements】

Flow Rate ml/mim 130 ml/min ± 10% 135ml/min

Connection port Transparent having 6% Taper with luer lock facility

Conform

Length 5 cm ± 10mm Accept

Tube O.D. 4.0 mm ± 0.05mm Accept

Tube I.D. 2.7 mm ± 0.05mm Accept

Leakage Test

• Leakage proof when tested by Leakage tester apply air with an internal excess pressure 3 bar, for time 15 seconds of underwater at (23

1) °C and (40 ±1) ˚С Fill the accessory with distilled water

and apply an internal excess pressure of

3 bar for 15 min for any leakage of

water

at (10 1) °C and (40 ±1) ˚С

• The accessory shall be so designed

that no water/air leakage.

Leakage proof between its

own components.

Leakage proof at connection

points with another device.

No leakage at injection site. No leakage at check valve

No Leakage

Leakage with I.V. cannula

• Leak proof complies as per iso594-1&2

• Ok No Leakage

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Leakage with I.V. set • Leak proof complies as per iso594-

1&2

• Ok No Leakage

Tensile strength

The accessory to be tested in longitudinal direction to a static tensile force of 15 N for 15, In the case of stopcocks, connections between plug and housing shall withstand this tensile force when in any position. S


conform

Packaging

The sets are individually packed in Pouch consists of PVC & Medical Paper which maintains the integrity of the sets

Conform

packing

Each 50 sets are packed in inner box and each 10 Inner Boxes are packed in master carton.

Blister Pack: - Medical Grade paper /

Tyvek paper (Gsm-70 gm/m2) and Non

– toxic

PVC Rigid Film.

Conform

Labeling

The package labeling is complete and meets the requirements acc. to BS EN ISO 15223-1. The content should meet the requirements

Conform

Color of handle Blue Conform

Color channel Transparent and clear Conform

Avoidance of air bubbles

All components of accessories shall be designed such that no air bubbles are detected in flow channels when Tested Fill distilled water into the accessories to be tested as under usual practice conditions, Inspect visually the flow channels of transparent components for the presence of air bubbles.

Conform

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Particulate contamination

The volume of rinse fluid shall be at least 50 times the inner volume of a test specimen. ISO 8536-10:2015 - INFUSION ACCESSORIES

Conform

Manipulation of stopcocks

Stopcocks and stopcock manifolds shall be so designed that when tested as specified in flow channels can be opened and closed without any adverse effect on the functionality of adjacent components. ISO 8536-10:2015 - INFUSION ACCESSORIES

conform

Unit with injection site

Units with injection site shall enable injection. When tested no more than 10 drops per batch and no more than 2 drops per unit shall be lost


Conform

Unit with check valve

When tested the valve shall close tightly to prevent any leakage of water.


Conform

Biological Tests

Sterility test Sterile according Sterility Test No. (TSM-001)

Sterile

Endotoxin Pyrogen free according Pyrogen Test No. (TSM-002)

Pyrogen free

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Euromed (EURO-3 WAY STOP COCK) is 5 Years Expiration

➢ 7. Results of Packaging Test

Test Specs Results

Bubble Emission No bubble or seepage of fluid appear

Pass

Dye Penetration No streak of Methylene blue observed

Pass

Burst Test No rupture on the seal of the package observed

Pass

➢ 8. Results of Biocompatibility test 1-Contact duration of Euro-3WAY STOPCOCK (from 24 h to 30 days) i.e. B

According to table 1 at 10993-1

2. Nature of body contact (External communicating device Blood path, indirect).

According ISO 10993-1 (Annex A Biological evaluation tests) required for Euro- 3WAY

STOPCOCK are:

So the following tests are carried out

Test Study no Result

In vitro Cytotoxicity BIO-GT 912 Comply with ISO 10993-10 Sensitization BIO-TX 2996 Comply with ISO 10993-10

Irritation (intracutaneous reactivity ) BIO-TX 2997 Comply with ISO 10993-10 Systemic toxicity (acute BIO-TX 2998 Comply with ISO 10993-10 Haemocompatibility BIO-TX 2999 Comply with ISO 10993-10

Invito Cytotoxicity

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Based on the results obtained from biomed it is concluded that 3-way stopcock non-cytotoxic As Iso10993-5 As attach

2- Skin Sensitization test in guinea pigs

Based on the results obtained from biomed it is concluded that 3 way stopcock did not show any

sensitization reactions. As attach

3-Irritation (intracutaneous reactivity)

Based on the results obtained from biomed it is concluded that 3 way stopcock

non-reactive in the intracutaneous test As 10993-10 ,

4- Systemic toxicity (acute toxicity)

Based on the results obtained from biomed it is concluded that 3 way stopcock , Non Toxic

Report Attach

5- Haemocompatibility

Based on the results obtained from biomed it is concluded that 3 way stopcock supplied by

Euromed for Medical Industries, haeocombatible

And processed in procedure of performing biocombatibility study to comply with our

Ministery of health and Egyptian Regulation and perform contract with GlR which is

accrediated by 17025 and we will receive

Prepared By Reviewed By Approved By

Name Ahmed Zaki Shaimaa Rabeey Ahmed Gamal

Position Quality Assurance Quality Assurance Manger Executive Manger

Signature

Date 10/03/2019 10/03/2019 10/03/2019

PRODUCT PERFORMANCE QUALIFICATION - Euromedeuromed.com.eg/sites/default/files/pdf/PC-stop...

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