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 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 10263 : 1982
Reviewed In : 2021
Specification for deep fat fryer, single and double pan electrically operated, for large catering establishments
December, 2021
-
Indigenous
5.
IS 10264 : 1982
Reviewed In : 2021
Specification for trolley, hot food, for hospital and industrial cantee - Ns
December, 2021
-
Indigenous
6.
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
7.
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
8.
IS/ISO 10555-4 : 2013

Reviewed In : 2019
Sterile, single - Use intravascular catheters: Part 4 balloon dilatation catheters
December, 2019
-
Identical under single numbering
9.
IS/ISO 10555-5 : 2013

Intravascular catheters - Sterile and single - Use catheters: Part 5 over - Needle peripheral catheters (First Revision)
-
Identical under single numbering
10.
IS 10603 : 1983
Reviewed In : 2021
Specification for abdominal belts
February, 2021
-
Indigenous
11.
IS 10654 : 2018
ISO 7864 : 2016
Sterile hypodermic needles for single use - Requirements and test methods (Fourth Revision)
-
Identical under dual numbering
12.
IS 10783 : 1983
Reviewed In : 2021
Specification for patient - Lifting devices, mobile, manually operated
December, 2021
-
Indigenous
13.
IS 10985 : 1984
Reviewed In : 2017
Specification for needle, acupuncture
March, 2017
-
Indigenous
14.
IS 11040 (Part 1) : 2015
ISO 11040-1 : 2015
Prefilled syringes Part 1 : Glass cylinders for dental local anaesthetic cartridges
-
Identical under single numbering
15.
IS/ISO 11040-2 : 2011
ISO 11040-2:2011
Prefilled syringes Part 2 Plunger stoppers for dental local anaesthetic cartridges
-
Identical under single numbering
16.
IS/ISO 11040-3 : 2012
ISO 11040-3:2012
Prefilled syringes Part 3 Seals for dental local anaesthetic cartridges
-
Identical under single numbering
17.
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
18.
IS/ISO 11040-5 : 2012
ISO 11040-5:2012
Prefilled syringes Part 5 Plunger stoppers for injectables
-
Identical under single numbering
19.
IS 11043 : 1984
Reviewed In : 2017
Specification for needle, epidural
March, 2017
-
Indigenous
20.
IS 1108 : 1975
Reviewed In : 2017
Specification for pharmaceutical glass containers (Second Revision)
March, 2017
-
Indigenous
21.
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
22.
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
23.
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
24.
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
25.
IS/ISO 11138-1 : 2017
ISO 11138-1 : 2017
Sterilization of Health Care Products ― Biological Indicators Part 1 General Requirements
-
Identical under single numbering
26.
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
27.
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
28.
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
29.
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
30.
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
31.
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
32.
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
33.
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
34.
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
35.
IS 11400 : 1985
Reviewed In : 2017
Specification for hypodermic syringes, interchangeable type for general purposes
March, 2017
-
Indigenous
36.
IS/ISO 11418-1 : 2016
ISO 11418-1 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 1 Drop-Dispensing Glass
-
Identical under single numbering
37.
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
38.
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
39.
IS/ISO 11418-5 : 2015
ISO 11418-5 : 2015
Containers and Accessories for Pharmaceutical Preparations Part 5 Dropper Assemblies
-
Identical under single numbering
40.
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
41.
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
42.
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
43.
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
44.
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
45.
IS 12173 : 1987
Reviewed In : 2018
Specification for cervical halter
September, 2018
-
Indigenous
46.
IS 12227 : 2020
ISO 8537 : 2016
Sterile Single-Use Syringes, With or Without Needle, for Insulin ( Second Revision )
-
-
Identical under dual numbering
47.
IS 12430 : 1987
Reviewed In : 2018
Safety code for installation, servicing maintenanceand of sterilizers
July, 2018
-
Indigenous
48.
IS 13115 : 1991
Reviewed In : 2021
Portable first - Aid kit for general use - Specification
December, 2021
1
Indigenous
49.
IS B13115 : 1991
Reviewed In : 2016
Portable First Aid Kit for General Use (Bi-lingual)
December, 2016
1
Indigenous
50.
IS/ISO 13408-1 : 2008
ISO 13408-1:2008
Aseptic processing of health care products Part 1 General requirements
-
Identical under single numbering
51.
IS/ISO 13408-2 : 2018
ISO 13408-2:2018
Aseptic processing of health care products Part 2 Sterilizing filtration
-
Identical under single numbering
52.
IS 13422 : 1992
Reviewed In : 2018
Disposable surgical rubber gloves specification
June, 2018
-
Indigenous
53.
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
54.
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
55.
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
56.
IS 14193 : 1994
Reviewed In : 2021
Ovulation thermometers - Specification
February, 2021
-
Indigenous
57.
IS B14316 : 1995
Reviewed In : 2016
Swabs, Small, in Bag of 50 (Bi-lingual)
February, 2016
-
58.
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
59.
IS 15110 : 2002
Reviewed In : 2017
Veterinary thermometers, mercury - In - Glass type - Specification
March, 2017
-
Indigenous
60.
IS 15113 : 2002
Reviewed In : 2017
Clinical electrical thermometers with maximum device - Specification
March, 2017
1
Indigenous
61.
IS 15354 (Part 1) : 2018
ISO 11193-1 : 2008
Single - Use medical examination gloves: Part 1 specification for gloves made from rubber latex or rubber solution (First Revision)
-
Identical under dual numbering
62.
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
63.
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
64.
IS 15537 : 2021
ISO 9187-1:2018
Injection equipment for medical use Part 1 Ampoules for injectables First Revision
-
Identical under dual numbering
65.
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
66.
IS/ISO 15883-1 : 2006
ISO 15883-1 : 2006
Washer - Disinfectors: Part 1 general requirements, terms and definitions and tests
-
Identical under dual numbering
67.
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
68.
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
69.
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
70.
IS 16004 : 2013
ISO 6009: 1992
Reviewed In : 2018
Hypodermic needles for single use - Colour coding for identification
February, 2018
-
Identical under dual numbering
71.
IS 16097 : 2013
Reviewed In : 2018
Sterile single use scalp vein (Winged Needle) infusion set
March, 2018
-
Indigenous
72.
IS 17547 : 2021
Specification for Vaccine Freezer or Combined Vaccine Freezer and Water-Pack Freezer: Compression Cycle, General Requirements and Testing Methods
-
Indigenous
73.
IS 17588 : 2021
Specification for Cold Box — General requirements and Test methods
-
Modified/Technically Equivalent
74.
IS 17589 : 2021
Specification for Water Packs for use as ice-packs, cool-packs and warm-packs, Requirements and Test methods
-
Indigenous
75.
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
-
Identical under single numbering
76.
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
77.
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
78.
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
79.
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
80.
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
81.
IS 18288 : 2023
ISO 20696:2018
Sterile urethral catheters for single use
-
Identical under dual numbering
82.
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
83.
IS 18293 (Part 3) : 2023
ISO 13926-3:2019
Pen systems Part 3 Seals for pen-injectors for medical use
-
Identical under dual numbering
84.
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
85.
IS 18319 (Part 1) : 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
86.
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
87.
IS 18451 : 2023
ISO 20697:2018
Sterile drainage catheters and accessory devices for single use
-
Identical under dual numbering
88.
IS 18446 (Part 1) : 2023
ISO 11140-1:2014
Sterilization of health care products Chemical indicators Part 1: General requirements
-
Identical under dual numbering
89.
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
90.
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
91.
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
92.
IS 18478 : 2024
ISO 20698:2018
Catheter systems for neuraxial application Sterile and single-use catheters and accessories
-
Identical under dual numbering
93.
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
94.
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
95.
IS 1984 (Part 3) : 2023
ISO 8362-3:2001
Injection containers and accessories Part 3: Aluminum caps for injection vials
-
Identical under dual numbering
96.
IS 1984 (Part 4) : 2023
ISO 8362-2:2015
Injection containers and accessories Part 4: Closures for injection vials
-
Identical under dual numbering
97.
IS 3118 : 1978
Reviewed In : 2021
Specification for electric bacteriological incubators (First Revision)
December, 2021
-
Indigenous
98.
IS 3119 : 1978
Reviewed In : 2021
Specification for hot air sterilizers (First Revision)
December, 2021
-
Indigenous
99.
IS 3120 : 1999
Reviewed In : 2019
Baby incubators - Specification (Second Revision)
April, 2019
-
Indigenous
100.
IS 3236 : 1992
ISO 595-1
Reviewed In : 2018
Hypodermic syringes for general purposes - Specification (Second Revision)
January, 2018
-
Identical under dual numbering
101.
IS 3237 (Part 1) : 1985
Reviewed In : 2017
Specification for special purpose syringes: Part 1 insulin syringes (Second Revision)
February, 2017
1
Indigenous
102.
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
103.
IS 3237 (Part 3) : 1985
Reviewed In : 2017
Specification for special purpose syringes: Part 3 bcg syringes (Second Revision)
March, 2017
1
Indigenous
104.
IS 3237 (Part 4) : 1986
Reviewed In : 2017
Specification for special purpose syringes: Part 4 vaccine syringe
March, 2017
-
Indigenous
105.
IS 3237 (Part 5) : 1986
Reviewed In : 2017
Specification for special purpose syringes: Part 5 post operation care syringe (Second Revision)
March, 2017
-
Indigenous
106.
IS 3237 (Part 6) : 1986
Reviewed In : 2017
Specification for special purpose syringes: Part 6 irrigation syringe
March, 2017
-
Indigenous
107.
IS 3237 (Part 7) : 1986
Reviewed In : 2017
Specification for special purpose syringe: Part 7 forced feeding syringe
March, 2017
-
Indigenous
108.
IS 3237 (Part 8) : 1986
Reviewed In : 2017
Specification for special purpose syringes: Part 8 angiography syringe
March, 2017
-
Indigenous
109.
IS 3423 : 1973
Reviewed In : 2018
Specification for glass contafners for transfusion fluids (First Revision)
January, 2018
-
Indigenous
110.
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
111.
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
112.
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
113.
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
114.
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
115.
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
116.
IS 3829 (Part 3) : 1985
Reviewed In : 2021
Specification for steam sterilizers: Part 3 pressure sterilizers, vertical cylindrical type
December, 2021
2
Indigenous
117.
IS 3830 : 1979
Reviewed In : 2021
Specification for water stills for pyrogen - Free distilled water (Second Revision)
December, 2021
3
Indigenous
118.
IS 3831 : 1979
Reviewed In : 2021
Specification for sterilizer, shallow (Dressing Drum)
December, 2021
4
Indigenous
119.
IS 3992 : 1982
Reviewed In : 2021
Specification for trays, kidney (First Revision)
February, 2021
1
Indigenous
120.
IS 3993 : 1993
Reviewed In : 2019
Trays, instruments - Specification (Second Revision)
December, 2019
-
Indigenous
121.
IS 3994 : 1993
Reviewed In : 2019
Bowls,wash - Specification (Second Revision)
December, 2019
-
Indigenous
122.
IS 3997 : 1982
Reviewed In : 2021
Specification for jars, ointment (First Revision)
February, 2021
1
Indigenous
123.
IS 4033 : 1968
Reviewed In : 2021
General requirements for hospital furniture
December, 2021
1
Indigenous
124.
IS 4034 : 1979
Reviewed In : 2021
Specification for castors for hospital equipment (First Revision)
December, 2021
-
Indigenous
125.
IS 4035 : 1967
Reviewed In : 2021
Specification for trolleys, stretcher
December, 2021
1
Indigenous
126.
IS 4036 : 1967
Reviewed In : 2021
Specification for trolleys, patient
December, 2021
-
Indigenous
127.
IS 4037 : 1967
Reviewed In : 2021
Specification for stretchers and stretcher carriers
December, 2021
1
Indigenous
128.
IS 4148 : 1989
Reviewed In : 2021
Surgical rubber gloves - Specification (First Revision)
November, 2021
3
Indigenous
129.
IS 4266 : 1967
Reviewed In : 2021
Specification for lockers, bedside for hospital use
December, 2021
3
Indigenous
130.
IS 4267 : 1967
Reviewed In : 2021
Specification for stands, wash hand basin
December, 2021
-
Indigenous
131.
IS 4363 : 1980
Reviewed In : 2017
Specification for drip counter E. M. S. pattern (First Revision)
March, 2017
-
Indigenous
132.
IS 4445 : 1967
Reviewed In : 2021
Specification for filter and filter chamber for blood transfusion
December, 2021
-
Indigenous
133.
IS 4455 : 1967
Reviewed In : 2021
Specification for trolleys, soiled linen
December, 2021
-
Indigenous
134.
IS 4458 : 1967
Reviewed In : 2021
Specification for screens, bedside
December, 2021
-
Indigenous
135.
IS 4494 : 1968
Reviewed In : 2021
Specification for tables, overbed
December, 2021
1
Indigenous
136.
IS 4769 : 1968
Reviewed In : 2021
Specification for trolley, dressing
December, 2021
2
Indigenous
137.
IS 4787 : 1968
Reviewed In : 2021
Specification for table, examination
December, 2021
1
Indigenous
138.
IS 5022 : 1989
Reviewed In : 2019
Sterilizer, instruments, table model (Third Revision)
May, 2019
2
Indigenous
139.
IS 5029 : 1979
Reviewed In : 2021
Specification for bedsteads, hospital, general purposes (First Revision)
December, 2021
3
Indigenous
140.
IS 5035 : 1969
Reviewed In : 2021
Specification for sterilizers, bowl and utensil (Pedal Type)
December, 2021
-
Indigenous
141.
IS 5291 : 1969
Reviewed In : 2021
Specification for tables, operation, hydraulic, major
December, 2021
2
Indigenous
142.
IS 5336 : 1969
Reviewed In : 2021
Specification for back rest
December, 2021
-
Indigenous
143.
IS 5337 : 1969
Reviewed In : 2021
Specification for cot, dropside, baby, hospital
December, 2021
1
Indigenous
144.
IS 5630 : 1994
Reviewed In : 2019
Cribs (Cradles), maternity - Specification (First Revision)
April, 2019
-
Indigenous
145.
IS 5631 : 1970
Reviewed In : 2021
Specification for trolley, instrument, plain and curved
December, 2021
1
Indigenous
146.
IS 5880 : 1970
Reviewed In : 2021
Specification for stand, saline - Cum - Irrigator
December, 2021
-
Indigenous
147.
IS 6083 : 1971
Reviewed In : 2021
Specification for table, obstetric, labour
December, 2021
1
Indigenous
148.
IS 6106 : 1971
Reviewed In : 2021
Specification for tables, operation, hydraulic, minor
December, 2021
3
Indigenous
149.
IS 6328 : 1971
Reviewed In : 2021
Specification for table, operation, general purposes (Non - Hydraulic)
December, 2021
-
Indigenous
150.
IS 6593 : 1972
Reviewed In : 2021
Specification for electric serological water - Baths
December, 2021
3
Indigenous
151.
IS 6877 : 1977
Reviewed In : 2021
Specification for cabinet, instruments (First Revision)
December, 2021
-
Identical under dual numbering
152.
IS 6904 : 1973
Reviewed In : 2021
Specification for receptacle, waste
December, 2021
-
Indigenous
153.
IS 6905 : 1973
Reviewed In : 2021
Instruments Table, Mayo's Type
December, 2021
1
Indigenous
154.
IS 7036 : 1982
Reviewed In : 2021
Specification for table, postmortem (First Revision)
December, 2021
1
Indigenous
155.
IS 7081 : 1973
Reviewed In : 2019
Specification for stool, revolving, for hospital use
March, 2019
4
Indigenous
156.
IS 7083 : 1973
Reviewed In : 2021
Specification for trolley, medicine
December, 2021
2
Indigenous
157.
IS 7091 : 1973
Reviewed In : 2021
Specification for lifter, bed, adjustable
December, 2021
-
Indigenous
158.
IS 7099 : 1973
Reviewed In : 2021
Specification for trolley, dressing drum
December, 2021
-
Indigenous
159.
IS 7171 : 1974
Reviewed In : 2017
Specification for drip counter with filter
March, 2017
-
Indigenous
160.
IS 7350 : 1974
Reviewed In : 2018
Specification for needles, spinal
September, 2018
1
Indigenous
161.
IS 7378 : 1974
Reviewed In : 2021
Bed, Fowler's, Hospital
December, 2021
2
Indigenous
162.
IS 7387 : 1974
Reviewed In : 2018
Needle, Biopsy, Liver, Silverman's Pattern
August, 2018
-
Indigenous
163.
IS 7455 : 1974
Reviewed In : 2021
Specification for sterilizer, pressure, hot and cold water
December, 2021
-
Indigenous
164.
IS 7523 : 1974
Reviewed In : 2017
Specification for rubber catheter (Urinary)
March, 2017
1
Indigenous
165.
IS 7596 : 1974
Reviewed In : 2021
Table, Operation, Orthopaedic, Albee's Type
December, 2021
-
Indigenous
166.
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
167.
IS 8078 : 1976
Reviewed In : 2021
Specification for table, operation, paediatric
December, 2021
-
Indigenous
168.
IS 8079 : 1976
Reviewed In : 2021
Specification for table, operation, urological
December, 2021
-
Indigenous
169.
IS 8462 : 1977
Reviewed In : 2021
Specification for sterilizer, portable, vertical, pressure type
December, 2021
3
Indigenous
170.
IS B8462 : 1977
Reviewed In : 2016
Sterilizer, Portable, Vertical, Pressure Type (BI-LINGUAL)
December, 2016
3
Indigenous
171.
IS/ISO 8536-1 : 2011
ISO 8536-1:2011
Infusion equipment for medical use Part 1 Infusion glass bottles
-
Identical under dual numbering
172.
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
173.
IS 9132 : 1979
Reviewed In : 2021
Specification for table, operation, folding type
December, 2021
-
Indigenous
174.
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 (25953)
Revision of: IS 1984:2023
Injection Containers and Accessories Part 4 Closures for Injection Vials First Revision
2
MHD 12 (25954)
Revision of: IS/ISO 13408:2008
Aseptic Processing of Health Care Products Part 1 General Requirements First Revision
3
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
4
MHD 12 (25956)
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 1 Extractables in Aqueous Autoclavates
5
MHD 12 (25958)
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 2 Identification and Characterization
6
MHD 12 (25959)
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 3 Determination of Released-Particle Count
7
MHD 12 (25960)
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 4 Biological Requirements and Test Methods
8
MHD 12 (25961)
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 5 Functional Requirements and Testing
9
MHD 12 (25963)
Aluminium Caps and Aluminium Plastic Caps for Infusion Bottles and Injection Vials General Requirements and Test Methods
10
MHD 12 (25964)
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 1 Needle-Based Injection Systems
11
MHD 12 (25965)
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 3 Containers and Integrated Fluid Paths
12
MHD 12 (25967)
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 4 Needle-Based Injection Systems Containing Electronics
13
MHD 12 (25968)
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 5 Automated Functions
14
MHD 12 (25969)
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 6 On-body Delivery Systems
15
MHD 12 (25970)
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 7 Accessibility for Persons with Visual Impairment
16
MHD 12 (25972)
Primary Packaging Materials for Medicinal Products Particular Requirements for the Application of ISO 9001 2015 with Reference to Good Manufacturing Practice GMP Amendment - 1
17
MHD 12 (25974)
Prefilled Syringes Part 6 Plastic Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling
18
MHD 12 (25975)
Prefilled Syringes Part 7 Packaging Systems for Sterilized Subassembled Syringes Ready for Filling
19
MHD 12 (25976)
Prefilled Syringes Part 8 Requirements and Test Methods for Finished Prefilled Syringes

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 (19717)
Blood Donor Couch Specification
2
MHD 12 (24230)
Specification for refrigerator or combined refrigerator and water pack freezer intermittent mains powered - compression cycle- general requirement and test method
3
MHD 12 (24231)
Specification for Vaccine carrier - General requirements and test method
4
MHD 12 (25421)
Infusion Equipment for Medical Use Part 2 Closures for Infusion Bottles
5
MHD 12 (25422)
Infusion Equipment for Medical Use Part 3 Aluminium Caps for Infusion Bottles
6
MHD 12 (25423)
Infusion Equipment for Medical Use Part 5 Burette Infusion Sets for Single Use Gravity Feed
7
MHD 12 (25424)
Infusion Equipment for Medical Use Part 6 Freeze Drying Closures for Infusion Bottles
8
MHD 12 (25425)
Infusion Equipment for Medical Use Part 7 Caps Made of Aluminium-Plastics Combinations for Infusion Bottles
9
MHD 12 (25426)
Infusion equipment for medical use Part 8 Infusion sets for single use with pressure infusion apparatus
10
MHD 12 (25428)
Infusion Equipment for Medical Use Part 9 Fluid Lines for Single Use with Pressure Infusion Equipment
11
MHD 12 (25429)
Infusion Equipment for Medical Use Part 10 Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment
12
MHD 12 (25430)
Infusion Equipment for Medical Use Part 11 Infusion Filters for Single Use with Pressure Infusion Equipment
13
MHD 12 (25431)
Infusion Equipment for Medical Use Part 12 Check Valves for Single Use
14
MHD 12 (25432)
Infusion Equipment for Medical Use Part 13 Graduated Flow Regulators for Single Use with Fluid Contact
15
MHD 12 (25433)
Infusion Equipment for Medical Use Part 14 Clamps and Flow Regulators for Transfusion and Infusion Equipment without Fluid Contact
16
MHD 12 (25434)
Infusion Equipment for Medical Use Part 15 Light-Protective Infusion Sets for Single Use
17
MHD 12 (25435)
Aseptic Processing of Health Care Products Part 3 Lyophilization
18
MHD 12 (25436)
Aseptic Processing of Health Care Products Part 4 Clean-in-Place Technologies
19
MHD 12 (25437)
Aseptic Processing of Health Care Products Part 5 Sterilization in Place
20
MHD 12 (25439)
Aseptic Processing of Health Care Products Part 6 Isolator Systems
21
MHD 12 (25440)
Aseptic Processing of Health Care Products Part 7 Alternative Processes for Medical Devices and Combination Products
22
MHD 12 (25441)
Revision of: IS 16004:2013
Hypodermic Needles for Single Use Colour Coding for Identification First Revision
23
MHD 12 (25443)
Medical Devices Transfusion Set and Blood Bag Compatibility Test Method
24
MHD 12 (25444)
Sterile Packaged Ready for Filling Glass Cartridges
25
MHD 12 (25445)
Medical Devices Non-Electrically Driven Portable Infusion Devices
26
MHD 12 (25446)
Sterilization of Health Care Products Microbiological Methods Part 3 Bacterial Endotoxin Testing
27
MHD 12 (25448)
Stainless Steel Needle Tubing for the Manufacture of Medical Devices Requirements and Test Methods
28
MHD 12 (25449)
Revision of: IS/ISO 10555:2013
Intravascular Catheters Sterile and Single-Use Catheters Part 1 General Requirements Second Revision
29
MHD 12 (25583)
Revision of: IS/ISO 10555:2013
Intravascular Catheters Sterile and Single-Use Catheters Part 4 Balloon Dilatation Catheters Second Revision
30
MHD 12 (25584)
Intravascular Catheters Sterile and Single-Use Catheters Part 7 Peripherally Inserted Central Catheters
31
MHD 12 (25585)
Sterilization of Health Care Products Radiation Substantiation of Selected Sterilization Dose Method VDmaxSD
32
MHD 12 (25586)
Sterilization of Health Care Products Moist Heat Requirements for the Development Validation and Routine Control of a Sterilization Process for Medical Devices
33
MHD 12 (25589)
Sterile Hypodermic Syringes for Single Use Part 4 Syringes with Re-use Prevention Feature
34
MHD 12 (25590)
Needle-Based Injection Systems for Medical Use Requirements and Test Methods Part 2 Double-Ended Pen Needles

Finalized Draft Indian Standard

SI. No.
Doc No
TITLE
1
MHD 12 (19718)
Dialysis Chair
2
MHD 12 (22897)
Revision of: IS 4445:1967
Filter and Filter Chamber for Blood Transfusion- Specification First Revision

Finalized Draft Indian Standards under Print

SI. No.
Doc No
TITLE
1
MHD 12 (17339)
Transfusion equipment for medical use Part 5 Transfusion sets for single use with pressure infusion apparatus
2
MHD 12 (18073)

Revision of: IS 8462:1977
Sterilizer Portable Vertical Pressure Type Specification First Revision
3
MHD 12 (19187)
Sterile single-use intravascular introducers dilators and guidewire
4
MHD 12 (20820)
Sterile hypodermic syringes for single use Part 2 Syringes for use with power-driven syringe pumps
5
MHD 12 (20832)
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
6
MHD 12 (20835)
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
7
MHD 12 (23337)
Single-use Sterile Rubber Surgical Gloves Specification
8
MHD 12 (23591)
In vitro diagnostic medical devices Single-use containers for the collection of specimens from humans other than blood
9
MHD 12 (23650)
Injection Containers and Accessories Part 5 Freeze Drying Closures for Injection Vials
10
MHD 12 (23652)
Injection Containers and Accessories Part 6 Caps Made of Aluminium-Plastics Combinations for Injection Vials
11
MHD 12 (23655)
Plastic Containers for Intravenous Injections
12
MHD 12 (23900)
Guidance for assessment and evaluation of changes to drug delivery systems
13
MHD 12 (23985)
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
14
MHD 12 (23986)
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
15
MHD 12 (23990)
Guidance on quality of water for sterilizers sterilization and washer-disinfectors for health care products
16
MHD 12 (24229)
Walk-in Cooler Specification Temperature Range of 2 C to 8 C


Aspect Wise Report

 
 Product:   141
 Code of Practices :    12
 Methods of Test :   4
 Terminology :   1
 Dimensions :   0
 System Standard :   0
 Safety Standard :   0
 Others :    10
 Service Specification :    0
 Process Specification :    2
 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 1984 (Part 1) : 2003
ISO 8362-1
Reviewed In : 2008
Injection Containers for Injectables and Accessories - Part 1 Injection Vials Made of Glass Tubing
11.
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
12.
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
13.
IS 3235 : 1988
ISO 595-2
Reviewed In : 2021
General requirements for syringes for medical use Second Revision
14.
IS 3998 : 1982
Reviewed In : 2006
Cups Medicine
15.
IS 4068 : 1967
Reviewed In : 2007
Specification for broken brick Burnt Clay coarse aggregate for use in lime concrete
16.
IS 4510 : 1978
Redesignated as IS 3829 Part 2
17.
IS 489 (Part 1) : 1973
Reviewed In : 2008
Glass Ampoules - Part I Ampoules for Liquid Injectables
18.
IS 489 (Part 2) : 1973
Reviewed In : 2003
Glass Ampoules - Part II Ampoules for lyophilized injectable
19.
IS 490 : 1967
Vaccine Phials
20.
IS 5156 : 1969
Calorimeter Cup Duboscq Type
21.
IS 5335 : 1969
Tables bedsides
22.
IS 5764 : 1994
Bowls Solution
23.
IS 5782 : 1994
Bowls Sponge
24.
IS 6208 : 1971
Reviewed In : 2017
Specification for spoons plastics measuring medicine
25.
IS/ISO 8362-1 : 2003
ISO8362-1:2003
Reviewed In : 2019
Injection containers and accessories Part 1 injection vials made of glass tubing
26.
IS 9395 : 1979
Reviewed In : 2016
Specification for bed intensive care
27.
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
28.
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
29.
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 3) : 2021
ISO 7886-3:2020
Sterile hypodermic syringes for single use Part 3 Auto-disabled syringes for fixed-dose immunization First Revision
3.
IS 10263 : 1982
Reviewed In : 2021
Specification for deep fat fryer single and double pan electrically operated for large catering establishments
4.
IS 10264 : 1982
Reviewed In : 2021
Specification for trolley hot food for hospital and industrial cantee - Ns
5.
IS/ISO 10555-1 : 2013
ISO 10555-1 : 2013
Intravascular catheters - Sterile and single - Use catheters Part 1 general requirements First Revision
6.
IS/ISO 10555-3 : 2013
ISO 10555-3 : 2013
Intravascular catheters - Sterile and single - Use catheters Part 3 central venous catheters First Revision
7.
IS/ISO 10555-4 : 2013

Reviewed In : 2019
Sterile single - Use intravascular catheters Part 4 balloon dilatation catheters
8.
IS/ISO 10555-5 : 2013

Intravascular catheters - Sterile and single - Use catheters Part 5 over - Needle peripheral catheters First Revision
9.
IS 10603 : 1983
Reviewed In : 2021
Specification for abdominal belts
10.
IS 10654 : 2018
ISO 7864 : 2016
Sterile hypodermic needles for single use - Requirements and test methods Fourth Revision
11.
IS 10783 : 1983
Reviewed In : 2021
Specification for patient - Lifting devices mobile manually operated
12.
IS 10985 : 1984
Reviewed In : 2017
Specification for needle acupuncture
13.
IS 11040 (Part 1) : 2015
ISO 11040-1 : 2015
Prefilled syringes Part 1 Glass cylinders for dental local anaesthetic cartridges
14.
IS/ISO 11040-2 : 2011
ISO 11040-2:2011
Prefilled syringes Part 2 Plunger stoppers for dental local anaesthetic cartridges
15.
IS/ISO 11040-3 : 2012
ISO 11040-3:2012
Prefilled syringes Part 3 Seals for dental local anaesthetic cartridges
16.
IS/ISO 11040-4 : 2015
ISO 11040-4 : 2015
Prefilled syringes Part 4 Glass barrels for injectables and sterilized subassembled syringes ready for filling
17.
IS/ISO 11040-5 : 2012
ISO 11040-5:2012
Prefilled syringes Part 5 Plunger stoppers for injectables
18.
IS 11043 : 1984
Reviewed In : 2017
Specification for needle epidural
19.
IS 1108 : 1975
Reviewed In : 2017
Specification for pharmaceutical glass containers Second Revision
20.
IS/ISO 11138-1 : 2017
ISO 11138-1 : 2017
Sterilization of Health Care Products Biological Indicators Part 1 General Requirements
21.
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
22.
IS/ISO 11138-3 : 2017
ISO 11138-3 : 2017
Sterilization of Healthcare Products Biological Indicators Part 3 Biological Indicators for Moist Heat Sterilization Processes
23.
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
24.
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
25.
IS/ISO 1135-3 : 2016
ISO 1135-3:2016
Transfusion equipment for medical use Part 3 Blood-taking sets for single use
26.
IS/ISO 1135-4 : 2015
ISO 1135-4 : 2015
Transfusion Equipment for Medical Use Part 4 Transfusion Sets for Single use Gravity Feed
27.
IS 11400 : 1985
Reviewed In : 2017
Specification for hypodermic syringes interchangeable type for general purposes
28.
IS/ISO 11418-1 : 2016
ISO 11418-1 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 1 Drop-Dispensing Glass
29.
IS/ISO 11418-2 : 2016
ISO 11418-2 : 2016
Containers and Accessories for Pharmaceutical Preparations Part 2 Screw-Neck Glass Bottles for Syrups
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
31.
IS/ISO 11418-5 : 2015
ISO 11418-5 : 2015
Containers and Accessories for Pharmaceutical Preparations Part 5 Dropper Assemblies
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
33.
IS 12173 : 1987
Reviewed In : 2018
Specification for cervical halter
34.
IS 13115 : 1991
Reviewed In : 2021
Portable first - Aid kit for general use - Specification
35.
IS B13115 : 1991
Reviewed In : 2016
Portable First Aid Kit for General Use Bi-lingual
36.
IS 13422 : 1992
Reviewed In : 2018
Disposable surgical rubber gloves specification
37.
IS/ISO 13926-1 : 2018
ISO 13926-1:2018
Pen systems Part 1 Glass cylinders for pen-injectors for medical use
38.
IS/ISO 13926-2 : 2017
ISO 13926-2:2017
Pen systems Part 2 Plunger stoppers for pen-injectors for medical use
39.
IS 14193 : 1994
Reviewed In : 2021
Ovulation thermometers - Specification
40.
IS B14316 : 1995
Reviewed In : 2016
Swabs Small in Bag of 50 Bi-lingual
41.
IS 15110 : 2002
Reviewed In : 2017
Veterinary thermometers mercury - In - Glass type - Specification
42.
IS 15113 : 2002
Reviewed In : 2017
Clinical electrical thermometers with maximum device - Specification
43.
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
44.
IS 15537 : 2021
ISO 9187-1:2018
Injection equipment for medical use Part 1 Ampoules for injectables First Revision
45.
IS 15537 (Part 2) : 2023
ISO 9187-2:2010
Injection equipment for medical use Part 2 One-point-cut OPC ampoules
46.
IS/ISO 15883-1 : 2006
ISO 15883-1 : 2006
Washer - Disinfectors Part 1 general requirements terms and definitions and tests
47.
IS 16004 : 2013
ISO 6009: 1992
Reviewed In : 2018
Hypodermic needles for single use - Colour coding for identification
48.
IS 16097 : 2013
Reviewed In : 2018
Sterile single use scalp vein Winged Needle infusion set
49.
IS 17547 : 2021
Specification for Vaccine Freezer or Combined Vaccine Freezer and Water-Pack Freezer Compression Cycle General Requirements and Testing Methods
50.
IS 17588 : 2021
Specification for Cold Box General requirements and Test methods
51.
IS 17589 : 2021
Specification for Water Packs for use as ice-packs cool-packs and warm-packs Requirements and Test methods
52.
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
53.
IS 18288 : 2023
ISO 20696:2018
Sterile urethral catheters for single use
54.
IS 18292 (Part 6) : 2023
ISO 10555-6:2015
Intravascular catheters Sterile and single-use catheters Part 6 Subcutaneous implanted ports
55.
IS 18293 (Part 3) : 2023
ISO 13926-3:2019
Pen systems Part 3 Seals for pen-injectors for medical use
56.
IS 18451 : 2023
ISO 20697:2018
Sterile drainage catheters and accessory devices for single use
57.
IS 18446 (Part 1) : 2023
ISO 11140-1:2014
Sterilization of health care products Chemical indicators Part 1 General requirements
58.
IS 18478 : 2024
ISO 20698:2018
Catheter systems for neuraxial application Sterile and single-use catheters and accessories
59.
IS 1984 (Part 1) : 2023
ISO 8362-1:2018
Injection containers and accessories Part 1 Injection vials made of glass tubing First Revision
60.
IS 1984 (Part 2) : 2023
ISO 8362-4:2011
Injection containers and accessories Part 2 Injection vials made of moulded glass Third Revision
61.
IS 1984 (Part 3) : 2023
ISO 8362-3:2001
Injection containers and accessories Part 3 Aluminum caps for injection vials
62.
IS 1984 (Part 4) : 2023
ISO 8362-2:2015
Injection containers and accessories Part 4 Closures for injection vials
63.
IS 3118 : 1978
Reviewed In : 2021
Specification for electric bacteriological incubators First Revision
64.
IS 3119 : 1978
Reviewed In : 2021
Specification for hot air sterilizers First Revision
65.
IS 3120 : 1999
Reviewed In : 2019
Baby incubators - Specification Second Revision
66.
IS 3236 : 1992
ISO 595-1
Reviewed In : 2018
Hypodermic syringes for general purposes - Specification Second Revision
67.
IS 3237 (Part 1) : 1985
Reviewed In : 2017
Specification for special purpose syringes Part 1 insulin syringes Second Revision
68.
IS 3237 (Part 2) : 1985
ISO 594-2
Reviewed In : 2017
Specification for special purpose syringes Part 2 tuberculin syringes Second Revision
69.
IS 3237 (Part 3) : 1985
Reviewed In : 2017
Specification for special purpose syringes Part 3 bcg syringes Second Revision
70.
IS 3237 (Part 4) : 1986
Reviewed In : 2017
Specification for special purpose syringes Part 4 vaccine syringe
71.
IS 3237 (Part 5) : 1986
Reviewed In : 2017
Specification for special purpose syringes Part 5 post operation care syringe Second Revision
72.
IS 3237 (Part 6) : 1986
Reviewed In : 2017
Specification for special purpose syringes Part 6 irrigation syringe
73.
IS 3237 (Part 7) : 1986
Reviewed In : 2017
Specification for special purpose syringe Part 7 forced feeding syringe
74.
IS 3237 (Part 8) : 1986
Reviewed In : 2017
Specification for special purpose syringes Part 8 angiography syringe
75.
IS 3423 : 1973
Reviewed In : 2018
Specification for glass contafners for transfusion fluids First Revision
76.
IS/ISO 3826-1 : 2019
ISO 3826-1:2019
Plastics collapsible containers for human blood and blood components Part 1 Conventional containers First Revision
77.
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
78.
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
79.
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
80.
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
81.
IS 3829 (Part 2) : 1978
Reviewed In : 2021
Specification for steam sterilizers Part 2 horizontal cylindrical high speed steam sterilizers pressure type First Revision
82.
IS 3829 (Part 3) : 1985
Reviewed In : 2021
Specification for steam sterilizers Part 3 pressure sterilizers vertical cylindrical type
83.
IS 3830 : 1979
Reviewed In : 2021
Specification for water stills for pyrogen - Free distilled water Second Revision
84.
IS 3831 : 1979
Reviewed In : 2021
Specification for sterilizer shallow Dressing Drum
85.
IS 3992 : 1982
Reviewed In : 2021
Specification for trays kidney First Revision
86.
IS 3993 : 1993
Reviewed In : 2019
Trays instruments - Specification Second Revision
87.
IS 3994 : 1993
Reviewed In : 2019
Bowls wash - Specification Second Revision
88.
IS 3997 : 1982
Reviewed In : 2021
Specification for jars ointment First Revision
89.
IS 4033 : 1968
Reviewed In : 2021
General requirements for hospital furniture
90.
IS 4034 : 1979
Reviewed In : 2021
Specification for castors for hospital equipment First Revision
91.
IS 4035 : 1967
Reviewed In : 2021
Specification for trolleys stretcher
92.
IS 4036 : 1967
Reviewed In : 2021
Specification for trolleys patient
93.
IS 4037 : 1967
Reviewed In : 2021
Specification for stretchers and stretcher carriers
94.
IS 4148 : 1989
Reviewed In : 2021
Surgical rubber gloves - Specification First Revision
95.
IS 4266 : 1967
Reviewed In : 2021
Specification for lockers bedside for hospital use
96.
IS 4267 : 1967
Reviewed In : 2021
Specification for stands wash hand basin
97.
IS 4363 : 1980
Reviewed In : 2017
Specification for drip counter E M S pattern First Revision
98.
IS 4445 : 1967
Reviewed In : 2021
Specification for filter and filter chamber for blood transfusion
99.
IS 4455 : 1967
Reviewed In : 2021
Specification for trolleys soiled linen
100.
IS 4458 : 1967
Reviewed In : 2021
Specification for screens bedside
101.
IS 4494 : 1968
Reviewed In : 2021
Specification for tables overbed
102.
IS 4769 : 1968
Reviewed In : 2021
Specification for trolley dressing
103.
IS 4787 : 1968
Reviewed In : 2021
Specification for table examination
104.
IS 5022 : 1989
Reviewed In : 2019
Sterilizer instruments table model Third Revision
105.
IS 5029 : 1979
Reviewed In : 2021
Specification for bedsteads hospital general purposes First Revision
106.
IS 5035 : 1969
Reviewed In : 2021
Specification for sterilizers bowl and utensil Pedal Type
107.
IS 5291 : 1969
Reviewed In : 2021
Specification for tables operation hydraulic major
108.
IS 5336 : 1969
Reviewed In : 2021
Specification for back rest
109.
IS 5337 : 1969
Reviewed In : 2021
Specification for cot dropside baby hospital
110.
IS 5630 : 1994
Reviewed In : 2019
Cribs Cradles maternity - Specification First Revision
111.
IS 5631 : 1970
Reviewed In : 2021
Specification for trolley instrument plain and curved
112.
IS 5880 : 1970
Reviewed In : 2021
Specification for stand saline - Cum - Irrigator
113.
IS 6083 : 1971
Reviewed In : 2021
Specification for table obstetric labour
114.
IS 6106 : 1971
Reviewed In : 2021
Specification for tables operation hydraulic minor
115.
IS 6328 : 1971
Reviewed In : 2021
Specification for table operation general purposes Non - Hydraulic
116.
IS 6593 : 1972
Reviewed In : 2021
Specification for electric serological water - Baths
117.
IS 6877 : 1977
Reviewed In : 2021
Specification for cabinet instruments First Revision
118.
IS 6904 : 1973
Reviewed In : 2021
Specification for receptacle waste
119.
IS 6905 : 1973
Reviewed In : 2021
Instruments Table Mayo s Type
120.
IS 7036 : 1982
Reviewed In : 2021
Specification for table postmortem First Revision
121.
IS 7081 : 1973
Reviewed In : 2019
Specification for stool revolving for hospital use
122.
IS 7083 : 1973
Reviewed In : 2021
Specification for trolley medicine
123.
IS 7091 : 1973
Reviewed In : 2021
Specification for lifter bed adjustable
124.
IS 7099 : 1973
Reviewed In : 2021
Specification for trolley dressing drum
125.
IS 7171 : 1974
Reviewed In : 2017
Specification for drip counter with filter
126.
IS 7350 : 1974
Reviewed In : 2018
Specification for needles spinal
127.
IS 7378 : 1974
Reviewed In : 2021
Bed Fowler s Hospital
128.
IS 7387 : 1974
Reviewed In : 2018
Needle Biopsy Liver Silverman s Pattern
129.
IS 7455 : 1974
Reviewed In : 2021
Specification for sterilizer pressure hot and cold water
130.
IS 7523 : 1974
Reviewed In : 2017
Specification for rubber catheter Urinary
131.
IS 7596 : 1974
Reviewed In : 2021
Table Operation Orthopaedic Albee s Type
132.
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
133.
IS 8078 : 1976
Reviewed In : 2021
Specification for table operation paediatric
134.
IS 8079 : 1976
Reviewed In : 2021
Specification for table operation urological
135.
IS 8462 : 1977
Reviewed In : 2021
Specification for sterilizer portable vertical pressure type
136.
IS B8462 : 1977
Reviewed In : 2016
Sterilizer Portable Vertical Pressure Type BI-LINGUAL
137.
IS/ISO 8536-1 : 2011
ISO 8536-1:2011
Infusion equipment for medical use Part 1 Infusion glass bottles
138.
IS/ISO 8536-4 : 2019
ISO 8536-4:2019
Infusion equipment for medical use Part 4 Infusion sets for single use gravity feed
139.
IS 9132 : 1979
Reviewed In : 2021
Specification for table operation folding type
140.
IS 9133 : 1979
Reviewed In : 2021
Specification for trolley for general medical store