CE認證標準EN 1985《助行器一般要求和測試方法》

This standard specfies requirements and test methods for Walking Aids manipulated by one arm (Walking Aids used singly or in pairs, each manipulated by one arm, possibly in combination with the upper body) and Walking Aids manpulated by both arms (Walking Aids used singly, manipulated by both arms, possibly in combination with the upper body), as covered by the subclasses 1203 and 1206 in EN ISO 9999:1998. This standard does not apply to walking aids specially designed or with adaptations for specific disabled persons. NOTE: Appropriate parts of this standard may be applied to the above products and other walking aids outside this scope.

Test Requirement 測試要求：

Material test Cytotoxicity Test(ISO 10993-5)        
Irritation and delayed type hypersensitivity (ISO 10993-10)
Systemic toxicity(ISO 10993-11)
4 Risk analysis
5 Requirements regard
ng design and construction
5.1 Moving parts and traps
5.2 Biocompatibility and Toxicity of Materials
5.3 Contaminant of Materials
5.4 Cleaning
5.5 Ergonomical Principles
6 Requirements regarding construction and environmental properties
6.1 Ancillaries
6.2 Accessible edges, corners and surfaces
6.3 Manoeuvrable for indoor or outdoor use
7 Protection against mechanical and thermal risks
7.1 Static loading, fatigue(825,000 cycles), low temperature
7.2 Maximum limits of adjustment ranges
7.3 Folding and adjusting mechanisms
8 Information supplied by the manufacturer

Sample Size 樣品數量 / 送樣規格: 6pcs
Lead Time / TAT (Turn Around Time) 測試周期: 常規服務 Regular service 40 working days

Report Summary 報告摘要: