PHYSIKALISCHE EIGENSCHAFTEN

Transkript

1 SHIELDski n Xt r emest er i l ew hi t eni t r i l e 33 Dl + apsyst emsgmbh Lember gst r aße54 D727Reut l i ngen Tel ef on: / 989 Tel ef ax: / Emai l :i nf o( at ) apsyst ems. de I nt er net :www. apsyst ems. de

2 Sterile White Nitrile 33 DI+ DI+ Puderfreie, extra lange, DI Wasser gereinigte, handspezifische Nitrile Handschuhe, STERIL, 33 cm lang PSA Kategorie III (Complex Design) gemäss Council Directive 89/8/EEC In völliger Übereinstimmung mit der neuesten Version der PSA Norm - EN374:23 Handschuhe zum Schutz gegen Chemikalien und Mikroorganismen PRODUKT INFORMATION Grösse Artikel Nummern Entsprechen folgenden Normen und Piktogrammen EN374:23 EN374:23 123* Level 3 EN42:23 + A1:29 Auch gemäss EN455-1:2, EN455-2:29 + A2:213, EN455-3:215, EN455-4:29 bezogen auf Direktive 93/42/EEC Medizin Produkte Verordnung * TÜV Produkt Service, Ridlestrasse 3, D-8339 München, Germany Material: Synthetisches Soft-Nitrile-Polymer (Acrylonitrile Butadiene), basierend auf Skin Nitrile Technologie. Enthält kein Naturlatex. Design: Weiss, handspezifisch, Rollrand, texturierte Handinnenfläche und Finger Verpackung: Verpackung gemäss den Anforderungen im sterilen Produktionsumfeld. Handschuhe paarweise verpackt in einer PE Tasche und verschweisstem PE Beutel ( Peel-Pack ). Zwanzig (2) PE Beutel im verschweissten PE Aussenbeutel (2 doppelte PE Aussenverpackungen). Zehn (1) PE Aussenbeutel per doppelwandigem Aussenkarton (um Beschädigungen zu vermeiden). Zweihundert Paar (2) per Karton. PHYSIKALISCHE EIGENSCHAFTEN Charakteristik Wert Test Methode Feststellung Pinholes.5 AQL1 EN374:23 1 AQL as defined per ISO 2859 for sampling by attributes Reissfestigkeit Reissfestigkeit (min)typisch Äusserste Dehnbarkeit - Vor Alterung.N, min. 7.N 5%, min. - Nach beschleunigter Alterung.N, min. 8.N 4%, min. EN455-2:29 + A2:213, ASTM D5734(21) und ASTM D412-a(213)

3 PHYSIKALISCHE EIGENSCHAFTEN (weiterführend) Charakteristik Wert Abmessungen Messpunkte - Nominale Dicke (einfache Wandstärke) - Länge Test Methode mm mil Mittel - Finger Handinnen - Fläche Manschette mm, min. ASTM D377-3(214) 335mm, typischer Messwert EN42:23 + A1:29 Handflächenweite Nominale Weite (mm) EN42:23 + A1:29 (mm) Ergebnisse der Reinheitstests: Extractables Particles Per cm².5µm Test Method Specification <1.2 particles Extractables Specification Ion Typical value 9 particles IEST-RP-C5.4 Test Method Typical value 2.7 ug/cm2 Ammonium Nh.1 ug/cm Bromide Br.2 ug/cm2.14 ug/cm2 Calcium Ca.35 ug/cm2.25 ug/cm2 Chloride Cl.35 ug/cm2.25 ug/cm2 Copper Cu.5 ug/cm2.3 ug/cm2 Fluoride F.2 ug/cm2.14 ug/cm2 Iron Fe.5 ug/cm2.3 ug/cm2 Magnesium Mg.35 ug/cm2.25 ug/cm2 Nitrate No.3 ug/cm2.2 ug/cm2 Potassium K.1 ug/cm2.7 ug/cm2 Sodium Na.1 ug/cm2.7 ug/cm2 Sulfate So.1 ug/cm2.7 ug/cm2 Zinc Zn.35 ug/cm2.25 ug/cm2 IEST-RP-CC5.4

4 ZUSÄTZLICHE DATEN Biokompatibilität nachgewiesen durch Modified Buehler und Primärem Haut Irritations Test Nicht nachweissbare Werte von chemischen Allergenen gemessen mit aus wässriger Lösung Extraktion (PBS/Phosphate buffered solution) und High Performance Liquid Chromatography (HPLC) Prüfmethode für qualitative Analyse Frei von Thiuramen und Thiazolen: diese Vulkanisationsbeschleuniger werden in der Herstellung nicht verwendet Puderfrei gemäss EN ISO 21171:2 ( Medizinische Handschuhe Feststellung der Puderrückstände auf der Oberfläche ) um die potentiellen Gefahren durch das Einatmen von luftgetragenen Puderpartikeln zu vermeiden. Puderrückstandswerte liegen typischer Weise bei ca 1, mg/hs mit einem Limit nach oben von 2, mg/hs Mikroorganismen- und Virusresistent erreicht einen AQL.5 gemäss EN374-2:23 und erfüllt die Kriterien für höchste Resistenz vor Mikroorganismen (AQL <.5 Inspektionslevel G1 1 ml Wassertest). Viren Penetrationstest gemäss ASTM F171-97b bestanden, durchgeführt mit Phi-X 174 Bakteriophage Kompatibel für steriles Umfeld da ohne Papierverpackung und durch intensives Nachreinigen nach der Produktion sehr niedrige Rückstandswerte Gammasterilisiert gemäss Sterility Assurance Level (SAL) of 1 -, in Überseinstimmung mit den Richtlinien gemäss ANSI/AAMI/ EN ISO 11137:2 Sterilization of Healthcare Products Radiation Low in Endotoxin mit <2 EU/pair (EN455-3:215) nachgewiesen durch Limulus Amoebocyte Lysate (LAL) kinetic turbidimetric test FTIR: Silicone, Amide und DOP (IEST-RP-C5.4) nicht nachweisbar NVR: maximal 3 mg/g (IEST-RP-C5.4) ESD Verhalten verhalten getestet nach EN1149-1,-2,-3 und -5 Intensiv auf Chemikalienpermeation getestet nach EN374-3:23 mit einer grossen Auswahl an Chemikalien (genaue Information zu finden unter: QUALITÄTS SYSTEME Herstellung gemäss ISO 91:28 und ISO 13485:23 SHIELDskin, A revolution in Glove Technology SHIELDskin XtremeTM and Skin Nitrile are trade mark of SHIELD Scientific 27 Copyright SHIELD Scientific B.V. All Rights reserved Dr. Willem Dreeslaan ND Bennekom The Netherlands - Phone +31 () Fax +31 () Info@shieldscientific.com V7 SHIELDskin XTREME Sterile White Nitrile 33 DI+ DE 34215

5 SHIELDskin XTREME* Sterile White Nitrile 33 DI+ Category III PPE glove (PPE Directive 89/8/EEC) Complex Design - For mortal & irreversible risks Powder-free white nitrile glove Hand-specific 33 mm /.12 mm (EN 42:23 + A1:29) AQL.5 (EN 374-2:23 Level 3) Viral penetration test (ASTM F171-97b) Waterproof and for low chemical protection Tested for chemical permeation (EN :215 supersedes EN 374-3:23) Typical particle levels: less than 9 per cm² more or equal.5µm Tested according to EN & 5 Type I hypersensivity eliminated - Type IV hypersensivity reduced Acrylamide 4% 48' Ethidium bromide 5% 48' 5-- Formaldehyde, 37% 48' Glutaraldehyde 25% 48' Hydrogen Peroxide, 3% 48' Sodium Hydroxide, 4% 48' Sodium Hypochlorite 13% 48' Sulphuric acid 5% 48' Isopropanol 7% 155' Contact: info@shieldscientific.com Â 21- Copyright protected Shield Scientific - All rights reserved - Printed : 1/7/21 - * Trade Mark

6 SHIELDskin XTREME* Sterile White Nitrile 33 DI+ 3 Mixed Solution Klercide 7/3 sterile IPA 94' Ethanol, 7% 7' 2 Mixed Solution Klercide Premier - WFI 7/3 sterile IPA 55' Isopropanol 1% 44' Ammonium Hydroxide, 25% 27' Heptane 25' 1 Mixed Solution Klercide Premier - WFI /4 sterile Alcohol 23' Ethanol 1% 1' Sulphuric acid 95%-98% ' Xylene 98,5% 3' Acetone 99.8% 1' Acetonitrile 99,9% 1' 8-2- Methyl Methacrylate 99% 1' Contact: info@shieldscientific.com Â 21- Copyright protected Shield Scientific - All rights reserved - Printed : 1/7/21 - * Trade Mark

7 SHIELDskin XTREME* Sterile White Nitrile 33 DI Dichloromethane 99% ' Diethylamine 99,5% ' Contact: info@shieldscientific.com Â 21- Copyright protected Shield Scientific - All rights reserved - Printed : 1/7/21 - * Trade Mark

8

9 CHEMICAL ANALYTICAL SERVICES TEST REPORT ASTM D Project No: 8522-A SUBJECT: SAMPLE: Permeation testing per ASTM D on sample submitted SHIELDskin Sterile Nitrile Gloves, mil, lot# 274R8C (equivalent SHIELDskin Xtreme Sterile White Nitrile 33 DI gloves (code ) Test Laboratory: Akron Rubber Development Laboratories Inc 2887 Gilchrist Road Akron Ohio 4435 UNITED STATES TESTING CHEMOTHERAPY DRUGS: Table 1. List of the Testing Chemotherapy Drugs, Sources, and Expiration Dates Test Chemical Chemical Source Lot # Expiration date Carmustine (BCNU) Sigma 59H Cyclophosphamide (Cytoxan) Sigma 8K Doxorubicin Hydrochloride Teva 7N Fluorouracil APP Etoposide (Toposar) Teva B Paclitaxel (Taxol) Dabur Oncology PA8H Thiotepa Sigma 78K SHIELD Scientific B.V. Galvanistraat 1 71 AE EDE The Netherlands Phone +31 () Fax: +31() info@shieldscientific.com

10 COLLECTION MEDIA: The collection media which were selected are listed in Table 2. Table 2. Collection Media for Test Chemicals Test Chemical Concentration Collection Medium Carmustine (BCNU) 3.3 ppm 1% Ethanol Aqueous Solution Cyclophosphamide (Cytoxan) 2. ppm Distilled Water Doxorubicin Hydrochloride 2. ppm Distilled Water Fluorouracil 5. ppm 9.2 ph Sodium Hydroxide Solution Etoposide(Toposar) 2. ppm Distilled Water Paclitaxel (Taxol). ppm 3% Methanol Aqueous Solution Thiotepa 1. ppm Distilled Water NOTE: The chemotherapy drugs were prepared as required by the ASTM D Standard at , page 2, using the highest concentration of the drugs to which a healthcare worker might be exposed during handling as referenced in the most recent edition of the Physician s Desk Reference or the package inserts of the testing drugs. TESTING CONDITIONS: Standard Test Method Used: Deviation From Standard Test Method: Analytical Method: Testing Temperature: Collection System: Specimen Area Exposed: Selected Data Points: Number of Specimens Tested: Location Sampled From: Comments/Other Conditions: ASTM D Used 1 (2.54cm) Permeation Cell UV/VIS Spectrometry 35. C ± 2. Closed Loop 5.7 cm2 25/test 3/test Palm area Magnetic stir bar was used in the sampling chamber DETECTION METHOD OF CHEMICAL PERMEATION; UV/VIS ABSORPTION SPECTROMETRY Instrument: Perkin Elmer UV/VIS Spectrometer Lambda 25 UV/VIS Absorption Spectrometry was used to measure the absorbance of test chemicals which permeated through the specimens into the collection medium. The collection medium was circulated in a closed loop at 11 ml/minute of flow rate through the testing period. Data collection was performed according to the programmed schedule by means of UV Winlab software from the Perkin Elmer Corporation. The list of the characteristics wavelengths is shown in Table 3. SHIELD Scientific B.V. Galvanistraat 1 71 AE EDE The Netherlands Phone +31 () Fax: +31() info@shieldscientific.com

11 Table 3. Characteristics Wavelengths used in UV/VIS Absorption Spectrometry. Test Chemical Carmustine (BCNU) Cyclophosphamide (Cytoxan) Doxorubicin Hydrochloride Fluorouracil Etoposide (Toposar) Paclitaxel (Taxol) Thiotepa Wave length (nm) SAMPLE CHARACTERISTICS Table 4. Thickness Characteristics SAMPLE WEIGHT/UNIT AREA (g/m2) THICKNESS (mm) Carmustine (BCNU) Cyclophosphamide (Cytoxan) Doxorubicin Hydrochloride Fluorouracil Etoposide (Toposar) Paclitaxel (Taxol) Thiotepa #1.19 #2.18 #3.113 Average CALCULATION: Average permeation rate for each sampling time interval (except time = minutes) was calculated using the equation below: Pi= ((Ci-Ci -1) x Vt) / ((Ti-T Ci-1) x A) Where: Pi = Ci = Vt = i = Ti = A = average permeation rate, ug/cm2/min. at time interval Ti - Ti-1 concentration of test chemical detected in collection medium, ug/l,at time Ti volume of collection medium, I an index number starting with i = 1 for the first sample sampling time, minutes area of specimen in contact with the test chemical, cm2 SHIELD Scientific B.V. Galvanistraat 1 71 AE EDE The Netherlands Phone +31 () Fax: +31() info@shieldscientific.com

12 RESULTS Table 5. Permeation Test Results: Test Chemical Carmustine (BCNU) 3,3 ppm/ 3.3 mg/ml Cyclophosphamide (Cytoxan) 2, ppm/ 2. mg/ml Doxorubicin Hydrochloride 2, ppm/ 2. mg/ml Fluorouracil 5, ppm/ 5. mg/ml Etoposide (Toposar) 2, ppm/ 2. mg/ml Paclitaxel (Taxol), ppm/. mg/ml Thiotepa 1, ppm/ 1. mg/ml Average Breakthrough* Detection Time Average Steady State Permeation Rate Minutes 4.99 (Avg.)µg/cm2/min..84 (5.45, 4.7, 4.84) (.71,.515, 1.3) No breakthrough was detected up to 24 minutes No breakthrough was detected up to 24 minutes No breakthrough was detected up to 24 minutes No breakthrough was detected up to 24 minutes No breakthrough was detected up to 24 minutes (147., 17.37, 19.1) (.72,.325,.8) *Breakthrough detection time is the time in minutes measured from the start of the test to the sampling time that immediately precedes the sampling time at which the permeation rate reaches.1 µg/ cm2/min. SHIELD Scientific B.V. Date: Cisco Robles General Manager SHIELD Scientific B.V. Galvanistraat 1 71 AE EDE The Netherlands Phone +31 () Fax: +31() info@shieldscientific.com