Quality management and regulations
Every piece of equipment we produce meets strict quality benchmarks. We subject each product to comprehensive testing to guarantee it meets the highest standards before it reaches our clients. Our entire production process is managed within our Barcelona facilities, adhering to the ISO 9001:2015 Quality Management System and the ISO 14001:2015 Environmental Management System standards.
Certifications
ISO 9001:2015
Our company is committed to quality management excellence and is certified by SGS.
ISO 13485:2016
This standard exclusively certifies the quality management systems of our medical autoclave models.
ISO 14001:2015
Our dedication to environmental sustainability in autoclave production is recognized through international certifications.
CE Marking
Our laboratory autoclaves have CE marking and are certified by TÜV.
FDA and GMP
The controller and cloud-based connectivity of our Top Line autoclaves have been co-developed with Testo and comply with Part 11 of Title 21 of the Code of Federal Regulations (FDA 21 CFR Part 11).
RoHS
We guarantee that no environmentally hazardous substances have been used in the manufacture of our equipment.
Pressure vessel construction standards
PED
All our autoclaves are manufactured in compliance with the European Pressure Equipment Directive (PED) 2014/68/EU requirements.
AD 2000
The design codes for all our autoclave chambers are in accordance with the AD 2000 Merkblatt standards.
AISI-316L
The sterilization chambers of all our autoclaves are made from high-quality AISI-316L stainless steel, an alloy that is exceptionally resistant to corrosion.
ASME
Our range of Top Line autoclaves carries the ASME certification mark for boilers and pressure vessels, awarded by the American Society of Mechanical Engineers.
CRN
Our autoclaves comply with the CRN standard (Canadian Registration Number), ensuring they meet the safety requirements for use within Canadian territories.
AS1210
The AS1210 standard ensures our equipment meets specific safety regulations applicable in Australia.
MOM
Our autoclaves are approved by Singapore’s Ministry of Manpower (MOM), complying with national pressure equipment requirements.
Partners that certify our quality
Need assistance?
Should you have any inquiries about the certifications of our equipment, we are eager to provide you with the necessary support and information.
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