Document Details |
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| Name of Department/Committee : | MHD 12 |
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| Document Number : | MHD 12 ( 23985) |
| Document Title [English] : | 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 |
| Document Title [Hindi] : | स्वास्थ्य देखभाल उत्पादों का स्टरलाइज़ेशन - जानवरों के ऊतकों और उनके डेरिवेटिव का उपयोग करने वाले एकल-उपयोग चिकित्सा उपकरणों के लिए तरल रासायनिक स्टरलाइज़िंग एजेंट - चिकित्सा उपकरणों के लिए विसंक्रमण प्रक्रिया के वर्णन, विकास, सत्यापन और नियमित नियंत्रण के लिए आवश्यकताएँ |
| Document Type : | New |
| Language : | English |
| Priority : | 2 |
| ICS Code : | 11.080.01 |
| Date of Project Approval : | 30-10-2023 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Health care facilities |
| Sub Sub Group : | Sterilizers & incubators |
| Aspects : | Process Specification |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : | |
| Degree of Equivalence : | Identical under dual numbering |
| Identical/Equivalent Standards : | ISO 14160:2020 |
| Organization Type: | ISO |
::Cross Referenced Indian Standard:: |
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| Sl. No. | Is No & Year | IS Title | |
| 1 | IS 17932 : Part 1: 2023 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process | |
| 2 | IS/ISO 10993 : Part 17: 2002 | Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances | |
| 3 | IS/ISO 11737 : Part 1: 2018 | Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products | |
| 4 | IS/ISO 13408 : Part 2: 2018 | Aseptic processing of health care products Part 2 Sterilizing filtration | |
::Cross Referenced International Standard(s) & Standard(s) Of National SDO(s) :: |
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| Sl. No. | Prefix | Number | Part | Section | Year | |
| 1 | ISO | 13408 | 1 | - | 2023 | |
| 2 | ISO | 13408 | 3 | - | 2006 | |
| 3 | ISO | 13408 | 5 | - | 2005 | |
| 4 | ISO | 13408 | 6 | - | 2021 | |
| 5 | ISO | 13408 | 7 | - | 2012 | |
| Sl.No. | Synosis Points | |
| 1 | This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin. | |
| 2 | This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods | |
| 3 | This document is not applicable to material of human origin. This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents | |
| 4 | This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites. | |
| 5 | The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps | |
| 6 | This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device | |
| 7 | This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6). Guidance for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin is provided in informative . | |
Timeline Details |
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Stages |
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| Sl. No. |
Stage | Date of Occurence | Remarks | Circulated to | Files |
| 1 | Generation of Document Number | 30-10-2023 | ------- | ||
| 2 | P-Draft Waived | 30-10-2023 | ------- | ||
| 3 | WC Draft | 30-10-2023 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 30-10-2023 | WC approved by HOD |
MHDC MHD 12, | ------- |
| 5 | WC-Draft | 29-11-2023 | WC-Draft Email Notifications Sent | MHDC, MHD 12, | ------- |
| 6 | Skipped to Finalization | 18-04-2024 | Stage-Changed | ------- | |
| 7 | Finalization | 18-04-2024 | ------ | ------- | |
| 8 | Final Draft | 18-04-2024 | Submited for HOD approval |
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| 9 | Final Draft draft accepted by HOD and sent to Publication | 19-04-2024 | Final Draft approved by HOD | ------- | |
| 10 | Accepted by Publication | 22-04-2024 | Final Draft accepted by Publication Remarks: Accepted by Publication |
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