Document Details |
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| Name of Department/Committee : | MHD 09 |
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| Document Number : | MHD 09 ( 23481) |
| Document Title [English] : | Assistive products for walking manipulated by one arm — Requirements and Methods of Test Part 1 Elbow crutches |
| Document Title [Hindi] : | एक हाथ से चलने के लिए सहायक उत्पाद — अपेक्षाएँ और परीक्षण पद्धत्तियाँ भाग 1 कोहनी बैसाखी |
| Document Type : | New |
| Language : | English |
| Priority : | 1 |
| ICS Code : | 11.180.10 |
| Date of Project Approval : | 31-03-2023 |
| Standards to be Superseded : | |
Classification Details |
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| Group : | Medical and Hospital Equipments |
| Sub Group : | Rehabilitation Equipments |
| Sub Sub Group : | Rehabilitation equipment |
| Aspects : | Product Specification |
| Risk : | Low |
| Certification : | Voluntary Certification |
| Short Commom Man's Title : | Elbow Crutches |
| ITCHS Code : | |
| Ministry : |
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| Sustainable development Goals : |
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| Degree of Equivalence : | Modified/Technically Equivalent |
| Identical/Equivalent Standards : | ISO 11334-1:2007 |
| Organization Type: | ISO |
Division Council Chairperson Approval Details |
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| Sl. No. | Document No | Document Title | |
| 1 | MHD/14 / 23491 | Medical devices Information to be supplied by the manufacturer | |
| 2 | MHD/09 / 23482 | Assistive products Classification and terminology | |
| Sl.No. | Synosis Points | |
| 1 | This part of ISO 11334 specifies requirements and test methods for elbow crutches fully equipped with handgrip and tip. The methods specify testing of separation, static load capacity, fatigue and resistance to low temperature embrittlement. This part of ISO 11334 also gives the requirements relating to safety, ergonomics, performance, and information to be supplied by the manufacturer, including marking and labelling. The requirements and tests are based on every-day usage of elbow crutches when performing the through-swing gait, for a maximum user mass as specified by the manufacturer. This part of ISO 11334 is applicable to elbow crutches specified for a user mass of not less than 35 kg. Requirements and test methods for friction of rubber tips against the walking surface are dealt with separately. | |
Timeline Details |
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