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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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