• BIS

• ISO 

• IEC 

• IEEE 

• ASTM

• CLSI

• CEN & CENELEC

• AAMI

• British Standard (BS). Scope and Performance Requirements

  • Hygiene Standards. Link --  1. Antiseptics 2. Chemical disinfectants 3. Bacterial 4. Fungal 5. Hand Methods – Bacteria 6. Hand methods – viral 7. Mycobacteria 8. Viral.

  • Personal Protective Equipment. Link  -- 1. Face masks 2. Medical gloves 3. Protective clothing.

  • Ventilators. Link 

  • Risk management and business continuity. Link  -  1. Continuity and Resilience 2. Risk Management 3. Community Resilience 4. Emergency Management 5. Continuity and Resilience

• Labs for Testing of PPE for medical use

• Labs for testing of Sanitizer – Efficacy

• Labs for testing of Gloves –Sterility

• Labs for testing of Mask – Bioburden, Sterility

• Labs for testing of Textiles (Gowns) – Water repellency/resistance

• Labs for testing of Medical devices – Biocompatibility

• Labs for testing of Endotoxin in surgical/medical items

• Labs for testing of Pyrogen in medical devices

• Labs for Calibration of Medical Equipment

• General medical equipment

• Patient monitoring equipment

• Cardiovascular pulmonary (air/ fluid pump) equipment

• Ultrasound equipment

• Defibrillator

• BP apparatus

• Ultrasound ECG machine 

• Pulse oximeter

• Hematology analyzer

• Flowmeter

• CPAP machine (neonate & adult)

• Autoclave

• Infant incubator

• Applied current/ energy equipment

• Applied EM radiation equipment

•  Selected test standards (India)

• IS/ISO 5367: 2000 Breathing tubes intended for use with anesthetic apparatus and ventilators. Link

• IS/ISO 10651: Part 3: 1997 Lung Ventilators for Medical Use Part 3 Particular Requirements for Emergency and Transport Ventilators. Link

• IS/ISO 10651: Part 4: 2002 Lung Ventilators for Medical Use — Particular Requirements for Basic Safety and Essential Performance Part 4 Particular Requirements for Operator-Powered Resuscitator. Link

• IS/ISO 10651: Part 5: 2006 Lung Ventilators for Medical Use. Particular Requirements for Basic Safety and Essential Performance Part 5 Gas-Powered Emergency Resuscitators. Link

• IS/ISO 10651: Part 6: 2004 Lung ventilators for medical use – Particular requirements for basic safety and essential performance: Part 6 home – Care ventilatory support devices. Link

• IS/ISO 80601: Part 2: Sec 12: 2011 Medical electrical equipment: Part 2 – 12 particular requirements for basic safety and essential performance of critical care ventilators. Link

• Selected test standards (International)

• ISO 10651-5 First Edition 2006-02-01: Lung Ventilators for Medical Use – Particular Requirements for Basic Safety and Essential Performance – Part 5: Gas-Powered Emergency Resuscitators.

• ISO 80601-2-12 First Edition 2011-04-15: Medical Electrical Equipment – Part 2-12: Particular Requirements for the Safety of Lung Ventilators – Critical Care Ventilators.

• See complete list: Download

• Selected Guidance notes (India)

• MoHFW: Guidelines on Clinical Management of COVID – 19. Download

• Selected Guidance notes (International)

• US FDA Enforcement Policy. Download

• White Paper from the American Association for Respiratory Care (AARC), Safe-Initiation-and-Management-of-Mechanical-Ventilation. Download

• US FDA Classification. Link.

• Ventilator Accessories and Therapeutic Devices Classification. Link

• FAQ on Anesthesia Machine Use, Protection, and Decontamination During The COVID-19 Pandemic. Link

• Other useful links

• TUV Rheinland, India. Free test services for Ventilator Systems according to IEC 60601-1, IEC 60601-1-2, and IEC 80601-2-12. Link

• COVID-19 Response: Freely Available ISO Standards. Link

• COVID-19 Response: Freely Available IEC standards. Link

• COVID-19 Response: Freely Available IEEE standards. Link

• COVID-19 Response: Freely Available ASTM standards. Link

COVID-19 Response: Freely Available CLSI standards. Link

• Selected test standards (India)

• IS 15113: 2002 Clinical electrical thermometers with maximum device – Specification. Link

• Selected test standards (International)

• ISO 80601-2-56:2017(en) Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. Link

• IEC 60601-1:2005+AMD1:2012 CSV Consolidated version. Medical electrical equipment — Part 1: General requirements for basic safety and essential performance. Link

• IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests. Link

• IEC 60601-1-6:2010+AMD1:2013 CSV Consolidated version Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability. Link

• ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths. Link

• ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. Link

• See complete list: Link

• Selected Guidance notes (India)

• US FDA Approval Guidance. Link

• Selected Guidance notes (International)

• US FDA Enforcement policy. Link

US FDA Classification. Link

• Selected test standards (India)

• IS 15113: 2002 Clinical electrical thermometers with maximum device – Specification. Link

• Selected test standards (International)

• ISO 80601-2-56:2017(en) Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. Link

• IEC 60601-1:2005+AMD1:2012 CSV Consolidated version. Medical electrical equipment — Part 1: General requirements for basic safety and essential performance. Link

• IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests. Link

• IEC 60601-1-6:2010+AMD1:2013 CSV Consolidated version Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability. Link

• ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Thermometer Probe Covers and Sheaths. Link

• ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. Link

• See complete list: Link

• Selected Guidance notes (India)

• US FDA Approval Guidance. Link

• Selected Guidance notes (International)

• US FDA Enforcement policy. Link

US FDA Classification. Link

• Disinfection and Cleaning Related Resources Link NEW!

  • • • Chemical Disinfectants

        • Alcohol Link NEW!

        • Chlorine and Chlorine Compounds Link NEW!

        • Formaldehyde Link NEW!

        • Glutaraldehyde Link NEW!

        • Hydrogen Peroxide Link NEW!

        • Iodophors Link NEW!

        • Ortho-phthalaldehyde (OPA) Link NEW!

        • Peracetic Acid Link NEW!

        • Peracetic Acid and Hydrogen Peroxide Link NEW!

        • Phenolics Link NEW!

        • Quaternary Ammonium Compounds Link NEW!

      • Miscellaneous Inactivating Agents Link NEW!

        • Other Germicides Link NEW!

        • Metals as Microbicides Link NEW!

        • Ultraviolet Radiation (UV) Link NEW!

        • Pasteurization Link NEW!

        • Flushing- and Washer-Disinfectors Link NEW!

    • Sterilization Related Resources Link NEW!

      • Steam Sterilization Link NEW!

      • Flash Sterilization Link NEW!

      • Low-Temperature Sterilization Technologies Link NEW!

      • Ethylene Oxide “Gas” Sterilization Link NEW!

      • Hydrogen Peroxide Gas Plasma Link NEW!

      • Peracetic Acid Sterilization Link NEW!

      • Ionizing Radiation Link NEW!

      • Dry-Heat Sterilizers Link NEW!

      • Liquid Chemicals Link NEW!

      • Performic Acid Link NEW!

      • Filtration Link NEW!

      • Microwave Link NEW!

      • Glass Bead “Sterilizer” Link NEW!

      • Vaporized Hydrogen Peroxide (VHP) Link NEW!

      • Ozone Link NEW!

      • Formaldehyde Steam Link NEW!

      • Gaseous chlorine dioxide Link NEW!

      • Vaporized Peracetic Acid Link NEW!

      • Infrared radiation Link NEW!

    • Selected test standards (India)

      • IS 1061: 2017 Disinfectant Fluids, Phenolic Type – Specification (Fifth Revision). Link

      • Test Methods and standards: Drugs and Cosmetics Act ,1940 and Rules, 1945 (SCHEDULE O. Page No.: 529). Link

      • IS 11479 : Part 1 : 2001 Antibacterial toilet soap – Specification: Part 1 solid cake. Link

      • IS 11479 : Part 2 : 2001 Antibacterial toilet soap – Specification: Part 2 liquid. Link

    • Liquids:

    • Soaps:

    • Selected test standards (International)

    • ASTM E2755 – 15 Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of Adults. Link

    • ASTM E1174 – 13 Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations. Link

    • ASTM E2276 – 10(2019) Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults. Link

    • Selected Guidance notes (India)

    • BUREAU OF INDIAN STANDARDS (BIS) Product Manual. Link

    • Selected Guidance notes (International)

    • WHO: Guide to Local Production: WHO-recommended Handrub Formulations. Link

    • CDC: Guideline for Disinfection and Sterilization in Healthcare Facilities Link

    • Other useful links

    • Basic experimental design of current methods to test the efficacy of hand hygiene and surgical hand preparation formulations. Link

• Selected test standards (India)
• Selected test standards (International)
• Selected Guidance notes (India)
  • Centres for Validation and Batch Testing of COVID-19 Diagnostic Kits. Link NEW!

  • ICMR Kit Validation Portal. Link NEW!

  • ICMR-DCGI Guidelines for Validation and Batch Testing. Link NEW!

• Selected Guidance notes (International)

  • Technical guidance series for WHO prequalification of IVDs. Link

    • • TGS 1 Standards applicable to the WHO prequalification of in vitro diagnostics

      • TGS 2: Establishing stability of an in vitro diagnostic for WHO prequalification

      • Annex to TGS 2: Establishing component stability for in vitro diagnostic medical devices

      • TGS 3 Principles of performance studies of an in vitro diagnostic for WHO prequalification

      • TGS 4 Guidance on test method validation for an in vitro diagnostic medical devices

      • TGS 5 Designing Instructions for use for in vitro diagnostic medical devices

      • TGS 6 Panels for quality assurance and quality control of in vitro diagnostic medical devices

      • TGS 7 Risk management for manufacturers of in vitro diagnostic medical devices

      • TGS 8 Quality control for in vitro diagnostic medical devices for WHO prequalification.

      • Instructions for Submission Requirements: In vitro diagnostics (IVDs) Detecting SARS-CoV-2 Nucleic Acid. Link

     

• Other useful links

• Update on COVID-19 in vitro diagnostics listed by National Regulatory Authorities in IMDRF jurisdictions. Link

• COVID-19 Approved IVDs listing in IMDRF jurisdiction (9 Countries database). Link

• Selected test standards (India)

• N95 Respirators/ Masks Related Resources. Link NEW!

• IS 15354: Part 1: 2018 / ISO 11193-1: 2008, Single-use Medical Examination Gloves Part 1 Specification for Gloves made from rubber latex or rubber solution (First Revision) Link

• IS 15354: Part 2: 2018 – Single-Use Medical Examination Gloves Part 2 Specification for Gloves Made from Poly (Vinyl Chloride) (First Revision) Link

• IS 17334: Medical Textiles- Surgical Gowns and Surgical Drapes Link

• IS 9473: Respiratory protective devices – Filtering half masks to protect against particles Link

• IS 16288 : 2014 Medical textiles – Method for evaluation of the bacterial filtration efficiency of surgical face masks. Link

• IS 16289: Medical Textiles – Surgical Face masks Link

• IS 14166 : 1994 Respiratory protective devices full – Face masks – Specification. Link

• IS 6190 : 1971 Specification for anaesthetic face masks. Link

• Selected test standards (International)

• ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risk Link

• ISO 13688:2013, Protective clothing – General requirements Link

• ISO 17510:2015, Medical devices — Sleep apnoea breathing therapy — Masks and application accessories Link

• Testing Labs (India)

• NABL ACCREDITED LABORATORIES FOR TESTING OF PPE FOR MEDICAL USE Link

• Selected Guidance notes (International)

• A scientific consortium for data-driven study of N95 filtering facepiece respirator decontamination. Link

• Other useful links

• ASTM F1494 – 14 – Standard Terminology Relating to Protective Clothing

• ASTM F2101 – 14 – Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

• ASTM F2299 / F2299M – 03(2017) – Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

• ASTM F1862 / F1862M – 17 – Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) 

• EU legislation and PPE Link

• India

• What are the laws/rules that apply?

• Medical Device Rules 2017. Download

• Drugs and Cosmetics Act,1940 and Rules, 1945. Download

• Recent notifications/ relaxations/ instructions  in context of COVID19

• Filter Half Masks to Protect against particles of Class FFP2 as per IS 9473:2002. Link

• Surgical Face Masks as per IS 16289:2014 Link

• Eye Protectors as per IS 5983:1980 Link

• 08 Apr 2020. PCR Kits approved for testing of Covid-19. Download

• 08 Apr 2020. Rapid / CLIA / ELISA Kits approved for testing of Covid-19. Download

• 07 Apr 2020. Granting permission to manufacturers of industrial oxygen to manufacture oxygen for medical use in the light of Covid-19.  Download

• 24 Mar 2020. Examples of hand sanitisers/surgical hand disinfectant approved by CDSCO including the WHO formula for reference purposes.. Download

• 23 Mar 2020 Notice regarding COVID-19 outbreak.. Download

• 20 Mar 2020. RCGM: OM on Rapid Response Regulatory Framework for COVID-19. Download

• 19 Mar 2020. Notice regarding Regulatory pathway for R&D of Drug or vaccine for COVID-19. Download

• 19 Mar 2020. Notice regarding Regulatory pathway for R&D of IVD kit for diagnosis of COVID-19. Download

• 18 Mar 2020. Monitoring of the quality standards of hand sanitizer as per Drugs and Cosmetics Act, 1940 and Rules made thereunder and expediting the licensing of manufacturers of such products. Download

• Who to contact?

• Approval of new drugs, Medical Devices, Equipment and clinical trials.

• Dr. V. G. Somani. DCGI, CDSCO. 91-11-23236965 dci@nic.in.

• Application to be submitted at –

• Drugs Controller Med Device Division: dcimd-cdsco@nic.in

• CDSCO Med Devices Division: cdscoonlinemd@gmail.com

• For SUGAM Portal Errors CDACcdscoonline-noida@cdac.in

• CDSCO West Zone: cdscowz16@gmail.com

• For Startups: startupinnov@cdsco.nic.in

• International

• What are the rules that apply?

• CDC: Chemical Disinfectants. Link

• Recent notifications/ relaxations/ instructions  in context of COVID19

• US FDA Emergency Use Authorization. Link

• Australia TGA Legal supply of COVID-19 test kits. Link

• Singapore HSA’s Updates and Advisories on COVID-19. Link

• Other important links

• List of approved health tech products. Link

• Guidelines and Approval related information. Link

• Resources for Healthcare workers

• Document For Verifying Authenticity of PPE Certificates Link

Checking the validity of ISO 9001 Quality Management Systems Certificates issued to you. Link

•  

• Example of ISO 9001 Authentic Certificate. Link

• Example of ISO 9001 Unauthentic Certificate. Link