antibiotic disc antibiotic disc

© Liofilchem® - Antibiotic Disc - Rev.9 / 20.02.2013
ANTIBIOTIC DISC
ENGLISH
Antibiotic discs for susceptibility tests
DESCRIPTION
ANTIBIOTIC 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
Escherichia coli ATCC® 35218
Haemophilus influenzae
ATCC®
Staphylococcus aureus ATCC® 29213
Enterococcus faecalis ATCC® 29212
49247
Haemophilus influenzae ATCC® 49766
Haemophilus influenzae NCTC 8468
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.
2
© Liofilchem® - Antibiotic Disc - Rev.9 / 20.02.2013
ANTIBIOTIC DISC
PORTUGUÊS
Discos antibiótico para antibiograma
DESCRIÇÃO
ANTIBIOTIC 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
Escherichia coli
ATCC®
ATCC®
27853
Enterococcus faecalis ATCC® 29212
35218
Haemophilus influenzae ATCC® 49247
Haemophilus influenzae
ATCC®
Staphylococcus aureus ATCC® 29213
49766
Haemophilus influenzae NCTC 8468
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.
7
© Liofilchem® - Antibiotic Disc - Rev.9 / 20.02.2013
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.
CLSI 1,2
EUCAST 3,4,5
BSAC 6
PACKAGING
DESCRIPTION
µg
Amikacin
AK
30
✓
✓
✓
5x50 Discs
Amoxicillin
AML
30
5x50 Discs
Amoxicillin
AML
25
5x50 Discs
Amoxicillin
AML
10
✓
5x50 Discs
Amoxicillin
AML
2
✓
5x50 Discs
Amoxicillin + Clavulanic acid
AUG
30 (20+10)
✓
✓
✓
5x50 Discs
Amoxicillin + Clavulanic acid
AUG
3 (2+1)
✓
5x50 Discs
Ampicillin
AMP
2
✓
✓
5x50 Discs
Ampicillin
AMP
10
✓
✓
✓
5x50 Discs
Ampicillin + Sulbactam
AMS
20 (10+10)
✓
✓
5x50 Discs
Ampliclox (AMP + CX)
ACL
30 (25+5)
5x50 Discs
Azithromycin
AZM
15
✓
✓
5x50 Discs
Azlocillin
AZL
75
✓
5x50 Discs
Aztreonam
ATM
30
✓
✓
✓
5x50 Discs
Bacitracin
BA
10 IU
5x50 Discs
Boronic acid
BO
5x50 Discs
Carbenicillin
CAR
100
✓
✓
5x50 Discs
Cefaclor
CEC
30
✓
✓
✓
5x50 Discs
Cefadroxil
CDX
30
✓
✓
5x50 Discs
Cefamandole
MA
30
✓
✓
5x50 Discs
Cefazolin
KZ
30
✓
5x50 Discs
Cefepime
FEP
30
✓
✓
✓
5x50 Discs
Cefepime + Clavulanic acid
FEL
40 (30+10)
5x50 Discs
Cefixime
CFM
5
✓
✓
✓
5x50 Discs
Cefoperazone
CFP
75
✓
5x50 Discs
Cefoperazone
CFP
30
✓
5x50 Discs
Cefotaxime
CTX
30
✓
✓
5x50 Discs
Cefotaxime
CTX
5
✓
✓
5x50 Discs
Cefotaxime + Clavulanic acid
CTL
40 (30+10)
5x50 Discs
Cefotetan
CTT
30
✓
5x50 Discs
Cefpirome
CR
30
5x50 Discs
Cefpodoxime
PX
10
✓
✓
✓
5x50 Discs
Cefpodoxime + Clavulanic acid
PXL
11 (10+1)
5x50 Discs
Cefoxitin
FOX
30
✓
✓
✓
5x50 Discs
Cefoxitin + Cloxacillin
FOC
230 (30+200)
5x50 Discs
Cefprozil
CPR
30
✓
5x50 Discs
Cefsulodin
CSD
30
5x50 Discs
Ceftaroline
CPT
5
✓
5x50 Discs
Ceftazidime
CAZ
30
✓
✓
5x50 Discs
Ceftazidime
CAZ
10
✓
5x50 Discs
Ceftazidime + Clavulanic acid
CAL
40 (30+10)
5x50 Discs
Ceftibuten
CTB
30
✓
✓
5x50 Discs
Ceftizoxime
CZX
30
✓
✓
5x50 Discs
Ceftriaxone
CRO
30
✓
✓
✓
5x50 Discs
Cefuroxime
CXM
30
✓
✓
✓
5x50 Discs
Cephalexin
CL
30
✓
5x50 Discs
Cephalothin
KF
30
✓
✓
5x50 Discs
Cephradine
CE
30
✓
5x50 Discs
Chloramphenicol
C
30
✓
✓
✓
5x50 Discs
Chloramphenicol
C
10
✓
5x50 Discs
Cinoxacin
CIN
100
✓
5x50 Discs
Ciprofloxacin
CIP
5
✓
✓
✓
5x50 Discs
Clarithromycin
CLR
15
✓
5x50 Discs
Clindamycin
CD
2
✓
✓
✓
5x50 Discs
Cloxacillin
CX
5
5x50 Discs
Colistin sulfate
CS
25
✓
5x50 Discs
Colistin sulfate
CS
10
✓
5x50 Discs
Dicloxacillin
DCX
1
5x50 Discs
Dipicolinic acid
DP
5x50 Discs
Doripenem
DOR
10
✓
✓
5x50 Discs
Doxycycline
DXT
30
✓
✓
5x50 Discs
Ertapenem
ETP
10
✓
✓
✓
5x50 Discs
Erythromycin
E
15
✓
✓
5x50 Discs
Erythromycin
E
2
5x50 Discs
Fosfomycin (includes G-6-P)
FOS
200
✓
5x50 Discs
Fosfomycin (includes G-6-P)
FOS
100
5x50 Discs
Fosfomycin
FOS
50
✓
5x50 Discs
Furazolidon
FR
50
5x50 Discs
Fusidic acid
FC
10
✓
✓
✓
5x50 Discs
Fusidic acid
FC
30
5x50 Discs
Gatifloxacin
GAT
5
✓
5x50 Discs
Gentamicin
CN
10
✓
✓
✓
5x50 Discs
Gentamicin
CN
30
✓
5x50 Discs
Gentamicin
CN
120
5x50 Discs
Imipenem
IMI
10
✓
✓
✓
5x50 Discs
8
REF.
9004
9005
9179
9133
9151
9048
9191
9115
9006
9031
9122
9105
9007
9008
9051
9193
9009
9010
9052
9014
9015
9104
9143
9089
9108
9016
9017
9152
9182
9081
9185
9064
9190
9018
9144
9112
9053
9195
9019
9153
9145
9101
9054
9020
9021
9011
9013
9055
9022
9128
9057
9056
9098
9047
9058
9184
9023
9093
9194
9154
9059
9061
9024
9180
9109
9121
9025
9099
9049
9111
9169
9026
9125
9124
9079
© Liofilchem® - Antibiotic Disc - Rev.9 / 20.02.2013
DESCRIPTION
Imipenem + Cilastatin
Imipenem + EDTA
Kanamycin
Levofloxacin
Lincomycin
Lincomycin
Linezolid
Linezolid
Lomefloxacin
Loracarbef
Mecillinam
Meropenem
Meropenem + Boronic acid
Meropenem + Cloxacillin
Meropenem + Dipicolinic acid
Meropenem + EDTA
Methicillin
Metronidazole
Metronidazole
Mezlocillin
Minocycline
Miokamicin
Moxifloxacin
Mupirocin
Nafcillin
Nalidixic acid
Neomycin
Netilmicin
Netilmicin
Nitrofurantoin
Nitrofurantoin
Nitrofurantoin
Norfloxacin
Novobiocin
Novobiocin
Ofloxacin
Oxacillin
Oxacillin
Oxolinic acid
Oxytetracycline
Pefloxacin
Penicillin G
Penicillin G
Penicillin G
Phenoxymethylpenicillin
Pipemidic acid
Piperacillin
Piperacillin
Piperacillin + Tazobactam
Piperacillin + Tazobactam
Polymyxin B
Polymyxin B
Quinupristin-Dalfopristin
Rifampicin
Rifampicin
Rokitamycin
Roxithromycin
Sisomycin
Sodium Fusidate
Spectinomycin
Spiramycin
Streptomycin
Streptomycin
Sulbactam
Sulfafurazole
Sulfamethoxazole
Sulfaprim
Sulphonamide
Teicoplanin
Telithromycin
Temocillin
Tetracycline
Tiamulin
Ticarcillin
Ticarcillin + Clavulanic acid
Tigecycline
Tobramycin
Tobramycin
IMC
IMD
K
LEV
MY
MY
LNZ
LNZ
LOM
LOR
MEC
MRP
MR+BO
MR+CL
MR+DP
MR+ED
MET
LZ
LZ
MEZ
MN
MK
MOX
MUP
NAF
NA
N
NET
NET
F
F
F
NOR
NO
NO
OFX
OX
OX
OA
OT
PEF
P
P
P
PV
PI
PRL
PRL
TZP
TZP
PB
PB
QDA
RD
RD
ROK
RXT
SIS
FC
SPC
SP
S
S
SU
SF
SMX
SXT
S3
TEC
TEL
TMO
TE
T
TC
TTC
TGC
TOB
TOB
µg
20 (10+10)
760 (10+750)
30
5
15
2
10
30
10
30
10
10
5
50
5
75
30
15
5
200
1
30
30
10
30
50
100
300
10
30
5
5
1
5
2
30
5
10
2
1
10
20
30
100
110
36
100
300
15
30
5
30
15
30
30
100
100
10
300
20
300
50
50
300
30
15
30
30
30
75
85
15
10
30
CLSI 1,2
EUCAST 3,4,5
BSAC 6
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
IU
IU
IU
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
(100+10)
(30+6)
IU
IU
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
(75+10)
9
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
PACKAGING
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
REF.
9095
9183
9027
9102
9116
9028
9155
9136
9113
9173
9156
9068
9176
9175
9177
9178
9029
9119
9076
9062
9030
9106
9103
9157
9174
9001
9032
9170
9033
9181
9158
9034
9035
9063
9117
9080
9036
9135
9002
9065
9091
9037
9127
9130
9171
9003
9159
9038
9100
9160
9066
9120
9161
9039
9118
9192
9060
9046
9131
9067
9088
9040
9162
9129
9041
9084
9132
9126
9050
9172
9186
9043
9094
9070
9096
9147
9044
9163
© Liofilchem® - Antibiotic Disc - Rev.9 / 20.02.2013
DESCRIPTION
Trimethoprim
Trimethoprim
Trimethoprim-Sulfamethoxazole
Tylosin
Vancomycin
Vancomycin
TM
TM
SXT
TY
VA
VA
µg
5
2.5
25 (1.25+23.75)
30
5
30
CLSI 1,2
EUCAST 3,4,5
BSAC 6
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
PACKAGING
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
5x50 Discs
REF.
9110
9083
9042
9082
9164
9045
Note: Breakpoints of Antibiotic Disc concentrations not recommended by standards have to be validate by user.
1.
2.
3.
4.
5.
6.
7.
8.
9.
BIBLIOGRAFIA / BIBLIOGRAPHY / BIBLIOGRAFIA / BIBLIOGRAPHIE / ΒΙΒΛΙΟΓΡΑΦΊΑ / BIBLIOGRAFIA
CLSI M100-S23 - Performance Standards for Antimicrobial Susceptibility Testing, January 2013.
CLSI M02-A10 - Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-Tenth Edition.
EUCAST. Breakpoint tables for interpretation of MICs and zone diameters, Version 3.0, January 2013.
Routine internal quality control as recommended by EUCAST, Version 3.0, January 2013.
Extended quality control as recommended by EUCAST, Version 1.0, January 2013
BSAC Methods for Antimicrobial Susceptibility Testing, Version 10.2, May 2011.
FDA (1978) Codes of Fed.Rebs. 21.Part 460.
WHO (1977) Tech rep.Ser.n°610.
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 Diagnostik
Producto sanitario para diagnóstico in vitro / Dispositif médical de diagnostic in vitro
In 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 catálogo
Fragile, 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 lote
Liofilchem® and the Liofilchem company logo are registered trademarks of LIOFILCHEM s.r.l.
LIOFILCHEM® s.r.l.
IVD
Via Scozia zona ind.le, 64026 Roseto degli Abruzzi (Te) Italy
Tel. +39 0858930745
Fax +39 0858930330
www.liofilchem.net
10
liofilchem@liofilchem.net
F01511
Rev.9 / 20.02.2013