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RIVM report 318902013 / 2003
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ACP de Bruijn, AW van Drongelen,
GWM Peters – Volleberg
This investigation has been performed by order of and for the account of the Dutch Health
Care Inspectorate, within the framework of project 318902, Technical Support of the
Inspectorate for Medical Technology
RIVM, P.O. Box 1, 3720 BA Bilthoven, telephone: 31 – 30 – 274 91 11; telefax: 31 – 30 – 274 29 71
RIVM report 318902013 page 2 of 30
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Until 1995 all disinfectants available on the Dutch market were registered under the
Pesticides Act. With the introduction of the Medical Device Directive in the Dutch law
disinfectants specifically intended for use on medical devices are considered as medical
devices. These are CE marked by the manufacturer and freely marketed in the EU without the
need for national approval. In the Netherlands users of disinfectants are concerned that
without the strict registration procedures demanded by the Pesticides Act, manufacturers
make unfounded product claims. Therefore, product labels and user’s instructions of
disinfectants were analysed. From the 85 products, 35 (41%) showed faulty application of the
CE mark. This is mainly due to the faulty application of rule 15 of the classification rules in
the MDD by manufacturers and notified bodies. The choice of a disinfectant for a certain
application has to be made on the claims of the manufacturer. The information provided on
the label alone is generally insufficient to make an educated choice. For the safe use of a
disinfectant, detailed information about concentration, contact time, (minimum) temperature,
microbial species against which the product is active and the field of application need to be
clearly stated. Therefore, a standard for the labelling of disinfectants is desired.
RIVM report 318902013 page 3 of 30
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The study described in this report could not have been performed without the kind
corporation of the Dutch hospitals, the Dutch suppliers of disinfectants, the European
manufacturers of disinfectants and the notified bodies. Special gratitude goes to Mr. E.
Kolsteeg from the Dutch Dental Suppliers Association (VGT) for his substantial contribution
in the collection of product labels and user’s instructions.
RIVM report 318902013 page 4 of 30
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2.2.1 Identification of the potential suppliers of disinfectants with CE mark 8
2.2.2 Request to the suppliers for product information 8
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2.3.1 Evaluation of the accompanying information 9
2.3.2 Evaluation whether the CE mark has been applied rightfully 9
2.3.3 Identification of the notified bodies 9
2.3.4 Identification of the conformity assessment procedures 9
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2.4.1 Identification of the product test procedures 10
2.4.2 Evaluation of product test procedures 10
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3.1.1 Identification of the potential suppliers of disinfectants with CE mark 11
3.1.2 Request to the suppliers for product information 11
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3.2.1 Evaluation of the accompanying information 11
3.2.2 Evaluation whether the CE mark has been applied rightfully 13
3.2.3 Identification of the notified bodies 13
3.2.4 Identification the conformity assessment procedures 13
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3.3.1 Identification of the product test procedures 14
3.3.2 Evaluation of the product test procedures 15
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RIVM report 318902013 page 5 of 30
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Tot 1995 werden alle desinfectantia op de Nederlandse markt geregistreerd onder de
Bestrijdingsmiddelenwet. Met de introductie van het Besluit medische hulpmiddelen worden
desinfectantia die specifiek bedoeld zijn voor de desinfectie van medische hulpmiddelen
geclassificeerd als medische hulpmiddelen. Conform de bepalingen in het Besluit worden
deze door de fabrikant voorzien van het CE merk en kunnen vrij in de Europese gemeenschap
verhandeld worden zonder aanvullende nationale toelatingen. De gebruikers van
desinfectantia vrezen dat zonder de strikte eisen uit de Bestrijdingsmiddelenwet de
fabrikanten eigenschappen aan hun producten toekennen die ze niet volledig kunnen
onderbouwen. Op verzoek van de Inspectie voor de gezondheidszorg (IGZ) heeft het RIVM
een onderzoek uitgevoerd. De fabrikanten, ziekenhuizen en de aangemelde instanties werden
benaderd voor informatie over het aanbod van desinfectantia op de Nederlandse markt, de
gevolgde CE conformiteitsprocedures, het testen van de producten en de informatie op de
etiketten van de producten. De informatie is gegroepeerd en geanalyseerd.
Van de 85 producten waarvan de informatie op het etiket is geëvalueerd is op 35 producten
(41%) het CE merk ten onrechte aangebracht. Dit is veelal terug te leiden naar de ‘ruime’
interpretatie die door de fabrikanten en aangemelde instanties aan het begrip medisch
hulpmiddel wordt gegeven en de daaruit voortvloeiende onterechte toepassing van regel 15
uit de classificatieregels uit het Besluit . Het is aan te bevelen dat de aangemelde instanties
als onderdeel van de conformiteitbeoordeling een actievere rol spelen in de evaluatie van de
testprotocollen, teneinde de werkzaamheid van het desinfectans te waarborgen.
De gebruikers moeten op basis van de informatie op het etiket beoordelen of het product
geschikt is voor de gewenste toepassing, tenzij de gebruiker bereid is om de testvoorschriften
en de testresultaten op te vragen bij de fabrikant en deze te bestuderen. De informatie op het
etiket is over het algemeen onvoldoende om een verantwoorde keus te kunnen maken. Voor
het veilig gebruik van een desinfectans moet concrete informatie over de concentratie,
inwerktijd, de (minimale) temperatuur, het microbiologisch spectrum waartegen het middel
werkzaam is en de beoogde toepassing op de verpakking vermeld worden. Een standaard
voor de informatie op het etiket van desinfectantia is dan ook gewenst.
RIVM report 318902013 page 6 of 30
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Until 1995 all disinfectants available on the Dutch market were registered under the
Pesticides Act. With the introduction of the Medical Device Directive (MDD) in the Dutch
law disinfectants specifically intended for use on medical devices are classified as medical
devices. These are CE marked by the manufacturer and freely marketed in the EU without the
need for national approval. In the Netherlands, users of disinfectants are concerned that
without the strict registration procedures demanded by the Pesticides Act, manufacturers
make unfounded product claims. These concerns were noted by the Dutch Health Care
Inspectorate (IGZ). Therefore, manufacturers, hospitals and notified bodies were asked for
information about the available disinfectants on the Dutch market, the CE conformity
procedures, product testing and the product labels. The information was grouped and
analysed.
From the 85 products of which the information on the label is evaluated, 35 products (41%)
showed faulty application of the CE mark.This is mainly due to the fact that manufacturers
and notified bodies have a broad interpretation of the definition of medical device and
consequent faulty application of rule 15 of the classification rules in the MDD. To assure the
manufacturer’s claim it is recommendable that notified bodies incorporate the evaluation of
test protocols in their conformity assessment.
The choice of a disinfectant for a certain application has to be made on the claims of the
manufacturer, unless the user is willing to ask for and study the test protocols and test results
from the manufacturer. The information provided on the label alone is generally insufficient
to make an educated choice. For the safe use of a disinfectant, detailed information about
concentration, contact time, (minimum) temperature, microbial species against which the
product is active and the field of application need to be clear stated. Therefore, a standard for
the labelling of disinfectants is desired.
RIVM report 318902013 page 7 of 30
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After the implementation of the Medical Device Directive (MDD) in the Dutch law,
disinfectants for medical devices are no longer registered by the Board for the authorisation
of pesticides (College Toelating Bestrijdingsmiddelen; CTB). Until 1995 all disinfectants
were registered under the Pesticides Act. Under the new law, disinfectants that are
specifically intended to be used on medical devices are considered as medical devices. Thus
the requirements of the MDD apply to this group of disinfectants.
The procedure for market approval has therefore changed considerably. The manufacturer of
a disinfectant follows the directions given in the MDD to CE mark the product. The
evaluation of the product for micro-biocidal efficacy, safety for the user, the risk of residues
on the disinfected product and product testing, which was part of the CTB registration
procedure, is now performed under the responsibility of the manufacturer of the product.
Nowadays, all products that are CE marked can be freely marketed throughout the European
Community, without the legal requirement for additional third party certification or product
testing. Nevertheless, additional testing may be required by the users of the product. E.g. in
Germany users ask for registration of the product by the German Society for Hygiene and
Microbiology (DGHM).
In the Netherlands concern was raised by users of disinfectants. They were worried that
without the strict registration procedures demanded by the Pesticides Act, manufacturers may
make claims they cannot fully substantiate. European standards to test the efficacy of
disinfectants for medical devices under simulated use conditions are still unavailable.
Therefore, manufactures have to select tests from national standards and guidelines or even
develop their own test methods.
With the change of the admittance procedure, the Dutch Health Care Inspectorate (IGZ) felt
the need to gain an insight in the new evaluation procedures of disinfectants. The following
questions were raised by IGZ:
Which annex is used to claim conformity with the MDD?
Are disinfectants rightfully CE marked?
Which conformity assessment procedures do the notified bodies use as part of the
certification?
Do different notified bodies apply similar procedures ?
Is the product information given on the product label and in the manual sufficient for the
user to make a valid decision whether to use the disinfectant for a certain application?
RIVM report 318902013 page 8 of 30
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The study was performed in three phases.
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Identification of the suppliers of disinfectants with CE mark.
Request to the suppliers for product information. 3KDVH%
Evaluation of the information provided on the label and/or manual of the disinfectants
with the Essential Requirements in the MDD.
Evaluation whether the CE mark has been applied rightfully.
Identification of the notified bodies that were involved in the CE conformity procedure
followed by the manufacturer.
Identification of the procedures followed by the Notified Bodies in the assessment of the
CE conformity procedures followed by the manufacturer. 3KDVH&
Identification of the test procedures followed by the manufacturer to establish the efficacy
of the disinfectant.
Establish whether the tests that are performed by the manufacturer are sufficient to
substantiate the claims of the manufacturer.
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From the following sources, a list of the potential suppliers of disinfectants on the Dutch
market was made.
The authors’ knowledge of suppliers’ assortment.
The internet.
Suppliers’ catalogues.
The yearbook of the Dutch Federation of Technology Branches (FHI).
The Dutch Dental Suppliers Association (VGT).
In addition, 110 hospitals were asked to identify the disinfectants that were used for the
disinfection of medical devices.
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The suppliers identified were requested to name all the CE marked disinfectants they sold at
the time in the Netherlands and they were asked to provide the RIVM with copies of the
product labels and the manuals.
RIVM report 318902013 page 9 of 30
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From the requirements in the MDD a checklist was ‘distilled’ and guidance to the
interpretation of the requirements was added (see appendix 1). The interpretation given by the
authors is not necessarily in line with the original ideas of the European Commission at the
time the directive was written. Although the medical device directive provides requirements
for labels on medical devices, specific requirements for the information on the labels and in
the manuals of disinfectants are not given. The requirements for the information provided on
labels and in manuals are given in several sections of the directive. Some requirements are
repeated in different sections, but are not always identical. The labels and manuals were
evaluated using the checklist.
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The MDD states in the classification rules (annex IX, chapter III clause 4.3) that ‘all devices
intended specifically to be used for disinfecting medical devices are in Class IIa’. Thus, a
disinfectant is a medical device when:
It is only to be used for the disinfection of medical devices.
It is not to be used for the disinfection of any other item.
The CE mark shall only be applied when the product is a medical device. Disinfectants that
have a broader application by explicit or implicit claim by the manufacturer are not medical
devices and should therefore not be CE marked.
Checks were made whether the products were classified correctly, according to the above
mentioned rule.
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The notified body that was involved in the CE procedure is identified by the number that is
printed with the CE mark. A list of the notified bodies and addresses was found on the
internet at http://www.dimdi.de/de/mpg/adress/nb-list.htm.
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A request was sent by IGZ to the notified bodies to name:
The annex of the medical device directive that was used in the conformity assessment
procedure for the disinfectants baring the CE mark number of that particular notified
body.
The names and numbers of the international, European or national product/test standards
that were applied in the conformity assessment procedures for each of the products in the
list.
The request was sent to thirteen notified bodies, seven in Germany, four in Great Britain, one
in France and one in Austria. The addresses of the notified bodies were found on the internet
at http://www.dimdi.de/de/mpg/adress/nb-list.htm.
RIVM report 318902013 page 10 of 30
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From the list of disinfectants (appendix 2) twenty products were chosen at random. From this
group, the products not bearing the CE mark or of which no label or manual was received,
were removed. From the remaining products only one per brand was allowed in the list. The
first ten products that fulfilled these criteria were put on the final list.
The IGZ wrote a letter to the manufacturers of the selected products requesting the test
procedures which were used to substantiate the manufacturer’s claims.
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The information received from the manufacturer was evaluated to make a list of the European
or national standards that have been followed and to check whether these standards are
applicable for the specific product. Where national guidelines were followed, RIVM asked
for an expert’s advise whether these guidelines were acceptable.
RIVM report 318902013 page 11 of 30
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From the information that was available from the various sources a list of 125 possible
suppliers was assembled.
From the 110 hospitals that were requested for a list of the disinfectants used in the hospital
for the disinfection of medical devices, about half of the hospitals (61) responded to the
request. The hospitals named 82 products, including 30 detergents or maintenance products.
Of the disinfectants four were intended for skin disinfection, five were alcohol in water
solutions. Domestic chlorine bleach was mentioned three times. Under the current legislation
the products for skin disinfection are registered as medicinal products, the alcohol in water
solutions were historically exempt from the registration under the Pesticides Act. Domestic
chlorine bleach is registered under the Pesticides Act by the CTB for other applications than
the disinfection of medical devices. The remaining products were also identified by the
suppliers (see 3.1.2).
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From the 125 potential suppliers, initially 87 suppliers responded, including the members of
VGT. VGT responded on behalf of it’s members and sent a list of the disinfectants sold by
the member companies as well as the requested documentation. From the 38 companies that
initially not responded, 11 companies were contacted by telephone which led to 7 more
responses. In total 75% of the addressed companies responded. From the collected
information a list of 104 different products was composed.
From the list of 104 products 19 products were deleted. For ten products, no labels were
provided or the labels were illegible. For two of these ten only a manual was provided. Two
products were identified as a skin disinfectant, five products were registered under the
Pesticides Act and two products were identified as 80% ethanol in water solutions.Of the
remaining 85 products, 80 were CE marked including the identification number of a notified
body. See appendix 2 for the list of these 80 CE marked disinfectants, sorted per notified
body.
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The results of the evaluation of the labels and the manuals of the 85 products are summarised
below in the three major groups
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In general (83%) the manufacture’s instructions gave information on the concentration,
minimum exposure time and where applicable the temperature. Although the activity of all
disinfectants is temperature depended by nature, none of the manufacturers stated a minimum
temperature. The necessary exposure times for some products (alcohols) may be unrealistic
high, taking the volatility of the product into consideration.
RIVM report 318902013 page 12 of 30
No attention was drawn to the risks related with residues of the disinfectant on the disinfected
medical devices. In 45% of the examined products instructions were given for the post
disinfection treatment. For 30% of the products no post disinfection treatment was necessary
because the product leaves no residues or the disinfected objects are put through a washing
process afterwards. For quite a large number of products (25%) no instructions for the post
disinfection treatment were given. Where rinsing with water was prescribed, no specification
for the quality, temperature and amount of the rinse water were given. Only for disinfectants
for dialysis machines guidance was given to establish the efficacy of the post disinfection
rinse. Contrary, with products for the disinfection of dental burrs the manufacturers gave the
explicit instruction not to rinse the device after disinfection. This to prevent an adverse
reaction (i.c. corrosion) between the material of the device and the disinfectant solution. The
maximum period of use after the disinfectant has been diluted or activated is limited by time
alone (e.g. the solution may be used for a period of 14 days). No manufacturer stated a
maximum number of reuses, although the suitability of the solution is limited by evaporation
of the actives, dilution with adhering rinse water or contamination from poorly cleaned
medical devices. Means to check the concentration of the active ingredients were only offered
with two products, both from the same manufacturer. The expiry date and batch number were
not printed on the label in 48% of the cases. It is unclear whether these data were omitted or
that they were printed on the disinfectant container itself.
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For 88% of the products the manufacturers gave an indication of the anti microbial spectrum
in broad terms; bactericidal, virucidal and/or fungicidal properties. For 75% of the products
activity against HBV and HIV was claimed and action against tuberculoses was mentioned
for 24% of the products. According to the information on the label 33% of the products were
listed by the DGHM. Compliance with the AFNOR standards was stated for 18% of the
products.
Virucidi is not tested in a direct manner. The Morphological Alteration and Disintegration
Test (MADT) is mentioned on 12% of the products, the Hepatitis B surface antigen test
(HBsAg) also on 12% of products. Reference to the German Association against Virus
Diseases (DVV) was made on 3% of the labels.
There is, however, some concern about the claims made by the manufacturers. The
inactivation of viruses by quaternary ammonium compounds (quads) is not beyond doubt. A
quad is not a univocal compound. The composition of the four ‘tails’ of the molecule can be
varied in many ways, all influencing the biocidal properties of the product. Although quads
may have virucidal properties this is not necessarily the case for every quad.
For some alcohol mixtures intended for surface disinfection the biocidal properties were
claimed for an exposure time of 15 minutes. Given the volatility of the liquid, it is unlikely
that 15 minutes exposure is feasible on an open surface.
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Much information was provided about the safe use and storage of the product (79% of the
labels), but always focussed on the safety of the person handling the product or other persons
(e.g. keep away from children). No information was given about the safety of the patient. The
so-called R (Risk) and S (Safety) sentences that should be printed on the label (Law on
hazardous substances; 67/548/EEC) were omitted on 64% of the products. In 5 cases (6%)
the warning symbols were missing
RIVM report 318902013 page 13 of 30
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From the 85 products of which the information on the label was evaluated, on 35 products
(41%) the CE mark was not applied rightfully. In these cases the application of the product as
recommended by the manufacturer was wider than only the disinfection of medical devices,
e.g. medical instruments and table tops. For some products the intended application was
somewhat vague, e.g. the surfaces of medical equipment or medical objects. Rule 15 of the
classification criteria does not apply to these disinfectants. These particular products were
mainly alcohol sprays, wipes or pads impregnated with an alcohol based solution. For a
number of products it was uncertain whether the items that were intended to be disinfected
with the particular product were medical devices, eg therapeutic baths, dental imprints that
are used as a mould for dental prosthesis or cooling water for dental drills (see also
appendix 3).
One product did not bear the CE mark, where it should. It was a disinfecting solution to be
used in combination with pumice stone powder as a polishing paste for teeth. The polishing
paste is a medical device, therefore this particular disinfectant was a medical device (see also
appendix 4).
Two products were CE marked ,but were wrongly classified as class I. One product was a
dedicated detergent to be used in a particular instrument washer. The manufacture claimed
anti-microbial action of the product, therewith positioning the product as a disinfectant. The
intended use of the other product was not limited to the disinfection of medical devices and
should not be CE marked at all (see also appendix 4).
One product did not bear the CE mark and it was unclear whether this is wrongful or not. The
disinfectant was a chlorine solution and had a wide range of applications. Therefore, it was
not a medical device and should not bear the CE mark. The manual of a therapeutic bath
specified this particular disinfectant for the disinfection of the bath. The disinfectant could
therefore be considered an accessory to the bath. In that case the disinfectant should bear the
CE mark (see also appendix 4).
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Thirteen notified bodies were identified by the number on the product label (see appendix 2).
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From the thirteen notified bodies that were addressed, nine (69%) responded to the request
for information. Seven notified bodies indicated that annex II (EC declaration of conformity;
full quality assurance system) of the medical device directive was used. One of these seven
indicated that annex V (EC declaration of conformity; production quality assurance) was used
for a product that is originally manufactured by another manufacturer than the manufacturer
named on the label; the so-called original equipment manufacturer (OEM). One notified body
only mentioned the use of annex V. However, the use of annex V is only allowed when this is
done to complement the procedure described in annex VII. One notified body mentioned
annex VII in combination with annex V.
RIVM report 318902013 page 14 of 30
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1. Germany II –
2. Germany II –
3. Germany II + Guidelines of DGHM
4. Germany IIV
in case OEM
products

5. Germany VII in connection with
V
+ Guidelines of DGHM.
6. Germany 1RUHDFWLRQUHFHLYHG
7. Germany 1RUHDFWLRQUHFHLYHG
8. United Kingdom II + AOAC methods,
TGO 54
NF T 72-201, NF T 72-231,
NF T 72-151, NF T 72-171,
NF T 72-180
9. United Kingdom II –
10. United Kingdom II –
11. United Kingdom V –
12. Austria 1RUHDFWLRQUHFHLYHG
13. France 1RUHDFWLRQUHFHLYHG
The notified bodies indicated that they were not involved in the product testing or the
evaluation of the test results. For test procedures and test reports the notified bodies refer to
the manufacturers of the product. One notified body attached the declaration of conformity
from the manufacturer. This manufacturer stated that the product is tested by third parties and
conforms to the guidelines of the DGHM.
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From the ten manufacturers that were addressed for information about the test procedures for
the specified products, eight responded. The two non-responders were in fact one
manufacturer who was addressed twice, for two products that are marketed under different
brand names. One manufacturer refused to submit the requested information. The
manufacturer ‘advised’ us to contact his competent authority whenever there is doubt on the
quality of his products. In total five of the responding manufacturers specified the test
procedures.
The manufactures indicated that the CE conformity procedure annex II or V is used. In the
MDD annex V is only given as an option for class IIa devices when used in combination with
annex VII. Two manufacturers sent a copy of the certificate of the quality assurance system
assessment as well as a list of the products that were manufactured under this quality
assurance system. These lists contained disinfectants that were not specifically used for the
RIVM report 318902013 page 15 of 30
disinfection of medical devices. These products are not medical devices and should not be CE
marked.
See appendix 5 for more information on the response from the manufacturers.
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Four out of the five manufacturers tested their products to the national standards and
guidelines. Three German manufactures had their products tested by third parties to the
guidelines from the DGHM. One of these manufacturers ‘complained’ that to his observation,
there does not seem to be a unique DGHM guideline. This manufacturer also stated that
recent tests were successfully performed by a third party to prEN137271. One Swiss
manufacturer named, besides the guidelines of the DGHM, the guidelines from the DVV /
Bundes-gesundheitsamt (BAG) and the AFNOR/European standards. The fifth manufacturer
gave a detailed list of the tests that have been performed by seven independent bodies and
four studies by the manufacturer’s laboratory. In absence of European standards the
manufacturer used ‘national standards’. The manufacturer did not specify these standards, but
they were identified by the notified body as the DGHM guidelines.
One manufacturer stated that the disinfecting wipes are effective with a contact time of
2 minutes. A contact time of 2 minutes is hard to realise with a wipe. Practice is that wipes
are used to wipe surfaces, where the contact time between the surface and the wipe is in the
range of seconds. The liquid that remains on the surface after wiping has a high alcohol
content and is likely to evaporate swiftly. The information in the DGHM list of March 2000
states that for wipes the disinfecting solution is tested, rather than the finished product. Thus
the wiping process is not taken into account.
1 Preliminary publication of the European standard; Chemical disinfectants; Quantitative suspension test for evaluation of
bactericidal activity of chemical disinfectants for instruments used in the medical area; Test method and requirements (Phase
2/Step 1)
RIVM report 318902013 page 16 of 30
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The response from manufacturers, hospitals and notified bodies to the requests from the
RIVM and the IGZ was rather disappointing. Especially with regard to the request for the
test procedures from IGZ to the manufacturers we have expected a swift response. For
only five of the ten selected products the test method was received. The same holds true
for the response of the notified bodies to the requests from IGZ. We would have expected
a timely and accurate response to the requests from a national competent authority.
The admittance of disinfectants on the Dutch market is regulated in two laws. The
disinfectants for medical devices are admitted under the Medical Device Directive. All
other disinfectants are admitted under the Pesticides Act, which will be amended
according the Biocide Directive in due time. There is no registration of disinfectants that
fulfil the requirements of the MDD. All disinfectants that are admitted under the
Pesticides Act are registered and the information about the active ingredients, instructions
for use and the field of application are evaluated by an independent committee. For
disinfectants with a CE mark users have to rely on the information provided by the
manufacturer.
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The quality of the information on the label of the product varies. Manufacturers are
sometimes vague in stating the field of application. E.g. it is presented as a broad
application on medical items, not necessarily medical devices. The CE mark is applied
unjustly in these cases. For nearly all products the anti-microbial spectrum is indicated in
broad terms; the manufacturer is claiming bactericidal, virucidal and/or fungicidal
properties. The claimed effectivity is not beyond doubt for a number of products e.g. the
inactivation of viruses by quaternary ammonium compounds.
In general the manufacturer’s instructions are clear for the concentration, minimum
exposure time and, where applicable, the temperature. None of the manufacturers state a
minimum temperature. The necessary exposure times for some products may be
unrealistic high. Given the volatility of alcohol solutions/mixtures, it is unlikely that
prolonged exposure (in the order of minutes) is feasible on an open surface. The risks
related with residues of the disinfectant on the disinfected medical devices are not given.
The maximum period of use is limited by time alone (e.g. the solution may be used for a
period of 14 days). No manufacturer states the number of reuses (e.g. not to be used more
than 10 times). Only one manufacturer offers a method to check the concentration of the
active ingredients.
1RWLILHGERGLHV
The notified bodies that are consulted for the CE conformity procedures were easily
identified by the identification number printed with the CE mark.
The involvement of the notified bodies in the CE procedure is limited to the evaluation of
the quality control system according annex II. Alternatively annex VII in combination
with annex V is used. The application of only Annex V is also mentioned, although it is
not an option given in the MDD. Notified bodies typically do not perform product tests or
evaluation of the product tests carried out by the manufacturers or third parties.
RIVM report 318902013 page 17 of 30
3URGXFWWHVWLQJ
The product evaluation by the manufacturers is mainly based on test procedures given in
national guidelines. The European standards are followed by only a few manufacturers.
Based on the information on the labels, 33% of the products fulfil the requirements of the
DGHM. The use of the European standards and the DGHM guidelines is acceptable.
Products fulfilling these requirements are deemed to give the desired bactericidal effect.
However, users of disinfectants must be aware that a particular field of application may
require particular action of the disinfectant on specific micro-organisms, e.g.
mycobacteria, viruses, yeasts and fungi.
More relevant European methods for product testing on simulated medical devices are
still under development. The test methods in the published European standards and the
methods recommended by the DGHM are so called suspension tests. The results from
these test do not necessarily correspond with the results from simulated use tests.
RIVM report 318902013 page 18 of 30
 &RQFOXVLRQVDQGUHFRPPHQGDWLRQV
The choice for a disinfectant for a certain application has to be based on the claims of the
manufacturer, unless the user is willing to ask for and study the test protocols and test results
from the manufacturer. Independent verification of the product is not necessarily provided by
the current legislation, but on a national level, professional associations may provide third
party evaluation of disinfectants, e.g. the DGHM in Germany.
With the availability of European standards for disinfectants, the product tests and the
information on the label are likely to become standardised in time. This is especially the case
when the standards are supported by professional associations for microbiology, hygiene and
infection prevention.
All the important information for the user should be printed on the label. The MDD does,
however, not give sufficient detail about the required information to be printed on the labels
of disinfectants. For the effective use of a disinfectant information about concentration,
contact time, (minimum) temperature, microbial species against which the product is active
and the field of application need to be absolutely clear. A standard for the label of a
disinfectant is desired. Imperfections in the provided information on the labels of medical
devices are not unique for disinfectants. A recent Dutch study about Class I medical devices
showed flaws in all the label and/or instructions for use (RIVM report 318902010, 2003).
Initiatives for the standardisation of the label are taken by CEN TC2162 and the Organisation
for Economic Cooperation and Development (OECD). Under the Pesticides act, registration
of a disinfectant was only possible if the product was able to pass the standard suspension test
and the information on the label was sufficiently detailed. The instructions on the label had to
be evaluated, and by proper labelling this lead to registration of the product in clear relation
with the claims of the manufacturer and the field of application. Under the MDD the quality
of the product and the label is the sole responsibility of the manufacturer. It is under these
circumstances possible that the label may not provide all the necessary information.
Professional users, like hygienists and micro-biologists, are able to obtain more information
or advise from professional associations to judge whether a particular disinfectant is suitable
for the job. However, users with less knowledge of hygiene or micro biology, like dentists,
general practitioners and paramedics, may not have access to more detailed information and
may lack the knowledge to make an educated decision. Especially, for the latter group a clear
and detailed label is necessary.
Disinfectants should be provided with means to check the correct function of the product, to
test the concentration before first use and in case of re-use of the disinfectant, to establish the
number of re-uses. Only one manufacturer provides test strips to indicate the concentration of
the active ingredient in his products.
Testing of products by the manufacturer is not unacceptable, provided that recognised and
validated test procedures are used. German manufacturers make clear reference to the
guidelines of the DGHM. The question remains whether all manufacturers are using reliable,
validated test methods. The standards or guidelines used for the testing of the product should
be stated on the label so that the user can determine the suitability of the product for its
propose.
2 Chemical disinfectants and antiseptics – Application of European Standards for chemical disinfectants and
antiseptics.
RIVM report 318902013 page 19 of 30
There is a lack of relevant harmonised (European) standards. The development of the
European standards is being worked on, but progress is slow. Standards should become
available as soon as possible and be adapted by the national organisations involved in the
testing and registration of disinfectants.
The study indicates inappropriate use of the CE mark. Manufacturers tend to be vague about
the intended use of the product or to stretch the definition of medical device so that materials
and objects used in the doctor’s practise are considered medical devices. It is recommendable
that notified bodies are consulted for the interpretation of the definition for medical device
and for the classification procedure to be followed.
The CE conformity procedure based on Annex II alone, does not provide the same level of
assurance that the manufacture’s claims are valid as does independent testing or alternatively,
evaluation of the test protocols of the manufacturer. It would be recommendable that notified
bodies would incorporate the evaluation of test protocols in their conformity assessment.
RIVM report 318902013 page 20 of 30
$SSHQGL[ &KHFNOLVWIRUWKHLQIRUPDWLRQSURYLGHZLWK&(PDUNHGGLVLQIHFWDQWV G
(The text printed in LWDOLFV give the interpretation of the authors of the particular requirement
in the MDD).
MDD essential requirements [er] 13.1 “Each device must be accompanied by the information
needed to use it safely and to identify the manufacturer, taking account of the training and
knowledge of the potential users. This information comprises the details on the label and the
data in the instructions for use.”
&KHFNOLVWODEHOVRI&(PDUNHGGLVLQIHFWDQWV
1. CE mark including the identification number of the notified body responsible for the
implementation of the procedures set out in Annexes II, IV, V and VI.
(MDD art. 17.)
2. Information necessary for safe use of the product.
(MDD er 13.1)
– VDIHW\SUHFDXWLRQV HJYHQWLODWLRQRIZRUNDUHD
– SHUVRQDOSURWHFWLRQ HJFORWKLQJJORYHVJODVVHV
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3. Warnings and/or precautions to take
(MDD er 13.3.k)
4. The name or trade name and address of the manufacturer.
(MDD er 13.3.a)
– QDPHDQGDGGUHVVLQWKH(8
5. The details strictly necessary for the user to identify the device and the contents of the
packaging.
(MDD er 13.3.b)
– FQRDPPSHRRVILWWLKRHQS UPRDGLXQFFWRGPHSVLRJXQQDGWVLRDQQWGKDFRWQWKFHHQSWUURDGWLXRFQW LVDFKHPLFDOGLVLQIHFWDQWFKHPLFDO
6. Batch code or the serial number.
(MDD er 13.3.d)
7. Expiry date.
(MDD er 13.3.e)
8. Where appropriate, an indication that the device is for single use.
(MDD er 13.3.f)
– LQWULQVLFZLWKLPSUHJQDWHGSDGVZLSHVDQGVSUD\V
9. Any special storage and/or handling conditions.
(MDD er 13.3.i)
– ZLWKZLSHVDQGSDGVWKHLQVWUXFWLRQWRFORVHWKHFRQWDLQHU
– LQJHQHUDONHHSDZD\IURPFKLOGUHQ
10. Any special operation instructions.
(MDD er 13.3.j)
– DQFHWFLHYVDVWDRUU\SUHSDUDWLRQRIWKHSURGXFW HJGLOXWLRQZLWKZDWHURUDGGLWLRQRIDQ
– LRQIVDWUQX\FµWGLRHQGVLFIDRWUHXGV¶HD SHSJOLFFDRWLQRFQHQRWIUWDKWHLRSQURFGRXQFWWDFOWLNWHLPZHDVWKHPHUSGHLUVDLQWXIHUHFWRRUUVW KHLGHQWLILFDWLRQ
RIVM report 318902013 page 21 of 30
– W\SHVRIPLFURRUJDQLVPVZKLFKDUHGHDFWLYDWHGIRUYLUXVHVDQGP\FREDFWHULD E\WKHSURGXFWZLWKVSHFLDODWWHQWLRQ
– LGHQWLILFDWLRQRIWKHPHGLFDOGHYLFHVWKDWFDQEHGLVLQIHFWHGZLWKWKHSURGXFW
– QSUHRFHGVXVFDWU\SUHWUHDWPHQWRIWKHPHGLFDOGHYLFHVWKDWDUHWREHGLVLQIHFWHGZLWKWKH
– QHFHVVDU\SRVWWUHDWPHQW ULQVLQJ RIWKHGLVLQIHFWHGPHGLFDOGHYLFHV
– PD[LPXPSHULRGRIXVHRIWKHSURGXFWZKHQLWLVSUHSDUHGIRULWVLQWHQGHGXVH
11. If the intended purpose of the device is not obvious to the user, the manufacturer must
clearly state it on the label and the instructions for use.
(MDD er 13.4.) $WOHDVWWKHIROORZLQJLQIRUPDWLRQVKRXOGEHSURYLGHG
– LGGLVHLQQWILHILFFWDDWQLRWQRIWKHSURGXFWDVDQFKHPLFDOGLVLQIHFWDQWDQGWKHSXUSRVHRIWKH
– tKH PHGLFDOGHYLFHVLQWHQGHGWREHGLVLQIHFWHGZLWKWKHSURGXFW
– W\SHVRIPLFURRUJDQLVPVZKLFKDUHGHDFWLYDWHGE\WKHSURGXFW
12. Has the CE marked been applied rightfully? ,’VLWVKLQHISHFUWRDGQXWFVWIDRUPZHKGLLFFKDOWKGHHYDLSFSHODLFVDGWLHRIQLQDHGVVES\H5FLXILOHHGRQRWIKWHKHOD&EOHDOVRVULILLFQDWWKLRHQP&DUQLXWHDUOLLDV”QRW OPLPHGLWLHFGDOWRILHPOGHGWKLFDDWODGUHHYQLFRHWVP HHGJLFWDDOEGOHHYWLRFSHVVDVQXGUIDVKFDHVOOLQQRWWKEHHZDRUUWNKLHQJ&(DUPHDDURNE MHFWVLQWKH
&KHFNOLVWPDQXDOSURYLGHGZLWK&(PDUNHGGLVLQIHFWDQW
13. A manual is not necessary when the product can be safely used without a manual.
(MDD er 13.1, 13.4.) $ PDQXDOLVQRWQHFHVVDU\ZKHQ
– WGKLDHOS\UVRLVGPXFDWFLKVLQIRHU GHGLFDWHGXVH HJDSDUWLFXODUW\SHRIZDVKHUGLVLQIHFWRURU
– WKHLQIRUPDWLRQWKDWLVQHFHVVDU\IRUWKHVDIHXVHRIWKHSURGXFWLVJLYHQRQWKHODEHO
14. CE mark including the identification number of the notified body.
(MDD art. 17.)
15. The name or trade name and address of the manufacturer.
(MDD er 13.6.a)
– QDPHDQGDGGUHVVLQWKH(8
16. Identification of the contents of the container.
(MDD er 13.6.a)
– FQRDPPSHRRVILWWLKRHQS UPRDGLXQFFWRGPHSVLRJXQQDGWVLRDQQWGKDFRWQWKFHHQSWUURDGWLXRFQW LVDFKHPLFDOGLVLQIHFWDQWFKHPLFDO
17. Where appropriate, an indication that the device is for single use.
(MDD er 13.6.a)
18. Any special storage and/or handling conditions.
(MDD er 13.6.a)
19. Warnings and/or precautions to take
(MDD er 13.6.a)
20. Performance of the product as claimed by the manufacturer and undesirable side-effects
(MDD er 13.6.b).
21. If the device must he installed with or connected to other medical devices or equipment in
order to operate as required for its intended purpose, sufficient details of its characteristics
to identify the correct devices or equipment to use in order to obtain a safe combination.
(MDD er 13.6.c)
RIVM report 318902013 page 22 of 30
,GHQWLILFDWLRQRIWKHHTXLSPHQWLQZKLFKWKHSURGXFWLVIRUIOH[LEOHHQGRVFRSHV RUDVSHFLILFDWLRQRIWKHPHGLFWDROEGHHYXLVFHHGV IHRUJZZKDLFVKKHWKUHGSLVULRQGIHXFFWWRLUV LQWHQGHG HJGLDO\VLVPDFKLQH 
22. All the information needed to verify whether the device is properly installed and can
operate correctly and safely, plus details of the nature and frequency of the maintenance
and calibration needed to ensure that the devices operate properly and safely at all times.
(MDD er 13.6.d)
– KZDKYHHQDWKOHLPSLUWHRGGXSFHWULLVRGSXRWILXQVWHRXWKVHHFDRIQWHFUHDQFWUWDLYWDLRWLQRRQIRWIKWHKDHFSWLUYRHGFXRFPWRSURZXQLWGKVSVUKRRGXXOGFWVEHWKDW FKHFNHG HJZLWKDQLQGLFDWRUVWULS
23. Information regarding the risks of reciprocal interference posed by the presence of the
device during specific investigations or treatment.
(MDD er 13.6.f)
– WGKHHWHUULLVRNUVDRWLIRWQKHRISWUKHHVHPQHFGHLRFIDOUHGVHLYGLXFHHVVRRIQWKZHKSLFUKRGWKXHFWSRURQGGXLFVLWQLIVHXFWVHHGGPDQHGGLRFDUOPGDHWYHLUFLHDVO FRPSDWLELOLW\VKRXOGEHLGHQWLILHG
24. Details of any further treatment or handling needed before the device can be used (for
example, sterilization, final assembly, etc.)
(BMH er 13.6.i)
– DGGLWLRQRIDQDFWLYDWRUWRWKHSURGXFW
– GLOXWLRQRIWKHFRQFHQWUDWH
Additional requirements regarding hazards accompanying the product.
25. Hazardous products shall be marked with particular warnings in written form (so called R
and S sentence and symbols). The rules regarding these markings are complex and the
evaluation of hazards for the user in relation to the products was outside the scope of this
study. L+QRIRZUHPYHHGUEF\KWHKPHLFLQDIORGULPVLDQWILHRFQWDRQQWVWKDHUHODKEDH]ODDUEGRRXXWVWSKUHRSGRXLFVWRVQER\XVQDDWQXGUHRU7LKQHIODXPVHPUDVKEDOHOOQEDHWXUH RIWKHSURGXFWDQGWKHQHFHVVDU\SUHFDXWLRQVWRWDNH
RIVM report 318902013 page 23 of 30
$SSHQGL[ /LVWRISURGXFWVEHDULQJ&(PDUN
%UDQGQDPH W0KDHQ1XHIWDKFHWXUOUDHQUG6VXSSOLHULQ Q1RXWPLILEHHGUERRIGW\KH
Stammophen ‘+UHLQ+ULF6KWVDWPUP*PE+ ’XLWVOD%QHGUOLQ
Dr. H. Stamm bv
124
Stammopur 23 Dr. H. Stamm bv 124
Stammopur 24 Dr. H. Stamm bv 124
Stammopur DB Dr. H. Stamm bv 124
Stammopur DR Dr. H. Stamm bv 124
Stammopur DR2 Dr. H. Stamm bv 124
Stammopur DR8 Dr. H. Stamm bv 124
FD 322 2*5P2E+&+(&0R,(.’*UU3IOXJ ‘0D[3ODQ.FNRU6QWZUHVWKHLP ‘XLWVODQG
Dürr Dental Nederland
124
FD 333 Dürr Dental Nederland 124
FD 350 Dürr Dental Nederland 124
FD520 Dürr Dental Nederland 124
ID 212 Dürr Dental Nederland 124
ID 212 Forte Dürr Dental Nederland 124
ID 220 Dürr Dental Nederland 124
Orotol Plus Dürr Dental Nederland 124
Vector Dürr Dental Nederland 124
Omniwipes 2PQLGHQW
Dental Union BV
124
Belimed %’HROULPIVWHUGDV$V*H&+ =%ZDOLOWZVHLOUODQG
Pentax Benelux B.V.
44
Cidex 14 dagen
oplossing
-/RLPKQLWVHRGQ -RKQVRQ0HGLFDO 6*NDLSUJWRUQDYH %*’URRW%5UL;WWDQLs
J & J Medical B.V.
86
RIVM report 318902013 page 24 of 30
Steris 20 5+X2H6(3,7)+pU(R5Q$VD %%HOJLH %”U XVVHO
Steris Nederland
86
Ecoster +RVSDO0,QHG\]XLVHWXU\ )UDQNULMN
Hospal BV
86
Turbocidol $2OUORP&HQOHGDVWQUD&VKVHHPLH$* =&Z+LWVHUODQ)GHKUDOWRUI
A.D. Jansen Zwolle bv
120
Aseptoprint Rapid Oro Clean Chemie 120
Dentiro Light Oro Clean Chemie 120
Dentiro Mikro Oro Clean Chemie 120
Dentiro Schuim Oro Clean Chemie 120
Dentiro Sensitive Oro Clean Chemie 120
Dentiro Wipes Oro Clean Chemie 120
OroCid Multisept
Plus
Oro Clean Chemie 120
OroClean Plus Oro Clean Chemie 120
OroClean Ultra Oro Clean Chemie 120
OroLin Borenbad Oro Clean Chemie 120
Minutenspray $0ORSRURVZ’LHHVQHWQDVOW3UURG XFWH*PE+ ’XLWVOD6QWG*HRUJHQ
Alpro
123
Minutenwipes, Alpro 123
Alpron Alpro 123
Alpron Mint Alpro 123
BIB forte, Alpro 123
Diasteril )*UPHEVH+QLXV.DEL’HXWVFKODQG (OVH.U%|DQGHU+6RWPUEXUJYG+ ‘XLWVODQG
123
Micro-10+ 81$,’YH(Q1X7H(6X$JqQH3LWWDUG =&Z+LWVHUODQ*GHQqYH
Unident
123
Unisepta liquid Unident 123
RIVM report 318902013 page 25 of 30
Neodisher Drill &*KPHPE+LVF KH&)RD E ULN’U:HLJHUW ‘0KOHQKD+JDHQPEXUJ ‘XLWVODQG
Meko Holland B.V.
297
Neodisher Septo
DN
Meko Holland B.V. 297
Neodisher Septo
DN2
Meko Holland B.V. 297
Neodisher Septo SF Meko Holland B.V. 297
Dentavon 6’FKONH 10RUDG\HHUUVW*HGPWE+ ‘XLWVODQG
Schülke&Mayr Benelux
297
Gigasept Schülke&Mayr Benelux 297
Lysetol Med Schülke&Mayr Benelux 297
Mikrozid Tissues Schülke&Mayr Benelux 297
S&M matic Schülke&Mayr Benelux 297
Terralin Schülke&Mayr Benelux 297
Thermosept ED Schülke&Mayr Benelux 297
Mikrozid Liquid Schülke&Mayr Benelux, 297
Sekudrill +2H+Q*NHO(FRODE*PE+ &R 3’2’VVHOGRUI ‘XLWVODQG
HenkelEcolab BV
301
Sekumatic FD HenkelEcolab BV 301
Sekusept Forte HenkelEcolab BV, Maxxim 301
Sekusept Plus HenkelEcolab BV, Maxxim 301
Sekusept Poeder HenkelEcolab BV, Maxxim 301
Peresal HenkelEcolab BV, Maxxim 301
Olympus ETD
Desinfectans
Olympus, Maxxim 301
Calbenium $,5(UX/H0DUFHO3$8/ )UDQNU&LMN+$03,*1< Airel 433 Dentasept 3H, $3DQLYRpVG/XD0ERRUXDOWLRQLUHV /LOOH+HOOHPPHV Frankrijk Anios Laboratoires 459 Dentasept PE, Anios Laboratoires 459 Dentasept ph7 Anios Laboratoires 459 RIVM report 318902013 page 26 of 30 Dentasept Sol et Surfaces Anios Laboratoires 459 Dentasept Special rotatif Anios Laboratoires 459 Dentasept spray 41 Anios Laboratoires 459 Dentasept ultra Anios Laboratoires 459 Lingets Anios Laboratoires 459 Dialox 66R(F3Lp3W,p&GX*URXSH$,5 /,48,'( 4XD3LDGUÏLVUV&DH\GH[ )UDQNULMN Seppic 459 EuroSept Bur /+WHGQU\6R6XFWKKHDLOQO80.LG+GROHOVGHLQ[J8V % $8*URRW%ULWWDQQLs Henry Schein bv. 473 EuroSept Evac liquid Henry Schein bv. 473 EuroSept Evac powder Henry Schein bv. 473 EuroSept Impressions Henry Schein bv. 473 EuroSept Instrument Henry Schein bv. 473 EuroSept Surface Henry Schein bv. 473 EuroSept Wipes Henry Schein bv. 473 Drill Activ A+D 481 Sugo Activ A+D 481 Top Activ A+D 481 Hygiëne tucher &'DHQUOWD=OH&LVHVQ6WUWDUO*PE+ '*HUPDQ\7ULWWDX Dental Central 482 RIVM report 318902013 page 27 of 30 $SSHQGL[ 3URGXFWVWKDWDUHZURQJIXOO\&(PDUNHG 3URGXFW ,QWHQGHGSXUSRVHZKLFKH[FOXGHVWKHSURGXFWIURPFODVVLILFDWLRQUXOH 1 For the disinfection of respiratory masks for personal protection (not medical devices). 2 For the disinfection of respiratory masks for personal protection and laboratory glassware (not medical devices) 3 For the disinfection of dental imprints and imprint spoons (not medical devices) 4 For the disinfection and cleaning of the surfaces of medical devices such as dental hand pieces. (intended use is not precise) 5 Disinfecting powder for dental imprints (not medical devices) and orthodontic equipment. 6 Disinfectant for fast disinfection of small surfaces, medical instruments, medical equipment and the working area (mentioned 3 times). 7 Recommended for the careful disinfection and maintenance of medical equipment with sensitive surfaces and dental chairs. 8 Disinfecting wipes for small surfaces, medical instruments, medical equipment and surfaces. 9 Disinfecting wipes for the disinfection of surfaces of medical devices such as dental handpieces, handles of equipment and general furniture (not medical devices) (mentioned 2 times). 10 Concentrated disinfectant for the continues disinfection of water (not a medical device) and waterlines in dental units (mentioned 2 times). 11 Fast acting disinfectant to be sprayed on the inventory of the doctor’s office such as furniture, equipment and accessories (not medical devices). 12 Water disinfectant with prolonged action (not a medical device). 13 Cleaner/disinfectant for surgical instruments and laboratory equipment (not medical devices). 14 Disinfection of prosthesis material and dental imprints (not medical devices). 15 Disinfecting wipes for medical devices and equipment (not medical devices). 16 Surface disinfection of medical products (not medical devices). 17 Fast acting alcohol based disinfectant for medical devices and equipment (not medical devices). 18 Liquid disinfectant for washer disinfectants in the medical and laboratory application (not medical devices). 19 Surface disinfection in hospitals and general practises (not medical devices). 20 For the disinfection of medical linen; further application for domestic linen and towels is indicated with symbols (not medical devices). 21 For the disinfection of medical devices. Suitable for wettable surfaces (not medical devices) (mentioned 2 times). 22 Fast acting disinfectant spray for the medical inventory as per MDD. Also suitable for other alcohol compatible surfaces (not medical devices). 23 Active water purification compound and water softener (not a medical device). 24 Fast and thorough cleaning and disinfecting of floors, medical devices, walls RIVM report 318902013 page 28 of 30 and other surfaces (not medical devices). 25 Fast disinfection by spraying on surfaces, medical devices, units and tables (not medical devices). 26 Special cleaner (in the French, German, English end Spanish manual the product is called a disinfectant) for alginates and silicon dental imprints (not medical devices). 27 Very effective cleaner for the fast disinfection of instruments, medical equipment and other surfaces not medical devices). 28 The wrapping of the refill gives no indication of the application (no clear intention for medical devices). 29 For the disinfection of the surfaces of medical equipment (not medical devices). Especially for dental handpieces. 30 Hygienic tissues for general and dental practises (not medical devices). RIVM report 318902013 page 29 of 30 $SSHQGL[ ,QFRUUHFWO\FODVVLILHGRULQFRUUHFWOPDUNHGGLVLQIHFWDQWV \ 3URGXFWD Disinfecting liquid to be mixed with pumice powder, which as a mixture is used as a polishing paste by dentists. The product is an accessory to the medical device and should be CE marked. 3URGXFWE A disinfectant with a general application, registered under the Pesticides act. The product is specifically prescribed by the manufacturer of therapeutic baths for the cleaning and disinfection. The disinfectant is marketed under the name of the manufacturer of the baths. The baths are provided with a compartment designed for the reception of the disinfectant container and are provided with an automatic dosing system. In this particular case the disinfectant is an accessory to a medical device (the therapeutic bath) and should therefore be considered as an medical device and consequently be CE marked. 3URGXFWF The claim of the manufacturer is not unambiguous. The product is sold as a dedicated detergent to be used in a washing machine for medical devices. On the label the manufacturer claims that the product has ‘anti microbial properties’, thus implicating that the product is a disinfectant as well. The product is CE marked as a class I device; without the identification number of a notified body. Because of the additional claim of the manufacturer the product should be classified as a class IIa medical device. 3URGXFWG This product is intended for the cleaning of dental suction lines. The manufacturer does not make any anti microbial claim. The CE mark is however accompanied by a number of a notified body, implicating that the product is at least a class IIa medical device. 3URGXFWH “An aldehyde free concentrate for the disinfection and cleaning of surfaces. Good cleaning capability, biological degradable.” Since the product is not a medical device it is correctly not CE marked, but is it also not registered under the Pesticides act. 3URGXFWI Cleaning wipes for the disinfection of instruments and hard surfaces. The product is CE marked, without the identification number of a notified body. The product is recommended for the disinfection of instruments, but also all objects that need rapid disinfection during work like handles, surgical lamps, water taps, toilet seats, operating panels etc. The application is clearly not limited to medical devices, the product should therefore not be CE marked. RIVM report 318902013 page 30 of 30 $SSHQGL[ 5HVSRQVHIURPWKHPDQXIDFWXUHUV Manufacturer Response 1. The manufacturer has followed the CE conformity procedure described in Annex V of the MDD. The product has been tested in 1992 to the valid guidelines of the DGHM at the time. 2. The manufacture sent copies of the certificates for the quality assurance system for the design, production an sales of chemical disinfectants. The certificate is complemented with a list of the products that are produced under the quality assurance system. A number of disinfectants are listed that have a broader application than the disinfection of medical devices (e.g. sprays for surface disinfection). No information about the product tests has been given. 3. The manufacturer states that the disinfecting wipes are certificated using annex II of the MDD. The product has been tested to the guidelines of the DGHM and DVV/BASG as well as the French standard NF T 72170. The product has been tested by four third parties. 4. The manufacturer states that annex 5 of the MDD has been followed. The product has been tested to the guidelines of the DGHM. 5. The manufacture of disinfecting wipes has sent copies of the test reports from three third parties. The product fulfils the requirements of the DGHM with a contact time of 2 minutes. The product has been tested for virucidal activity with the ‘antigen inactivation test’. 6. The manufacture states that CE conformity procedure in annex V of the MDD is used. No information about the product tests was given. 7. The manufacture provided a list of the tests that have been performed on the product or with the product. The tests were performed by a number of different persons/organisations. The list also mentions the test organisms that have been used in the tests. The manufacturer refered to national standards, which were identified by the notified body as the DGHM guidelines. The manufacture sent copies of the certificates for the quality assurance system for the design, production an sales of chemical disinfectants. The certificate is complemented with a list of the products that are produced under the quality assurance system. A number of disinfectants are listed that have a broader application than the disinfection of medical devices (e.g. sprays for surface disinfection). 8. The manufacture stated that all product information has been evaluated by the notified body. In case of a problem with one of the products from his company he advises to seek contact with “our competent authority”. The manufacturer did not provide any information on the tests performed on his product. 9/10. Manufacture did not respond to the questions (2x)