11 Apr 2020Posted By: Mudit Handa

ISO Certification Standards Available for the Medical Equipment

Everyone knows that the Novel Coronavirus, better known as COVID-19, has influenced more than 110 countries of the world. Because of the number of deaths all through the globe coming about because of Coronavirus illness, various nations are presently on complete stop. In addition, the worldwide pandemic has additionally caused an overall monetary disturbance, remembering for India, where the administration is prompted to force a lockdown in numerous areas.

With regards to the Coronavirus emergency, the European Commission is now collaborating with the industry of the Member nations to expand the accessibility of ISO certified masks, gloves, outfits, and other clinical equipment. Businesses are now collaborating for expanding creation by existing makers, encouraging imports and initiating elective methods for delivering gear. Hence, the ISO certification will now be done on a large scale to increase the production of such products on a larger scale.


1. How will the ISO certification be implemented for clinical equipment?

Upon the earnest solicitation of the Commission, the European Committee for Standardization along with the European Committee for Electrotechnical Standardization, as a team with every one of their individuals, have consented to promptly make accessible various European and other international benchmarks such as ISO 9001 certification for certain clinical gadgets and individual defensive gear. 

This activity will support both EU and third-nation organizations ready to make these things to quickly begin creation and spot items on the inner market all the more effectively while guaranteeing a high level of safety.

2. Which global standards are being included in this initiative?

There is a total of 11 global benchmarks that have been created by the European Committee for Standardization (CEN) are included in this initiative of the European Commission. Conceivably, 3 key ISO certification standards will also be made accessible for supplies like the basic face mask, clinical gloves, and other defensive garments. Those 3 different ISO standards will be:-

  • ISO 374-5:2017 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks

  • ISO 13688:2013 Protective clothing - General requirements

  • ISO 10993-1:2009 Biological evaluation of medical devices

Nevertheless, these 3 key ISO standards are compatible with the quality management Standard i.e. ISO 9001 certification.

3. What is the objective of this initiative?

This activity supplements the Commission Recommendation on the congruity evaluation and market reconnaissance systems, which gives direction to national bodies on permitting non-CE mark individual security hardware that follows the vital health and safety norms to enter the EU showcase inside the setting of the Coronavirus.

4. How access to the ISO standards will help manufacturers of clinical equipment?

Giving direct access to the national selections of these European measures helps both EU and third-nation organizations which are reconverting their creation lines to fabricate rapidly these basic things for forestalling the coronavirus pandemic. The utilization of the measures will empower organizations that utilization them to get to the market for such principal clinical and insurance gear snappier and to furnish those deprived with such clinical hardware. 

Regularly, principles must be bought and utilized in accordance with the protected innovation right guidelines, as the copyright of the benchmarks lies with the associations, which have built up the norms. The disparagement from this plan of action is a solid European reaction, in view of a feeling of social duty and solidarity, to address the lack of safety gear against COVID-19.

5. How will the liberal access to the ISO standards be given to the manufacturing companies?

In support of EU product laws, the European Commission can now demand the improvement of European benchmarks to encourage consistency by producers of the important necessities. When concurred and referenced in the Official Journal of the European Union, these orchestrated norms become some portion of EU law and permit organizations simple and direct access to the interior market for their items, while guaranteeing a high level of safety for the purchaser.

Well, this is just a step forward to combat the pandemic of Coronavirus aka COVID-19.

If you require any other guidance with respect to thISO certification in India, please feel free to contact our business advisors at 8881-069-069.

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