Total Standards : 21
| S.No | IS Number | IS Title | Aspect | Degree of Equivalence (E) |
Date of Pub. (F) |
Document | Action |
|---|---|---|---|---|---|---|---|
| 1 | 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 | Terminology | Identical under dual numbering | 12-05-2023 | ||
| 2 | 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 | Others | Identical under dual numbering | 12-05-2023 | ||
| 3 | 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 | Code of Practice | Identical under dual numbering | 12-05-2023 | ||
| 4 | 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 | Others | Identical under dual numbering | 12-05-2023 | ||
| 5 | IS 1984 (Part 3) : 2023 ISO 8362-3:2001 |
Injection containers and accessories Part 3: Aluminum caps for injection vials | Product Specification | Identical under dual numbering | 16-06-2023 | ||
| 6 | 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 | Product Specification | Identical under dual numbering | 24-07-2023 | ||
| 7 | IS 18294 (Part 4) : 2023 ISO/TS11137-4:2020 |
Sterilization of health care products Radiation Part 4: Guidance on process control | Others | Identical under dual numbering | 24-07-2023 | ||
| 8 | IS 18288 : 2023 ISO 20696:2018 |
Sterile urethral catheters for single use | Product Specification | Identical under dual numbering | 01-09-2023 | ||
| 9 | IS 18292 (Part 6) : 2023 ISO 10555-6:2015 |
Intravascular catheters Sterile and single-use catheters Part 6: Subcutaneous implanted ports | Product Specification | Identical under dual numbering | 01-09-2023 | ||
| 10 | 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 | Methods of tests | Identical under single numbering | 01-11-2023 | ||
| 11 | IS 1984 (Part 1) : 2023 ISO 8362-1:2018 |
Injection containers and accessories Part 1 Injection vials made of glass tubing (First Revision) | Product Specification | Identical under dual numbering | 02-11-2023 | ||
| 12 | 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 | Methods of tests | Identical under dual numbering | 04-12-2023 | ||
| 13 | 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 | Process Specification | Identical under dual numbering | 02-01-2024 | ||
| 14 | 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 | Others | Identical under dual numbering | 09-01-2024 | ||
| 15 | IS 1984 (Part 4) : 2023 ISO 8362-2:2015 |
Injection containers and accessories Part 4: Closures for injection vials | Product Specification | Identical under dual numbering | 09-01-2024 | ||
| 16 | IS 18293 (Part 3) : 2023 ISO 13926-3:2019 |
Pen systems Part 3 Seals for pen-injectors for medical use | Product Specification | Identical under dual numbering | 09-01-2024 | ||
| 17 | IS 18451 : 2023 ISO 20697:2018 |
Sterile drainage catheters and accessory devices for single use | Product Specification | Identical under dual numbering | 09-01-2024 | ||
| 18 | IS 15537 (Part 2) : 2023 ISO 9187-2:2010 |
Injection equipment for medical use Part 2: One-point-cut OPC ampoules | Product Specification | Identical under dual numbering | 09-01-2024 | ||
| 19 | IS 18446 (Part 1) : 2023 ISO 11140-1:2014 |
Sterilization of health care products Chemical indicators Part 1: General requirements | Product Specification | Identical under dual numbering | 01-01-2024 | ||
| 20 | IS 18478 : 2024 ISO 20698:2018 |
Catheter systems for neuraxial application Sterile and single-use catheters and accessories | Product Specification | Identical under dual numbering | 01-03-2024 | ||
| 21 | IS 18468 (Part 5) : 2024 ISO 15883-5:2021 |
Washer-disinfectors Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy | Methods of tests | Identical under dual numbering | 09-04-2024 |