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Bastos Viegas SA always had and still has as one of its main objectives produce high quality and meeting the requirements of its customers and the market in general as well as all applicable legal requirements.
 
Therefore Bastos Viegas bet on the implementation and constant updating of a quality control system that currently has decades of experience.
 
In this sense always equipped its laboratories with modern testing equipment in order to be able to test and control everything it produces in accordance with all applicable directives, and in order to fully satisfy all requirements of a very diverse and demanding market for which they work.
 
Although the quality control laboratory is integrated in the ISO 9001 and ISO 13485 company Certification, it is not formally accredited, but given our vast experience and technical capacity we have decided to offer the laboratory service testing, which initially was only for internal use, to customers and suppliers and all those who seek very specific and differentiated tests according to the applicable standards, most of them related to the control of Medical Devices.

 

 

 
Tests for absorbent cotton gauze, absorbent cotton and viscose gauze - EN 14079-1
Tests for absorbent cotton gauze/cotton and viscose gauze compresses and wound packing products - EN 14079-2
Tests for nonwovens used in the manufacture of compresses for medical use - EN 1644-1
Tests for finished compresses for medical use - EN 1644-2
Tests for surgical gowns, drapes and clean air suits - EN 13795
Tests for plain paper, creped paper and nonwoven wrapping material - EN 868-2
Sterility tests - ISO 11737-2
Determination of a population of microorganisms on products (Bioburden) - ISO 11737-1
Accelerated aging - ASTM F 1980-02
Tests for materials, sterile barrier systems and packaging systems - ISO 11607-1
Tests for absorbent cotton - Portuguese Pharmacopeia
Test for Absorbent Capacity od Dressings - ISO 11948 
Tests for Adhesiveness - ISO 29862, PSTC 101 
Tests for endotoxins - AAMI ST72:2002/R2010

 

 
1- Tests for absorbent cotton gauze, absorbent cotton and viscose gauze - EN 14079-1
The European Standard EN 14079-1 describes the physical and chemical test methods and requirements for the evaluation of absorbent cotton gauze, absorbent cotton and viscose gauze used as materials for compresses and wound packing products for medical use. 


  


Test Code Test Description Number of replicas per sample Area required to perform test Price per sample
695001001 Fluorescence - 1 m2 €40
695001002 Thread count 3 counts in both directions 0,5 m2 €30
695001003 Mass per square metre - 1 m2 €40
695001004 Breaking load 10
5 MD + 5 CD
1 m2 €40
695001005 Liquid absorbency time 5 1 m2 €40
695001006 Liquid absorptive capacity 5 1 m2 €40
695001007 Fibre identification - 0,5 m2 €40
695001008 Acidity or alkalinity of aqueous extracts 7,0 g 0,5 m2 €40
695001009 Substances soluble in non-polar solvents 5,0 g 0,5 m2 €50
695001010 Water soluble substances 7,0 g 0,5 m2 €50
695001011 Starch and dextrin 7,0 g 0,5 m2 €30
695001012 Sulphated ash 5,0 g 0,5 m2 €50
695001013 Colour fastness of dyed gauze under moist conditions 2 1 m2 €30
695001014 Surface active substances 10 g 0,5 m2 €40
695999001 All tests EN 14079-1 - - €250
 
 
 

 
2- Tests for absorbent cotton gauze, absorbent cotton and viscose gauze compresses and wound packing products -EN 14079-2
The European Standard EN 14079-2 describes the physical and chemical test methods and requirements for the evaluation of absorbent cotton gauze, absorbent cotton and viscose gauze compresses and wound packing products.

 


Test Code
Test
Number of replicas per sample
Area required to perform test
Price per sample
695001015
Absorbent capacity (under development)
3
1 m2
€58
695001016
Absorption
3
1 m2
€42
695001017
Construction strength
3 dry + 3 wet
1 m2
€42
695001018
Dimensions of compress
-
-
€31
695999002
All tests EN 14079-2
-
4 m2
€160
 
 
 

 
3- Tests for nonwovens used in the manufacture of compresses for medical use- EN 1644-1
The European Standard EN 1644 -1 specifies the physical and chemical tests methods for the evaluation of Nonwovens used as materials for compresses for medical use.
 


Test Code
Test
Number of replicas per sample
Area required to perform the test
Price per sample
695002001
Liquid absorbency Time
5
1 m2
€42
695002002
Liquid absorptive capacity
5
1 m2
€42
695002003
Fluorescence
-
0,5 m2
€42
695002004
Acidity or alkalinity of aqueous extracts
7,0 g
0,5 m2
€42
695002005
Substances soluble in non-polar solvents
5,0 g
0,5 m2
€53
695002006
Water soluble substances
7,0 g
0,5 m2
€53
695002007
Surface active substances
10 g
0,5 m2
€42
695999003
All tests EN 1644-1
-
-
€220
 
 
 

 
4- Tests for finished compresses for medical use- EN 1644-2
The European Standard EN 1644 -2 specifies the physical and chemical tests methods for the evaluation of finished nonwoven compresses.
 


Test Code
Test
Number of replicas per sample
Area required to perform the test
Price per sample
695002008
Absorbent capacity
5
-
€58
695002009
Rate of absorption
5
1 m2
€42
695002010
Constructional strength
-
0,5 m2
€42
695002012
Dry linting
7,0 g
0,5 m2
€525
695002013
Surface active substances
10 g
0,5 m2
€42
695999004
All tests EN 1644-2
-
 
€555
 
 
 

 
5- Tests for surgical gowns, drapes and clean air suits- EN 13795-1
The European Standard EN 13795 has the purpose to give general guidance on the characteristics of single-use and reusable surgical drapes, gowns and clean air suits. To comply with the EN 13795 series of standards, products shall meet all the requirements specified in Tables of Part 3 when tested according to EN 13795-2 throughout their useful life.
 


Test Code
Test Description
Test Method
Number of replicas per sample
Area required to perform the test
Price per sample
695003001
Resistance to microbial penetration - wet
ISO 22610
5
1 m2
€265
695003002
Resistance to microbial penetration-dry
ISO 22612
12
1 m2
€265
695003003
Cleanliness-Microbial
EN ISO 11737-1
1
50 g
€105
695003004
Cleanliness-Particulate matter
ISO 9073-10
10
1 m2
€370
695003005
Linting
ISO 9073-10
10
1 m2
€525
695003006
Resistance to liquid penetration
EN 20811
5
1 m2
€53
695003007
Bursting strength – dry
ISO 13938-1
5
1 m2
€53
695003008
Bursting strength – wet
ISO 13938-1
5
1 m2
€53
695003009
Tensile strength – dry
ISO 9073-3
9
1 m2
€42
695003010
Tensile strength – wet
ISO 9073-3
9
1 m2
€42
695003011
Liquid control / Run-Off
EN 13795-2
5
1 m2
€53
695999005
All tests EN 13795
-
-
-
€1450
 
 
 

 
6- Tests for plain paper, creped paper and nonwoven wrapping material - EN 868 -2
The European Standard EN 868-2 describes test methods and values for materials for sterile barrier systems and /or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.
 


 

Plain paper

 

Test Code
Test Description
Test Method
Number of replicas per sample
Price per sample
695006001 Visual examination of a hot aqueous extract ISO 6588-2 5
€42
695006002 Average mass EN ISO 536 5
€42
695006003 pH ISO 6588-2 5
€42
695006004 Optical Brightness Annex B EN 868-2 5
€42
695006007 Bursting Strength EN ISO 2758 5
€53
695006008 Wet Bursting Strength ISO 3689 5
€53
695006009 Tensile Strength EN ISO 1924-2 5
€42
695006010 Tensile Strength wet ISO 3781 5
€42
695006010 All tests EN 868-2 - -
€315

 

Creped paper

 

Test Code
Test Description
Test Method
Number of replicas per sample
Price per sample
695006011
Visual examination of a hot aqueous extract
ISO 6588-2
5
€40
695006012
Average mass
EN ISO 536
5
€40
695006013
pH
ISO 6588-2
5
€40
695006014
Optical Brightness
Annex B EN 868-2
5
€40
695006015
Drapeability (under development)
Annex C EN 868-2
6
-
695006016
Elongation at break
EN ISO 1924-2
5
€40
695006017
Tensile strength
EN ISO 1924-2
5
€40
695006018
Tensile strength wet
ISO 3781
5
€40
695999008
All tests EN 868-2
-
-
€220

 

Nonwoven wrapping material

 

Test Code
Test Description
Test Method
Number of replicas per sample
Price per sample
695006019

Visual examination of a hot
aqueous extract

ISO 6588-2
5
€40
695006020
Average mass
EN ISO 536
5
€40
695006021
pH
ISO 6588-2
5
€40
695006022
Optical Brightness
Annex B EN 868-2
5
€40
695006023
Drapeability (under development)
Annex C EN 868-2
6
-
695006024
Elongation at break
EN ISO 1924-2
5
€40
695006025
Tensile strength
EN ISO 1924-2
5
€40
695006026
Tensile strength wet
ISO 3781
5
€40
695006027
Internal tearing resistance
EN 21974
5
€40
695006028
Bursting strength
EN ISO 2758
5
€50
695006029
Wet Bursting strength
ISO 3689
5
€50
695006030
Resistance to water penetration
EN 20811
5
€50
695999009
All tests EN 868-2
-
-
€360
 
 
 

 
7- Sterility tests - ISO 11737-2
Tests of sterility are carried through in accordance with ISO 11737-2 and consist of a direct aseptic immersion of the product, after the sterilization process, in a growth- promoting medium followed by incubation during a specific period of time. The number of samples needed for the sterility tests is at the discretion of the customer. Care should be taken in order to avoid inadvertent contamination of the product.
 


Test Code
Test
Number of samples
Price per sample
695007001

Sterility test (to 500mL)

Sterility test (to 500mL)

Sterility test (to 1000mL)

Sterility test (to 1000mL)

Sterility test (to 2000mL)

Sterility test (to 2000mL)

1 to 9 samples

More than 10 samples

1 to 9 samples

More than 10 samples

1 to 9 samples

More than 10 samples

€18 each

€16 each

€22 each

€20 each

€25 each

€13 each

695007002

Sterility test (to 500mL)

Sterility test (to 500mL)

Sterility test (to 1000mL)

Sterility test (to 1000mL)

Sterility test (to 2000mL)

Sterility test (to 2000mL)

1 to 9 samples

More than 10 samples

1 to 9 samples

More than 10 samples

1 to 9 samples

More than 10 samples

€18 each

€16 each

€22 each

€20 each

€25 each

€13 each

695007003 Sterility tests of Biological Indicators 1 to 9 samples
€12 each
695007004 Sterility tests of Biological Indicators More than 10 samples
€10 each
 
 
 

 
8- Determination of a population of microorganisms on products (Bioburden) - ISO 11737-1
The knowledge of the bioburden is crucial during a sterilization process validation, as well as during routine control of manufacturing processes. The estimation of population of microorganisms is determined in accordance with EN ISO 11737-1. The number, as well as the sampling criteria is of the responsibility of the entity that subcontracts the analysis. The handling should be done in order to avoid inadvertent contamination of the product .The sampling should be done in double packing.
 


Test Code
Test
Test Method
Price per sample
695008001 Bioburden – aerobic bacteria 1 to 9 samples € 48 each
695008002 Bioburden – aerobic bacteria More than 10 samples € 42 each
695008003 Bioburden- fungi 1 to 9 samples € 48 each
695008004 Bioburden- fungi More than 10 samples € 42 each
695008005 Bioburden – anaerobic bacteria 1 to 9 samples € 48 each
695008006 Bioburden – anaerobic bacteria More than 10 samples € 42 each
695008007 Bioburden - aerobic & anaerobic bacteria 1 to 9 samples € 70 each
695008008 Bioburden - aerobic & anaerobic bacteria More than 10 samples € 58 each
695008009 Bioburden – aerobic bacteria & fungi 1 to 9 samples € 70 each
695008010 Bioburden – aerobic bacteria & fungi More than 10 samples € 58 each
695008011 Recovery of Bacillus atropheus by Strips of Indicators - € 63 each
695008012

Specific microorganisms: Staphilococcus aureus, E.coli, Enterococcus, Pseudomonas aeruginosa

- € 63 each
695008013 Technical validation of bioburden determination 1 to 9 samples; € 1350 each  

More than 10 samples

€ 1200 each  

 
 
 

 
9- Accelerated aging - ASTM F 1980-02
An accelerated aging study is used to support the assignment of an expiration date. Accelerated aging is a process in which products and/or packaging are stored in a environmental chamber at an elevated temperature (T) and/or humidity (RH), (if humidity effects are need to be considered), to simulate a longer period of real time aging.
 


Test Code
Test Description
Test Method
Price per sample
695010001 Accelerated aging - High temperature 50ºC - 40 ½ weeks* - 5 years
- available volume: 0.9 m3
ASTM F 1980-02
€3500*
695010002 Accelerated aging - High temperature 50ºC - 32 ½ weeks* - 4 years
- available volume: 0.9 m3
ASTM F 1980-02
€2800*
695010003 Accelerated aging - High temperature 50ºC - 24 weeks* - 3 years
- available volume: 0.9 m3
ASTM F 1980-02
€2100*
695010004 Accelerated aging - 66º - 80% - 4 days
- available volume: 0.3 m3
PSTC-9
€160
 
 
 

 
10- Tests for materials, sterile barrier systems and packaging systems- ISO 11607
 ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
 


Test Code
Test Method
Test Description
Price per sterile barrier system
695011001
ASTM F1929:1998
Integrity (Dye migration)
€28
695011002
EN 868-5:2009Annex E
Peel-open characteristic
€28
695011003
EN 868-5:2009Annex D
Seal Peel strength
€47
695011004
ISO 5636:5
Air Permeance
€37
 695999006
ASTM F1929:1998, EN 868-5:2009 Annex E and EN 868-5:2009 Annex D
Integrity (Dye migration), Peel-open characteristic and Seal Peel strength
€100
695011005
EN 868-5:2009 Annex B
Determination of resistance to the intended sterilization process
65€
 
 
 

 
11- Tests for absorbent cotton - Portuguese Pharmacopeia
The Portuguese Pharmacopeia describes the physical, chemical test methods and requirements for the evaluation of absorbent cotton.
 


Test Code
Test Method
Test
Price per sample
695012001
Portuguese Pharmacopeia
Fluorescence
€42
695012002
Portuguese Pharmacopeia
Fibre Identification
€32
695012003
Portuguese Pharmacopeia
Weight
€42
695012004
Portuguese Pharmacopeia
Loss on drying
€42
695012005
Portuguese Pharmacopeia
Absorption time
€42
695012006
Portuguese Pharmacopeia
Absorption capacity
€42
695012008
Portuguese Pharmacopeia
Acidity or alkalinity of aqueous extracts
€42
695012009
Portuguese Pharmacopeia
Substances soluble in ether
€53
695012010
Portuguese Pharmacopeia
Substances soluble in water
€53
695012011
Portuguese Pharmacopeia
Fibers
€53
695012012
Portuguese Pharmacopeia
Suphated Ashes
€53
695012014
Portuguese Pharmacopeia
Tensides
€42
695012015
Portuguese Pharmacopeia
All the Tests
€265
 
 
   

12- Test for Absorbent Capacity od Dressings – ISO 11948  
ISO 11948 defines the appropriate method for defining the absorption capacity of absorbent dressings 

  


Test Code
Test Description Test Method Price per sample
695014001 Absorption capacity ISO 11948 €42
 
 
   

13- Tests for Adhesiveness – ISO 29862, PSTC 101 
ISO 29862 defines a set of methods for the determination of adhesiveness properties for adhesive materials. Tests of 90 and 180 ° and on different bases (stainless steel or other that imitate the application of the adhesive) are provided.
  


Test Code
Test Description Test Method Price per sample
695014001 Adhesiveness at 180° in steel plate or different matrix to be defined ISO 29862/PSTC 101 €70 (3 replicates)
695014002 Adhesiveness at 90° in steel plate or different matrix to be defined ISO 29862/PSTC 101 €70 (3 replicates)
 
 
   

14- Tests for endotoxins  - AAMI ST72:2002/R2010 
USP Chapter 85 defined the test method for detection and quantification of endotoxins from Gram negative bacteria using lysate from Limulus polyphemus or Tachypleus tridentatus. There are three techniques available for the test execution: gel-cloth (qualitative), turbidimetric and chromogenic (quantitative). The technique used by Bastos Viegas for quantification of endotoxins is the chromogenic.

  


Test Code
Test Description Test Method Price per sample
695014003 Endotoxins’ quantification

USP Chapter 85

AAMI ST72:2002/R2010
€70
695014004 Validation of the method for endotoxins’ quantification

USP Chapter 85

AAMI ST72:2002/R2010
€300  (3 batches)
   
 
 
 
 

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