ISO 17966标准 支撑使用者的个人卫生辅助用品-要求与测试方法
| ISO 17966 Assistive products for personal hygiene that support users - Requirements and test methods | |
| 支撑使用者的个人卫生辅助用品-要求与测试方法 | |
| Clause | Test Category |
| 4.1 Risk Analysis | |
| 5.2 Biocompatibility and Toxicity (ISO10993-1, 5 & 10) | |
| 4 | General requirements and test methods |
| 4.1 | Risk Analysis |
| 4.2 | Intended performance |
| 4.3 | Clinical evaluation and investigation |
| 4.4 | Assistive products for personal hygiene that can be dismantled |
| 4.5 | Fasteners |
| 4.6 | Means to prevent falling out |
| 4.7 | User mass/load limits |
| 4.8 | Apparatus |
| 5 | Materials |
| 5.2 | Flammability |
| 5.2.1 | General |
| 5.2.2 | Moulded parts used as enclosures for electrical equipment (IEC 60695-11-10) |
| 5.2.3 | Upholstered parts and moulded parts (ISO 8191-1 and ISO 8191-2) |
| 5.3 | Biocompatibility and Toxicity (ISO10993-1, 5 & 10) |
| 5.4 | Infection and microbiological contamination |
| 5.4.1 | Cleaning and disinfection |
| 5.4.2 | Resistance against temperature alternations |
| 5.4.3 | Animal tissue （ISO 22442-1） |
| 5.5 | Resistance to corrosion （ISO 9227， 72h） |
| 6 | Emitted sound and vibration (ISO 3746) |
| 7 | Electromagnetic compatibility |
| 8 | Electrical Safety |
| 9 | Overflow, leakage, and ingress of liquids |
| 10 | Temperatures of parts that come in contact with human skin |
| 11 | Safety of moving and folding parts |
| 12 | Prevention of traps for parts of the human body |
| 13 | Folding and adjusting mechanisms |
| 14 | Lifting and carrying means |
| 15 | Portable and hand-held products for personal hygiene or hand-held parts |
| 16 | Static strength, impact and durability |
| 16.4 | Static strength of lying support, arm and foot supports and seat and back surfaces |
| 16.5 | Durability |
| 16.6 | Impact |
| 17 | Stability |
| 18 | Surfaces, corners, edges and protruding parts |
| 19 | Small parts |
| 20 | Forces in soft tissues of the human body |
| 21 | Ergonomic principles |
| 22 | Mobile APPHs |
| 23 | Fixed APPHs |
| 24 | Static APPHs |
| 25 | Requirements for information supplied by the manufacturer |
| 26 | Packaging (risk assessment) |
| Sample size: 3 sets of finished products, with instruction.（except materials） | |
| TAT: 15-20 working days | |
| Information required for apply testing | Below informations shall be provided to calculate the cycles of durability. One or more from the three intended use environments :1)home care, 2)Institutions, 3)Public use Designed life time, in years User's body mass |
| 测试必须信息 | 须提供以下信息以计算出疲劳测试的次数： 以下三种场合中选择一种或多种适用的使用场合： 1）家用；2）机构使用； 3）公共场所使用 设计使用寿命 使用者体重范围 |
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