Document Details |
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| Name of Department/Committee : | MHD 12 |
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| Document Number : | MHD 12 ( 23888) |
| Document Title [English] : | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| Document Title [Hindi] : | टर्मिनली स्टरलाइज़्ड चिकित्सा उपकरणों के लिए पैकेजिंग - आईएसओ 11607-1 और आईएसओ 11607-2 के अनुप्रयोग पर मार्गदर्शन |
| Document Type : | New |
| Language : | English |
| Priority : | 2 |
| ICS Code : | 11.080.30 |
| Date of Project Approval : | 20-10-2023 |
| Standards to be Superseded : | |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 : | Code of Practice |
| Risk : | Medium |
| 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/TS 16775:2021 |
| Organization Type: | ISO |
::Cross Referenced Indian Standard:: |
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| Sl. No. | Is No & Year | IS Title | |
| 1 | IS/ISO 11607 : Part 1: 2019 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials sterile barrier systems and packaging systems First Revision | |
| 2 | IS/ISO 11607 : Part 2: 2019 | Packing for Terminally Sterilized Medical Devices Part 2 Validation Requirements for Forming Sealing and Assembly Processes (First Revision) | |
| Sl.No. | Synosis Points | |
| 1 | This document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and ISO 11607-2. This is an informative document, not normative. It does not include requirements to be used as basis of regulatory inspection or certification assessment activities. | |
| 2 | The guidance can be used to better understand the requirements of ISO 11607-1 and ISO 11607-2 and illustrates the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required that this document be used to demonstrate conformity with them. | |
| 3 | Guidance is given for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on validation requirements for forming, sealing and assembly processes is also given | |
| 4 | This document provides information for both healthcare facilities and the medical devices industry for terminally sterilized medical devices. | |
| 5 | This document does not provide guidance for applications of packaging materials and systems after their opening. In the use of packaging for other purposes such as a “sterile field” or transport of contaminated items, other regulatory standards will apply. | |
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 | 20-10-2023 | ------- | ||
| 2 | P-Draft Waived | 20-10-2023 | ------- | ||
| 3 | WC Draft | 20-10-2023 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 20-10-2023 | WC approved by HOD |
MHDC MHD 12, | ------- |
| 5 | Skipped to Finalization | 18-04-2024 | Stage-Changed | ------- | |
| 6 | Finalization | 18-04-2024 | ------ | ------- | |
| 7 | Final Draft | 18-04-2024 | Submited for HOD approval |
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| 8 | Final Draft draft accepted by HOD and sent to Publication | 19-04-2024 | Final Draft approved by HOD | ------- | |
| 9 | Accepted by Publication | 22-04-2024 | Final Draft accepted by Publication Remarks: Accepted by Publication |
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