| S.No | Document Number | Document Title | Doc Type | Priority | Language | Document Stage | Last Action Date |
|---|---|---|---|---|---|---|---|
| 1 |
MHD/12/17339 (Identical To: ISO 1135-5:2015) |
Transfusion equipment for medical use Part 5 Transfusion sets for single use with pressure infusion apparatus | New | 2 | English | Pdf from Department | 18-07-2024 |
| 2 |
MHD/12/18073 IS 8462: 1977 |
Sterilizer — Portable, Vertical, Pressure Type — Specification (First Revision) | Revision | 3 | English | PDF Sent To Technical Department | 25-06-2024 |
| 3 |
MHD/12/19187 (Identical To: ISO 11070:2014) |
Sterile single-use intravascular introducers, dilators and guidewire | New | 3 | English | PDF Sent To Technical Department | 24-06-2024 |
| 4 | MHD/12/19717 | Blood Donor Couch Specification | New | 3 | English | WC-Draft | 17-08-2023 |
| 5 | MHD/12/19718 | Dialysis Chair | New | 3 | English | Finalization | 19-04-2024 |
| 6 |
MHD/12/20820 (Identical To: ISO 7886-2:2020) |
Sterile hypodermic syringes for single use Part 2 Syringes for use with power-driven syringe pumps | New | 3 | English | PDF Sent To Technical Department | 24-06-2024 |
| 7 |
MHD/12/20832 (Identical To: 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 | New | 3 | English | PDF Sent To Technical Department | 24-06-2024 |
| 8 |
MHD/12/20835 (Identical To: 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 | New | 3 | English | Ready for Gazette | 25-06-2024 |
| 9 |
MHD/12/22897 IS 4445: 1967 |
Filter and Filter Chamber for Blood Transfusion- Specification (First Revision) | Revision | 3 | English | Finalization | 01-03-2024 |
| 10 |
MHD/12/23337 (Identical To: ISO 10282:2023) |
Single-use Sterile Rubber Surgical Gloves — Specification | New | 3 | English | Pdf from Department | 18-07-2024 |
| 11 |
MHD/12/23591 (Identical To: ISO 6717:2021) |
In vitro diagnostic medical devices Single-use containers for the collection of specimens from humans other than blood | New | 2 | English | Pdf from Department | 18-07-2024 |
| 12 |
MHD/12/23650 (Identical To: ISO 8362-5:2016) |
Injection Containers and Accessories Part 5 Freeze Drying Closures for Injection Vials | New | 2 | English | Ready for Gazette | 26-06-2024 |
| 13 |
MHD/12/23652 (Identical To: ISO 8362-6:2010) |
Injection Containers and Accessories Part 6 Caps Made of Aluminium-Plastics Combinations for Injection Vials | New | 2 | English | Pdf from Department | 18-07-2024 |
| 14 |
MHD/12/23655 (Identical To: ISO 15747:2018) |
Plastic Containers for Intravenous Injections | New | 2 | English | PDF Sent To Technical Department | 24-06-2024 |
| 15 |
MHD/12/23900 (Identical To: ISO 20069:2019) |
Guidance for assessment and evaluation of changes to drug delivery systems | New | 2 | English | Pdf from Department | 18-07-2024 |
| 16 |
MHD/12/23985 (Identical To: 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 | New | 2 | English | Pdf from Department | 18-07-2024 |
| 17 |
MHD/12/23986 (Identical To: 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 | New | 2 | English | Ready for Gazette | 19-06-2024 |
| 18 |
MHD/12/23990 (Identical To: ISO/TS 5111:2022) |
Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products | New | 2 | English | Ready for Gazette | 26-06-2024 |
| 19 | MHD/12/24229 | Walk-in Cooler — Specification (Temperature Range of 2°C to 8°C) | New | 1 | English | PDF Sent To Technical Department | 16-07-2024 |
| 20 | MHD/12/24230 | Specification for refrigerator or combined refrigerator and water pack freezer intermittent mains powered - compression cycle- general requirement and test method | New | 1 | English | WC-Draft | 16-12-2023 |
| 21 | MHD/12/24231 | Specification for Vaccine carrier - General requirements and test method | New | 1 | English | WC-Draft | 16-12-2023 |
| 22 |
MHD/12/25421 (Identical To: ISO 8536-2:2023) |
Infusion Equipment for Medical Use Part 2 Closures for Infusion Bottles | New | 3 | English | WC-Draft | 07-05-2024 |
| 23 |
MHD/12/25422 (Identical To: ISO 8536-3:2009+Amd1:2022) |
Infusion Equipment for Medical Use Part 3 Aluminium Caps for Infusion Bottles | New | 3 | English | WC-Draft | 07-05-2024 |
| 24 |
MHD/12/25423 (Identical To: ISO 8536-5:2004) |
Infusion Equipment for Medical Use Part 5 Burette Infusion Sets for Single Use, Gravity Feed | New | 3 | English | WC-Draft | 07-05-2024 |
| 25 |
MHD/12/25424 (Identical To: ISO 8536-6:2016) |
Infusion Equipment for Medical Use Part 6 Freeze Drying Closures for Infusion Bottles | New | 3 | English | WC-Draft | 07-05-2024 |
| 26 |
MHD/12/25425 (Identical To: ISO 8536-7:2009) |
Infusion Equipment for Medical Use Part 7 Caps Made of Aluminium-Plastics Combinations for Infusion Bottles | New | 3 | English | WC-Draft | 07-05-2024 |
| 27 |
MHD/12/25426 (Identical To: ISO 8536-8:2015) |
Infusion equipment for medical use Part 8 Infusion sets for single use with pressure infusion apparatus | New | 3 | English | WC-Draft | 07-05-2024 |
| 28 |
MHD/12/25428 (Identical To: ISO 8536-9:2015) |
Infusion Equipment for Medical Use Part 9 Fluid Lines for Single Use with Pressure Infusion Equipment | New | 3 | English | WC-Draft | 07-05-2024 |
| 29 |
MHD/12/25429 (Identical To: ISO 8536-10:2015) |
Infusion Equipment for Medical Use Part 10 Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment | New | 3 | English | WC-Draft | 07-05-2024 |
| 30 |
MHD/12/25430 (Identical To: ISO 8536-11:2015) |
Infusion Equipment for Medical Use Part 11 Infusion Filters for Single Use with Pressure Infusion Equipment | New | 3 | English | WC-Draft | 07-05-2024 |
| 31 |
MHD/12/25431 (Identical To: ISO 8536-12:2021) |
Infusion Equipment for Medical Use Part 12 Check Valves for Single Use | New | 3 | English | WC-Draft | 07-05-2024 |
| 32 |
MHD/12/25432 (Identical To: ISO 8536-13:2016) |
Infusion Equipment for Medical Use Part 13 Graduated Flow Regulators for Single Use with Fluid Contact | New | 3 | English | WC-Draft | 07-05-2024 |
| 33 |
MHD/12/25433 (Identical To: ISO 8536-14:2016) |
Infusion Equipment for Medical Use Part 14 Clamps and Flow Regulators for Transfusion and Infusion Equipment without Fluid Contact | New | 3 | English | WC-Draft | 07-05-2024 |
| 34 |
MHD/12/25434 (Identical To: ISO 8536-15:2022+Amd1:2023) |
Infusion Equipment for Medical Use Part 15 Light-Protective Infusion Sets for Single Use | New | 3 | English | WC-Draft | 07-05-2024 |
| 35 |
MHD/12/25435 (Identical To: ISO 13408-3:2006) |
Aseptic Processing of Health Care Products Part 3 Lyophilization | New | 3 | English | WC-Draft | 07-05-2024 |
| 36 |
MHD/12/25436 (Identical To: ISO 13408-4:2005) |
Aseptic Processing of Health Care Products Part 4 Clean-in-Place Technologies | New | 3 | English | WC-Draft | 07-05-2024 |
| 37 |
MHD/12/25437 (Identical To: ISO 13408-5:2006) |
Aseptic Processing of Health Care Products Part 5 Sterilization in Place | New | 3 | English | WC-Draft | 08-05-2024 |
| 38 |
MHD/12/25439 (Identical To: ISO 13408-6:2021) |
Aseptic Processing of Health Care Products Part 6 Isolator Systems | New | 3 | English | WC-Draft | 08-05-2024 |
| 39 |
MHD/12/25440 (Identical To: ISO 13408-7:2012) |
Aseptic Processing of Health Care Products Part 7 Alternative Processes for Medical Devices and Combination Products | New | 3 | English | WC-Draft | 08-05-2024 |
| 40 |
MHD/12/25441 IS 16004: 2013 (Identical To: ISO 6009:2016) |
Hypodermic Needles for Single Use — Colour Coding for Identification (First Revision) | Revision | 3 | English | WC-Draft | 08-05-2024 |
| 41 |
MHD/12/25443 (Identical To: ISO/TS 23128:2019) |
Medical Devices — Transfusion Set and Blood Bag Compatibility Test Method | New | 3 | English | WC-Draft | 08-05-2024 |
| 42 |
MHD/12/25444 (Identical To: ISO 21881:2019) |
Sterile Packaged Ready for Filling Glass Cartridges | New | 3 | English | WC-Draft | 08-05-2024 |
| 43 |
MHD/12/25445 (Identical To: ISO 28620:2020) |
Medical Devices — Non-Electrically Driven Portable Infusion Devices | New | 3 | English | WC-Draft | 08-05-2024 |
| 44 |
MHD/12/25446 (Identical To: ISO 11737-3:2023) |
Sterilization of Health Care Products — Microbiological Methods Part 3 Bacterial Endotoxin Testing | New | 3 | English | WC-Draft | 08-05-2024 |
| 45 |
MHD/12/25448 (Identical To: ISO 9626:2016) |
Stainless Steel Needle Tubing for the Manufacture of Medical Devices — Requirements and Test Methods | New | 3 | English | WC-Draft | 08-05-2024 |
| 46 |
MHD/12/25449 IS/ISO 10555 : PART 1: 2013 (Identical To: ISO 10555-1:2023) |
Intravascular Catheters — Sterile and Single-Use Catheters Part 1 General Requirements (Second Revision) | Revision | 3 | English | WC-Draft | 08-05-2024 |
| 47 |
MHD/12/25583 IS/ISO 10555 : PART 4: 2013 (Identical To: ISO 10555-4:2023) |
Intravascular Catheters — Sterile and Single-Use Catheters Part 4 Balloon Dilatation Catheters (Second Revision) | Revision | 3 | English | WC-Draft | 08-05-2024 |
| 48 |
MHD/12/25584 (Identical To: ISO 10555-7:2023) |
Intravascular Catheters — Sterile and Single-Use Catheters Part 7 Peripherally Inserted Central Catheters | New | 3 | English | WC-Draft | 08-05-2024 |
| 49 |
MHD/12/25585 (Identical To: ISO 13004:2022) |
Sterilization of Health Care Products — Radiation — Substantiation of Selected Sterilization Dose: Method VDmaxSD | New | 3 | English | WC-Draft | 08-05-2024 |
| 50 |
MHD/12/25586 (Identical To: 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 | New | 3 | English | WC-Draft | 08-05-2024 |
| 51 |
MHD/12/25589 (Identical To: ISO 7886-4:2018) |
Sterile Hypodermic Syringes for Single Use Part 4 Syringes with Re-use Prevention Feature | New | 3 | English | WC-Draft | 08-05-2024 |
| 52 |
MHD/12/25590 (Identical To: ISO 11608-2:2022) |
Needle-Based Injection Systems for Medical Use — Requirements and Test Methods Part 2 Double-Ended Pen Needles | New | 3 | English | WC-Draft | 08-05-2024 |
| 53 |
MHD/12/25953 IS 1984 : Part 4: 2023 (Identical To: ISO 8362-2:2024) |
Injection Containers and Accessories Part 4 Closures for Injection Vials (First Revision) | Revision | 3 | English | Project-Approval | 24-06-2024 |
| 54 |
MHD/12/25954 IS/ISO 13408 : Part 1: 2008 (Identical To: ISO 13408-1:2023) |
Aseptic Processing of Health Care Products Part 1 General Requirements (First Revision) | Revision | 3 | English | Project-Approval | 24-06-2024 |
| 55 |
MHD/12/25955 IS/ISO 80369 : Part 7: 2016 (Identical To: ISO 80369-7:2021) |
Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 7 Connectors for Intravascular or Hypodermic Applications (First Revision) | Revision | 3 | English | Project-Approval | 24-06-2024 |
| 56 |
MHD/12/25956 (Identical To: ISO 8871-1:2003) |
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 1 Extractables in Aqueous Autoclavates | New | 3 | English | Project-Approval | 24-06-2024 |
| 57 |
MHD/12/25958 (Identical To: ISO 8871-2:2020) |
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 2 Identification and Characterization | New | 3 | English | Project-Approval | 24-06-2024 |
| 58 |
MHD/12/25959 (Identical To: ISO 8871-3:2003+AMD1:2018) |
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 3 Determination of Released-Particle Count | New | 3 | English | Project-Approval | 24-06-2024 |
| 59 |
MHD/12/25960 (Identical To: ISO 8871-4:2006) |
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 4 Biological Requirements and Test Methods | New | 3 | English | Project-Approval | 24-06-2024 |
| 60 |
MHD/12/25961 (Identical To: ISO 8871-5:2016) |
Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use Part 5 Functional Requirements and Testing | New | 3 | English | Project-Approval | 24-06-2024 |
| 61 |
MHD/12/25963 (Identical To: ISO 8872:2022) |
Aluminium Caps and Aluminium/Plastic Caps for Infusion Bottles and Injection Vials — General Requirements and Test Methods | New | 3 | English | Project-Approval | 24-06-2024 |
| 62 |
MHD/12/25964 (Identical To: ISO 11608-1:2022) |
Needle-Based Injection Systems for Medical Use — Requirements and Test Methods Part 1 Needle-Based Injection Systems | New | 3 | English | Project-Approval | 24-06-2024 |
| 63 |
MHD/12/25965 (Identical To: ISO 11608-3:2022) |
Needle-Based Injection Systems for Medical Use — Requirements and Test Methods Part 3 Containers and Integrated Fluid Paths | New | 3 | English | Project-Approval | 24-06-2024 |
| 64 |
MHD/12/25967 (Identical To: ISO 11608-4:2022) |
Needle-Based Injection Systems for Medical Use — Requirements and Test Methods Part 4 Needle-Based Injection Systems Containing Electronics | New | 3 | English | Project-Approval | 24-06-2024 |
| 65 |
MHD/12/25968 (Identical To: ISO 11608-5:2022) |
Needle-Based Injection Systems for Medical Use — Requirements and Test Methods Part 5 Automated Functions | New | 3 | English | Project-Approval | 24-06-2024 |
| 66 |
MHD/12/25969 (Identical To: ISO 11608-6:2022) |
Needle-Based Injection Systems for Medical Use — Requirements and Test Methods Part 6 On-body Delivery Systems | New | 3 | English | Project-Approval | 24-06-2024 |
| 67 |
MHD/12/25970 (Identical To: ISO 11608-7:2016) |
Needle-Based Injection Systems for Medical Use — Requirements and Test Methods Part 7 Accessibility for Persons with Visual Impairment | New | 3 | English | Project-Approval | 24-06-2024 |
| 68 |
MHD/12/25972 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 ) Amendment - 1 | Amendment | 3 | English | Project-Approval | 24-06-2024 |
| 69 |
MHD/12/25974 (Identical To: ISO 11040-6:2019) |
Prefilled Syringes Part 6 Plastic Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling | New | 3 | English | Project-Approval | 24-06-2024 |
| 70 |
MHD/12/25975 (Identical To: ISO 11040-7:2024) |
Prefilled Syringes Part 7 Packaging Systems for Sterilized Subassembled Syringes Ready for Filling | New | 3 | English | Project-Approval | 24-06-2024 |
| 71 |
MHD/12/25976 (Identical To: ISO 11040-8:2016) |
Prefilled Syringes Part 8 Requirements and Test Methods for Finished Prefilled Syringes | New | 3 | English | Project-Approval | 24-06-2024 |