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 CE. 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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