The mercurial sphygmomanometers are instruments used for measuring blood pressure with the help of a mercury column. They are popular because of the precision with which they can measure blood pressure. Being critical tools that assist in diagnosing patients, it is very important to maintain certain standards of quality, performance and safety while manufacturing these devices.
For ensuring uniformity in construction and precise readings, mercurial sphygmomanometers must be manufactured based on the IS 3390:1988 standard requirements. Important factors that the standard requires include construction requirements, accuracy of pressure measurements, quality of material, markings, performance of the mercury reservoir, airtightness, durability and overall workmanship. It is mandatory for all manufacturers of mercurial sphygmomanometers to get themselves certified by the Bureau of Indian Standards as per the applicable Indian Standard IS 3390:1988.
This is the Indian Standard for Mercurial Sphygmomanometers intended to measure blood pressure in clinics and hospitals. This standard outlines the requirements for accuracy and reliability over time. According to the Bureau of Indian Standards (BIS), these instruments are:
The BIS Certification of Mercurial Sphygmomanometers according to IS 3390:1988 ensures that the equipment complies with the necessary criteria in terms of accuracy of measurements, construction quality, and efficiency. The ISI Mark signifies that the equipment conforms to certain standards regarding its calibration, hermeticity, and durability. Thus assisting medical practitioners to make precise measurements using the Sphygmomanometers (Mercurial). Some benefits include:
BIS authorisation under IS 3390:1988 is required for businesses involved in manufacturing, importing, or supplying mercury sphygmomanometers in India.
Applicable to:
To ensure consistent quality of Mercurial Sphygmomanometers used for medical blood pressure measurement, the Bureau of Indian Standards outlines the minimum requirements under IS 3390:1988. This certification ensures that manufacturers produce devices with accurate measurement performance, proper calibration, durability and reliable functioning for safe clinical and diagnostic use. The BIS testing parameters and quality checks for Mercurial Sphygmomanometers are listed below:
The BIS Approval process ensures that Mercurial Sphygmomanometers meet the required standards for accuracy and safe measurement of blood pressure. This process is set by the Bureau of Indian Standards (BIS) and includes the following steps:
The Foreign manufacturers must designate an Authorized Indian Representative (AIR) in India. The representative is the local point of contact for the Bureau of Indian Standards (BIS) and manages all compliance and regulatory requirements in India.
Once the manufacturer obtains a BIS license, the Standard Mark for Mercurial Sphygmomanometers must be clearly and permanently marked on the product and/or its packaging. The marking should also include essential details such as the manufacturer's identification and the BIS licence number (CM/L). This ensures compliance with the prescribed quality and safety standards under IS 3390:1988. Additional details are provided below:
Note: Marking is typically applied using durable stamping, tagging, or permanent printing to ensure clear identification during handling, storage, and transportation, as per BIS marking requirements.
The BIS certification cost for Mercurial Sphygmomanometers includes charges for application processing, product testing, factory inspection, licensing and marking. These fees are payable to the Bureau of Indian Standards as per Scheme-I guidelines.
Note:
The ISO certified Mercurial Sphygmomanometers, as per IS 3390:1988, guarantee the measurement of blood pressure with high accuracy and reliability in hospitals, clinics and various health care facilities. The standard specifies the necessary parameters like construction, measurement accuracy, marking graduation, air tightness, materials and their properties and overall durability of the sphygmomanometer.
Following the guidelines laid out by the Bureau of Indian Standards (BIS) shows that a particular manufacturing company takes the necessary measures in terms of quality and compliance. With respect to the above, EVTL India supports the manufacturers of mercurial sphygmomanometers in getting the documentation and certification done in line with the relevant Indian standards.