Programme of work


BUREAU OF INDIAN STANDARDS


Medical Equipment and Hospital Planning Department

Programme of Work




MHD12 : Hospital Equipment and Surgical Disposable Products


  • Scope : To formulate Indian Standards for: i) Hospital equipment used in OPD wards and operation theaters such as Sterilizers, Incubators, hospital furniture, and operation tables etc. ii) Surgical disposable products like Transfusion, infusion and injection equipment etc., and devices for administration of medical product and intravascular catheters
  • Liaison :
    ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use - Participating (P)
    ISO/TC 84 - Devices for administration of medicinal products and catheters - Participating (P)
    ISO/TC 198 - Sterilization of health care products - Participating (P)
    ISO TC 198/WG 1 - Industrial ethylene oxide sterilization
    ISO TC 198/WG 12 - Information for reprocessing of resterilizable devices
    ISO TC 198/WG 13 - Washer-disinfectors
    ISO TC 198/WG 2 - Radiation sterilization
    ISO TC 198/WG 3 - Moist heat sterilization
    ISO TC 198/WG 4 - Biological indicators
    ISO TC 198/WG 5 - Terminology
    ISO TC 198/WG 6 - Chemical indicators
    ISO TC 198/WG 7 - Packaging
    ISO TC 198/WG 8 - Microbiological methods
    ISO TC 198/WG 9 - Aseptic processing
    ISO TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment
    ISO TC 76/WG 2 - Rigid container systems and related accessories for parenterals and injectables
    ISO TC 76/WG 4 - Elastomeric parts and components and related secondary packaging components
    ISO TC 84/WG 10 - Needles
    ISO TC 84/WG 11 - Syringes
    ISO TC 84/WG 16 - Drug delivery system requirements for paediatrics and other demographics
    ISO TC 84/WG 3 - Needle-based injection systems - Injector, container and pen needle
    ISO TC 84/WG 8 - Sharps containers
    ISO TC 84/WG 9 - Catheters
    ISO TC 84/WG 17 - Specification and demonstration of reliability of single-use drug delivery systems
    IEC PC 130 - Cold Storage Equipment for Medical Use - Participating (P)

Published Standards

SI. No.
IS No.
Title
Reaffirmation Details
No. of Amendments
Degree of Equivalence
1.
IS 10258 (Part 1):2022
7886-1:2017
Sterile hypodermic syringes for single use Part 1: Syringes for manual use Third Revision
-
Identical under dual numbering
2.
IS 10258 (Part 2):2024
ISO 7886-2:2020
Sterile hypodermic syringes for single use Part 2 Syringes for use with power-driven syringe pumps
-
Identical under dual numbering
3.
IS 10258 (Part 3):2021
ISO 7886-3:2020
Sterile hypodermic syringes for single use Part 3 Auto-disabled syringes for fixed-dose immunization First Revision
-
Identical under dual numbering
4.
IS 10258 (Part 4):2024
ISO 7886-4:2018
Sterile Hypodermic Syringes for Single Use Part 4 Syringes with Re-use Prevention Feature
-
Identical under dual numbering
5.
IS/ISO 10555-3:2013
ISO 10555-3 : 2013
Reviewed In : 2025
Intravascular catheters - Sterile and single - Use catheters: Part 3 central venous catheters (First Revision)
August, 2025
-
Identical under single numbering
6.
IS/ISO 10555-5:2013

Reviewed In : 2025
Intravascular catheters - Sterile and single - Use catheters: Part 5 over - Needle peripheral catheters (First Revision)
August, 2025
-
Identical under single numbering
7.
IS 10654:2018
ISO 7864 : 2016
Reviewed In : 2025
Sterile hypodermic needles for single use - Requirements and test methods (Fourth Revision)
July, 2025
-
Identical under dual numbering
8.
IS 11040 (Part 1):2015
ISO 11040-1 : 2015
Prefilled syringes Part 1 : Glass cylinders for dental local anaesthetic cartridges
-
Identical under single numbering
9.
IS/ISO 11040-2:2011
ISO 11040-2:2011
Prefilled syringes Part 2 Plunger stoppers for dental local anaesthetic cartridges
-
Identical under single numbering
10.
IS/ISO 11040-3:2012
ISO 11040-3:2012
Prefilled syringes Part 3 Seals for dental local anaesthetic cartridges
-
Identical under single numbering
11.
IS/ISO 11040-4:2015
ISO 11040-4 : 2015
Reviewed In : 2025
Prefilled syringes Part 4 Glass barrels for injectables and sterilized subassembled syringes ready for filling
August, 2025
1
Identical under single numbering
12.
IS/ISO 11040-5:2012
ISO 11040-5:2012
Prefilled syringes Part 5 Plunger stoppers for injectables
-
Identical under single numbering
13.
IS 11043:1984
Reviewed In : 2025
Specification for needle, epidural
March, 2025
-
Indigenous
14.
IS/ISO 11135:2014
ISO 11135 : 2014
Reviewed In : 2025
Sterilization of health - Care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
August, 2025
1
Identical under single numbering
15.
IS/ISO 11137-1:2006
ISO 11137-1 : 2006
Reviewed In : 2025
Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices
August, 2025
1
Identical under dual numbering
16.
IS/ISO 11137-2:2013
ISO 11137-2 : 2013
Reviewed In : 2025
Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose
August, 2025
1
Identical under dual numbering
17.
IS/ISO 11137-3:2017
ISO 11137-3 : 2017
Sterilization of Health Care Products ― Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control
-
Identical under single numbering
18.
IS/ISO 11138-1:2017
ISO 11138-1 : 2017
Reviewed In : 2025
Sterilization of Health Care Products ― Biological Indicators Part 1 General Requirements
August, 2025
-
Identical under single numbering
19.
IS/ISO 11138-2:2017
ISO 11138-2 : 2017
Reviewed In : 2025
Sterilization of Health Care Products ― Biological Indicators Part 2 Biological Indicators for Ethylene Oxide Sterilization Processes
August, 2025
-
Identical under single numbering
20.
IS/ISO 11138-3:2017
ISO 11138-3 : 2017
Reviewed In : 2025
Sterilization of Healthcare Products ― Biological Indicators Part 3 Biological Indicators for Moist Heat Sterilization Processes
August, 2025
-
Identical under single numbering
21.
IS/ISO 11138-4:2017
ISO 11138-4 : 2017
Reviewed In : 2025
Sterilization of Health Care Products ― Biological Indicators Part 4 Biological Indicators for Dry Heat Sterilization Processes
August, 2025
-
Identical under single numbering
22.
IS/ISO 11138-5:2017
ISO 11138-5 : 2017
Sterilization of Health Care Products ― Biological Indicators Part 5 Biological Indicators for Low-Temperature Steam and Formaldehyde Sterilization Processes
-
Identical under single numbering
23.
IS/ISO 11140-3:2007
ISO 11140-3 : 2007
Reviewed In : 2025
Sterilization of health care products - Chemical indicators: Part 3 class 2 indicator systems for use in the bowie and dick - Type steam penetration test
August, 2025
-
Identical under single numbering
24.
IS/ISO 11140-4:2007
ISO 11140-4 : 2007
Reviewed In : 2025
Sterilization of health care products - Chemical indicators: Part 4 class 2 indicators as an alternative to the bowie and dick - Type test for detection of steam penetration
August, 2025
-
Identical under single numbering
25.
IS/ISO 11140-5:2007
ISO 11140-5 : 2007
Reviewed In : 2025
Sterilization of health care products - Chemical indicators: Part 5 class 2 indicators for bowie and dick - Type air removal tests
August, 2025
-
Identical under single numbering
26.
IS/ISO 1135-3:2016
ISO 1135-3:2016
Transfusion equipment for medical use Part 3 Blood-taking sets for single use
-
Identical under single numbering
27.
IS/ISO 1135-4:2015
ISO 1135-4 : 2015
Transfusion Equipment for Medical Use Part 4 Transfusion Sets for Single use, Gravity Feed
-
Identical under single numbering
28.
IS/ISO 11418-1:2016
ISO 11418-1 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 1 Drop-Dispensing Glass
-
Identical under single numbering
29.
IS/ISO 11418-2:2016
ISO 11418-2 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 2 Screw-Neck Glass Bottles for Syrups
-
Identical under single numbering
30.
IS/ISO 11418-3:2016
ISO 11418-3 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 3 Screw-Neck Glass Bottles ( Veral ) for Solid and Liquid Dosage Forms
-
Identical under single numbering
31.
IS/ISO 11418-5:2015
ISO 11418-5 : 2015
Containers and Accessories for Pharmaceutical Preparations Part 5 Dropper Assemblies
-
Identical under single numbering
32.
IS/ISO 11418-7:2016
ISO 11418-7 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 7 Screw-Neck Vials Made of Glass Tubing for Liquid Dosage Forms
-
Identical under single numbering
33.
IS/ISO 11607:2019
ISO 11607-1:2019
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision
1
Identical under single numbering
34.
IS/ISO 11607:2019
ISO 11607-2:2019
Reviewed In : 2025
Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision)
August, 2025
-
Identical under single numbering
35.
IS/ISO 11737-1:2018
ISO 11737-1:2018
Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products
1
Identical under single numbering
36.
IS/ISO 11737-2:2019
ISO 11737-2:2019
Sterilization of health care products Microbiological methods Part 2 Tests of sterility performed in the definition validation and maintenance of a sterilization process
-
Identical under single numbering
37.
IS 12173:1987
Reviewed In : 2025
Specification for cervical halter
January, 2025
-
Indigenous
38.
IS 12227:2020
ISO 8537 : 2016
Reviewed In : 2025
Sterile Single-Use Syringes, With or Without Needle, for Insulin ( Second Revision )
January, 2025
-
Identical under dual numbering
39.
IS 12430:1987
Reviewed In : 2025
Safety code for installation, servicing maintenanceand of sterilizers
January, 2025
-
Indigenous
40.
IS/ISO 13408-1:2008
ISO 13408-1:2008
Aseptic processing of health care products Part 1 General requirements
-
Identical under single numbering
41.
IS/ISO 13408-2:2018
ISO 13408-2:2018
Reviewed In : 2025
Aseptic processing of health care products Part 2 Sterilizing filtration
August, 2025
-
Identical under single numbering
42.
IS 13422:2024
ISO 10282:2023
Single-use Sterile Rubber Surgical Gloves � Specification (First Revision)
-
Identical under dual numbering
43.
IS/ISO 13926-1:2018
ISO 13926-1:2018
Pen systems Part 1 Glass cylinders for pen-injectors for medical use
-
Identical under single numbering
44.
IS/ISO 13926-2:2017
ISO 13926-2:2017
Pen systems Part 2 Plunger stoppers for pen-injectors for medical use
-
Identical under single numbering
45.
IS B14316:1995
Reviewed In : 2025
Swabs, Small, in Bag of 50 (Bi-lingual)
July, 2025
-
46.
IS/ISO 14937:2009
ISO 14937:2009
Reviewed In : 2025
Sterilization of health care products General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices
August, 2025
-
Identical under single numbering
47.
IS 15113:2002
Reviewed In : 2025
Clinical electrical thermometers with maximum device - Specification
July, 2025
1
Indigenous
48.
IS 15354 (Part 1):2023
ISO 11193-1:2020
Single-use medical examination gloves Part 1 Specification for gloves made from rubber latex or rubber solution Second Revision
-
Identical under dual numbering
49.
IS/ISO 15378:2017
IS/ISO 15378 : 2017
Primary Packaging Materials for Medicinal Products — Particular Requirements for the Application of ISO 9001 : 2015, with Reference to Good Manufacturing Practice ( GMP )
-
Identical under single numbering
50.
IS 15537:2021
ISO 9187-1:2018
Injection equipment for medical use Part 1 Ampoules for injectables First Revision
-
Identical under dual numbering
51.
IS 15537 (Part 2):2023
ISO 9187-2:2010
Injection equipment for medical use Part 2: One-point-cut OPC ampoules
-
Identical under dual numbering
52.
IS/ISO 15883-1:2006
ISO 15883-1 : 2006
Reviewed In : 2025
Washer - Disinfectors: Part 1 general requirements, terms and definitions and tests
August, 2025
-
Identical under dual numbering
53.
IS/ISO 15883-2:2006
ISO 15883-2 : 2006
Reviewed In : 2025
Washer - Disinfectors: Part 2 requirements and tests for washer - Disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc
August, 2025
-
Identical under single numbering
54.
IS/ISO 15883-3:2006
ISO 15883-3 : 2006
Reviewed In : 2025
Washer - Disinfectors: Part 3 requirements and tests for washer - Disinfectors employing thermal disinfection for human waste containers
August, 2025
-
Identical under dual numbering
55.
IS/ISO 15883-6:2011
ISO 15883-6 : 2011
Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
-
Identical under dual numbering
56.
IS 16004:2024
ISO 6009:2016
Hypodermic Needles for Single Use � Colour Coding for Identification (First Revision)
-
Identical under dual numbering
57.
IS 16097:2013
Reviewed In : 2025
Sterile single use scalp vein (Winged Needle) infusion set
January, 2025
-
Indigenous
58.
IS 17547:2021
Specification for Vaccine Freezer or Combined Vaccine Freezer and Water-Pack Freezer: Compression Cycle, General Requirements and Testing Methods
-
Indigenous
59.
IS 17588:2021
Specification for Cold Box — General requirements and Test methods
-
Modified/Technically Equivalent
60.
IS 17589:2021
Specification for Water Packs for use as ice-packs, cool-packs and warm-packs, Requirements and Test methods
-
Indigenous
61.
IS 17964 (Part 7):2025
ISO 80369-7:2021
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 7 Connectors for Intravascular or Hypodermic Applications
-
Identical under dual numbering
62.
IS 18240 (Part 89):2023
ISO 11139:2018
Sterilization of health care products Vocabulary of terms used in sterilization and related equipment and process standards
-
Identical under dual numbering
63.
IS 18243:2023
ISO/TS 19930:2017
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 106
-
Identical under dual numbering
64.
IS 18244:2023
ISO 21387:2020
Sterilization of medical devices Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
-
Identical under dual numbering
65.
IS 18245:2023
ISO/TS 16775:2021
Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607- 2
-
Identical under dual numbering
66.
IS 18287:2023
ISO/TS 22421
Sterilization of health care products Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
-
Identical under dual numbering
67.
IS 18288:2023
ISO 20696:2018
Sterile urethral catheters for single use
-
Identical under dual numbering
68.
IS 18292 (Part 1):2024
ISO 10555-1:2023
Intravascular Catheters � Sterile and Single-Use Catheters Part 1 General Requirements
-
Identical under dual numbering
69.
IS 18292 (Part 4):2024
ISO 10555-4:2023
Intravascular Catheters � Sterile and Single-Use Catheters Part 4 Balloon Dilatation Catheters (First Revision)
-
Identical under dual numbering
70.
IS 18292 (Part 6):2023
ISO 10555-6:2015
Intravascular catheters Sterile and single-use catheters Part 6: Subcutaneous implanted ports
-
Identical under dual numbering
71.
IS 18292 (Part 7):2024
ISO 10555-7:2023
Intravascular Catheters � Sterile and Single-Use Catheters Part 7 Peripherally Inserted Central Catheters
-
Identical under dual numbering
72.
IS 18293 (Part 3):2023
ISO 13926-3:2019
Pen systems Part 3 Seals for pen-injectors for medical use
-
Identical under dual numbering
73.
IS 18294 (Part 4):2023
ISO/TS11137-4:2020
Sterilization of health care products Radiation Part 4: Guidance on process control
-
Identical under dual numbering
74.
IS 18319:2024
ISO 17665 : 2024
Sterilization of Health Care Products - Moist Heat - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices (First Revision)
-
Identical under dual numbering
75.
IS 18344 (Part 4):2023
ISO 15883-4:2018
Washer-disinfectors Part 4 Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
-
Identical under single numbering
76.
IS 18446 (Part 6):2024
ISO 11140-6:2022
Sterilization of Health Care Products � Chemical Indicators Part 6 Type 2 Indicators and Process Challenge Devices for Use in Performance Testing of Small Steam Sterilizers
-
Identical under dual numbering
77.
IS 18451:2023
ISO 20697:2018
Sterile drainage catheters and accessory devices for single use
-
Identical under dual numbering
78.
IS 18446 (Part 1):2023
ISO 11140-1:2014
Sterilization of health care products Chemical indicators Part 1: General requirements
-
Identical under dual numbering
79.
IS 18468 (Part 5):2024
ISO 15883-5:2021
Washer-disinfectors Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
-
Identical under dual numbering
80.
IS 18469 (Part 7):2023
ISO 11138-7:2019
Sterilization of health care products Biological indicators Part 7: Guidance for the selection use and interpretation of results
-
Identical under dual numbering
81.
IS 18469 (Part 8):2023
ISO 11138-8:2021
Sterilization of health care products Biological indicators Part 8: Method for validation of a reduced incubation time for a biological indicator
-
Identical under dual numbering
82.
IS 18474 (Part 5):2024
ISO 1135-5:2015
Transfusion equipment for medical use Part 5 Transfusion sets for single use with pressure infusion apparatus
-
Identical under dual numbering
83.
IS 18478:2024
ISO 20698:2018
Catheter systems for neuraxial application Sterile and single-use catheters and accessories
-
Identical under dual numbering
84.
IS 18529:2024
ISO 11070:2014
Sterile single-use intravascular introducers, dilators and guidewire
-
Identical under dual numbering
85.
IS 18618:2024
ISO/TS 5111:2022
Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products
-
Identical under dual numbering
86.
IS 18723:2024
ISO 6717:2021
In vitro diagnostic medical devices � Single-use containers for the collection of specimens from humans other than blood
-
Identical under dual numbering
87.
IS 18730:2024
ISO 14160:2020
Sterilization of health care products � Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives � Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
-
Identical under dual numbering
88.
IS 18735:2024
ISO 15747:2018
Plastic Containers for Intravenous Injections
-
Identical under dual numbering
89.
IS 18735 (Part 1):2023

Medical Suction Equipment Part 1 Electrically Powered Suction Equipment
-
90.
IS 18742 (Part 1):2024
ISO 17664-1:2021
Processing of health care products � Information to be provided by the medical device manufacturer for the processing of medical devices Part 1 Critical and semi-critical medical devices
-
Identical under dual numbering
91.
IS 18742 (Part 2):2024
ISO 17664-2:2021
Processing of health care products � Information to be provided by the medical device manufacturer for the processing of medical devices Part 2 Non-critical medical devices
-
Identical under dual numbering
92.
IS 18744:2024
ISO 20069:2019
Guidance for assessment and evaluation of changes to drug delivery systems
-
Identical under dual numbering
93.
IS 18855:2024
ISO/TS 23128:2019
Medical Devices � Transfusion Set and Blood Bag Compatibility Test Method
-
Identical under dual numbering
94.
IS 18863 (Part 3):2024
ISO 11737-3:2023
Sterilization of Health Care Products � Microbiological Methods Part 3 Bacterial Endotoxin Testing
-
Identical under dual numbering
95.
IS 18866:2024
ISO 9626:2016
Stainless Steel Needle Tubing for the Manufacture of Medical Devices � Requirements and Test Methods
-
Identical under dual numbering
96.
IS 18871:2024
ISO 28620:2020
Medical Devices � Non-Electrically Driven Portable Infusion Devices
-
Identical under dual numbering
97.
IS 18872:2024
ISO 21881:2019
Sterile Packaged Ready for Filling Glass Cartridges
-
Identical under dual numbering
98.
IS 18879 (Part 2):2024
ISO 8536-2:2023
Infusion Equipment for Medical Use Part 2 Closures for Infusion Bottles
-
Identical under dual numbering
99.
IS 18879 (Part 3):2024
ISO 8536-3:2009+Amd1:2022
Infusion Equipment for Medical Use Part 3 Aluminium Caps for Infusion Bottles
-
Identical under dual numbering
100.
IS 18879 (Part 5):2024
ISO 8536-5:2004
Infusion Equipment for Medical Use Part 5 Burette Infusion Sets for Single Use, Gravity Feed
-
Identical under dual numbering
101.
IS 18879 (Part 6):2024
ISO 8536-6:2016
Infusion Equipment for Medical Use Part 6 Freeze Drying Closures for Infusion Bottles
-
Identical under dual numbering
102.
IS 18879 (Part 7):2024
ISO 8536-7:2009
Infusion Equipment for Medical Use Part 7 Caps Made of Aluminium-Plastics Combinations for Infusion Bottles
-
Identical under dual numbering
103.
IS 18879 (Part 8):2024
ISO 8536-8:2015
Infusion equipment for medical use Part 8 Infusion sets for single use with pressure infusion apparatus
-
Identical under dual numbering
104.
IS 18879 (Part 9):2024
ISO 8536-9:2015
Infusion Equipment for Medical Use Part 9 Fluid Lines for Single Use with Pressure Infusion Equipment
-
Identical under dual numbering
105.
IS 18879 (Part 10):2024
ISO 8536-10:2015
Infusion Equipment for Medical Use Part 10 Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment
-
Identical under dual numbering
106.
IS 18879 (Part 11):2024
ISO 8536-11:2015
Infusion Equipment for Medical Use Part 11 Infusion Filters for Single Use with Pressure Infusion Equipment
-
Identical under dual numbering
107.
IS 18879 (Part 12):2024
ISO 8536-12:2021
Infusion Equipment for Medical Use Part 12 Check Valves for Single Use
-
Identical under dual numbering
108.
IS 18879 (Part 13):2024
ISO 8536-13:2016
Infusion Equipment for Medical Use Part 13 Graduated Flow Regulators for Single Use with Fluid Contact
-
Identical under dual numbering
109.
IS 18879 (Part 14):2024
ISO 8536-14:2016
Infusion Equipment for Medical Use Part 14 Clamps and Flow Regulators for Transfusion and Infusion Equipment without Fluid Contact
-
Identical under dual numbering
110.
IS 18879 (Part 15):2024
ISO 8536-15:2022+Amd1:2023
Infusion Equipment for Medical Use Part 15 Light-Protective Infusion Sets for Single Use
-
Identical under dual numbering
111.
IS 18880:2024
ISO 13004:2022
Sterilization of Health Care Products � Radiation � Substantiation of Selected Sterilization Dose: Method VDmaxSD
-
Identical under dual numbering
112.
IS 18881 (Part 1):2025
ISO 13408-1:2023
Aseptic Processing of Health Care Products Part 1 General Requirements
-
Identical under dual numbering
113.
IS 18881 (Part 3):2024
ISO 13408-3:2006
Aseptic Processing of Health Care Products Part 3 Lyophilization
-
Identical under dual numbering
114.
IS 18881 (Part 4):2024
ISO 13408-4:2005
Aseptic Processing of Health Care Products Part 4 Clean-in-Place Technologies
-
Identical under dual numbering
115.
IS 18881 (Part 5):2024
ISO 13408-5:2006
Aseptic Processing of Health Care Products Part 5 Sterilization in Place
-
Identical under dual numbering
116.
IS 18881 (Part 6):2024
ISO 13408-6:2021
Aseptic Processing of Health Care Products Part 6 Isolator Systems
-
Identical under dual numbering
117.
IS 18881 (Part 7):2024
ISO 13408-7:2012
Aseptic Processing of Health Care Products Part 7 Alternative Processes for Medical Devices and Combination Products
-
Identical under dual numbering
118.
IS 18980:2025
Blood Donor Couch
-
Indigenous
119.
IS 18981:2025
Dialysis Chair
-
Indigenous
120.
IS 19099:2025
Vaccine Carriers � General Requirements and Test Methods
-
Indigenous
121.
IS 19106:2025
Refrigerator or Combined Refrigerator and Water-Pack Freezer Intermittent Mains Powered � Compression Cycle � General Requirements and Test Methods
-
Indigenous
122.
IS 19282 (Part 1):2025
ISO 11608-1:2022
Needle-Based Injection Systems for Medical Use � Requirements and Test Methods Part 1 Needle-Based Injection Systems
-
Identical under dual numbering
123.
IS 19282 (Part 2):2025
ISO 11608-2:2022
Needle-Based Injection Systems for Medical Use � Requirements and Test Methods Part 2 Double-Ended Pen Needles
-
Identical under dual numbering
124.
IS 19329 (Part 4):2025
ISO 11040-4:2024
Prefilled Syringes Part 4 Glass Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling
-
Identical under dual numbering
125.
IS 1984 (Part 1):2023
ISO 8362-1:2018
Injection containers and accessories Part 1 Injection vials made of glass tubing (First Revision)
-
Identical under dual numbering
126.
IS 1984 (Part 2):2023
ISO 8362-4:2011
Injection containers and accessories Part 2 Injection vials made of moulded glass Third Revision
-
Identical under dual numbering
127.
IS 1984 (Part 3):2023
ISO 8362-3:2001
Injection containers and accessories Part 3: Aluminum caps for injection vials
-
Identical under dual numbering
128.
IS 17901:2025
ISO 8362-2:2024
Injection Containers and Accessories Part 4 Closures for Injection Vials (First Revision)
-
Identical under dual numbering
129.
IS 1984 (Part 5):2024
ISO 8362-5:2016
Injection Containers and Accessories Part 5 Freeze Drying Closures for Injection Vials
-
Identical under dual numbering
130.
IS 1984 (Part 6):2024
ISO 8362-6:2010
Injection Containers and Accessories Part 6 Caps Made of Aluminium-Plastics Combinations for Injection Vials
-
Identical under dual numbering
131.
IS 3118:1978
Reviewed In : 2021
Specification for electric bacteriological incubators (First Revision)
December, 2021
-
Indigenous
132.
IS 3119:1978
Reviewed In : 2021
Specification for hot air sterilizers (First Revision)
December, 2021
-
Indigenous
133.
IS/ISO 3826-1:2019
ISO 3826-1:2019
Plastics collapsible containers for human blood and blood components Part 1 Conventional containers First Revision
1
Identical under single numbering
134.
IS/ISO 3826-2:2008

Reviewed In : 2025
Plastics collapsible containers for human blood and blood components: Part 2 graphical symbols for use on labels and instruction leaflets
August, 2025
-
Identical under single numbering
135.
IS/ISO 3826-3:2006
ISO 3826-3 : 2008
Reviewed In : 2025
Plastics collapsible containers for human blood and blood components: Part 3 blood bag systems with integrated features
August, 2025
-
Identical under single numbering
136.
IS/ISO 3826-4:2015
ISO 3826-4 : 2015
Reviewed In : 2025
Plastics Collapsible Containers for Human Blood and Blood Components Part 4 Aphaeresis Blood Bag Systems with Integrated Features
August, 2025
-
Identical under single numbering
137.
IS 3829 (Part 1):1999
Reviewed In : 2025
Specification for steam sterilizers: Part 1 horizontal cylindrical and horizontal rectangular steam sterilizers, pressure type (For Hospital And Pharmaceutical Use) (Second Revision)
January, 2025
-
Indigenous
138.
IS 3829 (Part 2):1978
Reviewed In : 2021
Specification for steam sterilizers: Part 2 horizontal cylindrical high speed steam sterilizers, pressure type (First Revision)
December, 2021
4
Indigenous
139.
IS 3829 (Part 3):1985
Reviewed In : 2021
Specification for steam sterilizers: Part 3 pressure sterilizers, vertical cylindrical type
December, 2021
2
Indigenous
140.
IS 3830:1979
Reviewed In : 2021
Specification for water stills for pyrogen - Free distilled water (Second Revision)
December, 2021
3
Indigenous
141.
IS 3831:1979
Reviewed In : 2021
Specification for sterilizer, shallow (Dressing Drum)
December, 2021
4
Indigenous
142.
IS 3992:1982
Reviewed In : 2021
Specification for trays, kidney (First Revision)
February, 2021
1
Indigenous
143.
IS 3993:1993
Reviewed In : 2025
Trays, instruments - Specification (Second Revision)
January, 2025
-
Indigenous
144.
IS 4033:1968
Reviewed In : 2021
General requirements for hospital furniture
December, 2021
1
Indigenous
145.
IS 4035:1967
Reviewed In : 2021
Specification for trolleys, stretcher
December, 2021
1
Indigenous
146.
IS 4036:1967
Reviewed In : 2021
Specification for trolleys, patient
December, 2021
-
Indigenous
147.
IS 4037:1967
Reviewed In : 2021
Specification for stretchers and stretcher carriers
December, 2021
1
Indigenous
148.
IS 4266:1967
Reviewed In : 2021
Specification for lockers, bedside for hospital use
December, 2021
3
Indigenous
149.
IS 4267:1967
Reviewed In : 2021
Specification for stands, wash hand basin
December, 2021
-
Indigenous
150.
IS 4445:2025
Filter and Filter Chamber for Blood Transfusion - Specification (First Revision)
-
Indigenous
151.
IS 4455:1967
Reviewed In : 2021
Specification for trolleys, soiled linen
December, 2021
-
Indigenous
152.
IS 4458:1967
Reviewed In : 2021
Specification for screens, bedside
December, 2021
-
Indigenous
153.
IS 4494:1968
Reviewed In : 2021
Specification for tables, overbed
December, 2021
1
Indigenous
154.
IS 4769:1968
Reviewed In : 2021
Specification for trolley, dressing
December, 2021
2
Indigenous
155.
IS 4787:1968
Reviewed In : 2021
Specification for table, examination
December, 2021
1
Indigenous
156.
IS 5022:1989
Reviewed In : 2025
Sterilizer, instruments, table model (Third Revision)
January, 2025
2
Indigenous
157.
IS 5035:1969
Reviewed In : 2021
Specification for sterilizers, bowl and utensil (Pedal Type)
December, 2021
-
Indigenous
158.
IS 5291:1969
Reviewed In : 2021
Specification for tables, operation, hydraulic, major
December, 2021
2
Indigenous
159.
IS 5631:1970
Reviewed In : 2021
Specification for trolley, instrument, plain and curved
December, 2021
1
Indigenous
160.
IS 5880:1970
Reviewed In : 2021
Specification for stand, saline - Cum - Irrigator
December, 2021
-
Indigenous
161.
IS 6083:1971
Reviewed In : 2021
Specification for table, obstetric, labour
December, 2021
1
Indigenous
162.
IS 6106:1971
Reviewed In : 2021
Specification for tables, operation, hydraulic, minor
December, 2021
3
Indigenous
163.
IS 6328:1971
Reviewed In : 2021
Specification for table, operation, general purposes (Non - Hydraulic)
December, 2021
-
Indigenous
164.
IS 6593:1972
Reviewed In : 2021
Specification for electric serological water - Baths
December, 2021
3
Indigenous
165.
IS 6904:1973
Reviewed In : 2021
Specification for receptacle, waste
December, 2021
-
Indigenous
166.
IS 6905:1973
Reviewed In : 2021
Instruments Table, Mayo's Type
December, 2021
1
Indigenous
167.
IS 7083:1973
Reviewed In : 2021
Specification for trolley, medicine
December, 2021
2
Indigenous
168.
IS 7091:1973
Reviewed In : 2021
Specification for lifter, bed, adjustable
December, 2021
-
Indigenous
169.
IS 7099:1973
Reviewed In : 2021
Specification for trolley, dressing drum
December, 2021
-
Indigenous
170.
IS 7350:1974
Reviewed In : 2025
Specification for needles, spinal
January, 2025
1
Indigenous
171.
IS 7378:1974
Reviewed In : 2021
Bed, Fowler's, Hospital
December, 2021
2
Indigenous
172.
IS 7387:1974
Reviewed In : 2025
Needle, Biopsy, Liver, Silverman's Pattern
January, 2025
-
Indigenous
173.
IS 7596:1974
Reviewed In : 2021
Table, Operation, Orthopaedic, Albee's Type
December, 2021
-
Indigenous
174.
IS/ISO 80369-7:2016
ISO 80369-7 : 2016
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 7 Connectors for Intravascular or Hypodermic Applications
-
Identical under single numbering
175.
IS 8078:1976
Reviewed In : 2021
Specification for table, operation, paediatric
December, 2021
-
Indigenous
176.
IS 8079:1976
Reviewed In : 2021
Specification for table, operation, urological
December, 2021
-
Indigenous
177.
IS 8462:1977
Reviewed In : 2021
Specification for sterilizer, portable, vertical, pressure type
December, 2021
3
Indigenous
178.
IS B8462:1977
Reviewed In : 2016
Sterilizer, Portable, Vertical, Pressure Type (BI-LINGUAL)
December, 2016
3
Indigenous
179.
IS/ISO 8536-1:2011
ISO 8536-1:2011
Infusion equipment for medical use Part 1 Infusion glass bottles
-
Identical under dual numbering
180.
IS/ISO 8536-4:2019
ISO 8536-4:2019
Infusion equipment for medical use Part 4: Infusion sets for single use gravity feed
-
Identical under single numbering
181.
IS 9132:1979
Reviewed In : 2021
Specification for table, operation, folding type
December, 2021
-
Indigenous
182.
IS 9133:1979
Reviewed In : 2021
Specification for trolley for general medical store
December, 2021
-
Indigenous

Standards Under Develpoment

Projects Approved

SI. No.
Doc No
TITLE
1
MHD 12 (28317)
Washer-Disinfectors Part 7 Requirements and Tests for Washer-Disinfectors Employing Chemical Disinfection for Non-Critical Thermolabile Medical Devices and Health Care equipment

Preliminary Draft Standards

SI. No.
Doc No
TITLE
1
MHD 12 (26308)
Walk-in-Freezer General Requirements and Test Methods
2
MHD 12 (26309)
Vaccine Refrigerator or Combined Refrigerator and Water-Pack Freezer Powered by Solar Direct Drive System with No Battery General Requirements and Test Methods

Drafts Standards in WC Stage

SI. No.
Doc No
TITLE
1
MHD 12 (27699)
Walk-in Cooler Specification Temperature Range of 2 C to 8 C
2
MHD 12 (28624)
Amendment of: IS 5022:1989
Table Model Type Instrument Sterilizer - Specification Fourth Revision
3
MHD 12 (28625)
Amendment of: IS 5035:1969
Pedal Type Bowl and Utensil Sterilizer - Specification First Revision
4
MHD 12 (28634)
Amendment of: IS 7378:1974
Manual Fowler Beds Requirements and Dimensional Details First Revision
5
MHD 12 (28635)
Burn Sheet Specification

Draft Standards Completed WC Stage

SI. No.
Doc No
TITLE
No Records Found

Finalized Draft Indian Standard

SI. No.
Doc No
TITLE
1
MHD 12 (28304)
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 2 Identification and Characterization
2
MHD 12 (28307)
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 5 Functional Requirements and Testing
3
MHD 12 (28309)
Prefilled Syringes Part 6 Plastic Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling
4
MHD 12 (28310)
Prefilled Syringes Part 7 Packaging Systems for Sterilized Subassembled Syringes Ready for Filling
5
MHD 12 (28311)
Prefilled Syringes Part 8 Requirements and Test Methods for Finished Prefilled Syringes
6
MHD 12 (28312)
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 3 Containers and Integrated Fluid Paths
7
MHD 12 (28316)
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 7 Accessibility for Persons with Visual Impairment
8
MHD 12 (28318)
Intravascular Catheters Sterile and Single-Use Catheters Part 8 Catheters for Extracorporeal Blood Treatment

Finalized Draft Indian Standards under Print

SI. No.
Doc No
TITLE
1
MHD 12 (28293)
Transfusion Equipment for Medical Use Part 4 Transfusion Sets for Single Use Gravity Feed
2
MHD 12 (28294)

Amendment of: IS 18474:2024
Transfusion Equipment for Medical Use Part 5 Transfusion Sets for Single Use with Pressure Infusion Apparatus First Revision
3
MHD 12 (28295)

Amendment of: IS 18879:2024
Infusion Equipment for Medical Use Part 6 Freeze Drying Closures for Infusion Bottles First Revision
4
MHD 12 (28296)

Amendment of: IS 18879:2024
Infusion Equipment for Medical Use Part 13 Graduated Flow Regulators for Single Use with Fluid Contact First Revision
5
MHD 12 (28298)
Sterilization of Health Care Products Radiation Part 1 Requirements for the Development Validation and Routine Control of a Sterilization Process for Medical Devices
6
MHD 12 (28299)
Washer-Disinfectors Part 1 General Requirements Terms and Definitions and Tests
7
MHD 12 (28300)
Washer-Disinfectors Part 2 Requirements and Tests for Washer-Disinfectors Employing Thermal Disinfection for Critical and Semi-Critical Medical Devices
8
MHD 12 (28301)
Washer-Disinfectors Part 3 Requirements and Tests for Washer-Disinfectors Employing Thermal Disinfection for Human Waste Containers
9
MHD 12 (28302)
Injection Containers and Accessories Part 7 Injection Caps Made of Aluminium-Plastics Combinations Without Overlapping Plastics Part
10
MHD 12 (28303)
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 1 Extractables in Aqueous Autoclavates
11
MHD 12 (28305)
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 3 Determination of Released-Particle Count
12
MHD 12 (28306)
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 4 Biological Requirements and Test Methods
13
MHD 12 (28308)
Aluminium Caps and Aluminium Plastic Caps for Infusion Bottles and Injection Vials General Requirements and Test Methods
14
MHD 12 (28313)
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 4 Needle-Based Injection Systems Containing Electronics
15
MHD 12 (28314)
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 5 Automated Functions
16
MHD 12 (28315)
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 6 On-body Delivery Systems
17
MHD 12 (28615)

Amendment of: IS 11043:1984
Epidural Needle Specification First Revision
18
MHD 12 (28616)

Amendment of: IS 3119:1978
Hot Air Sterilizers Specification Second Revision
19
MHD 12 (28618)

Amendment of: IS 3829:1999
Steam Sterilizers Specification Part 1 Pressure Type Horizontal Cylindrical and Horizontal Rectangular Steam Sterilizers Third Revision
20
MHD 12 (28619)

Amendment of: IS 3829:1978
Steam Sterilizers Specification Part 2 Pressure Type Horizontal Cylindrical High Speed Steam Sterilizers Second Revision
21
MHD 12 (28621)

Amendment of: IS 3829:1985
Steam Sterilizers Specification Part 3 Vertical Cylindrical Pressure Sterilizers First Revision
22
MHD 12 (28622)

Amendment of: IS 3831:1979
Shallow Sterilizer Dressing Drum Specification Third Revision
23
MHD 12 (28623)

Amendment of: IS 3993:1993
Instrument Tray Specification Third Revision
24
MHD 12 (28626)

Amendment of: IS 4035:1967
Stretcher Trolley - Specification First Revision
25
MHD 12 (28627)

Amendment of: IS 4036:1967
Patient Trolley - Specification First Revision
26
MHD 12 (28628)

Amendment of: IS 4037:1967
Stretchers and Stretcher Carriers - Specification First Revision
27
MHD 12 (28630)

Amendment of: IS 4266:1967
Bedside Locker for Hospital Use - Specification First Revision
28
MHD 12 (28631)

Amendment of: IS 4267:1967
Hand Wash Basin and Stand - Specification First Revision
29
MHD 12 (28632)

Amendment of: IS 4458:1967
Bedside Screens - Specification First Revision
30
MHD 12 (28633)

Amendment of: IS 7350:1974
Spinal Needle Specification First Revision
31
MHD 12 (28657)
Sterilization of health care products Low temperature vaporized hydrogen peroxide Requirements for the development validation and routine control of a sterilization process for medical devices
32
MHD 12 (33288)
Hospital Furniture - General Requirements First Revision


Aspect Wise Report

 
 Product:   137
 Code of Practices :    13
 Methods of Test :   6
 Terminology :   1
 Dimensions :   0
 System Standard :   0
 Safety Standard :   0
 Others :    10
 Service Specification :    0
 Process Specification :    12
 Unclassified :    2
 


Annexure-I :List of Indian Standards Withdrawn/Superseded

SI. No.
IS No.
Title
1.
IS 10150:1981
Reviewed In : 2021
Guide for sterilization of medical products
2.
IS 10263:1982
Reviewed In : 2021
Specification for deep fat fryer single and double pan electrically operated for large catering establishments
3.
IS 10264:1982
Reviewed In : 2021
Specification for trolley hot food for hospital and industrial cantee - Ns
4.
IS/ISO 10555-1:2013
ISO 10555-1 : 2013
Intravascular catheters - Sterile and single - Use catheters Part 1 general requirements First Revision
5.
IS/ISO 10555-2:1996
Reviewed In : 2014
Sterile single-use intravascular catheters-Part 2 Angiographic Catheters
6.
IS/ISO 10555-4:2013
ISO 10555-4 : 2013
Reviewed In : 2025
Intravascular Catheters Sterile and Single-Use Catheters Part 4 Balloon Dilatation Catheters First Revision
7.
IS 10603:1983
Reviewed In : 2021
Specification for abdominal belts
8.
IS 10783:1983
Reviewed In : 2021
Specification for patient - Lifting devices mobile manually operated
9.
IS 10985:1984
Reviewed In : 2017
Specification for needle acupuncture
10.
IS 1108:1975
Reviewed In : 2017
Specification for pharmaceutical glass containers Second Revision
11.
IS 11400:1985
Reviewed In : 2017
Specification for hypodermic syringes interchangeable type for general purposes
12.
IS 12050:1986
Reviewed In : 2017
Specification for sterile hypodermic syringes with needle attached for single use
13.
IS 12227:2002
ISO 8537
Reviewed In : 2012
Sterile Single-Use Syringes With or Without Needle for Insulin
14.
IS 12655 (Part 4):2003
ISO 8536-4
Reviewed In : 2018
Infusion equipment for medical use Part 4 infusion sets for single use gravity feed First Revision
15.
IS 13115:1991
Reviewed In : 2021
Portable first - Aid kit for general use - Specification
16.
IS B13115:1991
Reviewed In : 2016
Portable First Aid Kit for General Use Bi-lingual
17.
IS/ISO 14161:2009
ISO 14161 : 2009
Sterilization of health care products - Biological indicators - Guidance for the selection use and interpretation of results
18.
IS 14193:1994
Reviewed In : 2021
Ovulation thermometers - Specification
19.
IS 15102:2002
ISO 3826
Reviewed In : 2017
Plastics Collapsible Containers for Human Blood and Blood Components
20.
IS 15110:2002
Reviewed In : 2017
Veterinary thermometers mercury - In - Glass type - Specification
21.
IS 15354:2003
ISO 11193
Reviewed In : 2014
Single-Use Rubber Examination Gloves
22.
IS 15354 (Part 2):2018
ISO 11193-2 : 2006
Single - Use medical examination gloves Part 2 specification for gloves made from poly Vinyl Chloride First Revision
23.
IS/ISO/TS 15883-5:2005
ISO/TS 15883-5 : 200
Washer-disinfectors Part 5 Test soils and methods for demonstrating cleaning efficacy
24.
IS/ISO 17664:2017
ISO 17664:2017
Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
25.
IS 1984 (Part 1):2003
ISO 8362-1
Reviewed In : 2008
Injection Containers for Injectables and Accessories - Part 1 Injection Vials Made of Glass Tubing
26.
IS 3120:1999
Reviewed In : 2019
Baby incubators - Specification Second Revision
27.
IS 3234 (Part 1):1986
ISO 594-1
Reviewed In : 2017
Specification for conical fittings with a 6 Luer taper for syringes needles and other medical equipment Part 1 general requirements Second Revision
28.
IS 3234 (Part 2):1995
ISO 594-2
Reviewed In : 2016
Conical flTttNgs with a 6 Luer taper for syringes needles and certain other medical equipment Part 2 lock fittings
29.
IS 3235:1988
ISO 595-2
Reviewed In : 2021
General requirements for syringes for medical use Second Revision
30.
IS 3236:1992
Reviewed In : 2018
Hypodermic syringes for general purposes - Specification Second Revision
31.
IS 3237 (Part 1):1985
Reviewed In : 2017
Specification for special purpose syringes Part 1 insulin syringes Second Revision
32.
IS 3237 (Part 2):1985
Reviewed In : 2017
Specification for special purpose syringes Part 2 tuberculin syringes Second Revision
33.
IS 3237 (Part 3):1985
Reviewed In : 2017
Specification for special purpose syringes Part 3 bcg syringes Second Revision
34.
IS 3237 (Part 4):1986
Reviewed In : 2017
Specification for special purpose syringes Part 4 vaccine syringe
35.
IS 3237 (Part 5):1986
Reviewed In : 2017
Specification for special purpose syringes Part 5 post operation care syringe Second Revision
36.
IS 3237 (Part 6):1986
Reviewed In : 2017
Specification for special purpose syringes Part 6 irrigation syringe
37.
IS 3237 (Part 7):1986
Reviewed In : 2017
Specification for special purpose syringe Part 7 forced feeding syringe
38.
IS 3237 (Part 8):1986
Reviewed In : 2017
Specification for special purpose syringes Part 8 angiography syringe
39.
IS 3423:1973
Reviewed In : 2018
Specification for glass contafners for transfusion fluids First Revision
40.
IS 3994:1993
Reviewed In : 2019
Bowls wash - Specification Second Revision
41.
IS 3997:1982
Reviewed In : 2021
Specification for jars ointment First Revision
42.
IS 3998:1982
Reviewed In : 2006
Cups Medicine
43.
IS 4034:1979
Reviewed In : 2021
Specification for castors for hospital equipment First Revision
44.
IS 4068:1967
Reviewed In : 2007
Specification for broken brick Burnt Clay coarse aggregate for use in lime concrete
45.
IS 4148:1989
Reviewed In : 2021
Surgical rubber gloves - Specification First Revision
46.
IS 4363:1980
Reviewed In : 2017
Specification for drip counter E M S pattern First Revision
47.
IS 4510:1978
Redesignated as IS 3829 Part 2
48.
IS 489 (Part 1):1973
Reviewed In : 2008
Glass Ampoules - Part I Ampoules for Liquid Injectables
49.
IS 489 (Part 2):1973
Reviewed In : 2003
Glass Ampoules - Part II Ampoules for lyophilized injectable
50.
IS 490:1967
Vaccine Phials
51.
IS 5029:1979
Reviewed In : 2021
Specification for bedsteads hospital general purposes First Revision
52.
IS 5156:1969
Calorimeter Cup Duboscq Type
53.
IS 5335:1969
Tables bedsides
54.
IS 5336:1969
Reviewed In : 2021
Specification for back rest
55.
IS 5337:1969
Reviewed In : 2021
Specification for cot dropside baby hospital
56.
IS 5630:1994
Reviewed In : 2019
Cribs Cradles maternity - Specification First Revision
57.
IS 5764:1994
Bowls Solution
58.
IS 5782:1994
Bowls Sponge
59.
IS 6208:1971
Reviewed In : 2017
Specification for spoons plastics measuring medicine
60.
IS 6877:1977
Reviewed In : 2021
Specification for cabinet instruments First Revision
61.
IS 7036:1982
Reviewed In : 2021
Specification for table postmortem First Revision
62.
IS 7081:1973
Reviewed In : 2019
Specification for stool revolving for hospital use
63.
IS 7171:1974
Reviewed In : 2017
Specification for drip counter with filter
64.
IS 7455:1974
Reviewed In : 2021
Specification for sterilizer pressure hot and cold water
65.
IS 7523:1974
Reviewed In : 2017
Specification for rubber catheter Urinary
66.
IS/ISO 8362-1:2003
ISO8362-1:2003
Reviewed In : 2019
Injection containers and accessories Part 1 injection vials made of glass tubing
67.
IS 9395:1979
Reviewed In : 2016
Specification for bed intensive care
68.
IS 9824 (Part 1):1996
ISO 1135-1
Reviewed In : 2018
Transfusion equipment for medical use - Specification Part 1 glass transfusion bottles closures and caps First Revision
69.
IS 9824 (Part 2):1995
ISO 1135-3
Reviewed In : 2016
Transfusion equipment for medical use - Specification Part 2 blood - Taking set for single use First Revision
70.
IS 9824 (Part 3):1996
ISO 1135-4
Reviewed In : 2018
Transfusion equipment for medical use - Specification Part 3 transfusion set for single use First Revision


Annexure-II :List of Indian Product Standards

SI. No.
IS No. & Year
Title
1.
IS 10258 (Part 1):2022
7886-1:2017
Sterile hypodermic syringes for single use Part 1 Syringes for manual use Third Revision
2.
IS 10258 (Part 2):2024
ISO 7886-2:2020
Sterile hypodermic syringes for single use Part 2 Syringes for use with power-driven syringe pumps
3.
IS 10258 (Part 3):2021
ISO 7886-3:2020
Sterile hypodermic syringes for single use Part 3 Auto-disabled syringes for fixed-dose immunization First Revision
4.
IS 10258 (Part 4):2024
ISO 7886-4:2018
Sterile Hypodermic Syringes for Single Use Part 4 Syringes with Re-use Prevention Feature
5.
IS/ISO 10555-3:2013
ISO 10555-3 : 2013
Reviewed In : 2025
Intravascular catheters - Sterile and single - Use catheters Part 3 central venous catheters First Revision
6.
IS/ISO 10555-5:2013

Reviewed In : 2025
Intravascular catheters - Sterile and single - Use catheters Part 5 over - Needle peripheral catheters First Revision
7.
IS 10654:2018
ISO 7864 : 2016
Reviewed In : 2025
Sterile hypodermic needles for single use - Requirements and test methods Fourth Revision
8.
IS 11040 (Part 1):2015
ISO 11040-1 : 2015
Prefilled syringes Part 1 Glass cylinders for dental local anaesthetic cartridges
9.
IS/ISO 11040-2:2011
ISO 11040-2:2011
Prefilled syringes Part 2 Plunger stoppers for dental local anaesthetic cartridges
10.
IS/ISO 11040-3:2012
ISO 11040-3:2012
Prefilled syringes Part 3 Seals for dental local anaesthetic cartridges
11.
IS/ISO 11040-4:2015
ISO 11040-4 : 2015
Reviewed In : 2025
Prefilled syringes Part 4 Glass barrels for injectables and sterilized subassembled syringes ready for filling
12.
IS/ISO 11040-5:2012
ISO 11040-5:2012
Prefilled syringes Part 5 Plunger stoppers for injectables
13.
IS 11043:1984
Reviewed In : 2025
Specification for needle epidural
14.
IS/ISO 11138-1:2017
ISO 11138-1 : 2017
Reviewed In : 2025
Sterilization of Health Care Products Biological Indicators Part 1 General Requirements
15.
IS/ISO 11138-2:2017
ISO 11138-2 : 2017
Reviewed In : 2025
Sterilization of Health Care Products Biological Indicators Part 2 Biological Indicators for Ethylene Oxide Sterilization Processes
16.
IS/ISO 11138-3:2017
ISO 11138-3 : 2017
Reviewed In : 2025
Sterilization of Healthcare Products Biological Indicators Part 3 Biological Indicators for Moist Heat Sterilization Processes
17.
IS/ISO 11138-4:2017
ISO 11138-4 : 2017
Reviewed In : 2025
Sterilization of Health Care Products Biological Indicators Part 4 Biological Indicators for Dry Heat Sterilization Processes
18.
IS/ISO 11138-5:2017
ISO 11138-5 : 2017
Sterilization of Health Care Products Biological Indicators Part 5 Biological Indicators for Low-Temperature Steam and Formaldehyde Sterilization Processes
19.
IS/ISO 1135-3:2016
ISO 1135-3:2016
Transfusion equipment for medical use Part 3 Blood-taking sets for single use
20.
IS/ISO 1135-4:2015
ISO 1135-4 : 2015
Transfusion Equipment for Medical Use Part 4 Transfusion Sets for Single use Gravity Feed
21.
IS/ISO 11418-1:2016
ISO 11418-1 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 1 Drop-Dispensing Glass
22.
IS/ISO 11418-2:2016
ISO 11418-2 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 2 Screw-Neck Glass Bottles for Syrups
23.
IS/ISO 11418-3:2016
ISO 11418-3 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 3 Screw-Neck Glass Bottles Veral for Solid and Liquid Dosage Forms
24.
IS/ISO 11418-5:2015
ISO 11418-5 : 2015
Containers and Accessories for Pharmaceutical Preparations Part 5 Dropper Assemblies
25.
IS/ISO 11418-7:2016
ISO 11418-7 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 7 Screw-Neck Vials Made of Glass Tubing for Liquid Dosage Forms
26.
IS 12173:1987
Reviewed In : 2025
Specification for cervical halter
27.
IS 13422:2024
ISO 10282:2023
Single-use Sterile Rubber Surgical Gloves Specification First Revision
28.
IS/ISO 13926-1:2018
ISO 13926-1:2018
Pen systems Part 1 Glass cylinders for pen-injectors for medical use
29.
IS/ISO 13926-2:2017
ISO 13926-2:2017
Pen systems Part 2 Plunger stoppers for pen-injectors for medical use
30.
IS B14316:1995
Reviewed In : 2025
Swabs Small in Bag of 50 Bi-lingual
31.
IS 15113:2002
Reviewed In : 2025
Clinical electrical thermometers with maximum device - Specification
32.
IS 15354 (Part 1):2023
ISO 11193-1:2020
Single-use medical examination gloves Part 1 Specification for gloves made from rubber latex or rubber solution Second Revision
33.
IS 15537:2021
ISO 9187-1:2018
Injection equipment for medical use Part 1 Ampoules for injectables First Revision
34.
IS 15537 (Part 2):2023
ISO 9187-2:2010
Injection equipment for medical use Part 2 One-point-cut OPC ampoules
35.
IS/ISO 15883-1:2006
ISO 15883-1 : 2006
Reviewed In : 2025
Washer - Disinfectors Part 1 general requirements terms and definitions and tests
36.
IS 16097:2013
Reviewed In : 2025
Sterile single use scalp vein Winged Needle infusion set
37.
IS 17547:2021
Specification for Vaccine Freezer or Combined Vaccine Freezer and Water-Pack Freezer Compression Cycle General Requirements and Testing Methods
38.
IS 17588:2021
Specification for Cold Box General requirements and Test methods
39.
IS 17589:2021
Specification for Water Packs for use as ice-packs cool-packs and warm-packs Requirements and Test methods
40.
IS 17964 (Part 7):2025
ISO 80369-7:2021
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 7 Connectors for Intravascular or Hypodermic Applications
41.
IS 18287:2023
ISO/TS 22421
Sterilization of health care products Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
42.
IS 18288:2023
ISO 20696:2018
Sterile urethral catheters for single use
43.
IS 18292 (Part 1):2024
ISO 10555-1:2023
Intravascular Catheters Sterile and Single-Use Catheters Part 1 General Requirements
44.
IS 18292 (Part 4):2024
ISO 10555-4:2023
Intravascular Catheters Sterile and Single-Use Catheters Part 4 Balloon Dilatation Catheters First Revision
45.
IS 18292 (Part 6):2023
ISO 10555-6:2015
Intravascular catheters Sterile and single-use catheters Part 6 Subcutaneous implanted ports
46.
IS 18292 (Part 7):2024
ISO 10555-7:2023
Intravascular Catheters Sterile and Single-Use Catheters Part 7 Peripherally Inserted Central Catheters
47.
IS 18293 (Part 3):2023
ISO 13926-3:2019
Pen systems Part 3 Seals for pen-injectors for medical use
48.
IS 18446 (Part 6):2024
ISO 11140-6:2022
Sterilization of Health Care Products Chemical Indicators Part 6 Type 2 Indicators and Process Challenge Devices for Use in Performance Testing of Small Steam Sterilizers
49.
IS 18451:2023
ISO 20697:2018
Sterile drainage catheters and accessory devices for single use
50.
IS 18446 (Part 1):2023
ISO 11140-1:2014
Sterilization of health care products Chemical indicators Part 1 General requirements
51.
IS 18474 (Part 5):2024
ISO 1135-5:2015
Transfusion equipment for medical use Part 5 Transfusion sets for single use with pressure infusion apparatus
52.
IS 18478:2024
ISO 20698:2018
Catheter systems for neuraxial application Sterile and single-use catheters and accessories
53.
IS 18529:2024
ISO 11070:2014
Sterile single-use intravascular introducers dilators and guidewire
54.
IS 18723:2024
ISO 6717:2021
In vitro diagnostic medical devices Single-use containers for the collection of specimens from humans other than blood
55.
IS 18735:2024
ISO 15747:2018
Plastic Containers for Intravenous Injections
56.
IS 18866:2024
ISO 9626:2016
Stainless Steel Needle Tubing for the Manufacture of Medical Devices Requirements and Test Methods
57.
IS 18871:2024
ISO 28620:2020
Medical Devices Non-Electrically Driven Portable Infusion Devices
58.
IS 18872:2024
ISO 21881:2019
Sterile Packaged Ready for Filling Glass Cartridges
59.
IS 18879 (Part 2):2024
ISO 8536-2:2023
Infusion Equipment for Medical Use Part 2 Closures for Infusion Bottles
60.
IS 18879 (Part 3):2024
ISO 8536-3:2009+Amd1:2022
Infusion Equipment for Medical Use Part 3 Aluminium Caps for Infusion Bottles
61.
IS 18879 (Part 5):2024
ISO 8536-5:2004
Infusion Equipment for Medical Use Part 5 Burette Infusion Sets for Single Use Gravity Feed
62.
IS 18879 (Part 6):2024
ISO 8536-6:2016
Infusion Equipment for Medical Use Part 6 Freeze Drying Closures for Infusion Bottles
63.
IS 18879 (Part 7):2024
ISO 8536-7:2009
Infusion Equipment for Medical Use Part 7 Caps Made of Aluminium-Plastics Combinations for Infusion Bottles
64.
IS 18879 (Part 8):2024
ISO 8536-8:2015
Infusion equipment for medical use Part 8 Infusion sets for single use with pressure infusion apparatus
65.
IS 18879 (Part 9):2024
ISO 8536-9:2015
Infusion Equipment for Medical Use Part 9 Fluid Lines for Single Use with Pressure Infusion Equipment
66.
IS 18879 (Part 10):2024
ISO 8536-10:2015
Infusion Equipment for Medical Use Part 10 Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment
67.
IS 18879 (Part 11):2024
ISO 8536-11:2015
Infusion Equipment for Medical Use Part 11 Infusion Filters for Single Use with Pressure Infusion Equipment
68.
IS 18879 (Part 12):2024
ISO 8536-12:2021
Infusion Equipment for Medical Use Part 12 Check Valves for Single Use
69.
IS 18879 (Part 13):2024
ISO 8536-13:2016
Infusion Equipment for Medical Use Part 13 Graduated Flow Regulators for Single Use with Fluid Contact
70.
IS 18879 (Part 14):2024
ISO 8536-14:2016
Infusion Equipment for Medical Use Part 14 Clamps and Flow Regulators for Transfusion and Infusion Equipment without Fluid Contact
71.
IS 18879 (Part 15):2024
ISO 8536-15:2022+Amd1:2023
Infusion Equipment for Medical Use Part 15 Light-Protective Infusion Sets for Single Use
72.
IS 18980:2025
Blood Donor Couch
73.
IS 18981:2025
Dialysis Chair
74.
IS 19099:2025
Vaccine Carriers General Requirements and Test Methods
75.
IS 19106:2025
Refrigerator or Combined Refrigerator and Water-Pack Freezer Intermittent Mains Powered Compression Cycle General Requirements and Test Methods
76.
IS 19282 (Part 1):2025
ISO 11608-1:2022
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 1 Needle-Based Injection Systems
77.
IS 19282 (Part 2):2025
ISO 11608-2:2022
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 2 Double-Ended Pen Needles
78.
IS 19329 (Part 4):2025
ISO 11040-4:2024
Prefilled Syringes Part 4 Glass Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling
79.
IS 1984 (Part 1):2023
ISO 8362-1:2018
Injection containers and accessories Part 1 Injection vials made of glass tubing First Revision
80.
IS 1984 (Part 2):2023
ISO 8362-4:2011
Injection containers and accessories Part 2 Injection vials made of moulded glass Third Revision
81.
IS 1984 (Part 3):2023
ISO 8362-3:2001
Injection containers and accessories Part 3 Aluminum caps for injection vials
82.
IS 17901:2025
ISO 8362-2:2024
Injection Containers and Accessories Part 4 Closures for Injection Vials First Revision
83.
IS 1984 (Part 5):2024
ISO 8362-5:2016
Injection Containers and Accessories Part 5 Freeze Drying Closures for Injection Vials
84.
IS 1984 (Part 6):2024
ISO 8362-6:2010
Injection Containers and Accessories Part 6 Caps Made of Aluminium-Plastics Combinations for Injection Vials
85.
IS 3118:1978
Reviewed In : 2021
Specification for electric bacteriological incubators First Revision
86.
IS 3119:1978
Reviewed In : 2021
Specification for hot air sterilizers First Revision
87.
IS/ISO 3826-1:2019
ISO 3826-1:2019
Plastics collapsible containers for human blood and blood components Part 1 Conventional containers First Revision
88.
IS/ISO 3826-2:2008

Reviewed In : 2025
Plastics collapsible containers for human blood and blood components Part 2 graphical symbols for use on labels and instruction leaflets
89.
IS/ISO 3826-3:2006
ISO 3826-3 : 2008
Reviewed In : 2025
Plastics collapsible containers for human blood and blood components Part 3 blood bag systems with integrated features
90.
IS/ISO 3826-4:2015
ISO 3826-4 : 2015
Reviewed In : 2025
Plastics Collapsible Containers for Human Blood and Blood Components Part 4 Aphaeresis Blood Bag Systems with Integrated Features
91.
IS 3829 (Part 1):1999
Reviewed In : 2025
Specification for steam sterilizers Part 1 horizontal cylindrical and horizontal rectangular steam sterilizers pressure type For Hospital And Pharmaceutical Use Second Revision
92.
IS 3829 (Part 2):1978
Reviewed In : 2021
Specification for steam sterilizers Part 2 horizontal cylindrical high speed steam sterilizers pressure type First Revision
93.
IS 3829 (Part 3):1985
Reviewed In : 2021
Specification for steam sterilizers Part 3 pressure sterilizers vertical cylindrical type
94.
IS 3830:1979
Reviewed In : 2021
Specification for water stills for pyrogen - Free distilled water Second Revision
95.
IS 3831:1979
Reviewed In : 2021
Specification for sterilizer shallow Dressing Drum
96.
IS 3992:1982
Reviewed In : 2021
Specification for trays kidney First Revision
97.
IS 3993:1993
Reviewed In : 2025
Trays instruments - Specification Second Revision
98.
IS 4033:1968
Reviewed In : 2021
General requirements for hospital furniture
99.
IS 4035:1967
Reviewed In : 2021
Specification for trolleys stretcher
100.
IS 4036:1967
Reviewed In : 2021
Specification for trolleys patient
101.
IS 4037:1967
Reviewed In : 2021
Specification for stretchers and stretcher carriers
102.
IS 4266:1967
Reviewed In : 2021
Specification for lockers bedside for hospital use
103.
IS 4267:1967
Reviewed In : 2021
Specification for stands wash hand basin
104.
IS 4445:2025
Filter and Filter Chamber for Blood Transfusion - Specification First Revision
105.
IS 4455:1967
Reviewed In : 2021
Specification for trolleys soiled linen
106.
IS 4458:1967
Reviewed In : 2021
Specification for screens bedside
107.
IS 4494:1968
Reviewed In : 2021
Specification for tables overbed
108.
IS 4769:1968
Reviewed In : 2021
Specification for trolley dressing
109.
IS 4787:1968
Reviewed In : 2021
Specification for table examination
110.
IS 5022:1989
Reviewed In : 2025
Sterilizer instruments table model Third Revision
111.
IS 5035:1969
Reviewed In : 2021
Specification for sterilizers bowl and utensil Pedal Type
112.
IS 5291:1969
Reviewed In : 2021
Specification for tables operation hydraulic major
113.
IS 5631:1970
Reviewed In : 2021
Specification for trolley instrument plain and curved
114.
IS 5880:1970
Reviewed In : 2021
Specification for stand saline - Cum - Irrigator
115.
IS 6083:1971
Reviewed In : 2021
Specification for table obstetric labour
116.
IS 6106:1971
Reviewed In : 2021
Specification for tables operation hydraulic minor
117.
IS 6328:1971
Reviewed In : 2021
Specification for table operation general purposes Non - Hydraulic
118.
IS 6593:1972
Reviewed In : 2021
Specification for electric serological water - Baths
119.
IS 6904:1973
Reviewed In : 2021
Specification for receptacle waste
120.
IS 6905:1973
Reviewed In : 2021
Instruments Table Mayo s Type
121.
IS 7083:1973
Reviewed In : 2021
Specification for trolley medicine
122.
IS 7091:1973
Reviewed In : 2021
Specification for lifter bed adjustable
123.
IS 7099:1973
Reviewed In : 2021
Specification for trolley dressing drum
124.
IS 7350:1974
Reviewed In : 2025
Specification for needles spinal
125.
IS 7378:1974
Reviewed In : 2021
Bed Fowler s Hospital
126.
IS 7387:1974
Reviewed In : 2025
Needle Biopsy Liver Silverman s Pattern
127.
IS 7596:1974
Reviewed In : 2021
Table Operation Orthopaedic Albee s Type
128.
IS/ISO 80369-7:2016
ISO 80369-7 : 2016
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 7 Connectors for Intravascular or Hypodermic Applications
129.
IS 8078:1976
Reviewed In : 2021
Specification for table operation paediatric
130.
IS 8079:1976
Reviewed In : 2021
Specification for table operation urological
131.
IS 8462:1977
Reviewed In : 2021
Specification for sterilizer portable vertical pressure type
132.
IS B8462:1977
Reviewed In : 2016
Sterilizer Portable Vertical Pressure Type BI-LINGUAL
133.
IS/ISO 8536-1:2011
ISO 8536-1:2011
Infusion equipment for medical use Part 1 Infusion glass bottles
134.
IS/ISO 8536-4:2019
ISO 8536-4:2019
Infusion equipment for medical use Part 4 Infusion sets for single use gravity feed
135.
IS 9132:1979
Reviewed In : 2021
Specification for table operation folding type
136.
IS 9133:1979
Reviewed In : 2021
Specification for trolley for general medical store