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 : 2002
ISO 7886-1
Reviewed In : 2022
Sterile hypodermic syringes for single use (Second Revision)
June, 2022
-
Identical under dual numbering
3.
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
4.
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
5.
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
6.
IS 10263 : 1982
Reviewed In : 2021
Specification for deep fat fryer, single and double pan electrically operated, for large catering establishments
December, 2021
-
Indigenous
7.
IS 10264 : 1982
Reviewed In : 2021
Specification for trolley, hot food, for hospital and industrial cantee - Ns
December, 2021
-
Indigenous
8.
IS/ISO 10555-1 : 2013
ISO 10555-1 : 2013
Intravascular catheters - Sterile and single - Use catheters: Part 1 general requirements (First Revision)
-
Identical under single numbering
9.
IS/ISO 10555-3 : 2013
ISO 10555-3 : 2013
Intravascular catheters - Sterile and single - Use catheters: Part 3 central venous catheters (First Revision)
-
Identical under single numbering
10.
IS/ISO 10555-4 : 2013
ISO 10555-4 : 2013
Reviewed In : 2019
Intravascular Catheters — Sterile and Single-Use Catheters Part 4 Balloon Dilatation Catheters (First Revision)
December, 2019
-
Identical under single numbering
11.
IS/ISO 10555-5 : 2013

Intravascular catheters - Sterile and single - Use catheters: Part 5 over - Needle peripheral catheters (First Revision)
-
Identical under single numbering
12.
IS 10603 : 1983
Reviewed In : 2021
Specification for abdominal belts
February, 2021
-
Indigenous
13.
IS 10654 : 2018
ISO 7864 : 2016
Sterile hypodermic needles for single use - Requirements and test methods (Fourth Revision)
-
Identical under dual numbering
14.
IS 10783 : 1983
Reviewed In : 2021
Specification for patient - Lifting devices, mobile, manually operated
December, 2021
-
Indigenous
15.
IS 10985 : 1984
Reviewed In : 2017
Specification for needle, acupuncture
March, 2017
-
Indigenous
16.
IS 11040 (Part 1) : 2015
ISO 11040-1 : 2015
Prefilled syringes Part 1 : Glass cylinders for dental local anaesthetic cartridges
-
Identical under single numbering
17.
IS/ISO 11040-2 : 2011
ISO 11040-2:2011
Prefilled syringes Part 2 Plunger stoppers for dental local anaesthetic cartridges
-
Identical under single numbering
18.
IS/ISO 11040-3 : 2012
ISO 11040-3:2012
Prefilled syringes Part 3 Seals for dental local anaesthetic cartridges
-
Identical under single numbering
19.
IS/ISO 11040-4 : 2015
ISO 11040-4 : 2015
Prefilled syringes Part 4 Glass barrels for injectables and sterilized subassembled syringes ready for filling
1
Identical under single numbering
20.
IS/ISO 11040-5 : 2012
ISO 11040-5:2012
Prefilled syringes Part 5 Plunger stoppers for injectables
-
Identical under single numbering
21.
IS 11043 : 1984
Reviewed In : 2017
Specification for needle, epidural
March, 2017
-
Indigenous
22.
IS 1108 : 1975
Reviewed In : 2017
Specification for pharmaceutical glass containers (Second Revision)
March, 2017
-
Indigenous
23.
IS/ISO 11135 : 2014
ISO 11135 : 2014
Sterilization of health - Care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
1
Identical under single numbering
24.
IS/ISO 11137-1 : 2006
ISO 11137-1 : 2006
Sterilization of health care products - Radiation: Part 1 requirements for development, validation and routine control of a sterilization process for medical devices
1
Identical under dual numbering
25.
IS/ISO 11137-2 : 2013
ISO 11137-2 : 2013
Sterilization of health care products - Radiation: Part 2 establishing the sterilization dose
1
Identical under dual numbering
26.
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
27.
IS/ISO 11138-1 : 2017
ISO 11138-1 : 2017
Sterilization of Health Care Products ― Biological Indicators Part 1 General Requirements
-
Identical under single numbering
28.
IS/ISO 11138-2 : 2017
ISO 11138-2 : 2017
Sterilization of Health Care Products ― Biological Indicators Part 2 Biological Indicators for Ethylene Oxide Sterilization Processes
-
Identical under single numbering
29.
IS/ISO 11138-3 : 2017
ISO 11138-3 : 2017
Sterilization of Healthcare Products ― Biological Indicators Part 3 Biological Indicators for Moist Heat Sterilization Processes
-
Identical under single numbering
30.
IS/ISO 11138-4 : 2017
ISO 11138-4 : 2017
Sterilization of Health Care Products ― Biological Indicators Part 4 Biological Indicators for Dry Heat Sterilization Processes
-
Identical under single numbering
31.
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
32.
IS/ISO 11140-3 : 2007
ISO 11140-3 : 2007
Sterilization of health care products - Chemical indicators: Part 3 class 2 indicator systems for use in the bowie and dick - Type steam penetration test
-
Identical under single numbering
33.
IS/ISO 11140-4 : 2007
ISO 11140-4 : 2007
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
-
Identical under single numbering
34.
IS/ISO 11140-5 : 2007
ISO 11140-5 : 2007
Sterilization of health care products - Chemical indicators: Part 5 class 2 indicators for bowie and dick - Type air removal tests
-
Identical under single numbering
35.
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
36.
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
37.
IS 11400 : 1985
Reviewed In : 2017
Specification for hypodermic syringes, interchangeable type for general purposes
March, 2017
-
Indigenous
38.
IS/ISO 11418-1 : 2016
ISO 11418-1 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 1 Drop-Dispensing Glass
-
Identical under single numbering
39.
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
40.
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
41.
IS/ISO 11418-5 : 2015
ISO 11418-5 : 2015
Containers and Accessories for Pharmaceutical Preparations Part 5 Dropper Assemblies
-
Identical under single numbering
42.
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
43.
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
44.
IS/ISO 11607 : 2019
ISO 11607-2:2019
Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision)
-
Identical under single numbering
45.
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
46.
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
47.
IS 12173 : 1987
Reviewed In : 2018
Specification for cervical halter
September, 2018
-
Indigenous
48.
IS 12227 : 2020
ISO 8537 : 2016
Sterile Single-Use Syringes, With or Without Needle, for Insulin ( Second Revision )
-
-
Identical under dual numbering
49.
IS 12430 : 1987
Reviewed In : 2018
Safety code for installation, servicing maintenanceand of sterilizers
July, 2018
-
Indigenous
50.
IS 13115 : 1991
Reviewed In : 2021
Portable first - Aid kit for general use - Specification
December, 2021
1
Indigenous
51.
IS B13115 : 1991
Reviewed In : 2016
Portable First Aid Kit for General Use (Bi-lingual)
December, 2016
1
Indigenous
52.
IS/ISO 13408-1 : 2008
ISO 13408-1:2008
Aseptic processing of health care products Part 1 General requirements
-
Identical under single numbering
53.
IS/ISO 13408-2 : 2018
ISO 13408-2:2018
Aseptic processing of health care products Part 2 Sterilizing filtration
-
Identical under single numbering
54.
IS 13422 : 2024
ISO 10282:2023
Single-use Sterile Rubber Surgical Gloves � Specification (First Revision)
-
Identical under dual numbering
55.
IS 13422 : 1992
Reviewed In : 2018
Disposable surgical rubber gloves specification
June, 2018
-
Identical under dual numbering
56.
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
57.
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
58.
IS/ISO 14161 : 2009
ISO 14161 : 2009
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
-
Identical under single numbering
59.
IS 14193 : 1994
Reviewed In : 2021
Ovulation thermometers - Specification
February, 2021
-
Indigenous
60.
IS B14316 : 1995
Reviewed In : 2016
Swabs, Small, in Bag of 50 (Bi-lingual)
February, 2016
-
61.
IS/ISO 14937 : 2009
ISO 14937:2009
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
-
Identical under single numbering
62.
IS 15110 : 2002
Reviewed In : 2017
Veterinary thermometers, mercury - In - Glass type - Specification
March, 2017
-
Indigenous
63.
IS 15113 : 2002
Reviewed In : 2017
Clinical electrical thermometers with maximum device - Specification
March, 2017
1
Indigenous
64.
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
65.
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
66.
IS 15537 : 2021
ISO 9187-1:2018
Injection equipment for medical use Part 1 Ampoules for injectables First Revision
-
Identical under dual numbering
67.
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
68.
IS/ISO 15883-1 : 2006
ISO 15883-1 : 2006
Washer - Disinfectors: Part 1 general requirements, terms and definitions and tests
-
Identical under dual numbering
69.
IS/ISO 15883-2 : 2006
ISO 15883-2 : 2006
Washer - Disinfectors: Part 2 requirements and tests for washer - Disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc
-
Identical under single numbering
70.
IS/ISO 15883-3 : 2006
ISO 15883-3 : 2006
Washer - Disinfectors: Part 3 requirements and tests for washer - Disinfectors employing thermal disinfection for human waste containers
-
Identical under dual numbering
71.
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
72.
IS 16004 : 2024
ISO 6009:2016
Hypodermic Needles for Single Use � Colour Coding for Identification (First Revision)
-
Identical under dual numbering
73.
IS 16004 : 2013
ISO 6009: 1992
Reviewed In : 2018
Hypodermic needles for single use - Colour coding for identification
February, 2018
-
Identical under dual numbering
74.
IS 16097 : 2013
Reviewed In : 2018
Sterile single use scalp vein (Winged Needle) infusion set
March, 2018
-
Indigenous
75.
IS 17547 : 2021
Specification for Vaccine Freezer or Combined Vaccine Freezer and Water-Pack Freezer: Compression Cycle, General Requirements and Testing Methods
-
Indigenous
76.
IS 17588 : 2021
Specification for Cold Box — General requirements and Test methods
-
Modified/Technically Equivalent
77.
IS 17589 : 2021
Specification for Water Packs for use as ice-packs, cool-packs and warm-packs, Requirements and Test methods
-
Indigenous
78.
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
79.
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
80.
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
81.
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
82.
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
83.
IS 18288 : 2023
ISO 20696:2018
Sterile urethral catheters for single use
-
Identical under dual numbering
84.
IS 18292 (Part 1) : 2024
ISO 10555-1:2023
Intravascular Catheters � Sterile and Single-Use Catheters Part 1 General Requirements
-
Identical under dual numbering
85.
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
86.
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
87.
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
88.
IS 18293 (Part 3) : 2023
ISO 13926-3:2019
Pen systems Part 3 Seals for pen-injectors for medical use
-
Identical under dual numbering
89.
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
90.
IS 18319 : 2023
ISO 17665-1:2006
Sterilization of health care products Moist heat Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices
-
Identical under dual numbering
91.
IS 17812 (Part 1) : 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
92.
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
93.
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
94.
IS 18451 : 2023
ISO 20697:2018
Sterile drainage catheters and accessory devices for single use
-
Identical under dual numbering
95.
IS 18446 (Part 1) : 2023
ISO 11140-1:2014
Sterilization of health care products Chemical indicators Part 1: General requirements
-
Identical under dual numbering
96.
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
97.
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
98.
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
99.
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
100.
IS 18478 : 2024
ISO 20698:2018
Catheter systems for neuraxial application Sterile and single-use catheters and accessories
-
Identical under dual numbering
101.
IS 18529 : 2024
ISO 11070:2014
Sterile single-use intravascular introducers, dilators and guidewire
-
Identical under dual numbering
102.
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
103.
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
104.
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
105.
IS 18735 : 2024
ISO 15747:2018
Plastic Containers for Intravenous Injections
-
Identical under dual numbering
106.
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
107.
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
108.
IS 18744 : 2024
ISO 20069:2019
Guidance for assessment and evaluation of changes to drug delivery systems
-
Identical under dual numbering
109.
IS 18855 : 2024
ISO/TS 23128:2019
Medical Devices � Transfusion Set and Blood Bag Compatibility Test Method
-
Identical under dual numbering
110.
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
111.
IS 18866 : 2024
ISO 9626:2016
Stainless Steel Needle Tubing for the Manufacture of Medical Devices � Requirements and Test Methods
-
Identical under dual numbering
112.
IS 18871 : 2024
ISO 28620:2020
Medical Devices � Non-Electrically Driven Portable Infusion Devices
-
Identical under dual numbering
113.
IS 18872 : 2024
ISO 21881:2019
Sterile Packaged Ready for Filling Glass Cartridges
-
Identical under dual numbering
114.
IS 18879 (Part 2) : 2024
ISO 8536-2:2023
Infusion Equipment for Medical Use Part 2 Closures for Infusion Bottles
-
Identical under dual numbering
115.
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
116.
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
117.
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
118.
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
119.
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
120.
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
121.
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
122.
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
123.
IS 18880 : 2024
ISO 13004:2022
Sterilization of Health Care Products � Radiation � Substantiation of Selected Sterilization Dose: Method VDmaxSD
-
Identical under dual numbering
124.
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
125.
IS 18881 (Part 5) : 2024
ISO 13408-5:2006
Aseptic Processing of Health Care Products Part 5 Sterilization in Place
-
Identical under dual numbering
126.
IS 18881 (Part 6) : 2024
ISO 13408-6:2021
Aseptic Processing of Health Care Products Part 6 Isolator Systems
-
Identical under dual numbering
127.
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
128.
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
129.
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
130.
IS 1984 (Part 3) : 2023
ISO 8362-3:2001
Injection containers and accessories Part 3: Aluminum caps for injection vials
-
Identical under dual numbering
131.
IS 1984 (Part 4) : 2023
ISO 8362-2:2015
Injection containers and accessories Part 4: Closures for injection vials
-
Identical under dual numbering
132.
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
133.
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
134.
IS 3118 : 1978
Reviewed In : 2021
Specification for electric bacteriological incubators (First Revision)
December, 2021
-
Indigenous
135.
IS 3119 : 1978
Reviewed In : 2021
Specification for hot air sterilizers (First Revision)
December, 2021
-
Indigenous
136.
IS 3120 : 1999
Reviewed In : 2019
Baby incubators - Specification (Second Revision)
April, 2019
-
Indigenous
137.
IS 3236 : 1992
ISO 595-1
Reviewed In : 2018
Hypodermic syringes for general purposes - Specification (Second Revision)
January, 2018
-
Identical under dual numbering
138.
IS 3237 (Part 1) : 1985
Reviewed In : 2017
Specification for special purpose syringes: Part 1 insulin syringes (Second Revision)
February, 2017
1
Indigenous
139.
IS 3237 (Part 2) : 1985
ISO 594-2
Reviewed In : 2017
Specification for special purpose syringes: Part 2 tuberculin syringes (Second Revision)
March, 2017
-
Identical under dual numbering
140.
IS 3237 (Part 3) : 1985
Reviewed In : 2017
Specification for special purpose syringes: Part 3 bcg syringes (Second Revision)
March, 2017
1
Indigenous
141.
IS 3237 (Part 4) : 1986
Reviewed In : 2017
Specification for special purpose syringes: Part 4 vaccine syringe
March, 2017
-
Indigenous
142.
IS 3237 (Part 5) : 1986
Reviewed In : 2017
Specification for special purpose syringes: Part 5 post operation care syringe (Second Revision)
March, 2017
-
Indigenous
143.
IS 3237 (Part 6) : 1986
Reviewed In : 2017
Specification for special purpose syringes: Part 6 irrigation syringe
March, 2017
-
Indigenous
144.
IS 3237 (Part 7) : 1986
Reviewed In : 2017
Specification for special purpose syringe: Part 7 forced feeding syringe
March, 2017
-
Indigenous
145.
IS 3237 (Part 8) : 1986
Reviewed In : 2017
Specification for special purpose syringes: Part 8 angiography syringe
March, 2017
-
Indigenous
146.
IS 3423 : 1973
Reviewed In : 2018
Specification for glass contafners for transfusion fluids (First Revision)
January, 2018
-
Indigenous
147.
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
148.
IS/ISO 3826-2 : 2008

Plastics collapsible containers for human blood and blood components: Part 2 graphical symbols for use on labels and instruction leaflets
-
Identical under single numbering
149.
IS/ISO 3826-3 : 2006
ISO 3826-3 : 2008
Plastics collapsible containers for human blood and blood components: Part 3 blood bag systems with integrated features
-
Identical under single numbering
150.
IS/ISO 3826-4 : 2015
ISO 3826-4 : 2015
Plastics Collapsible Containers for Human Blood and Blood Components Part 4 Aphaeresis Blood Bag Systems with Integrated Features
-
Identical under single numbering
151.
IS 3829 (Part 1) : 1999
Reviewed In : 2019
Specification for steam sterilizers: Part 1 horizontal cylindrical and horizontal rectangular steam sterilizers, pressure type (For Hospital And Pharmaceutical Use) (Second Revision)
April, 2019
-
Indigenous
152.
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
153.
IS 3829 (Part 3) : 1985
Reviewed In : 2021
Specification for steam sterilizers: Part 3 pressure sterilizers, vertical cylindrical type
December, 2021
2
Indigenous
154.
IS 3830 : 1979
Reviewed In : 2021
Specification for water stills for pyrogen - Free distilled water (Second Revision)
December, 2021
3
Indigenous
155.
IS 3831 : 1979
Reviewed In : 2021
Specification for sterilizer, shallow (Dressing Drum)
December, 2021
4
Indigenous
156.
IS 3992 : 1982
Reviewed In : 2021
Specification for trays, kidney (First Revision)
February, 2021
1
Indigenous
157.
IS 3993 : 1993
Reviewed In : 2019
Trays, instruments - Specification (Second Revision)
December, 2019
-
Indigenous
158.
IS 3994 : 1993
Reviewed In : 2019
Bowls,wash - Specification (Second Revision)
December, 2019
-
Indigenous
159.
IS 3997 : 1982
Reviewed In : 2021
Specification for jars, ointment (First Revision)
February, 2021
1
Indigenous
160.
IS 4033 : 1968
Reviewed In : 2021
General requirements for hospital furniture
December, 2021
1
Indigenous
161.
IS 4034 : 1979
Reviewed In : 2021
Specification for castors for hospital equipment (First Revision)
December, 2021
-
Indigenous
162.
IS 4035 : 1967
Reviewed In : 2021
Specification for trolleys, stretcher
December, 2021
1
Indigenous
163.
IS 4036 : 1967
Reviewed In : 2021
Specification for trolleys, patient
December, 2021
-
Indigenous
164.
IS 4037 : 1967
Reviewed In : 2021
Specification for stretchers and stretcher carriers
December, 2021
1
Indigenous
165.
IS 4148 : 1989
Reviewed In : 2021
Surgical rubber gloves - Specification (First Revision)
November, 2021
3
Indigenous
166.
IS 4266 : 1967
Reviewed In : 2021
Specification for lockers, bedside for hospital use
December, 2021
3
Indigenous
167.
IS 4267 : 1967
Reviewed In : 2021
Specification for stands, wash hand basin
December, 2021
-
Indigenous
168.
IS 4363 : 1980
Reviewed In : 2017
Specification for drip counter E. M. S. pattern (First Revision)
March, 2017
-
Indigenous
169.
IS 4445 : 1967
Reviewed In : 2021
Specification for filter and filter chamber for blood transfusion
December, 2021
-
Indigenous
170.
IS 4455 : 1967
Reviewed In : 2021
Specification for trolleys, soiled linen
December, 2021
-
Indigenous
171.
IS 4458 : 1967
Reviewed In : 2021
Specification for screens, bedside
December, 2021
-
Indigenous
172.
IS 4494 : 1968
Reviewed In : 2021
Specification for tables, overbed
December, 2021
1
Indigenous
173.
IS 4769 : 1968
Reviewed In : 2021
Specification for trolley, dressing
December, 2021
2
Indigenous
174.
IS 4787 : 1968
Reviewed In : 2021
Specification for table, examination
December, 2021
1
Indigenous
175.
IS 5022 : 1989
Reviewed In : 2019
Sterilizer, instruments, table model (Third Revision)
May, 2019
2
Indigenous
176.
IS 5029 : 1979
Reviewed In : 2021
Specification for bedsteads, hospital, general purposes (First Revision)
December, 2021
3
Indigenous
177.
IS 5035 : 1969
Reviewed In : 2021
Specification for sterilizers, bowl and utensil (Pedal Type)
December, 2021
-
Indigenous
178.
IS 5291 : 1969
Reviewed In : 2021
Specification for tables, operation, hydraulic, major
December, 2021
2
Indigenous
179.
IS 5336 : 1969
Reviewed In : 2021
Specification for back rest
December, 2021
-
Indigenous
180.
IS 5337 : 1969
Reviewed In : 2021
Specification for cot, dropside, baby, hospital
December, 2021
1
Indigenous
181.
IS 5630 : 1994
Reviewed In : 2019
Cribs (Cradles), maternity - Specification (First Revision)
April, 2019
-
Indigenous
182.
IS 5631 : 1970
Reviewed In : 2021
Specification for trolley, instrument, plain and curved
December, 2021
1
Indigenous
183.
IS 5880 : 1970
Reviewed In : 2021
Specification for stand, saline - Cum - Irrigator
December, 2021
-
Indigenous
184.
IS 6083 : 1971
Reviewed In : 2021
Specification for table, obstetric, labour
December, 2021
1
Indigenous
185.
IS 6106 : 1971
Reviewed In : 2021
Specification for tables, operation, hydraulic, minor
December, 2021
3
Indigenous
186.
IS 6328 : 1971
Reviewed In : 2021
Specification for table, operation, general purposes (Non - Hydraulic)
December, 2021
-
Indigenous
187.
IS 6593 : 1972
Reviewed In : 2021
Specification for electric serological water - Baths
December, 2021
3
Indigenous
188.
IS 6877 : 1977
Reviewed In : 2021
Specification for cabinet, instruments (First Revision)
December, 2021
-
Identical under dual numbering
189.
IS 6904 : 1973
Reviewed In : 2021
Specification for receptacle, waste
December, 2021
-
Indigenous
190.
IS 6905 : 1973
Reviewed In : 2021
Instruments Table, Mayo's Type
December, 2021
1
Indigenous
191.
IS 7036 : 1982
Reviewed In : 2021
Specification for table, postmortem (First Revision)
December, 2021
1
Indigenous
192.
IS 7081 : 1973
Reviewed In : 2019
Specification for stool, revolving, for hospital use
March, 2019
4
Indigenous
193.
IS 7083 : 1973
Reviewed In : 2021
Specification for trolley, medicine
December, 2021
2
Indigenous
194.
IS 7091 : 1973
Reviewed In : 2021
Specification for lifter, bed, adjustable
December, 2021
-
Indigenous
195.
IS 7099 : 1973
Reviewed In : 2021
Specification for trolley, dressing drum
December, 2021
-
Indigenous
196.
IS 7171 : 1974
Reviewed In : 2017
Specification for drip counter with filter
March, 2017
-
Indigenous
197.
IS 7350 : 1974
Reviewed In : 2018
Specification for needles, spinal
September, 2018
1
Indigenous
198.
IS 7378 : 1974
Reviewed In : 2021
Bed, Fowler's, Hospital
December, 2021
2
Indigenous
199.
IS 7387 : 1974
Reviewed In : 2018
Needle, Biopsy, Liver, Silverman's Pattern
August, 2018
-
Indigenous
200.
IS 7455 : 1974
Reviewed In : 2021
Specification for sterilizer, pressure, hot and cold water
December, 2021
-
Indigenous
201.
IS 7523 : 1974
Reviewed In : 2017
Specification for rubber catheter (Urinary)
March, 2017
1
Indigenous
202.
IS 7596 : 1974
Reviewed In : 2021
Table, Operation, Orthopaedic, Albee's Type
December, 2021
-
Indigenous
203.
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
204.
IS 8078 : 1976
Reviewed In : 2021
Specification for table, operation, paediatric
December, 2021
-
Indigenous
205.
IS 8079 : 1976
Reviewed In : 2021
Specification for table, operation, urological
December, 2021
-
Indigenous
206.
IS 8462 : 1977
Reviewed In : 2021
Specification for sterilizer, portable, vertical, pressure type
December, 2021
3
Indigenous
207.
IS B8462 : 1977
Reviewed In : 2016
Sterilizer, Portable, Vertical, Pressure Type (BI-LINGUAL)
December, 2016
3
Indigenous
208.
IS/ISO 8536-1 : 2011
ISO 8536-1:2011
Infusion equipment for medical use Part 1 Infusion glass bottles
-
Identical under dual numbering
209.
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
210.
IS 9132 : 1979
Reviewed In : 2021
Specification for table, operation, folding type
December, 2021
-
Indigenous
211.
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 (26308)
Walk-in-Freezer Specification
2
MHD 12 (26309)
Vaccine Refrigerator or Combined Refrigerator and Water-Pack Freezer Powered by Solar Direct Drive System General Requirements and Testing Methods

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
1
MHD 12 (25590)
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 2 Double-Ended Pen Needles
2
MHD 12 (25953)
Revision of: IS 1984:2023
Injection Containers and Accessories Part 4 Closures for Injection Vials First Revision
3
MHD 12 (25954)
Revision of: IS/ISO 13408:2008
Aseptic Processing of Health Care Products Part 1 General Requirements First Revision
4
MHD 12 (25955)
Revision of: IS/ISO 80369:2016
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 7 Connectors for Intravascular or Hypodermic Applications First Revision

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 12 (19717)
Blood Donor Couch
2
MHD 12 (19718)
Dialysis Chair
3
MHD 12 (22897)

Revision of: IS 4445:1967
Filter and Filter Chamber for Blood Transfusion Specification First Revision
4
MHD 12 (24230)
Refrigerator or Combined Refrigerator and Water-Pack Freezer Intermittent Mains Powered Compression Cycle General Requirements and Test Methods
5
MHD 12 (24231)
Vaccine Carriers General Requirements and Test Methods
6
MHD 12 (25422)
Infusion Equipment for Medical Use Part 3 Aluminium Caps for Infusion Bottles
7
MHD 12 (25424)
Infusion Equipment for Medical Use Part 6 Freeze Drying Closures for Infusion Bottles
8
MHD 12 (25426)
Infusion equipment for medical use Part 8 Infusion sets for single use with pressure infusion apparatus
9
MHD 12 (25434)
Infusion Equipment for Medical Use Part 15 Light-Protective Infusion Sets for Single Use
10
MHD 12 (25435)
Aseptic Processing of Health Care Products Part 3 Lyophilization


Aspect Wise Report

 
 Product:   164
 Code of Practices :    14
 Methods of Test :   6
 Terminology :   1
 Dimensions :   0
 System Standard :   0
 Safety Standard :   0
 Others :    10
 Service Specification :    0
 Process Specification :    10
 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/ISO 10555-2 : 1996
Reviewed In : 2014
Sterile single-use intravascular catheters-Part 2 Angiographic Catheters
3.
IS 12050 : 1986
Reviewed In : 2017
Specification for sterile hypodermic syringes with needle attached for single use
4.
IS 12227 : 2002
ISO 8537
Reviewed In : 2012
Sterile Single-Use Syringes With or Without Needle for Insulin
5.
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
6.
IS 15102 : 2002
ISO 3826
Reviewed In : 2017
Plastics Collapsible Containers for Human Blood and Blood Components
7.
IS 15354 : 2003
ISO 11193
Reviewed In : 2014
Single-Use Rubber Examination Gloves
8.
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
9.
IS/ISO/TS 15883-5 : 2005
ISO/TS 15883-5 : 200
Washer-disinfectors Part 5 Test soils and methods for demonstrating cleaning efficacy
10.
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
11.
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
12.
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
13.
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
14.
IS 3235 : 1988
ISO 595-2
Reviewed In : 2021
General requirements for syringes for medical use Second Revision
15.
IS 3998 : 1982
Reviewed In : 2006
Cups Medicine
16.
IS 4068 : 1967
Reviewed In : 2007
Specification for broken brick Burnt Clay coarse aggregate for use in lime concrete
17.
IS 4510 : 1978
Redesignated as IS 3829 Part 2
18.
IS 489 (Part 1) : 1973
Reviewed In : 2008
Glass Ampoules - Part I Ampoules for Liquid Injectables
19.
IS 489 (Part 2) : 1973
Reviewed In : 2003
Glass Ampoules - Part II Ampoules for lyophilized injectable
20.
IS 490 : 1967
Vaccine Phials
21.
IS 5156 : 1969
Calorimeter Cup Duboscq Type
22.
IS 5335 : 1969
Tables bedsides
23.
IS 5764 : 1994
Bowls Solution
24.
IS 5782 : 1994
Bowls Sponge
25.
IS 6208 : 1971
Reviewed In : 2017
Specification for spoons plastics measuring medicine
26.
IS/ISO 8362-1 : 2003
ISO8362-1:2003
Reviewed In : 2019
Injection containers and accessories Part 1 injection vials made of glass tubing
27.
IS 9395 : 1979
Reviewed In : 2016
Specification for bed intensive care
28.
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
29.
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
30.
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 10263 : 1982
Reviewed In : 2021
Specification for deep fat fryer single and double pan electrically operated for large catering establishments
6.
IS 10264 : 1982
Reviewed In : 2021
Specification for trolley hot food for hospital and industrial cantee - Ns
7.
IS/ISO 10555-1 : 2013
ISO 10555-1 : 2013
Intravascular catheters - Sterile and single - Use catheters Part 1 general requirements First Revision
8.
IS/ISO 10555-3 : 2013
ISO 10555-3 : 2013
Intravascular catheters - Sterile and single - Use catheters Part 3 central venous catheters First Revision
9.
IS/ISO 10555-4 : 2013
ISO 10555-4 : 2013
Reviewed In : 2019
Intravascular Catheters Sterile and Single-Use Catheters Part 4 Balloon Dilatation Catheters First Revision
10.
IS/ISO 10555-5 : 2013

Intravascular catheters - Sterile and single - Use catheters Part 5 over - Needle peripheral catheters First Revision
11.
IS 10603 : 1983
Reviewed In : 2021
Specification for abdominal belts
12.
IS 10654 : 2018
ISO 7864 : 2016
Sterile hypodermic needles for single use - Requirements and test methods Fourth Revision
13.
IS 10783 : 1983
Reviewed In : 2021
Specification for patient - Lifting devices mobile manually operated
14.
IS 10985 : 1984
Reviewed In : 2017
Specification for needle acupuncture
15.
IS 11040 (Part 1) : 2015
ISO 11040-1 : 2015
Prefilled syringes Part 1 Glass cylinders for dental local anaesthetic cartridges
16.
IS/ISO 11040-2 : 2011
ISO 11040-2:2011
Prefilled syringes Part 2 Plunger stoppers for dental local anaesthetic cartridges
17.
IS/ISO 11040-3 : 2012
ISO 11040-3:2012
Prefilled syringes Part 3 Seals for dental local anaesthetic cartridges
18.
IS/ISO 11040-4 : 2015
ISO 11040-4 : 2015
Prefilled syringes Part 4 Glass barrels for injectables and sterilized subassembled syringes ready for filling
19.
IS/ISO 11040-5 : 2012
ISO 11040-5:2012
Prefilled syringes Part 5 Plunger stoppers for injectables
20.
IS 11043 : 1984
Reviewed In : 2017
Specification for needle epidural
21.
IS 1108 : 1975
Reviewed In : 2017
Specification for pharmaceutical glass containers Second Revision
22.
IS/ISO 11138-1 : 2017
ISO 11138-1 : 2017
Sterilization of Health Care Products Biological Indicators Part 1 General Requirements
23.
IS/ISO 11138-2 : 2017
ISO 11138-2 : 2017
Sterilization of Health Care Products Biological Indicators Part 2 Biological Indicators for Ethylene Oxide Sterilization Processes
24.
IS/ISO 11138-3 : 2017
ISO 11138-3 : 2017
Sterilization of Healthcare Products Biological Indicators Part 3 Biological Indicators for Moist Heat Sterilization Processes
25.
IS/ISO 11138-4 : 2017
ISO 11138-4 : 2017
Sterilization of Health Care Products Biological Indicators Part 4 Biological Indicators for Dry Heat Sterilization Processes
26.
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
27.
IS/ISO 1135-3 : 2016
ISO 1135-3:2016
Transfusion equipment for medical use Part 3 Blood-taking sets for single use
28.
IS/ISO 1135-4 : 2015
ISO 1135-4 : 2015
Transfusion Equipment for Medical Use Part 4 Transfusion Sets for Single use Gravity Feed
29.
IS 11400 : 1985
Reviewed In : 2017
Specification for hypodermic syringes interchangeable type for general purposes
30.
IS/ISO 11418-1 : 2016
ISO 11418-1 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 1 Drop-Dispensing Glass
31.
IS/ISO 11418-2 : 2016
ISO 11418-2 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 2 Screw-Neck Glass Bottles for Syrups
32.
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
33.
IS/ISO 11418-5 : 2015
ISO 11418-5 : 2015
Containers and Accessories for Pharmaceutical Preparations Part 5 Dropper Assemblies
34.
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
35.
IS 12173 : 1987
Reviewed In : 2018
Specification for cervical halter
36.
IS 13115 : 1991
Reviewed In : 2021
Portable first - Aid kit for general use - Specification
37.
IS B13115 : 1991
Reviewed In : 2016
Portable First Aid Kit for General Use Bi-lingual
38.
IS 13422 : 2024
ISO 10282:2023
Single-use Sterile Rubber Surgical Gloves Specification First Revision
39.
IS/ISO 13926-1 : 2018
ISO 13926-1:2018
Pen systems Part 1 Glass cylinders for pen-injectors for medical use
40.
IS/ISO 13926-2 : 2017
ISO 13926-2:2017
Pen systems Part 2 Plunger stoppers for pen-injectors for medical use
41.
IS 14193 : 1994
Reviewed In : 2021
Ovulation thermometers - Specification
42.
IS B14316 : 1995
Reviewed In : 2016
Swabs Small in Bag of 50 Bi-lingual
43.
IS 15110 : 2002
Reviewed In : 2017
Veterinary thermometers mercury - In - Glass type - Specification
44.
IS 15113 : 2002
Reviewed In : 2017
Clinical electrical thermometers with maximum device - Specification
45.
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
46.
IS 15537 : 2021
ISO 9187-1:2018
Injection equipment for medical use Part 1 Ampoules for injectables First Revision
47.
IS 15537 (Part 2) : 2023
ISO 9187-2:2010
Injection equipment for medical use Part 2 One-point-cut OPC ampoules
48.
IS/ISO 15883-1 : 2006
ISO 15883-1 : 2006
Washer - Disinfectors Part 1 general requirements terms and definitions and tests
49.
IS 16097 : 2013
Reviewed In : 2018
Sterile single use scalp vein Winged Needle infusion set
50.
IS 17547 : 2021
Specification for Vaccine Freezer or Combined Vaccine Freezer and Water-Pack Freezer Compression Cycle General Requirements and Testing Methods
51.
IS 17588 : 2021
Specification for Cold Box General requirements and Test methods
52.
IS 17589 : 2021
Specification for Water Packs for use as ice-packs cool-packs and warm-packs Requirements and Test methods
53.
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
54.
IS 18288 : 2023
ISO 20696:2018
Sterile urethral catheters for single use
55.
IS 18292 (Part 1) : 2024
ISO 10555-1:2023
Intravascular Catheters Sterile and Single-Use Catheters Part 1 General Requirements
56.
IS 18292 (Part 4) : 2024
ISO 10555-4:2023
Intravascular Catheters Sterile and Single-Use Catheters Part 4 Balloon Dilatation Catheters First Revision
57.
IS 18292 (Part 6) : 2023
ISO 10555-6:2015
Intravascular catheters Sterile and single-use catheters Part 6 Subcutaneous implanted ports
58.
IS 18292 (Part 7) : 2024
ISO 10555-7:2023
Intravascular Catheters Sterile and Single-Use Catheters Part 7 Peripherally Inserted Central Catheters
59.
IS 18293 (Part 3) : 2023
ISO 13926-3:2019
Pen systems Part 3 Seals for pen-injectors for medical use
60.
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
61.
IS 18451 : 2023
ISO 20697:2018
Sterile drainage catheters and accessory devices for single use
62.
IS 18446 (Part 1) : 2023
ISO 11140-1:2014
Sterilization of health care products Chemical indicators Part 1 General requirements
63.
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
64.
IS 18478 : 2024
ISO 20698:2018
Catheter systems for neuraxial application Sterile and single-use catheters and accessories
65.
IS 18529 : 2024
ISO 11070:2014
Sterile single-use intravascular introducers dilators and guidewire
66.
IS 18723 : 2024
ISO 6717:2021
In vitro diagnostic medical devices Single-use containers for the collection of specimens from humans other than blood
67.
IS 18735 : 2024
ISO 15747:2018
Plastic Containers for Intravenous Injections
68.
IS 18866 : 2024
ISO 9626:2016
Stainless Steel Needle Tubing for the Manufacture of Medical Devices Requirements and Test Methods
69.
IS 18871 : 2024
ISO 28620:2020
Medical Devices Non-Electrically Driven Portable Infusion Devices
70.
IS 18872 : 2024
ISO 21881:2019
Sterile Packaged Ready for Filling Glass Cartridges
71.
IS 18879 (Part 2) : 2024
ISO 8536-2:2023
Infusion Equipment for Medical Use Part 2 Closures for Infusion Bottles
72.
IS 18879 (Part 5) : 2024
ISO 8536-5:2004
Infusion Equipment for Medical Use Part 5 Burette Infusion Sets for Single Use Gravity Feed
73.
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
74.
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
75.
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
76.
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
77.
IS 18879 (Part 12) : 2024
ISO 8536-12:2021
Infusion Equipment for Medical Use Part 12 Check Valves for Single Use
78.
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
79.
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
80.
IS 1984 (Part 1) : 2023
ISO 8362-1:2018
Injection containers and accessories Part 1 Injection vials made of glass tubing First Revision
81.
IS 1984 (Part 2) : 2023
ISO 8362-4:2011
Injection containers and accessories Part 2 Injection vials made of moulded glass Third Revision
82.
IS 1984 (Part 3) : 2023
ISO 8362-3:2001
Injection containers and accessories Part 3 Aluminum caps for injection vials
83.
IS 1984 (Part 4) : 2023
ISO 8362-2:2015
Injection containers and accessories Part 4 Closures for injection vials
84.
IS 1984 (Part 5) : 2024
ISO 8362-5:2016
Injection Containers and Accessories Part 5 Freeze Drying Closures for Injection Vials
85.
IS 1984 (Part 6) : 2024
ISO 8362-6:2010
Injection Containers and Accessories Part 6 Caps Made of Aluminium-Plastics Combinations for Injection Vials
86.
IS 3118 : 1978
Reviewed In : 2021
Specification for electric bacteriological incubators First Revision
87.
IS 3119 : 1978
Reviewed In : 2021
Specification for hot air sterilizers First Revision
88.
IS 3120 : 1999
Reviewed In : 2019
Baby incubators - Specification Second Revision
89.
IS 3236 : 1992
ISO 595-1
Reviewed In : 2018
Hypodermic syringes for general purposes - Specification Second Revision
90.
IS 3237 (Part 1) : 1985
Reviewed In : 2017
Specification for special purpose syringes Part 1 insulin syringes Second Revision
91.
IS 3237 (Part 2) : 1985
ISO 594-2
Reviewed In : 2017
Specification for special purpose syringes Part 2 tuberculin syringes Second Revision
92.
IS 3237 (Part 3) : 1985
Reviewed In : 2017
Specification for special purpose syringes Part 3 bcg syringes Second Revision
93.
IS 3237 (Part 4) : 1986
Reviewed In : 2017
Specification for special purpose syringes Part 4 vaccine syringe
94.
IS 3237 (Part 5) : 1986
Reviewed In : 2017
Specification for special purpose syringes Part 5 post operation care syringe Second Revision
95.
IS 3237 (Part 6) : 1986
Reviewed In : 2017
Specification for special purpose syringes Part 6 irrigation syringe
96.
IS 3237 (Part 7) : 1986
Reviewed In : 2017
Specification for special purpose syringe Part 7 forced feeding syringe
97.
IS 3237 (Part 8) : 1986
Reviewed In : 2017
Specification for special purpose syringes Part 8 angiography syringe
98.
IS 3423 : 1973
Reviewed In : 2018
Specification for glass contafners for transfusion fluids First Revision
99.
IS/ISO 3826-1 : 2019
ISO 3826-1:2019
Plastics collapsible containers for human blood and blood components Part 1 Conventional containers First Revision
100.
IS/ISO 3826-2 : 2008

Plastics collapsible containers for human blood and blood components Part 2 graphical symbols for use on labels and instruction leaflets
101.
IS/ISO 3826-3 : 2006
ISO 3826-3 : 2008
Plastics collapsible containers for human blood and blood components Part 3 blood bag systems with integrated features
102.
IS/ISO 3826-4 : 2015
ISO 3826-4 : 2015
Plastics Collapsible Containers for Human Blood and Blood Components Part 4 Aphaeresis Blood Bag Systems with Integrated Features
103.
IS 3829 (Part 1) : 1999
Reviewed In : 2019
Specification for steam sterilizers Part 1 horizontal cylindrical and horizontal rectangular steam sterilizers pressure type For Hospital And Pharmaceutical Use Second Revision
104.
IS 3829 (Part 2) : 1978
Reviewed In : 2021
Specification for steam sterilizers Part 2 horizontal cylindrical high speed steam sterilizers pressure type First Revision
105.
IS 3829 (Part 3) : 1985
Reviewed In : 2021
Specification for steam sterilizers Part 3 pressure sterilizers vertical cylindrical type
106.
IS 3830 : 1979
Reviewed In : 2021
Specification for water stills for pyrogen - Free distilled water Second Revision
107.
IS 3831 : 1979
Reviewed In : 2021
Specification for sterilizer shallow Dressing Drum
108.
IS 3992 : 1982
Reviewed In : 2021
Specification for trays kidney First Revision
109.
IS 3993 : 1993
Reviewed In : 2019
Trays instruments - Specification Second Revision
110.
IS 3994 : 1993
Reviewed In : 2019
Bowls wash - Specification Second Revision
111.
IS 3997 : 1982
Reviewed In : 2021
Specification for jars ointment First Revision
112.
IS 4033 : 1968
Reviewed In : 2021
General requirements for hospital furniture
113.
IS 4034 : 1979
Reviewed In : 2021
Specification for castors for hospital equipment First Revision
114.
IS 4035 : 1967
Reviewed In : 2021
Specification for trolleys stretcher
115.
IS 4036 : 1967
Reviewed In : 2021
Specification for trolleys patient
116.
IS 4037 : 1967
Reviewed In : 2021
Specification for stretchers and stretcher carriers
117.
IS 4148 : 1989
Reviewed In : 2021
Surgical rubber gloves - Specification First Revision
118.
IS 4266 : 1967
Reviewed In : 2021
Specification for lockers bedside for hospital use
119.
IS 4267 : 1967
Reviewed In : 2021
Specification for stands wash hand basin
120.
IS 4363 : 1980
Reviewed In : 2017
Specification for drip counter E M S pattern First Revision
121.
IS 4445 : 1967
Reviewed In : 2021
Specification for filter and filter chamber for blood transfusion
122.
IS 4455 : 1967
Reviewed In : 2021
Specification for trolleys soiled linen
123.
IS 4458 : 1967
Reviewed In : 2021
Specification for screens bedside
124.
IS 4494 : 1968
Reviewed In : 2021
Specification for tables overbed
125.
IS 4769 : 1968
Reviewed In : 2021
Specification for trolley dressing
126.
IS 4787 : 1968
Reviewed In : 2021
Specification for table examination
127.
IS 5022 : 1989
Reviewed In : 2019
Sterilizer instruments table model Third Revision
128.
IS 5029 : 1979
Reviewed In : 2021
Specification for bedsteads hospital general purposes First Revision
129.
IS 5035 : 1969
Reviewed In : 2021
Specification for sterilizers bowl and utensil Pedal Type
130.
IS 5291 : 1969
Reviewed In : 2021
Specification for tables operation hydraulic major
131.
IS 5336 : 1969
Reviewed In : 2021
Specification for back rest
132.
IS 5337 : 1969
Reviewed In : 2021
Specification for cot dropside baby hospital
133.
IS 5630 : 1994
Reviewed In : 2019
Cribs Cradles maternity - Specification First Revision
134.
IS 5631 : 1970
Reviewed In : 2021
Specification for trolley instrument plain and curved
135.
IS 5880 : 1970
Reviewed In : 2021
Specification for stand saline - Cum - Irrigator
136.
IS 6083 : 1971
Reviewed In : 2021
Specification for table obstetric labour
137.
IS 6106 : 1971
Reviewed In : 2021
Specification for tables operation hydraulic minor
138.
IS 6328 : 1971
Reviewed In : 2021
Specification for table operation general purposes Non - Hydraulic
139.
IS 6593 : 1972
Reviewed In : 2021
Specification for electric serological water - Baths
140.
IS 6877 : 1977
Reviewed In : 2021
Specification for cabinet instruments First Revision
141.
IS 6904 : 1973
Reviewed In : 2021
Specification for receptacle waste
142.
IS 6905 : 1973
Reviewed In : 2021
Instruments Table Mayo s Type
143.
IS 7036 : 1982
Reviewed In : 2021
Specification for table postmortem First Revision
144.
IS 7081 : 1973
Reviewed In : 2019
Specification for stool revolving for hospital use
145.
IS 7083 : 1973
Reviewed In : 2021
Specification for trolley medicine
146.
IS 7091 : 1973
Reviewed In : 2021
Specification for lifter bed adjustable
147.
IS 7099 : 1973
Reviewed In : 2021
Specification for trolley dressing drum
148.
IS 7171 : 1974
Reviewed In : 2017
Specification for drip counter with filter
149.
IS 7350 : 1974
Reviewed In : 2018
Specification for needles spinal
150.
IS 7378 : 1974
Reviewed In : 2021
Bed Fowler s Hospital
151.
IS 7387 : 1974
Reviewed In : 2018
Needle Biopsy Liver Silverman s Pattern
152.
IS 7455 : 1974
Reviewed In : 2021
Specification for sterilizer pressure hot and cold water
153.
IS 7523 : 1974
Reviewed In : 2017
Specification for rubber catheter Urinary
154.
IS 7596 : 1974
Reviewed In : 2021
Table Operation Orthopaedic Albee s Type
155.
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
156.
IS 8078 : 1976
Reviewed In : 2021
Specification for table operation paediatric
157.
IS 8079 : 1976
Reviewed In : 2021
Specification for table operation urological
158.
IS 8462 : 1977
Reviewed In : 2021
Specification for sterilizer portable vertical pressure type
159.
IS B8462 : 1977
Reviewed In : 2016
Sterilizer Portable Vertical Pressure Type BI-LINGUAL
160.
IS/ISO 8536-1 : 2011
ISO 8536-1:2011
Infusion equipment for medical use Part 1 Infusion glass bottles
161.
IS/ISO 8536-4 : 2019
ISO 8536-4:2019
Infusion equipment for medical use Part 4 Infusion sets for single use gravity feed
162.
IS 9132 : 1979
Reviewed In : 2021
Specification for table operation folding type
163.
IS 9133 : 1979
Reviewed In : 2021
Specification for trolley for general medical store