Hellenic Accreditation System S.A.

Annex F1/1 to the Certificate No. 422

SCOPE of ACCREDITATION
of the
Testing Laboratory
of
EKEVYL S.A.
Tested materials/ products / Types of test/ Properties to be measured / Applied methods/Techniques to be used /
1.  Elastomeric impression materials / Component colours / ELOT EN ISO 4823:2001§ 6.1
Mixing time / ELOT EN ISO 4823:2001 § 9.1
Working time / ELOT EN ISO 4823:2001 § 9.3
Detail reproduction / ELOT EN ISO 4823:2001 § 9.4
Linear dimensional change / ELOT EN ISO 4823:2001 § 9.5
Compatibility with gypsum / ELOT EN ISO 4823:2001 § 9.6
2.  Medical gloves for single use (Examination and surgical gloves) / Watertightness test for detection of holes / ELOT EN 455.01:2001 § 5
Length / ELOT EN 455.02:2001 § 4.2
Width / ELOT EN 455.02:2001 § 4.3
3.  Sterile synthetic absorbable sutures (monofilament and braided) / Length / European Pharmacopoeia 01/2008:0666 & 0667
Diameter / European Pharmacopoeia 01/2008:0666 & 0667
4.  Sterile non- absorbable sutures / Length / European Pharmacopoeia 01/2008:0324
Diameter / European Pharmacopoeia 01/2008:0324
5.  Elbow crutches / Dimensions / ELOT EN ISO 11334.01:2007 § 5.3.2
Adjusting devices / ELOT EN ISO 11334.01:2007 § 4.4
6.  Walking frames / Dimensions - Manoeuvrability / ELOT EN ISO 11199.01:2000 § 4.3, 4.4, 4.5
Visual inspection / ELOT EN ISO 11199.01:2000 § 5.2
Adjusting devices / ELOT EN ISO 11199.01:2000 § 4.6
7.  Walking sticks with three or more legs / Dimensions / ELOT EN ISO 11334.04:1999 § 4.1, 4.2
Visual inspection - Finish / ELOT EN ISO 11334.04:1999 § 4.5, 5.2
Adjusting devices / ELOT EN ISO 11334.04:1999 § 4.3
8.  Partial and total hip joint prostheses – Articulating surfaces made of metallic, ceramic & plastics materials / Sphericity of femoral prostheses / ISO 7206-2 § 4.3.1
Sphericity of acetabular components / ISO 7206-2 § 4.2.1
Surface finish of femoral prostheses / ISO 7206-2 § 4.3.2
Surface finish of acetabular components / ISO 7206-2 § 4.2.2
Dimensional tolerances of femoral prostheses / ISO 7206-2 § 4.3.3
Dimensional tolerances of acetabular components / ISO 7206-2 § 4.2.3
9.  Natural latex rubber condoms
9. Natural latex rubber condoms(con.) / Determination of length / ELOT ΕΝ ISO 4074 § 5.3.1. & Αnnex D
Determination of width / ELOT ΕΝ ISO 4074 § 5.3.2. & Αnnex E
Determination of thickness / ELOT ΕΝ ISO 4074 § 5.3.3. & Αnnex F
Determination of total lubricant for condoms in individual containers / ELOT ΕΝ ISO 4074 § 5.2 & Αnnex C
Testing for holes / ELOT ΕΝ ISO 4074 § 8 & Αnnex L
Testing for visible defects / ELOT ΕΝ ISO 4074 § 9 & Αnnex L
Package integrity / ELOT ΕΝ ISO 4074 § 10 & Αnnex M
Mechanical tests
1.  Elastomeric impression materials / Consistency / ELOT EN ISO 4823:2001 § 9.2
Elastic recovery / ELOT EN ISO 4823:2001 § 9.7
Strain-in-compression / ELOT EN ISO 4823:2001 § 9.8
2.  Medical gloves for single use (Examination and surgical gloves) / Force at break before accelerated ageing / ELOT EN 455.02:2001§ 5.2
Force at break after accelerated ageing / ELOT EN 455.02:2001§ 5.3
3.  Sterile synthetic absorbable sutures (monofilament and braided) / Minimum breaking load / European Pharmacopoeia 01/2008:0666 & 0667
Needle attachment / European Pharmacopoeia 01/2008:0666 & 0667
4.  Sterile non- absorbable sutures / Minimum breaking load / European Pharmacopoeia 01/2008:0324
Needle attachment / European Pharmacopoeia 01/2008:0324
5.  Elbow crutches / Forearm withdrawal test / ELOT EN ISO 11334.01:2007 § 5.4
Separation tests / ELOT EN ISO 11334.01:2007 § 5.5
Static loading test / ELOT EN ISO 11334.01:2007 § 5.6
Fatigue test / ELOT EN ISO 11334.01:2007 § 5.7
6.  Walking frames
6. Walking frames(con.) / Forward stability test / ELOT EN ISO 11199.01:2000 § 5.6
Backward stability test / ELOT EN ISO 11199.01:2000 § 5.7
Sideways stability test / ELOT EN ISO 11199.01:2000 § 5.8
Static loading test / ELOT EN ISO 11199.01:2000 § 5.4
Fatigue test / ELOT EN ISO 11199.01:2000 § 5.3
Static leg-strength test / ELOT EN ISO 11199.01:2000 § 5.5
7. Walking sticks with three or more legs / Inwards stability test / ELOT EN ISO 11334.04:1999 § 5.3
Outwards stability tests / ELOT EN ISO 11334.04:1999 § 5.4
Separation test / ELOT EN ISO 11334.04:1999 § 5.5
Static loading test / ELOT EN ISO 11334.04:1999 § 5.6
Fatigue test / ELOT EN ISO 11334.04:1999 § 5.7
8.  Natural latex rubber condoms / Determination of bursting volume and pressure / ELOT ΕΝ ISO 4074:2002 § 6.1 & Αnnex G
Determination of bursting volume and pressure for oven-treated condoms / ELOT ΕΝ ISO 4074:2002 § 6.2 & Αnnex G
Determination of force at break / ELOT ΕΝ ISO 4074:2002 § 6.3.2. & Αnnex Ι
Determination of elongation at break / ELOT ΕΝ ISO 4074:2002 § 6.3.2. & Αnnex Ι

Site of assessment: Permanent laboratory premises, 13-15 Smirnis St., Glifada,Attiki, Greece

Approved signatory: Georges Pappous, Filippos Kottis

The Accreditation Certificate No. 422, to ELOT EN ISO/IEC 17025:2005, is valid until 17 .4. 2012

Athens, 18 April 2008

N. Papaioannou

Chairman of ESYD

Page 1 of 4 Annex F1/1 to the Certificate ESYD No. 422 18.4.2008