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

	更新时间 2024-11-25 20:00:00 价格请来电询价测试周期 5-7天寄样地址深圳宝安价格费用电话详谈联系电话 17324413130 联系手机 17324413130 联系人罗卓文立即询价

详细介绍

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)
	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