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