Programme of work

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BUREAU OF INDIAN STANDARDS


Medical Equipment and Hospital Planning Department

Programme of Work




MHD14 : Hospital Planning


  • Scope : a) To prepare codes, guides and standards (physical, staff and equipment planning), quality management systems and operational systems for health care services; b) Standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems. This includes, for example, quality management, pre- and post-analytical procedures, analytical performance, laboratory safety, reference systems and quality assurance;
  • Liaison :
    ISO/TC 304 - Healthcare organization management - Participating (P)
    ISO/TC 210 - Quality management and corresponding general aspects for products with a health purpose including medical devices - Participating (P)
    ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems - Participating (P)
    ISO TC 210/WG 1 - Application of quality systems to medical devices
    ISO TC 210/WG 2 - General aspects stemming from the application of quality principles to medical devices
    ISO TC 210/WG 7 - Good engineering maintenance management
    ISO TC 212/WG 1 - Quality and competence in the medical laboratory
    ISO TC 212/WG 2 - Reference systems
    ISO TC 212/WG 5 - Laboratory biorisk management

Published Standards

SI. No.
IS No.
Title
Reaffirmation Details
No. of Amendments
Degree of Equivalence
1.
 IS 10905 (Part 1) : 1984
Reviewed In : 2018
Recommendations for basic requirements of general hospital buildings: Part 1 Administrative and hospital services department buildings
-
Indigenous
2.
 IS 10905 (Part 2) : 1984
Reviewed In : 2018
Recommendations for basic requirements of general hospital buildings: Part 2 medical services department buildings
-
Indigenous
3.
 IS 10905 (Part 3) : 1984
Reviewed In : 2018
Recommendations for basic requirements of general hospital buildings: Part 3 engineering services department buildings
-
Indigenous
4.
 IS 12377 : 2016
Classification and matrix for various categories of hospitals (First Revision)
-
Indigenous
5.
 IS 12433 (Part 1) : 1988
Reviewed In : 2018
Basic requirements for hospital planning: Part 1 up to 30 bedded hospital
2
Indigenous
6.
 IS 12433 (Part 2) : 2001
Reviewed In : 2018
Basic requirements for hospital planning: Part 2 up to 100 bedded hospital
-
Indigenous
7.
 IS/ISO 13485 : 2016
Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision )
-
Identical under single numbering
8.
 IS 13808 (Part 1) : 1993
Reviewed In : 2018
Quality management procedures for out - Patient department (OPD) and emergency services - Guidelines: Part 1 upto 30 bedded hospitals
1
Indigenous
9.
 IS 13808 (Part 2) : 1993
Reviewed In : 2018
Quality management procedures for diagnostic and blood transfusion services - Guidelines: Part 1 up to 30 - Bedded hospitals
1
Indigenous
10.
 IS 13808 (Part 3) : 1995
Reviewed In : 2016
Quality management for hospital services (Upto 30 - Bedded Hospitals) - Guidelines: Part 3 wards, nursing services and operation theatre
December, 2016
-
Indigenous
11.
 IS 13808 (Part 4) : 1996
Reviewed In : 2016
Quality management for hospital services (For 30 - Bedded Hospital) - Guidelines: Part 4 hospital support services
December, 2016
-
Indigenous
12.
 IS 13808 (Part 5) : 1996
Reviewed In : 2016
Quality management for hospital services (For 30 - Bedded Hospital) - Guidelines: Part 5 hospital equipment management
December, 2016
-
Indigenous
13.
 IS/ISO 14971 : 2019
ISO 14971:2019
Medical devices - Application of risk management to medical devices First Revision
-
Identical under single numbering
14.
 IS/ISO 15189 : 2022
ISO 15189 : 2022
Medical Laboratories Requirements for Quality and Competence Third Revision
-
Identical under single numbering
15.
 IS/ISO 15190 : 2003
ISO 15190 : 2003
Medical Laboratories - Requirements for Safety
-
Identical under single numbering
16.
 IS 15195 : 2002
Reviewed In : 2017
Performance guidelines for quality assurance in hospital services up to 30 - Bedded hospitals
October, 2017
-
Indigenous
17.
 IS/ISO 15195 : 2018
ISO 15195 : 2018
Laboratory Medicine - Requirements for the Competence of Calibration Laboratories Using Reference Measurement Procedures
-
Identical under single numbering
18.
 IS/ISO 15223-1 : 2016
ISO 15223-1 : 2016
Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied Part 1 General Requirements ( Second Revision )
-
-
Identical under single numbering
19.
 IS/ISO 15223-2 : 2010
ISO 15223-2 : 2010
Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied: Part 2 symbol development, selection and validation
-
Identical under single numbering
20.
 IS 15461 : 2004
Reviewed In : 2019
Performance guidelines for quality assurance in hospital services up to 100 - Bedded hospitals
July, 2019
-
Indigenous
21.
 IS 15551 : 2003
Reviewed In : 2019
Quality management systems - Guidelines for process improvements in health service organizations
December, 2019
-
Indigenous
22.
 IS 15784 : 2007
Reviewed In : 2017
Healthcare facilities - Particular requirements
September, 2017
-
Indigenous
23.
 IS 15902 : 2011
Reviewed In : 2020
Guidelines For Nursing Home
November, 2020
-
Indigenous
24.
 IS 15903 : 2010
Reviewed In : 2020
Guidelines For Maternity Nursing Home
November, 2020
-
Indigenous
25.
 IS 15904 : 2011
Reviewed In : 2020
Guidelines For Single Doctor Clinic--Including Dental Clinic
November, 2020
-
Indigenous
26.
 IS/ISO 16142-1 : 2016
ISO 16142-1 : 2016
Medical Devices - Recognized Essential Principles of Safety and Performance of Medical Devices Part 1 General Essential Principles and Additional Specific Essential Principles for all Non-IVD Medical Devices and Guidance on the Selection of Standards
-
Identical under single numbering
27.
 IS/ISO 16142-2 : 2017
ISO 16142-2 : 2017
Medical devices - Recognized essential principles of safety and performance of medical devices: Part 2 General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
-
Identical under single numbering
28.
 IS 17722 : 2021
ISO/TS 22583:2019
Guidance for supervisors and operators of point-of-care testing POCT devices
-
Identical under dual numbering
29.
 IS/ISO 17822-1 : 2014
ISO 17822-1 : 2014
In vitro diagnostic test systems - Qualitative nucleic acid - Based in vitro examination procedures for detection and identification of microbial pathogens: Part 1 general requirements, terms and definitions
-
Identical under single numbering
30.
 IS 17898 : 2023
ISO 15190:2020
Medical laboratories Requirements for safety (First Revision)
-
Identical under dual numbering
31.
 IS 17922 (Part 1) : 2023
IEC 62366-1: 2015 CSV
Medical Devices Part 1: Application of Usability Engineering
-
Identical under dual numbering
32.
 IS 17964 (Part 20) : 2023
ISO 80369-20: 2015
Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
-
Identical under dual numbering
33.
 IS 18105 (Part 1) : 2023
ISO 15223-1:2021
Medical devices Symbols to be used with information to be supplied by the manufacturer Part 1: General requirements
-
Identical under dual numbering
34.
 IS 18131 : 2023
ISO 17822:2020
In vitro diagnostic test systems Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens Laboratory quality practice guide (First Revision)
-
Identical under dual numbering
35.
 IS 18132 : 2023
ISO 22367 : 2020
Medical laboratories - Application of risk management
-
Identical under dual numbering
36.
 IS/ISO 18250-1 : 2018
ISO 18250-1:2018
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 1 General requirements and common test methods
-
Identical under single numbering
37.
 IS/ISO 18250-3 : 2018
ISO 18250-3:2018
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3 Enteral Applications
1
Identical under single numbering
38.
 IS/ISO 18250-6 : 2019
ISO 18250-6:2019
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 6 Neural Applications
-
Identical under single numbering
39.
 IS/ISO 18250-7 : 2018
ISO 18250-7:2018
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 7 Connectors for intravascular infusion
-
Identical under single numbering
40.
 IS/ISO 18250-8 : 2018
ISO 18250-8:2018
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 8 Citrate-based anticoagulant solution for apheresis applications
-
Identical under single numbering
41.
 IS 18325 : 2023
ISO/TS 20914:2019
Medical laboratories Practical guidance for the estimation of measurement uncertainty
-
Identical under dual numbering
42.
 IS 18374 : 2023
ISO 23162:2021
Basic semen examination Specification and test methods
-
Identical under dual numbering
43.
 IS 18376 : 2023
ISO/TR 20416: 2020
Medical devices Post-market surveillance for manufacturers
-
Identical under dual numbering
44.
 IS/ISO 20417 : 2021
ISO 20417:2021
Medical devices Information to be supplied by the manufacturer
-
Identical under single numbering
45.
 IS/ISO/TS 20658 : 2017
ISO/TS 20658 : 2017
Medical Laboratories - Requirements for Collection, Transport, Receipt, and Handling of Samples
-
Identical under single numbering
46.
 IS/ISO 20776-1 : 2019
ISO 20776-1 : 2019
Susceptibility Testing of Infectious Agents and Evaluation of Performance of Antimicrobial Susceptibility Test Devices Part 1 Broth Micro-Dilution Reference Method for Testing the in vitro Activity of Antimicrobial Agents Against Rapidly Growing Aerobic Bacteria Involved in Infectious Diseases
-
Identical under single numbering
47.
 IS/ISO 20776-2 : 2007
ISO 20776-2 : 2007
Clinical Laboratory Testing and In-vitro Diagnostic Test Systems - Susceptibility Testing of Infectious Agents and Evaluation of Performance of Antimicrobial Susceptibility Test Devices Part 2 Evaluation of Performance of Antimicrobial Susceptibility Test Devices
-
Identical under single numbering
48.
 IS/ISO/TS 22367 : 2008
ISO/TS 22367 : 2008
Medical Laboratories - Reduction of Error through Risk Management and Continual Improvement
-
Identical under single numbering
49.
 IS 23485 : 2019
Medical devices - Quality management system requirements and essential principles of safety and performance for medical devices
-
Indigenous
50.
 IS/ISO/TR 24971 : 2020
ISO/TR 24971:2020
Medical Devices Guidance on the Application of ISO 14971 (First Revision)
-
Identical under dual numbering
51.
 IS/ISO 35001 : 2019
ISO 35001:2019
Biorisk management for laboratories and other related organisations
-
Identical under single numbering
52.
 IS/ISO 62304 : 2015
ISO 62304 : 2015
Medical device software - Software life cycle processes
-
Identical under single numbering
53.
 IS/IEC/TR 62366-2 : 2016
IEC 62366-2 : 2016
Medical devices Part 2 Guidance on the Application of Usability Engineering to Medical Devices
-
Identical under single numbering
54.
 IS/ISO/TR 80002-2 : 2017
ISO/TR 80002-2 : 2017
Medical Device Software Part 2 Validation of Software for Medical Device Quality Systems
-
Identical under single numbering
55.
 IS/ISO 80369-1 : 2018
ISO 80369-1 : 2018
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 1 General Requirements
-
Identical under single numbering
56.
 IS/IEC 80369-5 : 2016
IEC 80369-5:2016
Small-bore connectors for liquids and gases in healthcare applications Part 5 Connectors for limb cuff inflation applications
-
Identical under single numbering
57.
 IS/IEC 80369-6 : 2016
ISO 80369-6:2016
Small bore connectors for liquids and gases in healthcare applications Part 6 Connectors for neuraxial applications
-
Identical under single numbering

Standards Under Develpoment

Projects Approved

SI. No.
Doc No
TITLE
No Records Found

Preliminary Draft Standards

SI. No.
Doc No
TITLE
No Records Found

Drafts Standards in WC Stage

SI. No.
Doc No
TITLE
No Records Found

Draft Standards Completed WC Stage

SI. No.
Doc No
TITLE
No Records Found

Finalized Draft Indian Standard

SI. No.
Doc No
TITLE
No Records Found

Finalized Draft Indian Standards under Print

SI. No.
Doc No
TITLE
1
MHD 14 (24687)

Revision of: IS/ISO/TS 20658:2017
Requirements for the collection and transport of samples for medical laboratory examinations First Revision
2
MHD 14 (24695)

Revision of: IS/ISO 20776:2007
Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices Part 2 Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution First Revision
3
MHD 14 (24698)
Medical device software Part 3 Process reference model of medical device software life cycle processes IEC 62304


Aspect Wise Report

 
 Product:   8
 Code of Practices :    25
 Methods of Test :   5
 Terminology :   1
 Dimensions :   0
 System Standard :   14
 Safety Standard :   2
 Others :    0
 Service Specification :    0
 Process Specification :    2
 Unclassified :    0
 


Annexure-I :List of Indian Standards Withdrawn/Superseded

SI. No.
IS No.
Title
1.
 IS 10578 : 1983
Reviewed In : 2006
Surgical Spring Trusses
2.
 IS 10764 : 1983
Boiling Pan Non-Pressure Type
3.
 IS 11882 : 1987
Frying Pan Tilting Type Electrically Operated
4.
 IS 11971 : 1987
Jacketed Cooking Vessel tilting Type electrically Operated
5.
 IS 15579 : 2005
Medical devices -Quality management systems-Requirements for regulatory purposes
6.
 IS 17723 : 2021
ISO 22870:2016
Point-of-care testing POCT Requirements for quality and competence
7.
 IS 3991 : 1993
Bowls Lotion
8.
 IS 3995 : 1980
Mugs
9.
 IS 3996 : 1982
Spittoons
10.
 IS/IEC 62366-1 : 2015
IEC 62366-1 : 2015 ‘
Medical Devices Part 1 Application of Usability Engineering to Medical Devices
11.
 IS 9310 : 1979
Water Purifier Potable
12.
 IS B9310 : 1979
Water Purifier Potable BI-LINGUAL


Annexure-II :List of Indian Product Standards

SI. No.
IS No. & Year
Title
1.
 IS/ISO 18250-1 : 2018
ISO 18250-1:2018
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 1 General requirements and common test methods
2.
 IS/ISO 18250-3 : 2018
ISO 18250-3:2018
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3 Enteral Applications
3.
 IS/ISO 18250-6 : 2019
ISO 18250-6:2019
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 6 Neural Applications
4.
 IS/ISO 18250-7 : 2018
ISO 18250-7:2018
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 7 Connectors for intravascular infusion
5.
 IS/ISO 18250-8 : 2018
ISO 18250-8:2018
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 8 Citrate-based anticoagulant solution for apheresis applications
6.
 IS/ISO 80369-1 : 2018
ISO 80369-1 : 2018
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 1 General Requirements
7.
 IS/IEC 80369-5 : 2016
IEC 80369-5:2016
Small-bore connectors for liquids and gases in healthcare applications Part 5 Connectors for limb cuff inflation applications
8.
 IS/IEC 80369-6 : 2016
ISO 80369-6:2016
Small bore connectors for liquids and gases in healthcare applications Part 6 Connectors for neuraxial applications