Sorry, but this is a news intended for the local Polish market only.
Management Systems Certification Specialist,
Medical Device Certification Specialist.
We invite interested persons to contact.
Category: Aktualności
X 2020
Dear Sirs,
In addition to the ICR Polska announcement of 27/03/2020 posted on the website https://icrpolska.com/en/2020/03/27/iii-2020/, we would like to inform you that the successive certificate numbers in the Attachment have been withdrawn.
Applicants are asked to contact us directly at icrpolska@icrqa.com in order to issue, in justified cases, a document confirming compliance on the new graphic template and under new number.
At the same time, we would like to inform you that the list of withdrawn and previously identified fakes will be forwarded to the customs authorities and market surveillance in order to effectively eliminate the phenomenon of illegal use of certificates.
We apologize for any inconvenience.
IX 2020
Please be advised that we have been recognized as the ExCB certification body in the IECEx scheme - the worldwide voluntary system for confirming the correct construction of explosion-proof devices.
We currently offer testing (ExTR) and full certification activities (Ex CoC), including audits of quality production system (QAR).
Actively operating for 20 years, IECEx is an organization associating 61 bodies from 35 countries dealing with conformity assessment and certification of products intended for operation in potentially explosive atmospheres.
ICR Polska is currently one of three such units in Poland.
Feel free to contact and cooperate.
VIII 2020
We have started the process of obtaining the status of a notified body in the scope of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.
Feel free to contact and cooperate.
IV 2020
In our laboratories, we perform the following tests of biocompatibility of medical devices in accordance with the standards of the ISO 10993 series:
-
- genotoxiciti tests:
- bacterial reverse mutation test
- in vitro chromosome aberration test
- in vivo micronucleus test
- in vitro cytotoxicity test
- acute systemic toxicity test,
- skin irritation test,
- intracutaneous (intradermal) reactivity test,
- oral mucosa irritation test,
- pyrogen test,
- subchronic systemic toxicity test and implantation test
- skin sensitization test
- genotoxiciti tests:
Feel free to contact and cooperate.
III 2020
Dear Sirs,
ICR Polska informs that:
– since 26th March, ICR Polska stopped accepting new certification inquiries in scope of covid-19 related products,
– all certificates issued by ICR Polska within the scope of covid-19 related products are voluntary basis
– voluntary certificates are not required by any legal act and are not equal to conformity assessment procedures restricted for notified bodies in that scope
– voluntary certificate is not obligatory to import goods to EU market
– voluntary certificate does not entitle manufacturer to affix CE mark on its product
– CE mark is designed to be placed on the product according to EU relevant regulation after fulfilling product applicable essential requirements
– all issued certificates in period of 1st – 26th March 2020 in scope of products related to Covid-19 has been withdrawn and ICR Polska is processing their re-issue on new certificate template and new identification numbers
– ICR Polska decided to conduct process of withdrawn and re-issue due to number of invalid or fake certificates and to make full clarification to certificate user about its condition and scope by re-editing its content
– from March 26th, following stamp is no longer in use in ICR Polska certificates
– status of certificate can be check: https://cert.icrpolska.com
online database is in its developmental stage, hence it may miss information and not does not contain all data about certificate requires for identification.
ICR Polska upgrades database on regular basis, yet certificate validity can be also confirmed through: icrpolska@icrqa.com
– ICR Polska has upload valid voluntary certificate template and examples of invalid certificates, that pretend to be issue by ICR Polska:
https://icrpolska.com/dokumenty-publiczne/
– certificates issued according to test report provided by China supplier Shanghai MICEZ Equipment Testing & Technical Co., Ltd. has not been re-issued and remains invalid or fake
– ICR Polska upload all certificates recognized as fake or invalid to online database
II 2020
On February 19-20, 2020, at the headquarters of ICR Polska in Warsaw, the assessment of our certification body as part of the global IECEx system was completed.
IECEx is an organization of 58 best units from 28 countries, dealing with conformity assessment and certification of products intended for use in potentially explosive atmospheres. ICR Polska is currently one of three such units in Poland.
During the audit, we expanded our powers, so we can offer testing and certification in both the European ATEX directive as well as in the global IECEx system.
Feel free to contact and cooperate.
XI 2019
Please be advised that as the only certification body in Poland, we are accredited for the certification of hydraulic, pneumatic and mechanical presses in accordance with the following standards:
EN ISO 16092-1:2018 [idt PN-EN ISO 16092-1:2018-03]
EN ISO 16092-3:2018 [idt PN-EN ISO 16092-3:2018-05]
These standards are harmonized with the Machinery Directive (MD) - 2006/42/EC and completely replace previous standards
EN 692:2005+A1:2009 [idt PN-EN 692+A1:2010]
and
EN 693:2001+A2:2011 [idt PN-EN 693+A2:2012]
X 2019
We offer voluntary certification of Unmanned Aircraft (DRON).
Certification confirms that the product meets the current legal and technical requirements. Verified are, among others operating conditions, environmental impact and safety of use.
DRONs with a total weight of up to 25 kg can be subjected to voluntary certification, controlled both in Visual Line of Sight (VLOS) and using a camera on board of DRON - Beyond Visual Line of Sight (BVLOS).
IX 2019
On September 23-27, 2019, we participated in the annual meeting of bodies operating in the IECEx system, which this time took place in Dubai. Together with other leading bodies in the field of Ex product testing and certification, we have established common assessment rules and test guidelines for the coming year.
More details about the meeting can be found at website of IECEx
