Every SHIVcare sterilizer is manufactured and tested against Indian national standards (BIS) and international quality systems. Certified copies available for all hospital purchase committees and government tender documentation.
For Indian hospital procurement, the following certifications are mandatory. SHIVcare holds all of them — and provides certified copies free with every quotation.
IS 3829 Part 1 (Bureau of Indian Standards) specifies the design, materials, construction, and safety requirements for steam sterilizers used in Indian healthcare settings. It mandates SS 316L inner chamber material, minimum safety valve settings, door interlock requirements, and pressure vessel design specifications. SHIVcare's HPHV sterilizers are certified to IS 3829 Part 1 — meaning every unit has been independently verified to meet BIS construction standards.
IS 3829 Part 2 specifies the performance testing protocols for steam sterilizers — including temperature uniformity (±0.5°C during holding phase), steam penetration validation, vacuum performance (residual air below specification), and cycle reproducibility. This is the performance standard most scrutinised by hospital biomedical engineers during NABH audits and government inspections. All SHIVcare HPHV sterilizers are tested and certified to IS 3829 Part 2 requirements.
ISO 13485:2016 is the international quality management system standard for medical device manufacturers. It goes beyond ISO 9001 by adding regulatory compliance requirements, risk management, and post-market surveillance obligations specific to medical devices. Shiv Shakti Enterprise is certified to ISO 13485:2016 — meaning the entire manufacturing process, from design and procurement to production, testing, and after-sales service, operates under a certified quality management system. This certification is required by most private hospital chains and is accepted internationally.
The CE Mark on SHIVcare sterilizers indicates conformity with the European Union's Medical Devices Regulation (MDR) requirements for steam sterilizers, including EN 285 (large steam sterilizers) and related harmonised standards. CE marking makes SHIVcare sterilizers eligible for export to EU member states, and is increasingly accepted by private Indian hospitals as an additional quality signal beyond BIS certification. The Declaration of Conformity (DoC) is available on request for international procurement.
Shiv Shakti Enterprise is a verified registered seller on the Government e-Marketplace (GeM), India's central government procurement platform. Government hospitals, ESIC facilities, CGHS-empanelled institutions, defence medical establishments, and central government health schemes can procure SHIVcare HPHV sterilizers directly through the GeM portal with full GST-compliant invoicing under HSN code 8419. Our team provides complete Tender Technical Bid documentation support at no additional cost.
IS 3829 P1 & P2 + GEM Registration + ISO 13485 — all three are typically required for government tenders.
IS 3829 P1 & P2 + ISO 13485 + IQ/OQ/PQ validation documentation — provided at commissioning.
IS 3829 P1 & P2 + ISO 13485:2016 + CE Marking — all available from SHIVcare on request.
CE Marking + ISO 13485 + Declaration of Conformity — enables export to EU, Southeast Asia, Africa, Middle East.
IS 3829 P2 + ISO 13485 + IQ/OQ/PQ validation for CDSCO and NABL-accredited laboratory audits.
IS 3829 P1 & P2 is sufficient for most dental and orthopaedic facility procurement requirements.