The Legal Metrology (General) Rules, 2011 prescribe technical and metrological requirements for specified measuring instruments. Non-invasive non-automated sphygmomanometers were earlier regulated under the Eighth Schedule with existing technical specifications. The Central Government has amended the Eighth Schedule to substitute Part VII-A relating to such instruments. The amendment applies to manufacturers, importers, and users of non-invasive non-automated sphygmomanometers.

Rule 2 of the notification substitutes Part VII-A in the Eighth Schedule of the Legal Metrology (General) Rules, 2011 with a revised Part VII-A titled “Non-invasive non-automated sphygmomanometer”.

The substituted Part VII-A lays down, inter alia, the following statutory provisions (verbatim in substance):

• Specification of scope covering non-invasive non-automated sphygmomanometers and their accessories used for indirect measurement of arterial blood pressure using inflatable cuffs.
• Definitions of terms such as oscillometric method, bladder, cuff, deflation valve, systolic pressure, diastolic pressure, manometer, pneumatic system, rapid exhaust valve, sleeve, and tamper proofing.
• Classification and description of instrument components, including manometer and pneumatic system.
• Permissible units of measurement as kilopascal (kPa) or millimetre of mercury (mmHg).
• Maximum permissible errors for cuff pressure indication under ambient, storage, and varying temperature conditions.
• Detailed technical requirements for cuffs, bladders, pneumatic systems, pressure indicating devices, mercury manometers, and aneroid manometers.
• Safety requirements covering mechanical safety, prevention of unauthorised access, electrical safety, tubing connectors, and durability of markings.
• Metrological control provisions including model approval, verification, sealing, marking of devices and cuffs, and manufacturer’s information.

Prescribed test procedures for conformity assessment, including tests for accuracy, air leakage, pressure reduction rate, rapid exhaust, hysteresis, stability, mechanical safety, and mercury leakage protection