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CARINE Medical

Certificates & Norms

Eu Type Examination Certificates & Test Reports BS EN 14605:2005+A1:2009
Personal Protective Equipment Protective clothing against liquid chemicals. Performance
2016/42 European Regulation (EU) 2016/425 covers the requirements for clothing with liquid-tight (Type 3) or
process for CE Marking Personal Protective Equipment spray-tight (Type 4) connections, including items providing
(PPE) described as any device or appliance designed to be protection to parts of the body only (Types PB [3] and PB [4])
worn or held by an individual for protection against one or
more health and safety hazards.
BS EN 13034:2005+A1:2009
"FDA approved" means that the agency has determined that Protective clothing against liquid chemicals. Performance
the "benefits of the product outweigh the known risks for the requirements for chemical protective clothing offering
870.40.40 intended use." Manufacturers must submit a premarket limited protective performance against liquid chemicals
approval (PMA) application and the results of clinical testing (Type 6 and Type PB [6] equipment)
in order to get approval.

BS EN 14126:2003
“ISO 9001 Certified” means an organization has met the Protective clothing. Performance requirements and tests
requirements in the ISO 9001 Quality Management System methods for protective clothing against infective agents
(QMS). ISO 9001:2008 is focused on meeting customer
expectations and delivering customer satisfaction so that
more focus can be served to the customer.
BS EN 13795-1:2019
EN 13795-1 Surgical clothing and drapes. Requirements and test
2019
Ekoteks Laboratory was founded in 1998, with the methods. Surgical drapes and gowns
investment of IHKIB (Istanbul Apparel Exporters
Association). With its trained, experienced and dynamic staff.
Ekoteks operates over 3,000 local and largest multinational BS EN 14325:2018-TC
corporations around the world. EN 14325 Tracked Changes. Protective clothing against chemicals.
2018- TC
Test methods and performance classification of chemical
protective clothing materials, seams, joins and
Notified Body Role
Through the notification of Kiwa Italy (N.B.0476) and Kiwa assemblages
Turkey (N.B.1984), Kiwa is able to provide globally conformity
assessment services for CE marking in compliance with
93/42/EEC directive and subsequent amendments.
BS EN 1149-5:2018
Based on the more general management standard ISO 9001, Protective clothing. Electrostatic properties. Material
ISO 13485 is aimed specifically at organizations in the
medical devices field, covering all stages, from design to performance and design requirements
installation and maintenance, and related services such as
sterilization and testing.
It sets out the specific requirements for a quality BS EN ISO 13982-1:2004+A1:2010
management system related to medical devices. In the EU, Protective clothing for use against solid particulates.
the requirements have been harmonized with those of
several regulations, including the Medical Device Directive Performance requirements for chemical protective clothing
(93/42/EEC), the Directive for In Vitro Diagnostic Medical providing protection to the full body against airborne solid
Devices (98/79/EC) and the Directive for Active Implantable particulates (type 5 clothing)
Medical Devices (90/385/EEC).
ISO 13485 follows a structure that makes it easy to use
alongside other management system standards, such as
ISO 14001.