DEIONIZED WATER IS BEING USED IN ALL PRODUCTIONS WHICH HAVE BEEN PERFORMED AT MANUFACTURING FACILITIES OF CABS MEDICAL :

In all productions, pure water ( deionized water ) is being used which has been privately manufactured in fully automatic water purification system which has been set up at facilities of Cabs Medical.

- In first step, water-which comes from water network- is being passed from sand filtration systems and then, it is being stored in water depot which was made from stainless steel.
- Stored water in water depots has been coming into Reverse Osmos system.According to its general definition,Reverse Osmos system is a system which removes anions and cations in water.Also, Reverse Osmos units - which are being applied as a advanced filtration method - are top level water purification equipments which have been used latest facilities of high technology.Working principle of these units can be explained with reverse working of osmotic balance in nature.
- Purified water - which comes from Reverse Osmos system - has been coming into Mixbed Demineralization system in next step.The aim here is to provide lowest level conductance ( 0.01 us/cm ) of purified water and obtain pure water.
- Pure water -which comes out from Mixbed Demineralization system - has been coming into UV Disinfection system for next step.Ultraviolet is a disinfection method which kills bacteria,virus,fungus and other microorganisms by UV ray.It does not make any difference in water's taste and its composition because of chemicals and heat are not being used during disinfection.

With a view to be provided of continuous quality and safety, the deionized water - which has been obtained at facilities of Cabs Medical - is being continuously tested by accredited laboratories.

QUALITY MANAGEMENT SYSTEMS ISO 9001:2008 AND ISO 13485:2003 ARE BEING APPLIED AT MANUFACTURING FACILITIES OF CABS MEDICAL :

WHAT IS QUALITY MANAGEMENT SYSTEM ISO 9001:2008 ?

* It is a indicator of continuously realizing capability to necessary activity for customers and legal arrangements.
* It is perfect system which prevents inaptitudes and improves continuously them.
* International comminucation language is an english and intercompany comminucation language is ISO 9001.
* ISO 9001:2008 is a application model which can be opened according to special requirements of companies.

WHAT IS MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM ISO 13485?

TS-EN-ISO 13485:2003 standart is a international standart which contains special terms for medical devices and which had been formed based on TS-EN-ISO 9001:2000.This standart includes terms of quality management system for a enterprise which should prove its achieving capability about medical devices supply and needs of customers and legal provisions which can be applied to medical devices and related services.Ultimate purpose of this standart is to simplify harmonized medical device legislation for quality management system.This standart determines terms of a quality management system which will be able to used by a organization for design,development and supplying of services about design, development,production,setting and service of medical devices.The terms of quality management system - which have been told in this standart - have qualification which integrates to technical clauses of product.To be accepted of quality management system must be a strategic decision of enterprise.The design and application of quality management system of enterprise are affected by varied needs,special targets,presented products,working processes and enterprise's size and its structure.In order to be documented about ISO 13485:2003,it is a necessity that criteria of this standart should be fulfilled by the company.

CABS MEDICAL HAS GOT PRODUCTION QUALITY ASSURANCE SYSTEM CERTIFICATE ACCORDING TO MEDICAL DEVICES DIRECTIVE 93/42/EEC ANNEX V, WHICH WAS GIVEN NOTIFIED BODY NAMED MEYER BELGELENDIRME HIZ. A.S. WHICH HAS BEEN AUTHORIZED BY COMMISSION OF EUROPEAN UNION.

WHAT IS " CE " MARK ?

It is shortening of initials of " Conformite Europeenne ".CE mark is a union mark which shows that products are conformable to directives and passed by all necessary conformity assessment activities that these products come within the scope of the New Approach Directives ( 23 units ) which were prepared based on New Approach Policy which was adopted by European Union in 1985 according to harmonization of technical legislation of EU.CE mark is a mark which shows that products will not cause offense to human health and goods safety,plants and animals,environment in case of their proper usage.In other words,it is a mark which shows that product is safety.

HOW ARE WAYS OF PUTTING CE MARK ON PRODUCT ?

Manufacturers have got two ways for putting CE mark on products :

A) Putting by manufacturer itself - Self Declaration : In this system, conformity of products - which had been manufactured by manufacturer - with directive's safety conditions, is being tested by manufacturer and Conformity Declaration and CE mark - manufacturer will issue - are being put on product by manufacturer.

B) Putting by notified body after completed checks : In this system, products - which had been manufactured by manufacturer - are being controlled,tested and approved by notified bodies which had been published their names on Official Journal of the European Union.If product - which had been passed by all necessary checks - is suitable, at this time, CE mark is being put on product by manufacturer further to approval of notified body.At the end of this process, there is number of notified body below CE mark.

WHAT IS NOTIFIED BODY ? WHAT IS FUNCTION OF IT?

As mentioned on relevant New Approach Directives,as third party,notified bodies enforce relevant duties about conformity assesment procedures.Basic duty of notified bodies is to do conformity assesment according to decisions which were determined in directives and they are free to give service of conformity assesment within the limits of their approved fields to every economic actor which had been established internal or abroad.Manufacturers however,they are free to prefer any of notified bodies which are authorized to do conformity assesment procedures as mentioned by relevant directive and which had been established internal or abroad.Member nations of European Union declare bodies -from among conformity assesment bodies which have been showing activity in their countries - as notified body to commission if member nations consider as they are sufficient as technically.In an effort to be announced to other member nations, the list of these notified bodies -which has been determined by member nations - is being published on Official Journal of the European Union.In accordance with decision of association council , notified bodies also - which had been nominated by Turkey - are being published on Official Journal of the European Union and appointed with identity number.Some criteria - such as implementation ability to procedures of technical sufficiency and conformity assesment, independency, objectiveness and honesty - are being taken into account for evaluation of body which will be announced to commission.

IN AN EFFORT TO PRESENT 100 % SAFETY PRODUCTS TO OUR ESTEEMED CUSTOMERS AS YOU, CABSGLIDE MEDICAL LUBRICANT GELS -WHICH HAVE BEEN MANUFACTURED BY CABS MEDICAL- ARE PRODUCTS WHICH HAVE BEEN CHECKED AND APPROVED IN ALL PROCESSES FROM BEGINNING OF PRODUCTION TO DELIVERING YOU BY MEYER BELGELENDIRME HIZMETLERI A.S. ( AS NOTIFIED BODY ) WHICH IS FIRST BODY IN TURKEY WHICH HAS TAKEN AUTHORIZATION OF ISSUING OF CE CERTIFICATE FROM COMMISSION OF EUROPEAN UNION ACCORDING TO MEDICAL DEVICES DIRECTIVE 93/42/EEC.

FOR SELF DECLARATION PRODUCTS, CHECKS OF PRODUCT ARE BEING MADE BY MANUFACTURER AND CE MARK IS BEING PUT PERSONALLY ON PRODUCT BY MANUFACTURER ITSELF.CE MARK APPEARS ON A PRODUCT ONLY AND THERE IS NO NUMBER BELOW CE MARK.HOWEVER, THERE ARE CE MARK AND NUMBER OF NOTIFIED BODY BELOW IT ON A PRODUCT WHICH HAD BEEN CONTROLLED AND APPROVED BY NOTIFIED BODY WHICH WAS AUTHORIZED BY EUROPEAN UNION.

IF IT IS NECESSARY TO SAY SHORTLY ;
IF NUMBER OF NOTIFIED BODY TAKES PLACE BELOW CE MARK, IT MEANS THAT,THIS PRODUCT IS A PRODUCT WHICH HAS BEEN GIVEN PERMISSION TO PUT ON THE MARKET AFTER THE ALL NECESSARY CHECKS WHICH WERE ACTUALIZED BY NOTIFIED BODY AND IS UNDER THE CONTROL CONTINUOUSLY BY SPOT CHECKS, IT IS NOT A SELF DECLARATION PRODUCT.

PLEASE CLICK LINK BELOW IN ORDER TO VIEW INFORMATIONS OF NOTIFIED BODY WHICH HAVE BEEN PUBLISHED AT PAGE OF EUROPEAN UNION...

http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=notifiedbody.notifiedbody&refe_cd=NANDO_INPUT_121541

IN ORDER TO CONTROL CABS MEDICAL AND CABSGLIDE MEDICAL LUBRICANT GEL HAVE BEEN DOCUMENTED BY NOTIFIED BODY, PLEASE FOLLOW STEPS BELOW ;

For control of Cabs Medical ISO 9001:2008 Certificate ;

A) Please click to link of http://www.meyer.gen.tr/belgesorgulama.aspx?mnid=3&did=1
B) Please write M8737 for document number ( Belge No in Turkish )
C) Enter the security code ( Güvenlik Kodu in Turkish )
D) Write 02.08.2014 for valid through ( Son Geçerlilik Tarihi in Turkish )
E) Please choose ISO 9001:2008 for document type ( Belge Türü in Turkish ) and then examine ( Sorgula in Turkish )

For control of Cabs Medical ISO 13485:2003 Certificate ;

A) Please click to link of http://www.meyer.gen.tr/belgesorgulama.aspx?mnid=3&did=1
B) Please write M8738 for document number ( Belge No in Turkish )
C) Enter the security code ( Güvenlik Kodu in Turkish )
D) Write 02.08.2014 for valid through ( Son Geçerlilik Tarihi in Turkish )
E) Please choose ISO 13485:2003 for document type ( Belge Türü in Turkish ) and then examine ( Sorgula in Turkish )

For control of Cabs Medical CE Certificate ( Medical Devices - 93/42/EEC ( Medikal Cihazlar 93/42/AT in Turkish ) ) ;

A) Please click to link of http://www.meyer.gen.tr/belgesorgulama.aspx?mnid=3&did=1
B) Please write 1984-MDD-11-109 for document number ( Belge No in Turkish )
C) Enter the security code ( Güvenlik Kodu in Turkish )
D) Write 04.08.2016 for valid through ( Son Geçerlilik Tarihi in Turkish )
E) Please choose Medical Devices-93/42/EEC ( Medikal Cihazlar 93/42/AT in Turkish ) for document type ( Belge Türü in Turkish ) and then examine ( Sorgula in Turkish ).

In order to view certificates that Cabs Medical got, please click here...

CABSGLIDE MEDICAL LUBRICANT GELS - WHICH HAVE BEEN MANUFACTURED BY CABS MEDICAL - HAVE SUCCESSFULLY PASSED FROM ALL NECESSARY BIO-COMPATIBILITY TESTS....

According to ISO 10993, Cabsglide Medical Lubricant Gel's bio-compatibility tests - such as Cytotoxicity,Sensitization and Irritation - have been actualized at Hacettepe University. Cabsglide Medical Lubricant Gels have been successfully passed from all tests which have been actualized.As a result of tests which have been actualized, following properties have been documented by Hacettepe University that Cabsglide Medical Lubricant Gels don't cause sensitization ( non allergic ), they are not cytotoxic ( no contain toxic substance ) and they don't cause any irritation ( they don't irritate ).