Document Details |
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| Name of Department/Committee : | MHD 11 |
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| Document Number : | MHD 11 ( 25224) |
| Document Title [English] : | Medical devices Sleep Apnoea Breathing Therapy Masks and Application Accessories |
| Document Title [Hindi] : | चिकित्सा उपकरण स्लीप एपनिया श्वास चिकित्सा मास्क और अनुप्रयोग सहायक उपकरण |
| Document Type : | New |
| Language : | English |
| Priority : | 3 |
| ICS Code : | 11.040.10 |
| Date of Project Approval : | 10-04-2024 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Clinical, pathological, anaesthetic and respiratory equipments and systems |
| Sub Sub Group : | Diagnostic , anaesthetic and respiratory equipment |
| Aspects : | Product Specification |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : |
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| Degree of Equivalence : | Modified/Technically Equivalent |
| Identical/Equivalent Standards : | ISO 17510: 2015 |
| Organization Type: | ISO |
| Sl.No. | Synosis Points | |
| 1 | This Indian Standard applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear). | |
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 | 10-04-2024 | ------- | ||
| 2 | P-Draft Waived | 10-04-2024 | This Indian standard is an ISO adoption | ------- | |
| 3 | WC Draft | 10-04-2024 | Duration : 30 Days Submitted for HOD approval |
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| 4 | WC Draft | 10-04-2024 | WC approved by HOD |
MHDC | ------- |
| 5 | WC Draft | 10-04-2024 | WC approved by HOD |
MHDC | ------- |