Over a few years, there have been significant changes to certify PPE when used by Healthcare Professionals. We have noticed that most of the manufacturers of medical devices and PPE kits are confused in the standards. In the time of urgency and when a different type of certification is being asked for on short notice, the client is not able to understand exactly which standard is most relevant for his activity. Earlier SITRA’s (ISO 16603) norms were followed. But as demand is raised the market has been flooded with low-quality material. It becomes mandatory to follow the standard for the manufacturer. There is another certification from DRDE and if fabrics are certified with SITRA certification need not to have DRDE. But nowadays as many manufacturers and purchasing authorities are new to this field are not able to distinguish between both certification and insist their supplier/manufacturers take both certifications.
Standardization assures that the personal protective equipment is designed under the guidelines and to safeguard wearers against all known possible hazards.
If you are a new manufacturer of PPE Kits/Mask/Gloves/Medical Devices you might look for any of these following certifications.
ISO 13485 – ISO 13485 is standard for Medical Devices Industry. This assures production quality & regulatory compliance. This international standard involves the process to monitor the quality management on one or more stages of the life cycle of the medical device. The standard provides the guidelines to Medical Device Industry to achieve effective quality management. In these times when the market is flooded with much medical device business, A company certified with 13485:2016 is always preferred by vendors of this industry. Standard ISO 13485 ensures medical devices in different places signify the same quality and credibility.
ISO 16603 – This standard is concerned about protection for clothing against contact with blood and body fluids. This is the test certification addresses performance of materials used in protective clothing. The primary purpose of this standard is to clarify the test method.
SITRA – The Union Ministry of Textile has mandated SITRA (South Indian Textile Research Association) Registration for the production of personal protective equipment (PPE). Manufacturer of PPE Kits needs to pass a laboratory test as set out by South Indian Textile Research Association.
DRDE Certification – This is a Laboratory test for Personal Protective Equipment (PPE) Body Coverall submitted by Indian Manufacturers. The test covers the guidelines of Ministry of Textile and issues for implementing the quality control mechanism. The sample for Test is submitted to the Institute of Nuclear Medicine & Allied Sciences.
CE Marking – This is applied to get recognition in the European Economic Area. This ensures that the product is safer and visually more appealing. IEU making Conformitè Europëenne (CE) a worldwide mark. The employers of healthcare professional must ensure that they tested the quality of PPE kit and weaknesses of the protection systems.
The CE mark has become mandatory for all PPE placed in Market after 2004. Any manufacturer of PPE kits of any medical device is obligated to ensure that its product and its documentation meet all mandatory provisions under the directive of CE marking.
To take the registration of ISO please click here https://www.mycorporation.in/india/iso-certification-consultant-standard-9001-2008