ANTIBIOTIC DISC
ENGLISHANTIBIOTIC DISC
Antibiotic discs for susceptibility tests
Antibiotic discs for susceptibility tests
DESCRIPTIONANTIBIOTIC DISC are paper discs with special features, that are impregnated with antibiotic and used for the susceptibility test according to the Kirby-Bauer antibiotic testing (KB testing or disk diffusion antibiotic sensitivity testing).
ANTIBIOTIC DISC are available in a large variety of configurations. Each configuration is available in packages of 50 and 250 tests. CONTENTS OF THE PACKAGES
The 50-test version contains: 1 cartridge with 50 discs packaged in a “blister” with a dryer.
The 250-test version contains: 5 cartridges with 50 discs, packaged in a “blister” with a dryer and an instruction sheet. METHOD PRINCIPLE
The discs are applied to the surface of a culture medium inoculated with the broth culture containing pure colonies of the microorganism under examination. After incubation, the plates are examined, the inhibition halos around each disc are examined and compared with the standard inhibition haloes: in this way the microorganisms are defined as being susceptible, intermediate or resistant to the tested antimicrobial agents. COMPOSITION
The discs are made of high-quality paper in compliance with WHO and FDA specifications.
Antibiotic potency: the discs are manufactured according to DIN specification, i.e. the concentration of each antibiotic is within 90-125% of the concentration stated on the disc.
GATHERING AND KEEPING SAMPLES
The colonies that are to be subjected to the susceptibility test are taken up by culture media that have been previously swabbed with the sample under examination. In the case of mixed colonies the bacterial strains must be purified before they are swabbed on the plates for the susceptibility test.
TEST PROCEDURE
For the details of the test procedure, refer to the bibliography indicated below or to microbiology manuals. Here the Kirby-Bauer method is shortly summarized:
1. Take the “blister” of cartridges from the refrigerator and leave it for about an hour at ambient temperature in order to prevent condensation forming on the discs when it is opened as such condensation could affect long-term stability;
2. Swab 4 to 5 well isolated and morphologically similar colonies with a culture medium and suspend them in 5 ml of a suitable broth culture such as Tryptic Soy broth;
3. Incubate the broth culture at 36+/-1°C until 0.5 McFarland turbidity is reached;
4. Immerse a sterile buffer in the broth culture or in a diluted form thereof and squeeze it on the wall of the test tube to eliminate excess liquid. Drag it along the surface of the susceptibility test medium contained on the plate so as to produce even growth;
5. Position the antibiotic discs within 15 minutes from inoculation of the plates, pressing them with a sterile pliers on the surface of the agar and within 15 minutes of depositing of the discs leave the plate to incubate at 36+/-1°C for 18-24 hours.
EVALUATING THE RESULTS
At the end of the incubation period, measure the inhibition halos and interpret according to the current reference standards. CLINICAL INTERPRETATION
The susceptibility test carried out in vitro cannot exactly reproduce in vivo conditions. Nevertheless, it shows the effect of the concentration of the antibiotic, which varies in the culture medium in relation to the growth of the microbial population.
The final choice of antibiotic to administer to the patient is the responsibility of the clinician who possesses all the information on the patient. QUALITY CONTROL
Each production batch of ANTIBIOTIC DISC is subjected to the quality control with the following bacterial strains: Escherichia coli ATCC® 25922 Neisseria gonorrhoeae ATCC® 49226
Staphylococcus aureus ATCC® 25923 Streptococcus pneumoniae ATCC® 49619
Pseudomonas aeruginosa ATCC® 27853 Staphylococcus aureus ATCC® 29213
Escherichia coli ATCC® 35218 Enterococcus faecalis ATCC® 29212
Haemophilus influenzae ATCC® 49247 Haemophilus influenzae NCTC 8468
Haemophilus influenzae ATCC® 49766 Streptococcus pneumoniae ATCC® 49619 LIMITS
Diffusion susceptibility tests use an in vitro technique and cannot therefore reproduce the extremely complex in vivo conditions. Nevertheless, it is a useful and important tool that helps the clinician choose the correct therapy. Many variable factors influence the final result of the diffusion susceptibility test. The main ones are: the culture medium used, impregnation of the discs, inoculation of the medium, temperature, time and incubation atmosphere of the plates, pre-incubation and pre-diffusion conditions, depth of the medium, etc.
PRECAUTIONS
The ANTIBIOTIC DISC cannot be classified as being hazardous according to current legislation but fall within the specific field of application where a safety datasheet must be supplied because they can cause phenomena of sensitisation in sensitive subjects if they come into contact with the skin.
ANTIBIOTIC DISC are disposable products. ANTIBIOTIC DISC are only for diagnostic in vitro use and are intended for professional use. They must be used in the laboratory by properly trained operators using approved aseptic and safety methods for pathogenic agents.
STORAGE
Store the unopened blister at -20°C to +8°C till the expiry date. Leftover discs from an opened package should be stored at 2-8°C avoiding humidity until the expiry date. To further reduce humidity, store the discs inside the disc dispenser, which contains desiccant. In such conditions, ANTIBIOTIC DISC can be used until the expiry date shown on the label. Do not use after this date. Dispose of if they show signs of deterioration. ELIMINATING USED MATERIAL
After use, ANTIBIOTIC DISC and the material that comes into contact with the sample must be decontaminated and disposed of in accordance with current laboratory techniques for the decontamination and disposal of potentially infected material.
ANTIBIOTIC DISC
PORTUGUÊSANTIBIOTIC DISC
Discos antibiótico para antibiograma
Discos antibiótico para antibiograma
DESCRIÇÃOANTIBIOTIC DISC, são discos em papel, com características especiais, impregnados com antibiótico, e destinados a ensaios de susceptibilidade anti-microbiano, pelo teste de Kirby-Bauer (Teste de KB ou teste de sensibilidade antibiótica por difusão em disco).
ANTIBIOTIC DISC estão disponíveis numa ampla variedade de apresentações.. Cada configuração é disponível na variante de 50 e 250 testes. CONTEÚDO DAS CONFECÇÕES
A variante de 50 testes contém: 1 cartucho com 50 discos confeccionados num “blister” em presença de um secador.
A variante de 250 testes contém: 5 cartuchos com 50 discos, confeccionados num “blister”, em presença de um secador, e 1 folha de instruções. PRINCÍPIO DO MÉTODO
Os discos são aplicados sobre a superfície de um terreno de cultura, inoculado com a cultura do líquido, preparada com colónias puras do microrganismo em exame. Depois da incubação, são examinadas as chapas, misturadas as auréolas de inibição ao redor de cada disco e comparados com os diâmetros das auréolas de inibição padrão: deste modo os microrganismos são definidos sensíveis, intermédios ou resistentes aos agentes anti-micróbios testados.
COMPOSIÇÃO
Os discos são produzidos em papel de alta qualidade em conformidade com as especificações da WHO e da FDA.
Concentração dos discos: estes são produzidos de acordo com as directrizes da DIN, ou seja, a concentração de cada antibiótico está entre 90 a 125 % a concentração definida para estes discos.
RECOLHA E CONSERVAÇÃO DAS AMOSTRAS
As colónias que devem ser submetidas ao antibiograma são recolhidas nos terrenos de cultura semeados preventivamente com a amostra em exame. Em caso de colónias mistas é necessário proceder à purificação das estirpes bactéricas antes da semeadura nas chapas para o antibiograma.
PROCEDIMENTO DO TESTE
Para informação mais detalhada sobre o procedimento, consultar a Bibliografia ou os Manuais de Microbiologia. Breve descrição do método de Kirby-Bauer:
1. Levantar o “blister” dos cartuchos do frigorífico e deixá-lo por cerca de uma hora a temperatura ambiente de modo a evitar que na abertura se deposite humidade de condensação nos discos, prejudicando a estabilidade no tempo;
2. Tocar 4-5 colónias bem isoladas e morfologicamente semelhantes, de um terreno de cultura e suspendê-las em 5 ml de um líquido cultural apto qual o Tryptic Soy broth;
3. Incubar a líquido em cultura a 36+/-1°C até obter uma turbidez igual ao 0.5 McFarland;
4. Imergir um tampão estéril no líquido de cultura ou numa sua diluição adequada e espremê-lo na parede da proveta para eliminar o excesso de líquido. Passar sobre a superfície do terreno para antibiograma, conteúdo em chapa, de modo a produzir um crescimento homogéneo; 5. Depositar os discos antibióticos dentro de 15 minutos do inoculo das chapas, premendo-os com uma pinça estéril na superfície do Agar e por
a incubar a chapa, dentro de 15 minutos da deposição dos discos, a 36+/-1°C por 18-24 horas. ANALISE DOS RESULTADOS
Após incubação, meça os halos de inibição e interprete-os, de acordo com as normas de referência. INTERPRETAÇÃO CLÍNICA
O antibiograma realizado in vitro não pode reproduzir exactamente as condições que se encontram in vivo, contudo é em grau de evidenciar o efeito da concentração de antibiótico, que varia no terreno cultural, nas comparações da população de micróbios em fase de desenvolvimento. A escolha final do antibiótico a subministrar ao paciente concerne ao clínico que é em posse de todos os dados que dizem respeito ao próprio paciente.
CONTROLO DA QUALIDADE
Cada lote de produção do ANTIBIOTIC DISC é sujeito a um controlo de qualidade com as seguintes estirpes de referência: Escherichia coli ATCC® 25922 Neisseria gonorrhoeae ATCC® 49226
Staphylococcus aureus ATCC® 25923 Streptococcus pneumoniae ATCC® 49619
Pseudomonas aeruginosa ATCC® 27853 Staphylococcus aureus ATCC® 29213
Escherichia coli ATCC® 35218 Enterococcus faecalis ATCC® 29212
Haemophilus influenzae ATCC® 49247 Haemophilus influenzae NCTC 8468
Haemophilus influenzae ATCC® 49766 Streptococcus pneumoniae ATCC® 49619 LIMITES
O antibiograma para difusão, utilizando uma técnica in vitro, não é em grau de reproduzir as condições extremamente complexas que se encontram “in vivo”; contudo, constitui um útil e importante suporte à escolha terapêutica do clínico.
Muitas são as variáveis que influenciam o resultado final do antibiograma por difusão; as principais são representadas pelo: terreno de cultura utilizado, impregnação dos discos, inóculo do terreno, temperatura, tempo e atmosfera de incubação das chapas, condições de pré-incubação e pré-difusão, espessura do terreno, etc.
PRECAUÇÕES
O produto ANTIBIOTIC DISC não é classificável como perigoso em conformidade com a legislação em vigor, mas, reentra no específico campo de aplicação da normativa relativa à obrigação de fornecimento de ficha de segurança, porque pode causar fenómenos de sensibilização em sujeitos sensíveis em caso de contacto com a pele.
ANTIBIOTIC DISC é um dispositivo de uso único. ANTIBIOTIC DISC é somente para o uso diagnóstico in vitro, é destinado a um âmbito profissional e deve ser utilizado em laboratório por operadores adequadamente treinados, com métodos aprovados de assepsia e de segurança nos confrontos dos agentes patogénicos.
ARMAZENAMENTO
O armazenamento de uma embalagem aberta deverá ser mantida de -20 a +8ºC, até ao término do prazo de validade. Os discos restantes de cada cartucho aberto, deverá ser mantido a 2-8ºC, ao abrigo de humidade, até expirar o prazo de validade. Para reduzir a humidade, armazene os discos no dispensador, que contem um dissecante. Nestas condições os ANTIBIOTIC DISC pode ser usado até à data de validade, indicada no rótulo. Mas não usado depois desta data. Rejeite o produto caso este apresente sinais de deterioração.
ELIMINAÇÃO DO MATERIAL UTILIZADO
Depois da utilização do ANTIBIOTIC DISC e do material que entrou a contacto com a amostra, devem ser descontaminados e eliminados em acordo com as técnicas em uso no laboratório para a descontaminação e a eliminação de material potencialmente infecto.
PRESENTAZIONE / PRESENTATION / PRESENTACIÓN / PRÉSENTATION / ΠΑΡΟΥΣΊΑΣ / APRESENTAÇÃO Single cartridges of 50 discs are available: add /1 to the catalogue ref. no. to indicate the relevant item.
Example: ref. 9045/1 indicates Vancomycin 30 µg in one single cartridge of 50 discs. DESCRIPTION
DESCRIPTION
DESCRIPTION µgµg CLSI 1,2 EUCAST 3,4,5 BSAC 6 PACKAGING REF.
Amikacin AK 30 ✓ ✓ ✓ 5x50 Discs 9004
Amoxicillin AML 30 5x50 Discs 9005
Amoxicillin AML 25 5x50 Discs 9179
Amoxicillin AML 10 ✓ 5x50 Discs 9133
Amoxicillin AML 2 ✓ 5x50 Discs 9151
Amoxicillin + Clavulanic acid AUG 30 (20+10) ✓ ✓ ✓ 5x50 Discs 9048
Amoxicillin + Clavulanic acid AUG 3 (2+1) ✓ 5x50 Discs 9191
Ampicillin AMP 2 ✓ ✓ 5x50 Discs 9115
Ampicillin AMP 10 ✓ ✓ ✓ 5x50 Discs 9006
Ampicillin + Sulbactam AMS 20 (10+10) ✓ ✓ 5x50 Discs 9031
Ampliclox (AMP + CX) ACL 30 (25+5) 5x50 Discs 9122
Azithromycin AZM 15 ✓ ✓ 5x50 Discs 9105
Azlocillin AZL 75 ✓ 5x50 Discs 9007
Aztreonam ATM 30 ✓ ✓ ✓ 5x50 Discs 9008
Bacitracin BA 10 IU 5x50 Discs 9051
Boronic acid BO 5x50 Discs 9193
Carbenicillin CAR 100 ✓ ✓ 5x50 Discs 9009
Cefaclor CEC 30 ✓ ✓ ✓ 5x50 Discs 9010
Cefadroxil CDX 30 ✓ ✓ 5x50 Discs 9052
Cefamandole MA 30 ✓ ✓ 5x50 Discs 9014
Cefazolin KZ 30 ✓ 5x50 Discs 9015
Cefepime FEP 30 ✓ ✓ ✓ 5x50 Discs 9104
Cefepime + Clavulanic acid FEL 40 (30+10) 5x50 Discs 9143
Cefixime CFM 5 ✓ ✓ ✓ 5x50 Discs 9089
Cefoperazone CFP 75 ✓ 5x50 Discs 9108
Cefoperazone CFP 30 ✓ 5x50 Discs 9016
Cefotaxime CTX 30 ✓ ✓ 5x50 Discs 9017
Cefotaxime CTX 5 ✓ ✓ 5x50 Discs 9152
Cefotaxime + Clavulanic acid CTL 40 (30+10) 5x50 Discs 9182
Cefotetan CTT 30 ✓ 5x50 Discs 9081
Cefpirome CR 30 5x50 Discs 9185
Cefpodoxime PX 10 ✓ ✓ ✓ 5x50 Discs 9064
Cefpodoxime + Clavulanic acid PXL 11 (10+1) 5x50 Discs 9190
Cefoxitin FOX 30 ✓ ✓ ✓ 5x50 Discs 9018
Cefoxitin + Cloxacillin FOC 230 (30+200) 5x50 Discs 9144
Cefprozil CPR 30 ✓ 5x50 Discs 9112
Cefsulodin CSD 30 5x50 Discs 9053
Ceftaroline CPT 5 ✓ 5x50 Discs 9195
Ceftazidime CAZ 30 ✓ ✓ 5x50 Discs 9019
Ceftazidime CAZ 10 ✓ 5x50 Discs 9153
Ceftazidime + Clavulanic acid CAL 40 (30+10) 5x50 Discs 9145
Ceftibuten CTB 30 ✓ ✓ 5x50 Discs 9101
Ceftizoxime CZX 30 ✓ ✓ 5x50 Discs 9054
Ceftriaxone CRO 30 ✓ ✓ ✓ 5x50 Discs 9020
Cefuroxime CXM 30 ✓ ✓ ✓ 5x50 Discs 9021 Cephalexin CL 30 ✓ 5x50 Discs 9011 Cephalothin KF 30 ✓ ✓ 5x50 Discs 9013 Cephradine CE 30 ✓ 5x50 Discs 9055 Chloramphenicol C 30 ✓ ✓ ✓ 5x50 Discs 9022 Chloramphenicol C 10 ✓ 5x50 Discs 9128
Cinoxacin CIN 100 ✓ 5x50 Discs 9057
Ciprofloxacin CIP 5 ✓ ✓ ✓ 5x50 Discs 9056
Clarithromycin CLR 15 ✓ 5x50 Discs 9098
Clindamycin CD 2 ✓ ✓ ✓ 5x50 Discs 9047
Cloxacillin CX 5 5x50 Discs 9058
Colistin sulfate CS 25 ✓ 5x50 Discs 9184
Colistin sulfate CS 10 ✓ 5x50 Discs 9023
Dicloxacillin DCX 1 5x50 Discs 9093
Dipicolinic acid DP 5x50 Discs 9194
Doripenem DOR 10 ✓ ✓ 5x50 Discs 9154
Doxycycline DXT 30 ✓ ✓ 5x50 Discs 9059
Ertapenem ETP 10 ✓ ✓ ✓ 5x50 Discs 9061
Erythromycin E 15 ✓ ✓ 5x50 Discs 9024
Erythromycin E 2 5x50 Discs 9180
Fosfomycin (includes G-6-P) FOS 200 ✓ 5x50 Discs 9109
Fosfomycin (includes G-6-P) FOS 100 5x50 Discs 9121
Fosfomycin FOS 50 ✓ 5x50 Discs 9025
Furazolidon FR 50 5x50 Discs 9099
Fusidic acid FC 10 ✓ ✓ ✓ 5x50 Discs 9049
Fusidic acid FC 30 5x50 Discs 9111
Gatifloxacin GAT 5 ✓ 5x50 Discs 9169
Gentamicin CN 10 ✓ ✓ ✓ 5x50 Discs 9026
Gentamicin CN 30 ✓ 5x50 Discs 9125
Gentamicin CN 120 5x50 Discs 9124
Imipenem IMI 10 ✓ ✓ ✓ 5x50 Discs 9079
DESCRIPTION DESCRIPTION
DESCRIPTION µgµg CLSI 1,2 EUCAST 3,4,5 BSAC 6 PACKAGING REF.
Imipenem + Cilastatin IMC 20 (10+10) 5x50 Discs 9095
Imipenem + EDTA IMD 760 (10+750) 5x50 Discs 9183
Kanamycin K 30 ✓ 5x50 Discs 9027
Levofloxacin LEV 5 ✓ ✓ ✓ 5x50 Discs 9102
Lincomycin MY 15 5x50 Discs 9116
Lincomycin MY 2 5x50 Discs 9028
Linezolid LNZ 10 ✓ ✓ 5x50 Discs 9155
Linezolid LNZ 30 ✓ 5x50 Discs 9136
Lomefloxacin LOM 10 ✓ 5x50 Discs 9113
Loracarbef LOR 30 ✓ 5x50 Discs 9173
Mecillinam MEC 10 ✓ ✓ ✓ 5x50 Discs 9156
Meropenem MRP 10 ✓ ✓ ✓ 5x50 Discs 9068
Meropenem + Boronic acid MR+BO 5x50 Discs 9176
Meropenem + Cloxacillin MR+CL 5x50 Discs 9175
Meropenem + Dipicolinic acid MR+DP 5x50 Discs 9177
Meropenem + EDTA MR+ED 5x50 Discs 9178
Methicillin MET 5 ✓ 5x50 Discs 9029
Metronidazole LZ 50 5x50 Discs 9119
Metronidazole LZ 5 ✓ 5x50 Discs 9076
Mezlocillin MEZ 75 ✓ ✓ 5x50 Discs 9062
Minocycline MN 30 ✓ ✓ ✓ 5x50 Discs 9030
Miokamicin MK 15 5x50 Discs 9106
Moxifloxacin MOX 5 ✓ ✓ ✓ 5x50 Discs 9103
Mupirocin MUP 200 ✓ 5x50 Discs 9157
Nafcillin NAF 1 ✓ 5x50 Discs 9174
Nalidixic acid NA 30 ✓ ✓ ✓ 5x50 Discs 9001
Neomycin N 30 5x50 Discs 9032
Netilmicin NET 10 ✓ 5x50 Discs 9170
Netilmicin NET 30 ✓ 5x50 Discs 9033
Nitrofurantoin F 50 5x50 Discs 9181
Nitrofurantoin F 100 ✓ 5x50 Discs 9158
Nitrofurantoin F 300 ✓ 5x50 Discs 9034
Norfloxacin NOR 10 ✓ ✓ 5x50 Discs 9035
Novobiocin NO 30 5x50 Discs 9063
Novobiocin NO 5 5x50 Discs 9117
Ofloxacin OFX 5 ✓ ✓ ✓ 5x50 Discs 9080
Oxacillin OX 1 ✓ ✓ ✓ 5x50 Discs 9036
Oxacillin OX 5 5x50 Discs 9135
Oxolinic acid OA 2 5x50 Discs 9002
Oxytetracycline OT 30 5x50 Discs 9065
Pefloxacin PEF 5 5x50 Discs 9091
Penicillin G P 10 IU ✓ 5x50 Discs 9037
Penicillin G P 2 IU 5x50 Discs 9127
Penicillin G P 1 IU ✓ ✓ 5x50 Discs 9130
Phenoxymethylpenicillin PV 10 5x50 Discs 9171
Pipemidic acid PI 20 5x50 Discs 9003
Piperacillin PRL 30 ✓ 5x50 Discs 9159
Piperacillin PRL 100 ✓ 5x50 Discs 9038
Piperacillin + Tazobactam TZP 110 (100+10) ✓ 5x50 Discs 9100
Piperacillin + Tazobactam TZP 36 (30+6) ✓ 5x50 Discs 9160
Polymyxin B PB 100 IU 5x50 Discs 9066
Polymyxin B PB 300 IU ✓ 5x50 Discs 9120
Quinupristin-Dalfopristin QDA 15 ✓ ✓ ✓ 5x50 Discs 9161
Rifampicin RD 30 5x50 Discs 9039
Rifampicin RD 5 ✓ ✓ ✓ 5x50 Discs 9118
Rokitamycin ROK 30 5x50 Discs 9192
Roxithromycin RXT 15 5x50 Discs 9060
Sisomycin SIS 30 5x50 Discs 9046
Sodium Fusidate FC 30 5x50 Discs 9131
Spectinomycin SPC 100 ✓ 5x50 Discs 9067 Spiramycin SP 100 5x50 Discs 9088 Streptomycin S 10 ✓ ✓ 5x50 Discs 9040 Streptomycin S 300 ✓ 5x50 Discs 9162 Sulbactam SU 20 5x50 Discs 9129 Sulfafurazole SF 300 5x50 Discs 9041 Sulfamethoxazole SMX 50 5x50 Discs 9084 Sulfaprim SXT 50 5x50 Discs 9132 Sulphonamide S3 300 5x50 Discs 9126
Teicoplanin TEC 30 ✓ ✓ ✓ 5x50 Discs 9050
Telithromycin TEL 15 ✓ ✓ ✓ 5x50 Discs 9172
Temocillin TMO 30 ✓ 5x50 Discs 9186
Tetracycline TE 30 ✓ ✓ 5x50 Discs 9043
Tiamulin T 30 5x50 Discs 9094
Ticarcillin TC 75 ✓ ✓ ✓ 5x50 Discs 9070
Ticarcillin + Clavulanic acid TTC 85 (75+10) ✓ ✓ 5x50 Discs 9096
Tigecycline TGC 15 ✓ ✓ ✓ 5x50 Discs 9147
Tobramycin TOB 10 ✓ ✓ ✓ 5x50 Discs 9044
DESCRIPTION DESCRIPTION
DESCRIPTION µgµg CLSI 1,2 EUCAST 3,4,5 BSAC 6 PACKAGING REF.
Trimethoprim TM 5 ✓ ✓ ✓ 5x50 Discs 9110 Trimethoprim TM 2.5 ✓ 5x50 Discs 9083 Trimethoprim-Sulfamethoxazole SXT 25 (1.25+23.75) ✓ ✓ ✓ 5x50 Discs 9042 Tylosin TY 30 5x50 Discs 9082 Vancomycin VA 5 ✓ ✓ 5x50 Discs 9164 Vancomycin VA 30 ✓ 5x50 Discs 9045
Note: Breakpoints of Antibiotic Disc concentrations not recommended by standards have to be validate by user.
BIBLIOGRAFIA / BIBLIOGRAPHY / BIBLIOGRAFIA / BIBLIOGRAPHIE / ΒΙΒΛΙΟΓΡΑΦΊΑ / BIBLIOGRAFIA 1. CLSI M100-S23 - Performance Standards for Antimicrobial Susceptibility Testing, January 2013.
2. CLSI M02-A10 - Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-Tenth Edition. 3. EUCAST. Breakpoint tables for interpretation of MICs and zone diameters, Version 3.0, January 2013.
4. Routine internal quality control as recommended by EUCAST, Version 3.0, January 2013. 5. Extended quality control as recommended by EUCAST, Version 1.0, January 2013 6. BSAC Methods for Antimicrobial Susceptibility Testing, Version 10.2, May 2011. 7. FDA (1978) Codes of Fed.Rebs. 21.Part 460.
8. WHO (1977) Tech rep.Ser.n°610.
9. DIN 58940-2 Medical microbiology!- Susceptibility testing of microbial pathogens to antimicrobial agents!- Part!2: Active substance carriers for the agar diffusion test; 2007-10.
TABELLA DEI SIMBOLI / TABLE OF SYMBOLS / TABELLE DER SYMBOLE / TABLA DE LOS SÍMBOLOS TABLEAU DES SYMBOLES / ΠΊΝΑΚΑΣ ΣΥΜΒΌΛΩ / MESA DE SÍMBOLOS
IVD
Dispositivo medico-diagnostico in vitro / In Vitro Diagnostic Medical Device / für In Vitro DiagnostikProducto sanitario para diagnóstico in vitro / Dispositif médical de diagnostic in vitroIn Vitro Διαγνωστικό Ιατροτεχνολογικό πρὀόν / Dispositivo médico para diagnóstico in vitro Non riutilizzare / Do not reuse / Nicht wiederverwenden / No reutilizar
Ne pas réutiliser / Μην κάνετε επαναληπτική χρήση / Não reutilizar
Fabbricante / Manufacturer / Hersteller / Fabricante Fabricant / Κατασκευαστής / Fabbricante
Contenuto sufficiente per "n" saggi / Contains sufficient for <n> tests / Enthält Material für <n> Tests / Contenido suficiente para <n> ensayos
Contenu suffisant pour "n" tests / Περιεχόµενο επαρκές για «ν» εξετάσεις / Conteúdo suficiente para “n” ensaios
REF
Numero di catalogo / Catalogue number / Bestellnummer / Número de catálogo Référence du catalogue / Αριθµός καταλόγου /Referência de catálogoFragile, maneggiare con cura / Fragile, handle with care / Zerbrechlich, mit Vorsicht behandeln / Frágil, manipular con precaución
Fragile, manipuler avec précaution / Εύθραυστο, να χρησιµοποιείται µε προσοχή / Frágil, manusear com cuidado Utilizzare entro / Use By / Verwendbar bis / Fecha de caducidad
Date limite d’utilisation / Ηµεροµηνία λήξης / Prazo de validade
Attenzione, vedere le istruzioni per l'uso / Caution,consult accompanying documents / Vorsicht, Begleitdokumente beachten / Atención,ver instrucciones de uso / Attention voir notice d'instructions
Προειδοποίηση, συµβουλευτείτε τα συνοδά έντυπα / Atenção, consulte a documentação incluída Limiti di temperatura / Temperature limitation / Temperaturbereich / Limite de temperatura
Limites de température / Περιορισµοί θερµοκρασίας / Limites de temperatura
LOT
Codice del lotto / Batch code / Charge / Codigo de lote numéro de lot. / Αριθµός Παρτίδας / Código do loteLiofilchem® and the Liofilchem company logo are registered trademarks of LIOFILCHEM s.r.l.
LIOFILCHEM
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IVD
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