 |
| Frequently asked questions |
|
| What
is ISO 13485:2003? |
| What
is CE Marking? |
| How
do these certifications benefit the consumer? |
| What
mask do you recommend for surgical procedures with high incidence
of fluid splash? |
| What
products do you offer that address issues of fogging on glasses? |
| What
is the appropriate mask for surgical staff members when performing
procedures for patients known to have TB or likely to have TB? |
| Should
patients with TB wear respirator masks? |
| What
is GMP? |
| Is
Mediklin Healthcare follow GMP standards? |
| |
| |
| What
is ISO 13485:2003? |
ISO 13485
applies to all types of organizations. It can help both product
and service oriented organizations achieve standards of quality
that are recognized and respected throughout the world. ISO
13485:2003 has replaced the old ISO 9001 2000 standard. In
addition, the old ISO 9001 2000 and ISO 9002 1994 quality
standards have been discontinued. They are now obsolete. |
|
| What is CE Marking? |
CE Mark is the symbol  . The letters
"CE" are the abbreviation of French phrase "Conformité
Européene" which literaturely means "European
Conformity". CE Marking on a product is a manufacturer's
declaration that the product complies with the essential requirements
of the relevant European health, safety and environmental
protection legislations.
CE Marking on a product indicates to governmental
officials that the product may be legally placed on the market
in their country.
CE Marking on a product ensures the free
movement of the product within the EFTA & European Union
(EU) single market (total 28 countries), and
CE Marking on a product permits the withdrawal
of the non-conforming products by customs and enforcement/vigilance
authorities.
Along with more directives' becoming
effective, more and more products are required to bear the
CE Marking for gaining access to the EFTA & European Union
market.
|
|
| How do these
certifications benefit the consumer? |
| Health is one area where there is no compromise.
ISO 9001:2000 and CE Marking ensures the customer of the safety
of the use of these products at the lowest possible price. At
Mediklin, we strive to make products that will protect the whole
healthcare industry and is affordable by all – but quality
is never compromised. |
|
| What mask do
you recommend for surgical procedures with high incidence of
fluid splash? |
| The correct barrier technique is by using
three layered mask i.e. Surgeon’s Mask. This has very
high bacterial filtration efficiency (over 99% BFE) and also
prevents fluid penetration. Surgeon’s Mask provides excellent
comfort, as the fabric is highly breathable. One could also
use Surgeon's masks with Visor. |
|
| What products
do you offer that address issues of fogging on glasses? |
| Surgeons that wear spectacles often experience
during long duration surgeries, experience blurring of vision
due the mask’s nose clip not fixing properly on the nose
but resting on the cheek bone. The water vapour in one’s
breath gets directed upwards and settles on the glasses. This
can be avoided by using Surgeon's masks with proper nose clip
wire dimensions. |
|
| What is the appropriate
mask for surgical staff members when performing procedures for
patients known to have TB or likely to have TB? |
| The international standard in patient protection
& protection of surgical team is using Surgeons Masks which
is three layered and the center high bacteria filtration fabric
helps in preventing or acquiring the spread of communicable
disease. |
|
| Should patients
with TB wear respirator masks? |
| Yes. Because patients with TB could be
potential carriers for spread of communicable disease to any
other person in their vicinity. |
|
| What is GMP? |
| GMP stands for Good Manufacturing Practice.
These are hygiene standards that should be followed by companies
providing healthcare services or products. GMP includes standards
for cleanliness, hygiene, dust-free manufacturing environment,
etc. |
|
| Is Mediklin
Healthcare follow GMP standards? |
| Mediklin has designed its facilities based
on the standards defined by GMP. Our facility has been benchmarked
by our competition. We continuously improve our facilities to
increase the quality and hygiene of the products that we deliver. |
|
| What was SARs? |
| SARs stands for Severe Acute Respiratory
Syndrome. An air-borne infection. |
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