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Document Details |
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| Name of Department/Committee : | MHD 12 |
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| Document Number : | MHD 12 ( 23587) |
| Document Title [English] : | Injection containers and accessories Part 5: Freeze drying closures for injection vials |
| Document Title [Hindi] : | इंजेक्शन कंटेनर और सहायक उपकरण - भाग 5: इंजेक्शन शीशियों के लिए फ्रीज सुखाने वाले क्लोजर |
| Document Type : | New |
| Language : | English |
| Priority : | 2 |
| ICS Code : | 11.040.20 |
| Date of Project Approval : | 18-09-2023 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Health, Sports and Fitness Services |
| Sub Group : | Health, Sports and Fitness Services |
| Sub Sub Group : | Health Services |
| Aspects : | Product 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 8362-5 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials. | |
| 2 | The dimensional requirements are not applicable to barrier-coated closures. | |
| 3 | Closures specified in this part of ISO 8362 are intended for single use only. | |
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