Catalogue values for Chemical Indicator for Steam Sterilization Process
| Category | Specification | Bid Requirement (Allowed Values) |
|---|---|---|
| GENERAL | Product Description | Chemical Indicator for Steam Sterilization Process |
| PRODUCT INFORMATION | Indicator Signal | Color Change |
| Class/Type of Chemical Indicator | Class/Type 2 | |
| Presentation of Indicator | PCD Strip | |
| CERTIFICATIONS | Compliance to Medical Device Rule (MDR) 2017 as amended till date | Yes |
| Availability of valid Medical Device license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date | Yes | |
| ISO:13485 (Latest) certification | Yes | |
| Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date | Yes | |
| Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement | Yes | |
| Conformity to standards IS/ISO 11140 | Yes | |
| SHELF LIFE | Shelf life in months from the date of manufacture | 60.0, 36.0 |
| Minimum shelf life of the product at the time of delivery to the consignee | 3/4 th of Total Shelf Life | |
| ADVANCE SAMPLE | Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding | Yes |
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