The Bureau of Indian Standards is India’s national standard body, responsible for developing and implementing quality and safety benchmarks for products in India. Obtaining a BIS certification for Hospital Equipment And Surgical Disposal is essential as these products directly affect patient health.
BIS certification ensures compliance with national standards, enhancing reliability and building user trust. Having a BIS certificate is also essential for manufacturers and importers who are planning to sell and market high-quality standard equipment for the healthcare industry.
Reach out to ELT corporate for further information and a grant of a BIS certificate for your products related to hospital equipment and surgical disposal. Connect with us today, and we will guide you through obtaining a BIS certificate for your products.
Overview Of BIS Certificate
BIS certificate is issued by the Bureau of Indian Standards, it is a benchmark of quality and safety for different products used across various domains, ensuring products meet complex regulatory standards in India. The BIS certificate-obtaining procedure involves comprehensive testing and evaluation of products to ensure compliance with regulatory standards.
Hospital equipment and surgical disposal rely on quality and precise equipment for patient care, it is crucial to undergo testing to evaluate the safety of equipment and surgical disposal. BIS certificate protects patients and the public from harmful hazards due to strict guidelines.
What Are Hospital Equipment And Surgical Disposal?
Hospital equipment and surgical disposal involves a wide range of devices, instruments, and equipment used in medical facilities. Some of the major examples of hospital equipment include ventilators, ECG machines, and defibrillators.
Surgical disposal is the single use of products used during medical procedures and surgeries to maintain hygiene and prevent infection. Some of the common examples include gloves and syringes.
Who Can Apply BIS Certification For Hospital Equipment And Surgical Disposal?
Following are the applicants who can apply for BIS certification for hospital equipment and surgical disposal:
- The manufacturer of the product is the primary applicant for applying BIS certificate.
- Importers who want to import and sell hospital equipment and surgical disposal in India can apply for a BIS certificate.
- Distributors or traders seeking BIS certificates for their products can apply for a BIS certificate, provided they must have the manufacturer’s authorization.
- An authorized person can apply for a BIS certificate on behalf of the manufacturer, importer, or foreign manufacturer or importer.
Also Read: BIS Certification For Medical Devices
What Are The Benefits of Obtaining BIS Certificate?
BIS certification for hospital equipment and surgical disposal has several benefits which are mentioned below:
- Regulatory Compliance: Ensure legal compliance with regulatory norms, avoiding any legal penalty or market-related issues.
- Product Quality: Ensures hospital equipment and surgical disposal meet quality and safety standards.
- Market Acceptance: BIS-certified equipment and products get easy and fast market acceptance in both domestic and international markets.
- Market Expansion: BIS-certified equipment and products can be easily exported to other countries.
- User Confidence: Build trust among healthcare professionals and doctors by guaranteeing high-quality standard equipment for patient safety.
- Patient Safety: Enhances doctors’ and other healthcare professional’s confidence and builds trust in the brand for use in patient care, as a BIS certificate is an assurance of quality and safety.
Documents Required For Obtaining BIS Certification For Hospital Equipment And Surgical Disposal
To apply BIS certification for hospital equipment and surgical disposal, an applicant must prepare and submit the following documents:
- Application Form
- Company Details
- Product Specification
- Manufacturer Declaration
- Test Reports
- Manufacturing Facility Details
- Import Export Code
- Equipment Labels and Packaging
Procedure for Obtaining BIS Certification Hospital Equipment And Surgical Disposal
Below are the key steps involved in obtaining a BIS certification for hospital equipment and surgical disposal that an applicant must follow:
- Visit BIS Website: Visit the BIS website and select the application form related to hospital equipment and surgical disposal and fill the form correctly.
- Submission of Documents: Upload and submit the required documents as listed above through the BIS portal.
- Fee Payment: Pay the applicable fees for the BIS certificate based on the type and number of products.
- BIS Audit Inspection: BIS may conduct an on-site inspection of your manufacturing plant for verification and confirmation of safety and quality practices.
- Grant of Certification: After the successful evaluation of documents and manufacturing facility, if everything is found as per the regulatory requirements, a BIS certificate will be granted.
- Post-Certification Surveillance: BIS may carry out periodic audits to ensure regulatory compliance.
What Are The Indian Standards For Hospital Equipment And Surgical Disposal?
Here we have listed down the Indian Standards for BIS certificate For Medical Laboratory Instruments, you can check them here:
| SI. No. | IS No. | TITLE |
|---|---|---|
| 1 | IS 10150: 1981 | Guide for sterilization of medical products |
| 2 | IS 10258: 2002/ISO 7886-1 | Sterile hypodermic syringes for single use (Second Revision) |
| (2 Revision) | ||
| 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 |
| (1 Revision) | ||
| 4 | IS 10263: 1982 | Specification for deep fat fryer, single and double pan electrically operated, for large catering establishments |
| 5 | IS 10264: 1982 | Specification for trolley, hot food, for hospital and industrial canteen |
| 6 | IS 10603: 1983 | Specification for abdominal belts |
| 7 | IS 10654: 2018/ISO 7864: 2016Ster | Sterile hypodermic needles for single use – Requirements and test methods (Fourth Revision) |
| (4 Revision) | ||
| 8 | IS 10783: 1983 | Specification for patient – Lifting devices, mobile, manually operated |
| 9 | IS 10985: 1984 | Specification for needle, acupuncture |
| 10 | IS 11040: Part 1: 2015/ISO 11040-1: 2015 | Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridges |
| 11 | IS 11043: 1984 | Specification for needle, epidural |
| 12 | IS 1108 : 1975 | Specification for pharmaceutical glass containers (Second Revision) |
| (2 Revision) | ||
| 13 | IS 11400: 1985 | Specification for hypodermic syringes, interchangeable type for general purposes |
| 14 | IS 12050: 1986 | Specification for sterile hypodermic syringes with a needle attached for single-use |
| 15 | IS 12173: 1987 | Specification for cervical halter |
| 16 | IS 12227: 2020/ISO 8537: 2016Ster | Sterile Single-Use Syringes, With or Without Needle, for Insulin ( Second Revision ) |
| (2 Revision) | ||
| 17 | IS 12430: 1987 | Safety code for installation, servicing maintenance and sterilizers |
| 18 | IS 13115: 1991 | Portable first – Aid kit for general use – Specification |
| 19 | IS 13422: 1992 | Disposable surgical rubber gloves specification |
| 20 | IS 14193: 1994 | Ovulation thermometers – Specification |
| 21 | IS 15110: 2002 | Veterinary thermometers, mercury – In – Glass type – Specification |
| 22 | IS 15113: 2002 | Clinical electrical thermometers with a maximum device – Specification |
| 23 | 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) |
| 24 | 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) |
| 25 | IS 15537: 2021/ISO 9187-1:2018 | Injection equipment for medical use Part 1 Ampoules for injectables First Revision |
| (1 Revision) | ||
| 26 | IS 16097: 2013 | Sterile single-use scalp vein (Winged Needle) infusion set |
| 27 | IS 17547: 2021 | Specification for Vaccine Freezer or Combined Vaccine Freezer and Water-Pack Freezer: Compression Cycle, General Requirements and Testing Methods |
| 28 | IS 17588: 2021 | Specification for Cold Box — General requirements and Test methods |
| 29 | IS 17589: 2021 | Specification for Water Packs for use as ice-packs, cool- packs and warm-packs, Requirements and Test methods |
| 30 | IS 1984 : Part 2: 2003 | Injection containers for injectables and accessories: Part 2 injection vials made of moulded glass (Second Revision) |
| (2 Revision) | ||
| 31 | IS 3118 : 1978 | Specification for electric bacteriological incubators (First Revision) |
| (1 Revision) | ||
| 32 | IS 3119 : 1978 | Specification for hot air sterilizers (First Revision) |
| (1 Revision) | ||
| 33 | IS 3120 : 1999 | Baby incubators – Specification (Second Revision) |
| (2 Revision) | ||
| 34 | IS 3235 : 1988/ISO 595-2 | General requirements for syringes for medical use (Second Revision) |
| (2 Revision) | ||
| 35 | IS 3236 : 1992/ISO 595-1 | Hypodermic syringes for general purposes – Specification (Second Revision) |
| (2 Revision) | ||
| 36 | IS 3237 : Part 1: 1985 | Specification for special purpose syringes: Part 1 insulin syringes (Second Revision) |
| (2 Revision) | ||
| 37 | IS 3237: Part 2: 1985/ISO 594-2 | Specification for special purpose syringes: Part 2 tuberculin syringes (Second Revision) |
| (2 Revision) | ||
| 38 | IS 3237 : Part 3: 1985 | Specification for special purpose syringes: Part 3 bcg syringes (Second Revision) |
| (2 Revision) | ||
| 39 | IS 3237 : Part 4: 1986 | Specification for special purpose syringes: Part 4 vaccine syringe |
| 40 | IS 3237 : Part 5: 1986 | Specification for special purpose syringes: Part 5 post operation care syringe (Second Revision) |
| 41 | IS 3237 : Part 6: 1986 | Specification for special purpose syringes: Part 6 irrigation syringe |
| 42 | IS 3237 : Part 7: 1986 | Specification for special purpose syringe: Part 7 forced feeding syringe |
| 43 | IS 3237 : Part 8: 1986 | Specification for special purpose syringes: Part 8 angiography syringe |
| 44 | IS 3423 : 1973 | Specification for glass containers for transfusion fluids (First Revision) |
| (1 Revision) | ||
| 45 | IS 3829: Part 1: 1999 | Specification for steam sterilizers: Part 1 horizontal cylindrical and horizontal rectangular steam sterilizers, pressure type (For Hospital And Pharmaceutical Use) (Second Revision) |
| (2 Revision) | ||
| 46 | IS 3829: Part 2: 1978 | Specification for steam sterilizers: Part 2 horizontal cylindrical high-speed steam sterilizers, pressure type (First Revision) |
| (1 Revision) | ||
| 47 | IS 3829: Part 3: 1985 | Specification for steam sterilizers: Part 3 pressure sterilizers, vertical cylindrical type |
| 48 | IS 3830: 1979 | Specification for water stills for pyrogen – Free distilled water (Second Revision) |
| (2 Revision) | ||
| 49 | IS 3831: 1979 | Specification for sterilizer, shallow (Dressing Drum) |
| (2 Revision) | ||
| 50 | IS 3992: 1982 | Specification for trays, kidney (First Revision) |
| (1 Revision) | ||
| 51 | IS 3993: 1993 | Trays, instruments – Specification (Second Revision) |
| (2 Revision) | ||
| 52 | IS 3994: 1993 | Bowls, wash – Specification (Second Revision) |
| (2 Revision) | ||
| 53 | IS 3997: 1982 | Specification for jars, ointment (First Revision) |
| 54 | IS 4033: 1968 | General requirements for hospital furniture |
| 55 | IS 4034: 1979 | Specification for castors for hospital equipment (First Revision) |
| (1 Revision) | ||
| 56 | IS 4035: 1967 | Specification for trolleys, stretchers |
| 57 | IS 4036: 1967 | Specification for trolleys, patient |
| 58 | IS 4037: 1967 | Specification for stretchers and stretcher carriers |
| 59 | IS 4148: 1989 | Surgical rubber gloves – Specification (First Revision) |
| (1 Revision) | ||
| 60 | IS 4266: 1967 | Specification for lockers, bedside for hospital use |
| 61 | IS 4267: 1967 | Specification for stands, wash hand basin |
| 62 | IS 4363: 1980 | Specification for drip counter E. M. S. pattern (First |
| (1 Revision) | Revision) | |
| 63 | IS 4445: 1967 | Specification for filter and filter chamber for blood transfusion |
| 64 | IS 4455: 1967 | Specification for trolleys, soiled linen |
| 65 | IS 4458: 1967 | Specification for screens, bedside |
| 66 | IS 4494: 1968 | Specification for tables, overbed |
| 67 | IS 4769: 1968 | Specification for trolley, dressing |
| 68 | IS 4787: 1968 | Specification for table, examination |
| 69 | IS 5022: 1989 | Sterilizer, instruments, table model (Third Revision) |
| (3 Revision) | ||
| 70 | IS 5029: 1979 | Specification for bedsteads, hospital, general purposes (First Revision) |
| (1 Revision) | ||
| 71 | IS 5035: 1969 | Specification for sterilizers, bowls and utensils (Pedal Type) |
| 72 | IS 5291: 1969 | Specification for tables, operation, hydraulic, major |
| 73 | IS 5336: 1969 | Specification for backrest |
| 74 | IS 5337: 1969 | Specification for cot, dropside, baby, hospital |
| 75 | IS 5630: 1994 | Cribs (Cradles), maternity – Specification (First Revision) |
| (1 Revision) | ||
| 76 | IS 5631: 1970 | Specification for trolley, instrument, plain and curved |
| 77 | IS 5880: 1970 | Specification for stand, saline – Cum – Irrigator |
| 78 | IS 6083: 1971 | Specification for table, obstetric, labour |
| 79 | IS 6106: 1971 | Specification for tables, operation, hydraulic, minor |
| 80 | IS 6208: 1971 | Specification for spoons, plastics, measuring, medicine |
| 81 | IS 6328: 1971 | Specification for table, operation, general purposes (Non – Hydraulic) |
| 82 | IS 6593: 1972 | Specification for electric serological water – Baths |
| 83 | IS 6877: 1977/ISO 20795-1 :2013 | Specification for cabinet, and instruments (First Revision) |
| (1 Revision) | ||
| 84 | IS 6904: 1973 | Specification for a receptacle, waste |
| 85 | IS 6905: 1973 | Instruments Table, Mayo’s Type |
| 86 | IS 7036: 1982 | Specification for table, postmortem (First Revision) |
| (1 Revision) | ||
| 87 | IS 7081: 1973 | Specification for stool, revolving, for hospital use |
| 88 | IS 7083: 1973 | Specification for trolley, medicine |
| 89 | IS 7091: 1973 | Specification for lifter, bed, adjustable |
| 90 | IS 7099: 1973 | Specification for trolley, dressing drum |
| 91 | IS 7171: 1974 | Specification for drip counter with filter |
| 92 | IS 7350: 1974 | Specification for needles, spinal |
| 93 | IS 7378: 1974 | Bed, Fowler’s, Hospital |
| 94 | IS 7387: 1974 | Needle, Biopsy, Liver, Silverman’s Pattern |
| 95 | IS 7455: 1974 | Specification for sterilizer, pressure, hot and cold water |
| 96 | IS 7523: 1974 | Specification for rubber catheter (Urinary) |
| 97 | IS 7596: 1974 | Table, Operation, Orthopaedic, Albee’s Type |
| 98 | IS 8078: 1976 | Specification for table, operation, paediatric |
| 99 | IS 8079: 1976 | Specification for table, operation, urological |
| 100 | IS 8462: 1977 | Specification for sterilizer, portable, vertical, pressure type |
| 101 | IS 9132: 1979 | Specification for table, operation, folding type |
| 102 | IS 9133: 1979 | Specification for trolley for general medical store |
| 103 | IS 9395: 1979 | Specification for bed, intensive care |
| 104 | IS 9824: Part 1: 1996/ISO 1135-1 | Transfusion equipment for medical use – Specification: Part 1 glass transfusion bottles, closures and caps (First Revision) |
| (1 Revision) | ||
| 105 | IS/ISO 10555: PART 1 :2013/ISO 10555-1: 2013 | Intravascular catheters – Sterile and single – Use catheters: Part 1 general requirements (First Revision) |
| (1 Revision) | ||
| 106 | IS/ISO 10555: PART 3 :2013/ISO 10555-3: 2013 | Intravascular catheters – Sterile and single – Use catheters: Part 3 central venous catheters (First Revision) |
| (1 Revision) | ||
| 107 | IS/ISO 10555: PART 4: 2013 | Sterile, single-use intravascular catheters: Part 4 balloon dilatation catheters |
| (1 Revision) | ||
| 108 | IS/ISO 10555: PART 5 :2013/ISO 10555-5:2013 | Intravascular catheters – Sterile and single – Use catheters: Part 5 over – Needle peripheral catheters (First Revision) |
| (1 Revision) | ||
| 109 | IS/ISO 11040: Part 2: 2011/ISO 11040-2:2011 | Prefilled syringes Part 2 Plunger stoppers for dental local anaesthetic cartridges |
| 110 | IS/ISO 11040: Part 3: 2012/ISO 11040-3:2012 | Prefilled syringes Part 3 Seals for dental local anaesthetic cartridges |
| 111 | IS/ISO 11040: Part 4: 2015/ISO 11040-4: 2015 | Prefilled syringes Part 4 Glass barrels for injectables and sterilized sub-assembled syringes ready for filling |
| 112 | IS/ISO 11040: Part 5: 2012/ISO 11040-5:2012 | Prefilled syringes Part 5 Plunger stoppers for injectables |
| 113 | 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 |
| 114 | IS/ISO 11137: Part 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 |
| 115 | IS/ISO 11137: Part 2: 2013/ISO 11137-2: 2013 | Sterilization of health care products – Radiation: Part 2 Establishing the sterilization dose |
| 116 | IS/ISO 11137: Part 3: 2017/ISO 11137-3: 2017 | Sterilization of Health Care Products ― Radiation Part 3 Guidance on Dosimetric Aspects of Development, Validation and Routine Control |
| 117 | IS/ISO 11138: Part 1: 2017/ISO 11138-1: 2017 | Sterilization of Health Care Products ― Biological Indicators Part 1 General Requirements |
| 118 | IS/ISO 11138: Part 2: 2017/ISO 11138-2: 2017 | Sterilization of Health Care Products ― Biological Indicators Part 2 Biological Indicators for Ethylene Oxide Sterilization Processes |
| 119 | IS/ISO 11138: Part 3: 2017/ISO 11138-3: 2017 | Sterilization of Healthcare Products ― Biological Indicators Part 3 Biological Indicators for Moist Heat Sterilization Processes |
| 120 | IS/ISO 11138: Part 4: 2017/ISO 11138-4: 2017 | Sterilization of Health Care Products ― Biological Indicators Part 4 Biological Indicators for Dry Heat Sterilization Processes |
| 121 | IS/ISO 11138: Part 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 |
| 122 | IS/ISO 11140: Part 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 |
| 123 | IS/ISO 11140: Part 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 |
| 124 | IS/ISO 11140: Part 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 |
| 125 | IS/ISO 1135: Part 3: 2016/ISO 1135-3:2016 | Transfusion equipment for medical use Part 3 Blood-taking sets for single use |
| 126 | IS/ISO 1135: Part 4: 2015/ISO 1135-4: 2015 Tr | Transfusion Equipment for Medical Use Part 4 Transfusion Sets for Single Use, Gravity Feed |
| 127 | IS/ISO 11418: Part 1: 2016/ISO 11418-1: 2016 | Containers and Accessories for Pharmaceutical Preparations Part 1 Drop-Dispensing Glass |
| 128 | IS/ISO 11418: Part 2: 2016 | Containers and Accessories for Pharmaceutical Preparations Part 2 Screw-Neck Glass Bottles for Syrups |
| 129 | IS/ISO 11418: Part 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 |
| 130 | IS/ISO 11418: Part 5: 2015/ISO 11418-5: 2015 | Containers and Accessories for Pharmaceutical Preparations Part 5 Dropper Assemblies |
| 131 | IS/ISO 11418: Part 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 |
| 132 | IS/ISO 11607: Part 1: 2019/ISO 11607-1: 2006 | Packaging for terminally sterilized medical devices – Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision |
| (1 Revision) | ||
| 133 | IS/ISO 11607: Part 2: 2019/ISO 11607-2:2019 | Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision) |
| (1 Revision) | ||
| 134 | IS/ISO 13408: Part 2: 2018/ISO 13408-2:2018 | Aseptic processing of health care products Part 2 Sterilizing filtration |
| 135 | IS/ISO 13926: Part 1: 2018/ISO 13926-1:2018 | Pen systems Part 1 Glass cylinders for pen-injectors for medical use |
| 136 | IS/ISO 13926: Part 2: 2017/ISO 13926-2:2017 | Pen systems Part 2 Plunger stoppers for pen-injectors for medical use |
| 137 | IS/ISO 14161: 2009/ISO 14161 :2009 | Sterilization of health care products – Biological indicators – Guidance for the selection, use and interpretation of results |
| 138 | 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 |
| 139 | IS/ISO 15378: 2017/ISO 15378 :2017 | Primary Packaging Materials for Medicinal Products — Particular Requirements for the Application of ISO 9001: 2015, about Good Manufacturing Practice ( GMP ) |
| 140 | IS/ISO 15883: Part 1: 2006/ISO 15883-1: 2006 | Washer – Disinfectors: Part 1 general requirements, terms and definitions and tests |
| 141 | IS/ISO 15883: Part 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 |
| 142 | IS/ISO 15883: Part 3: 2006/ISO 15883-3: 2006 | Washer – Disinfectors: Part 3 requirements and tests for washer – Disinfectors employing thermal disinfection for human waste containers |
| 143 | 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 |
| 144 | IS/ISO 3826: Part 1: 2019/ISO 3826-1: 2013 | Plastics collapsible containers for human blood and blood components Part 1 Conventional containers First Revision |
| (1 Revision) | ||
| 145 | IS/ISO 3826: Part 2: 2008/ISO 3826-2: 2008 | Plastics collapsible containers for human blood and blood components: Part 2 graphical symbols for use on labels and instruction leaflets |
| 146 | IS/ISO 3826: Part 3: 2006/ISO 3826-3:2006 | Plastics collapsible containers for human blood and blood components: Part 3 blood bag systems with integrated features |
| 147 | IS/ISO 3826: Part 4: 2015/ISO 3826-4: 2015 | Plastics Collapsible Containers for Human Blood and Blood Components Part 4 Aphaeresis Blood Bag Systems with Integrated Features |
| 148 | IS/ISO 80369: Part 7: 2016/ISO 80369-7 | Small-Bore Connectors for Liquids and Gases in Healthcare Applications Part 7 Connectors for Intravascular or Hypodermic Applications |
| 149 | IS/ISO 8362: PART 1: 2003/ISO8362-1:2003 | Injection containers and accessories: Part 1 injection vials made of glass tubing |
| 150 | IS/ISO 8536: Part 1: 2011/ISO 8536-1:2011 | Infusion equipment for medical use Part 1 Infusion glass bottles |
| 151 | IS/ISO 8536: Part 4: 2019/ISO 8536-4:2019 | Infusion equipment for medical use Part 4: Infusion sets for single-use gravity feed |
| 152 | IS/ISO/TS 15883: Part 5 :2005/ISO/TS 15883-5: 200 | Washer-disinfectors â€― Part 5: Test soils and methods for demonstrating cleaning efficacy |
What Is The Validity Of BIS Certification For Hospital Equipment And Surgical Disposal?
The BIS certification for hospital equipment and surgical disposal is valid for one year. You may renew it annually by completing the application and fulfilling the necessary conditions.
Also Read: BIS Certificate For Ophthalmic Instruments And Appliances
Timeline For Obtaining BIS Certification For Hospital Equipment And Surgical Disposal
The timeline for granting a BIS certificate for hospital equipment and surgical disposal takes around 30-40 working days. However, it depends on the application’s completeness and the manufacturer’s responsiveness.
How ELT Corporate Can Assist You with Obtaining BIS Certificate?
At ELT Corporates, we understand the complete process of obtaining a BIS certificate and strict regulatory standards. Our expert team can make obtaining a BIS certificate seamless through in-depth Industrial knowledge, ensuring you understand each step of the certification process.
From initial consultation to certification issuance, we will be with you at each step, ready to address any challenge that may arise during the certification process.
Can I Sell Surgical Disposal Without BIS Certificate?
No, you can neither sell nor market surgical disposal without a BIS certificate, because it is necessary to ensure the safety and quality of surgical disposal before using them for surgery purposes.
Are Foreign Manufacturers Eligible For BIS Certificates?
Yes, foreign manufacturers are eligible to apply and obtain a BIS certificate, provided they have an authorized representative to handle the application process in India.
What If My Application For BIS Certificate Is Rejected?
If your application is rejected, BIS will offer feedback on the reasons. ELT Corporate can assist in addressing these issues and help you resubmit the application effectively.