COVID19 Resource Center for Regulations and Test Standards

The following is a list of selected regulations, guidance notes and test standards relevant to products needed urgently for the national response to the COVID19 crisis.

Compiled and Edited by Navnath Kadam & Chetna Dharmavat. Last update: 27 June 2020

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FREELY AVAILABLE STANDARDS

BIS, Standards. Link
ISO Standards. Link
IEC Standards. Link
IEEE Standards. Link
ASTM Standards. Link
CLSI Standards. Link
CEN & CENELEC. Link
AAMI Standards. Link
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.
- 1. Face masks 2. Medical gloves 3. Protective clothing.

Hygiene Standards. Link
Personal Protective Equipment. Link
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

Offices or associates of Notified Bodies in India (See End of the Page)

NABL ACCREDITED LABORATORIES FOR TESTING

CLICK HERE FOR TEST PROTOCOL, STANDARDS & LABS

VENTILATORS:

(Continuous, Minimal Ventilatory Support, Facility Use)

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

CLINICAL ELECTRONIC THERMOMETER:

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 STERILIZATION – METHODS, TYPES& AGENTS

- Other Germicides Link NEW!
- Metals as Microbicides Link NEW!
- Ultraviolet Radiation (UV) Link NEW!
- Pasteurization Link NEW!
- Flushing- and Washer-Disinfectors Link NEW!
- Chemical Disinfectants
- Miscellaneous Inactivating Agents 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

IN-VITRO DIAGNOSTICS (IVDS):

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

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

PPEs: MEDICAL TEXTILES, DRAPES, GOWNS, MASKS, GLOVES:

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

GENERAL INFORMATION ON REGULATIONS:

India

What are the

India
What are the laws/rules that apply?

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

OFFICES OR ASSOCIATES OF NOTIFIED BODIES IN INDIA

Link to MDD Directive		Link to PPE Directive	Courtesy: Anil Jauhri, Ex CEO, NABCB
Offices or associates of Notified Bodies in India			(Ver. 01 as of 27 May 20)
Sr	Name	Contact	Notified Body	Areas for Which Notified
1	Aradhana Mishra	Email: amishra@mtic-group.in Phone: +91 99028 26219	MTIC InterCert	MDD/ MDR & PPE
2	Atul Bali	Email: atul.bali@ind.tuv.com Phone: +91 86575 53004	TuV Rheinland	MDD/ MDR
3	Hariharan Sundareswara Iyer	Email: Hariharan.Sundareswara.Iyer@dnv.com Phone: +91 94450 10251	DNV	MDD/ MDR
4	Lavanya Pavan	Email: Lavanya.pavan@ul.com Phone:+919663840174	UL	MDD/ MDR
5	Mahesh Gaur	Email: mgaur@tuv-nord.com Phone:+91 99251 00410	TUV NORD	MDD/ MDR
6	Parvinder Singh	Email: Parvinder.singh@intertek.com Phone: +91 99715 28800	Intertek	MDD/ MDR
7	Sarita Srivastava Aaranaya Management Services P Ltd	Email: sarita@aaranayacertification.com Phone: +91 98180 66855	Universal Certification & MNA Lab	PPE
8	Soumik Mondal	Email: Soumik.Mondal@sgs.com Phone: +91 99038 39874	SGS	MDD/ MDR & PPE

ISO CERTIFICATE VERIFICATION

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

RIFC Services: Get written regulatory roadmaps, standards interpretation, document preparation/ review support, clinical study design, and other such services. For more visit http://rifc.venturecenter.co.in/services/