EMKI has competence in conformity assessment - on the basis of EU directives 93 /42/EEC - for companies dealing with product ranges listed below.

Transcription

1 EMKI COMPETENCE in MD EMKI has competence in conformity assessment - on the basis of EU directives 93 /42/EEC - for companies dealing with product ranges listed below. Annex II.: EC DECLARATION OF CONFORMITY (Full quality assurance system) Annex III.: EC TYPE-EXAMINATION Annex IV.: EC VERIFICATION Annex V.: EC DECLARATION OF CONFORMITY (Production quality assurance) Annex VI.: EC DECLARATION OF CONFORMITY (Product quality assurance) MD 000 MD 00 MD 002 MD 003 MD 004 MD 005 MD 006 MD 007 MD 008 MD 009 MD 0200 MD 020 MD 0202 MD 0203 MD 0204 MD 0300 MD 030 MD 0302 MD 0303 MD 0400 MD 040 MD 0402 MD 0403 MD SCOPE EXPRESSIONS, Annex NON-ACTIVE MEDICAL DEVICES II. III. IV. V. VI. General non-active, non-implantable medical devices Non-active devices for anaesthesia, emergency and intensive care Non-active devices for injection, infusion, transfusion and dialysis Non-active orthopaedic and rehabilitation devices Non-active medical devices with measuring function Non-active ophthalmologic devices Non-active instruments Contraceptive medical devices Non-active medical devices for disinfecting, cleaning, rinsing Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Non-active implants Non-active cardiovascular implants Non-active orthopaedic implants Non-active functional implants Non-active soft tissue implants Devices for wound care Bandages and wound dressings Suture material and clamps Other medical devices for wound care Non-active dental devices and accessories Non-active dental equipment and instruments Dental materials Dental implants For Annex III. and IV. designation excluding materials of desinfecting, cleaning and rinsing. For Annex II., V., VI. there are no limitation.

2 EMKI COMPETENCE in MD EMKI has competence in conformity assessment - on the basis of EU directives 93 /42/EEC- for companies dealing with product ranges listed below. Annex II.: EC DECLARATION OF CONFORMITY (Full quality assurance system) Annex III.: EC TYPE-EXAMINATION Annex IV.: EC VERIFICATION Annex V.: EC DECLARATION OF CONFORMITY (Production quality assurance) Annex VI.: EC DECLARATION OF CONFORMITY (Product quality assurance) MD 00 MD 0 MD 02 MD 03 MD 04 MD 05 MD 06 MD 07 MD 08 MD 09 MD 0 MD MD 200 MD 20 MD 202 MD 300 MD 30 MD 302 MD 400 MD 40 MD 402 MD 403 MD 404 AIMD 000 AIMD 00 MDS 7000 MDS 7002, except for TSE/BSE MDS 7004 MDS 7005 MDS 7006 MDS 7009 MD SCOPE EXPRESSIONS Annex ACTIVE (NON-IMPLANTABLE) MEDICAL DEVICES II. II. IV. V. VI. General active medical devices Devices for extra-corporal circulation, infusion and haemopheresis Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia Devices for stimulation or inhibition Active surgical devices Active ophthalmologic devices Active dental devices Active devices for disinfection and sterilisation Active rehabilitation devices and active prostheses Active devices for patient positioning and transport Active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Software Devices for imaging Imaging devices utilising ionizing radiation Imaging devices utilising non-ionizing radiation Monitoring devices Monitoring devices of non-vital physiological parameters Monitoring devices of vital physiological parameters Devices for radiation therapy and thermo therapy Devices utilising ionizing radiation Devices utilising non-ionizing radiation Devices for hyperthermia / hypothermia Devices for (extracorporal) shock-wave therapy (lithotripsy) General active implantable medical devices Active implantable medical devices for stimulation / inhibition MD / AIMD Specifics Medical devices utilising tissues of animal origin Medical devices referencing the Directive 2006/42/EC on machinery Medical devices referencing the Directive 89/686/EEC on personal protective equipment (PPE) Medical devices in sterile condition / Sterilization Method for Medical Devices /Ethylene oxide gas sterilization (EOG) Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed

3 EMKI COMPETENCE in AIMD EMKI has competence in conformity assessment - on the basis of EU directive 9 0/385/EEC - for companies dealing with product ranges listed below. Annex II.: EC DECLARATION OF CONFORMITY (Complete quality assurance system) Annex III.: EC TYPE-EXAMINATION Annex IV.: EC VERIFICATION Annex V.: EC DECLARATION OF CONFORMITY TO TYPE (Assurance of production quality) AIMD 000 AIMD 00 IVD SCOPE EXPRESSIONS Annex ACTIVE IMPLANTABLE MEDICAL DEVICES II. III. IV. V. General active implantable medical devices Active implantable medical devices for stimulation / inhibition

4 EMKI COMPETENCE in IVD EMKI has competence in conformity assessment - on the basis of EU directive 98/79/EC - for companies dealing with product ranges listed below. Annex III.: EC DECLARATION OF CONFORMITY Annex IV.: EC DECLARATION OF CONFORMITY (FULL QUALITY ASSURANCE SYSTEM) Annex V.: EC TYPE-EXAMINATION Annex VI.: EC VERIFICATION Annex VII.: EC DECLARATION OF CONFORMITY (PRODUCTION QUALITY ASSURANCE) IVD SCOPE EXPRESSIONS Annex III.6. IV. V. VI. VII. IVD 000 List A Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups IVD 00 AB0 system IVD 002 Rhesus (C, c, D, E, e) IVD 003 Anti-Kell IVD 0300 List B Reagents, reagent products and devices for self - diagnosis, including related calibrators and control materials, for determining, detection, quantification, diagnosing, evaluating IVD 0302 Irregular anti-erythrocytic antibodies IVD 0307 Tumoral marker: PSA IVD 0308 Risk of trisomy 2 (incl. software) IVD 0309 Device for self-diagnosis: device for the measurement of blood sugar IVD 0400 Devices for self-testing IVD 040 Clinical chemistry IVD 0405 Pregnancy and ovulation MDS 7200 IVD Specifics MDS 7206 IVDs in sterile condition 2 3 MDS 7209 IVDs utilising biological active coating and/or material 4 5 MDS 720 IVDs utilising material of human origin except Annex IV. 6. except Annex VII. 5. except Annex IV. 6. except Annex VII. 5.

5 EMKI COMPETENCE in ISO 3485 EMKI has competence in conformity assessment for companies dealing with products withscopes listed on the following table according to their IAF MD 9:20 Annex A Medical Device Technical Areas: MD SCOPE EXPRESSIONS, NON-ACTIVE MEDICAL DEVICES MD 000 MD 00 MD 002 MD 003 MD 004 MD 005 MD 006 MD 007 MD 008 MD 009 MD 0200 MD 020 MD 0202 MD 0203 MD 0204 MD 0300 MD 030 MD 0302 MD 0303 MD 0400 MD 040 MD 0402 MD 0403 General non-active, non-implantable medical devices Non-active devices for anaesthesia, emergency and intensive care Non-active devices for injection, infusion, transfusion and dialysis Non-active orthopaedic and rehabilitation devices Non-active medical devices with measuring function Non-active ophthalmologic devices Non-active instruments Contraceptive medical devices Non-active medical devices for disinfecting, cleaning, rinsing Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Non-active implants Non-active cardiovascular implants Non-active orthopaedic implants Non-active functional implants Non-active soft tissue implants Devices for wound care Bandages and wound dressings Suture material and clamps Other medical devices for wound care Non-active dental devices and accessories Non-active dental equipment and instruments Dental materials Dental implants For Annex III. and IV. designation excluding materials of desinfecting, cleaning and rinsing. For Annex II., V., VI. there are no limitation.

6 EMKI COMPETENCE in ISO 3485 EMKI has competence in conformity assessment for companies dealing with products withscopes listed on the following table according to their IAF MD 9:20 Annex A Medical Device Technical Areas: MD 00 MD 0 MD 02 MD 03 MD 04 MD 05 MD 06 MD 07 MD 08 MD 09 MD 0 MD MD 200 MD 20 MD 202 MD 300 MD 30 MD 302 MD 400 MD 40 MD 402 MD 403 MD 404 MDS 7000 MDS 7002, except for TSE/BSE MDS 7004 MDS 7005 MDS 7006 MDS 7009 MD SCOPE EXPRESSIONS ACTIVE (NON-IMPLANTABLE) MEDICAL DEVICES General active medical devices Devices for extra-corporal circulation, infusion and haemopheresis Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia Devices for stimulation or inhibition Active surgical devices Active ophthalmologic devices Active dental devices Active devices for disinfection and sterilisation Active rehabilitation devices and active prostheses Active devices for patient positioning and transport Active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Software Devices for imaging Imaging devices utilising ionizing radiation Imaging devices utilising non-ionizing radiation Monitoring devices Monitoring devices of non-vital physiological parameters Monitoring devices of vital physiological parameters Devices for radiation therapy and thermo therapy Devices utilising ionizing radiation Devices utilising non-ionizing radiation Devices for hyperthermia / hypothermia Devices for (extracorporal) shock-wave therapy (lithotripsy) MD / AIMD Specifics Medical devices utilising tissues of animal origin Medical devices referencing the Directive 2006/42/EC on machinery Medical devices referencing the Directive 89/686/EEC on personal protective equipment (PPE) Medical devices in sterile condition / Sterilization Method for Medical Devices /Ethylene oxide gas sterilization (EOG) Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed

7 EMKI COMPETENCE in ISO 3485 EMKI has competence in conformity assessment for companies dealing with products withscopes listed on the following table according to their IAF MD 9:20 Annex A Medical Device Technical Areas: AIMD 000 AIMD 00 IVD SCOPE EXPRESSIONS ACTIVE IMPLANTABLE MEDICAL DEVICES General active implantable medical devices Active implantable medical devices for stimulation / inhibition IVD SCOPE EXPRESSIONS IVD 000 IVD 00 List A Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups AB0 system IVD 002 Rhesus (C, c, D, E, e) IVD 003 IVD 0300 IVD 0302 IVD 0307 IVD 0308 IVD 0309 IVD 0400 IVD 040 IVD 0405 MDS 7200 MDS 7206 MDS 7209 MDS 720 Anti-Kell List B Reagents, reagent products and devices for self - diagnosis, including related calibrators and control materials, for determining, detection, quantification, diagnosing, evaluating Irregular anti-erythrocytic antibodies Tumoral marker: PSA Risk of trisomy 2 (incl. software) Device for self-diagnosis: device for the measurement of blood sugar Devices for self-testing Clinical chemistry Pregnancy and ovulation IVD Specifics IVDs in sterile condition IVDs utilising biological active coating and/or material IVDs utilising material of human origin

8 EMKI COMPETENCE in ISO 900 EMKI has competence in conformity assessment for companies dealing with products and/or services with scopes listed on the following table according to their IAF (International Accreditation Forum) codes: IAF IAF 4 Textiles and textile products 2 Chemicals, chemical products and fibers 4 Rubber and plastic products 7 Basic metals and fabricated metal products 8 Machinery and equipment 9 Electrical and optical equipment 23 Manufacturing not elsewhere classified 29 Wholesale and retail trade: Repair of motor vehicles, motorcycles and personal and household goods 38 Health and social work