CERTIFICATIONS

PURPOSE

The technology has the strategic objective of responding to the stringent legislation on the management of medical waste belonging to the European Waste Catalog (CER), using modern technology applied to a highly automated technological process. The final result transforms and recovers the sanitary waste into a waste that is no longer dangerous.

In many states, there are different regulations to comply with when potentially infected waste is processed and transformed. The Italian state has one of the most stringent regulations ever in the medical waste sector.

Among the major international authorities that officially recognize the need to use alternative techniques to incineration in addition to numerous national regulations in various countries, the following stand out:

OMS

World Health Organization

(WHO, or World Health Organization, WHO in English): UN specialized agency for health, was founded on 22 July 1946 and entered into force on 7 April 1948 with headquarters in Geneva

UN Environment

United Nations Program for the Environment

(UNEP): an international organization that has been operating since 1972 against climate change in favor of environmental protection and the sustainable use of natural resources

HCVH

Health Care
Without Harm

a coalition of 500 members from 53 countries working to innovate the healthcare sector worldwide.

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Reg. Number 18426-A                   Valid from 2019-10-30
First release 2019-10-30            Last modification 2019-10-30
Expiration 2022-10-29                    Sector IAF 34

Quality Management System Certificate ISO 9001:2015

Eco.System Surl is an ISO 9001: 2015 certified company

ISO 9001: 2015 is a globally recognized quality management certification, granted to companies around the world that meet or exceed rigorous international standards in quality management. The standard is based on several quality management principles, including a strong customer focus, the involvement of high-level business management, a process approach and continuous improvement of the service provided.

With this certification, it is recognized that Eco.System adopts a system of rules, responsibilities, controls and procedures compliant with the ISO 9000 family of standards.

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ISPRA OPINION

Opinion from the Higher Institute for Environmental Protection and Research (ISPRA – public research body used by the Ministry of the Environment) in which it is highlighted that treatment with high pressure saturated steam alone is sufficient for sterilization of sanitary refusal at infectious risk.

 “THE IMPLANT IS DESIGNED TO GUARANTEE […] A SAL (STERILITY ASSURANCE LEVEL) NOT LOWER THAN 10-6”

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UNIVERSITY OF BARI “Aldo Moro”

According to the provisions of UNI 10384/94, carried out by the Department of Biomedical Sciences and Human Oncology of the University of Bari “Aldo Moro”.

The professor. G. Signorile says that:

 “… NO SPORES SURVIVED IN THE DIFFERENT MONITORED CYCLES”.

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RDF PRODUCED BY A STERILIZATION PLANT CALLED ECOSYST

CHEMICAL ANALYSIS LABORATORY – APULIALAB

Laboratory “Apulia Lab” in San Giovanni Rotondo.

CERTIFICATE OF ANALYSIS N ° 198 / REG-EST / 21:

“THE ANALYZED SAMPLE RESPECTS THE CHEMICAL-PHYSICAL SPECIFICATION CHARACTERISTICS REFERRED TO IN THE UNI EN ISO 21640: 2021 STANDARD, WHICH REPLACES UNI EN 15359, AS REPORTED IN THE DM 14 FEBRUARY 2013, N.22,”

QUALITY AND SAFETY

The technology complies with the Machinery Directive 2006/42 / EC and with the Directives 2004/108 / EC (CEM) and 2006/95 / EC (DBT).

It also complies with the following harmonized standards: CEI 61010-1: 2013, CEI 61010-2040: 2005, CEI 60204-1: 2010.
The pressure chamber complies with the PED Directive 2014/68 / EU.