Vademecum Acquisti e commercializzazione DPI. Certificazioni ed adempimenti normativi. Adempimenti adottati e tutela della clientela - FC Experience
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Vademecum
Acquisti e commercializzazione DPI.
Certificazioni ed adempimenti normativi.
Adempimenti adottati e tutela della clientela.
Operatività acquisti da produttori Extra Eu.
Certificati di conformità e verifica.
Operatività acquisti da produttori EU.
Operatività acquisti da distributori EU.
Adempimenti legali e operativi.
Fornitura di adeguata documentazione ai clienti.
Indice
Offerta e presentazione prodotti.
Nota anti speculativa.
Comunicazione Inail in deroga.
Sdoganamento extra EU
In prima fase l’acquisto deve essere tentato presso
produttore che ci forniscono certificati di conformità
VERIFICABILI E VERIFICATE CE.
Queste verifiche possono essere effettuate presso il sito
apposito della comunità europea, la certificazione deve
contenere oltre al marchio CE anche le 4 cifre
Operatività corrispondenti all’ente certificatore.
acquisti da In caso di non possibile reperibilità da tali fornitori,
produttori sino al proclamato termine dell’emergenza, è
Extra Eu consentito l’acquisto presso produttori previa richiesta
del Test Report (solo in lingua inglese) e Certificato
Volontario di verifica di conformità dei fascicoli
Test Report, in questo caso è però necessario l’invio in
deroga all’Inail secondo quanto disposto
dall’Art 15 DL 17/03/2020. Il certificato di conformità CE deve essere rilasciato da
ente abilitato e verificato presso il seguente link:
https://www.accredia.it/coronavirus/
https://ec.europa.eu/growth/toolsdatabases/nando/index.cfm?
fuseaction=country.notifiedbody&cou_id=380
In caso di verifica positiva non serve procedere ad
Certificato di ulteriori verifiche.
conformità CE Il certificato di conformità CE (non volontario) deve
contenere tutti i dati dell’ente, la società alla quale è
rilasciato, le normative di rifermento (in questo caso
2016/425) per le mascherine protettive
EN:149:2001+A1:2009 In caso di acquisto da produttori nel territorio europeo,
per ora limitandoci al territorio italiano, si chiede ad
essi di aver inoltrato quanto previsto in deroga all’Inail
come da indicazioni al seguente link:
https://www.inail.it/cs/internet/comunicazione/s
Operatività ala-stampa/comunicati-stampa/com-stampa-validazione-straordinaria-
dpi-2020.html
acquisti da Si procede alla verifica al seguente link :
produttori EU https://www.inail.it/cs/internet/docs/alg-elenco-autorizzati-
validazione-straordinaria-
dpi_6443146117777.pdf?section=attivita
Se non ancora presente autorizzazione nei Database
Inail si richiede al produttore copia della stessa. Per gli acquisti da distributori sul territorio nazionale
Operatività far compilare e firmare la dichiarazioni in allegato che
attesta di aver ottemperato a tutte le normative in
acquisti da essere.
distributori EU In caso di dubbio provvedere comunque alla richiesto
di quanto necessario per la comunicazione Inail in
deroga. Alle farmacie rivenditori e aziende va fornito:
- Certificato di conformità CE autenticato
Oppure :
- Test Report PPE
Fornitura di - Certificato di conformità volontario emesso
da ente accreditato e verificato.
adeguata - Autocertificazione in deroga INAIL
documentazione
ai clienti. Ove richiesto la stessa documentazione può essere
inviata anche a clienti privati che ne facciano esplicita
richiesta oscurando però per privacy eventuali dati
sensibili riportati sugli stessi documenti. Il prodotto deve essere proposto nel seguente modo:
mascherina filtrante KN95 con standard CE FFP2 EN
149:2001+A1:2009
Inail non concede la possibilità di pubblicizzare la propria
certificazione e come detto prima può essere solo fornita
in privato a chi ne fa richiesta oscurando i dati sensibili.
Offerta e Va evidenziato che la nostra azienda riporta il seguente
presentazione codice Ateco :
- 46.46.30 COMMERCIO ALL'INGROSSO DI
prodotti. ARTICOLI MEDICALI ED ORTOPEDICI
Incluso il commercio all’ingrosso di strumenti e
apparecchi per uso medico e ospedaliero
Questo Vademecum può essere divulgato e pubblicizzato. Le linee guida inerenti l’ anti speculativo dicono che
l’applicazione massima di ricarico è 40% all’ ingrosso
e 50% alla rivendita.
La nostra azienda adotterà la seguente tabella inferiore:
Nota anti
speculativa. TABELLA RICARICHI
TABELLA MARGINI
PA e Sanitari
RICARICO
Ingrosso
RICARICO
Dettaglio
RICARICO
ESPEMPIO PRATICO IVA ESCLUSA
Prezzo Acuisto PA e Sanitari Ingrosso Dettaglio
Prezzo Aquisto 20% 25% 40% PREZZO ACQUISTO € 2,8 € 3,36 € 3,50 € 3,92
MOL Margine Operativo Lordo 14% 14% 28% MOL Margine Operativo Lordo € 0,47 € 0,49 € 1,08
MON Margine Operativo Netto 11% 11% 22% MON Margine Operativo Netto € 0,37 € 0,39 € 0,89 Richiedere al produttore, rivenditore e distributore i
seguenti documenti:
- Certificato Volontario.
Comunicazione - PPE Test Report.
Inail in deroga. Seguire le linea guida qui riportate :
https://www.inail.it/cs/internet/attivita/ricerca-e-
tecnologia/certificazione-verifica-e-innovazione/validazione-in-deroga-
dpi-covid19.html Per lo sdoganamento seguire i protocolli al seguente
link :
Sdoganamento https://www.adm.gov.it/portale/documents/20182/557
extra EU 7147/Guida+per+lo+sdoganamento+delle+mascherine.pdf/04c
9e908-9518-44bb-9c25-bea39069f407PPE TEST REPORT
For
Guangdong Kangju Medicine Science Co., Ltd.
Product Name: KN95 Mask
Model: KJ-L
Prepared For: Guangdong Kangju Medicine Science Co., Ltd.
Longling Industrial Area,Liangying Town,Chaonan
District,Shantou City,Guangdong Province,China.
Prepared By : Ningbo HTK Testing Technology Co.,Ltd
37#,No 658,Renming Road,Jiangbei District,Ningbo City,
Zhejiang Province,China
Report Number: HTK202004010005S
Date of Test: Mar.11,2020
Date of Report: Apr.3,2020
Ningbo HTK Testing Technology Co.,Ltd
37#,No 658,Renming Road,Jiangbei District,Ningbo City,Zhejiang Province,China
Tel:0574-87566068 Fax:0574-87566167
Email: htk_service@163.com
Page 1 of 10TEST REPORT DECLARATION
Applicant : Guangdong Kangju Medicine Science Co., Ltd.
Address : Longling Industrial Area,Liangying Town,Chaonan District,Shantou
City,Guangdong Province,China.
Manufacturer : Guangdong Kangju Medicine Science Co., Ltd.
Address : Longling Industrial Area,Liangying Town,Chaonan District,Shantou
City,Guangdong Province,China.
EUT Description : KN95 Mask
Model No. : KJ-L
Technical Data : -
Remark : N/A
Test Procedure Used:
EN 149:2001+A1:2009
The results of this test report are only valid for the mentioned equipment under test. The
test report with all its sub-reports, e.g. tables, photographs and drawings, is copyrighted.
Unauthorized utilization, especially without permission of the test laboratory, is not allowed
and punishable. For copying parts of the test report, a written permission by the test
laboratory is needed.
The test results of this report relate only to the tested sample identified in this report.
Prepared by :
(Jane)
Checked by :
(Tina)
Approved by :
(Mark)
Page 2 of 10Property Method Principle / Requirements Result
Classification EN 149:2001+ Particle filtering half masks are classified Pass.
A1:2009 according to their filtering efficiency and their FFP2
Clause 5 maximum total inward leakage. There are
three classes of devices:FFP1, FFP2 and
FFP3.
Designation EN 149:2001+ Particle filtering half masks meeting the Pass.
A1:2009 requirements of this European Standard shall
Clause 6 be designated in the following manner:
Particle filtering half mask EN 149, year of
publication, classification, option (where "D"
is an option for a non re-useable particle
filtering half mask and mandatory for re-
useable particle filtering half mask).
Nominal EN 149:2001+ Unless otherwise specified, the values stated Pass.
values and A1:2009 in this European Standard are expressed as
tolerances Clause 7.2 nominal values. Except for temperature limits,
values which are not stated as maxima or
minima shall be subject to a tolerance of
±5 %. Unless otherwise specified, the ambient
temperature for testing shall be (16 - 32) ° C,
and the temperature limits shall be subject to
an accuracy of ± 1 °C.
Visual EN 149:2001+ The visual inspection shall also include the Pass
inspection A1:2009 marking and the information supplied by the
Clause 7.3 manufacturer.
Packaging EN 149:2001+ Particle filtering half masks shall be offered Pass
A1:2009 for sale packaged in such a way that they are
Clause 7.4& protected against mechanical damage and
Clause 8.2 contamination before use.
Testing shall be done in accordance with 8.2.
Material EN 149:2001+ Materials used shall be suitable to withstand Pass.
A1:2009 handling and wear over the period for which
Clause 7.5& the particle filtering half mask is designed to
Clause 8.3 be used.
After undergoing the conditioning described
in 8.3.1 none of the particle filtering half
masks shall have suffered mechanical failure
of the facepiece or straps.
Three particle filtering half masks shall be
tested.
When conditioned in accordance with 8.3.1
and 8.3.2 the particle filtering half mask shall
not collapse.
Any material from the filter media released by
the air flow through the filter shall not
constitute a hazard or nuisance for the wearer.
Testing shall be done in accordance with 8.2
Page 3 of 10Cleaning and EN 149:2001+ If the particle filtering half mask is designed to Pass
disinfecting A1:2009 be re-usable, the materials used shall withstand
Clause 7.6& the cleaning and disinfecting agents and
Clause 8.4& procedures to be specified by the manufacturer.
Clause 8.5 Testing shall be done in accordance with 8.4
and 8.5.
With reference to 7.9.2, after cleaning and
disinfecting the re-usable particle filtering half
mask shall satisfy the penetration requirement
of the relevant class.
Testing shall be done in accordance with 8.11.
Practical EN 149:2001+ Walking test Pass.
performance A1:2009 The subjects wearing normal working clothes The particle
Clause 7.7& and wearing the particle filtering half mask filtering half
Clause 8.4 shall walk at a regular rate of 6 km/h on a mask can
level course. The test shall be continuous, undergo
without removal of the particle filtering half practical
mask, for a period of 10 min. performance
Work simulation test tests under
The individual activities shall be arranged so realistic
that sufficient time is left for the comments conditions.
prescribed.
a) walking on the level with headroom of
(1,3 ± 0,2) m for 5 min;
b) crawling on the level with headroom of
(0,70 ± 0,05) m for 5 min;
c) filling a small basket (see Figure 1,
approximate volume = 8 l) with chippings or
other suitable material from a hopper which
stands 1,5 m high and has an opening at the
bottom to allow the contents to be shovelled
out and a further opening at the top where the
basket full of chippings is returned.
The subject shall stoop or kneel as he wishes
and fill the basket with chippings. He shall
then lift the basket and empty the contents
back into the hopper. This shall be done 20
times in 10 min.
Page 4 of 10Property Method Principle / Requirements Result
Finish of parts EN 149:2001+ Parts of the device likely to come into contact Pass.
A1:2009 with the wearer shall have no sharp edges or No sharp edges
Clause 7.8& burrs. and burrs.
Clause 8.2 Testing shall be done in accordance with 8.2.
Total inward EN 149:2001+ 1)walking for 2 min without head movement Pass.
leakage A1:2009 or talking; Total inward
Clause 7.9.1& 2) turning head from side to side (approx. 15 leakage=7.89
Clause 8.5 times), as if inspecting the walls of a tunnel %
for 2 min;
3) moving the head up and down (approx. 15
times), as if inspecting the roof and floor for
2 min;
4) reciting the alphabet or an agreed text out
loud as if communicating with a colleague
for 2 min;
5)walking for 2 min without head movement
or talking.
The leakage P shall be calculated from
measurements made over the last 100s of each
of the exercise periods to avoid carry over
of results from one exercise to the other.
where
C1is the challenge concentration
C2is the measured mean concentration in the
breathing zone of the test subject
tINis the total duration of inhalation tEX
is the total duration of exhalation
Penetration of EN 149:2001+ The device shall be mounted in a leaktight Pass.
filter material A1:2009 manner on a suitable adaptor and subjected to Sodium chloride
Clause 7.9.2 the test(s), ensuring that components of the test 95
device that could affect filter penetration l/min=5.97%
values such as valves and harness attachment
points are exposed to the challenge aerosol. Paraffin oil
Testing of penetration, exposure and storage test 95
shall be done in accordance with EN13274-7. l/min=5.89%
The penetration of the filter of the particle
filtering half mask shall meet the requirements
of Table 1.
Compatibility EN 149:2001+ Materials that may come into contact with the Pass.
with skin A1:2009 wearer's skin shall not be known to be likely No adverse
Clause 7.10r to cause irritation or any other adverse effect effect.
to health.
Page 5 of 10Property Method Principle / Requirements Result
Flammability EN 149:2001+ The material used shall not present a danger Pass.
A1:2009 for the wearer and shall not be of highly The particle
Clause 7.11& flammable nature. filtering half
Clause 8.6 When tested, the particle filtering half mask mask does not
shall not burn or not to continue to burn for burn for more
more than 5 s after removal from the flame. than 5 s after
The particle filtering half mask does not have removal from
to be usable after the test. the flame.
Testing shall be done in accordance with 8.6.
Carbon EN 149:2001+ The carbon dioxide content of the inhalation air Pass.
dioxide A1:2009 (dead space) shall not exceed an average of Carbon
content of the Clause 7.12& 1,0 % (by volume). dioxide
inhalation air Clause 8.7 Testing shall be done in accordance with 8.7. content of the
inhalation
air=0.97
Page 6 of 10Property Method Principle / Requirements Result
Head harness EN 149:2001+ The head harness shall be designed so that the Pass
A1:2009 particle filtering half mask can be donned and
Clause 7.13 removed easily.
The head harness shall be adjustable or self-
adjusting and shall be sufficiently robust to
hold the particle filtering half mask firmly in
position and be capable of maintaining total
inward leakage requirements for the device.
Field of vision EN 149:2001+ The field of vision is acceptable if determined Pass.
A1:2009 so in practical performance tests.
Clause 7.14
Exhalation EN 149:2001+ A particle filtering half mask may have one or N.A.
valve(s) A1:2009 more exhalation valve(s), which shall
Clause 7.15 function correctly in all orientations.
Exhalation valve(s), if fitted, shall continue to
operate correctly after a continuous exhalation
flow of 300 l/min over a period of
30 s.
When the exhalation valve housing is
attached to the faceblank, it shall withstand
axially a tensile force of 10 N applied for 10
s.
Breathing EN 149:2001+ Seal the particle filtering half mask on the Pass.
resistance A1:2009 Sheffield dummy head. Measure the Inhalation 30
Clause 7.16& exhalation resistance at the opening for mouth l/min=0.68
Clause 8.9 of the dummy head using the adapter shown Inhalation 95
in Figure 6 and a breathing machine adjusted l/min=2.37
to 25 cycles/min and 2.0 l/stroke or a Exhalation=2.9
continous flow 160 l/min. Use a suitable 8
pressure transducer.
Measure the exhalation resistance with the
dummy head successively placed in 5 defined
positions:
- facing directly ahead
- facing vertically upwards
- facing vertically downwards
- lying on the left side
- lying on the right side
Test the inhalation resistance at 30 l/min and
95 l/min continuous flow.
The breathing resistances apply to valved and
valveless particle filtering half masks and
shall meet the requirements of Table 2.
Page 7 of 10Property Method Principle / Requirements Result
Clogging EN 149:2001+ Convey dust from the distributor to the dust N.A.
A1:2009 chamber where it is dispersed into the air
Clause 7.17& stream of 60 m /h.
Clause 8.10 Fit the sample particle filtering half mask in a
leaktight manner to a dummy head or a
suitable filter holder located in the dust
chamber. Connect the breathing machine and
humidifier to the sample and operate for the
specified testing time.
The concentration of dust in the test chamber
may be measured by drawing air at 2 l/min
through a sampling probe equipped with a pre-
weighed, high efficiency filter (open face,
diameter 37 mm) located near the test sample,
as shown in Figure 10.
Calculate the dust concentration from the
weight of dust collected, the flow rate
through the filter and the time of collection.
Demountable EN 149:2001+ All demountable parts (if fitted) shall be N.A.
parts A1:2009 readily connected and secured, where
Clause 7.18 possible by hand.
Page 8 of 10ANNEX A: Photo-documentation Photo 1 View front Photo 2 View back
Report Remark
1. There is any discrepancy in this report, please after receipt of the report made in writing within 15
days.
2. This report is considered invalidated without the Special Seal for Inspection of the HTK. At any
time ,without the written approval of HTK report shall not be part of the copy detection.
3. The authorized agencies responsible for the authenticity of the representative of the sample and
the information, otherwise, the unit does not undertake any responsibility.
4. This report is only responsible for the test sample, not as a social justice data usage. Only for the
purpose of customer entrustment, scientific research, teaching or internal quality control.For the use
of test data and the use of direct or indirect losses and legal consequences, My company does not
undertake any economic and legal responsibility.
5. Do not repetitive or retest samples, entrust unit giving up of retest. The Report refers only to the
tested sample (Sample information is provided by customer) and does not apply to the bulk, unless
the sampling has been carried out by the Company and is stated as such in the Report.
6. The Company shall not be called or be liable to be called to give evidence or testimony on the
Report in a court of law without its prior written consent, unless required by the relevant
governmental authorities, laws or court orders.
7. In the event of the improper use of the report as determined by the Company, the Company
reserves the right to withdraw it, and to adopt any other additional remedies which may be
appropriate. Samples submitted for testing are accepted on the understanding that the Report issued
cannot form the basis of, or be the instrument for, any legal action against the Company.
8. Clients wishing to use the Report in court proceedings or arbitration shall inform the Company to
that effect prior to submitting the sample for testing.
9. Fifteen working days later,my company has the right to the complete test after processing the
measured samples.
10. My company to ensure that the test objective, impartial to entrust units of the commercial
information, technical documents such as commercial secrets confidential obligations.The data and
information will be disposed of after the aforementioned retention period has elapsed. Under no
circumstances shall we provide any data and information which has been disposed of after retention
period. Under no circumstances shall we be liable for damage of any kind, including (but not limited
to) compensatory damages, lost profits, lost data, or any form of special, incidental, indirect,
consequential or punitive damages of any kind, whether based on breach of contract of warranty, tort
(including negligence), product liability or otherwise, even if we are informed in advance of the
possibility of such damages.
------ End of Report ------
Page 10 of 1029/4/2020 https://webmail.pec.it/layout/origin/html/printMsg.html?_v_=v4r2b26.20200416_1300&contid=&folder=SU5CT1guSW52aWF0YQ==&… Da "info@pec.fornitureconti.it" A "dpiart15@postacert.inail.it." Data martedì 28 aprile 2020 - 10:04 Validazione in deroga DPI Covid-19 Buongiorno, come da vostra direttiva, in allegato il vostro modulo compilato e firmato per la validazione in deroga DPI Covid-19 delle mascherine KN95 FFP2 da importare da produttore Cinese. Rimaniamo in attesa di un vostro riscontro. Nel caso in cui servissero altri documenti sarà nostra premura inoltrarveli. Fc Fotoforniture Srl Via Papa Giovanni XXIII, 27/10 24061 Albano Sant'Alessandro (BG) P.IVA/C.F. 04027030164 Allegato(i) DICHIARAZIONE PER INAIL CHINA JANE.pdf (1108 Kb) certificato KN95.jpg (330 Kb) PPE REPORT CE.pdf (317 Kb) https://webmail.pec.it/layout/origin/html/printMsg.html?_v_=v4r2b26.20200416_1300&contid=&folder=SU5CT1guSW52aWF0YQ==&msgid=159&… 1/1
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