Unicare Medical Solutions

Compliance Guides for Operation Theatres and MGPS

Plain-language overviews of the standards and regulations commonly referenced in hospital infrastructure projects.

NABH Guidelines for Modular Operation Theatres – An Overview

A general overview of how NABH hospital accreditation relates to operation theatre planning: zoning, air quality, infection control and documentation.

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Medical Gas Pipeline System (MGPS) Standards – An Overview

An overview of the standards commonly referenced when designing a medical gas pipeline system in India, including ISO 7396-1, HTM 02-01 and NFPA 99.

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HTM 02-01 for Medical Gas Pipeline Systems – An Overview

What HTM 02-01 is, what it broadly covers for medical gas pipeline systems and why Indian hospital projects sometimes reference it.

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NFPA 99 Health Care Facilities Code – An Overview

A general overview of NFPA 99, the US Health Care Facilities Code, and the medical gas and vacuum topics it covers.

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ISO 13485 Quality Management for Medical Devices – An Overview

What ISO 13485 is, who it applies to and what hospitals can ask suppliers about quality management for medical devices.

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CDSCO and Medical Devices Rules 2017 – An Overview

A general overview of India's Medical Devices Rules, 2017, the role of CDSCO and the risk-based classification of medical devices.

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IEC 60601-2-41 for Surgical Lights – An Overview

An overview of IEC 60601-2-41, the particular standard for the safety and performance of surgical and diagnostic luminaires.

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This page is a general overview for planning purposes. It is not legal or regulatory advice. Always refer to the current official text of the standard or regulation and your hospital's accreditation consultant.

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