| 1. | 通報成員：厄瓜多爾 |
| 2. | 負責機構：Servicio Ecuatoriano de Normalización, INEN (Ecuadorian Standardization Service) |
| 3. |
通報依據(jù)的條款：Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ]
通報依據(jù)的條款其他：
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| 4. | 覆蓋的產(chǎn)品：Orthopaedic or fracture appliances (HS 902110); Appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability (excluding artificial parts of the body, hearing aids and pacemakers) (HS 902190)
ICS：[] HS：[] |
| 5. |
通報標題：厄瓜多爾第262號技術法規(guī)草案（PRTE INEN）《行走輔助產(chǎn)品》頁數(shù)：12 使用語言：西班牙語 鏈接網(wǎng)址： |
| 6. |
內(nèi)容簡述： The notified Ecuadorian Technical Regulation establishes the requirements to be met by assistive products for walking, prior to the marketing of domestic and imported products, with the aim of protecting human health and safety and preventing deceptive practices. It applies to the following products: · Walking frames; · Rollators; · Walking tables; · Elbow crutches fully equipped with handgrip and tip, and specified for a user weight of not less than 35 kg; · Walking sticks with three or more legs, fully equipped with handle and tips, and specified for a weight of not less than 35 kg. It does not apply to: · Walking sticks with three or more legs with underarm or forearm support; Walking chairs. |
| 7. | 目的和理由：Prevention of deceptive practices and consumer protection; Protection of human health or safety |
| 8. | 相關文件： Normative references:1.ISO 2859-1:1999+Amd 1:2011, Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection;2.ISO 9999:2016, Assistive products for persons with disability - Classification and terminology;3.ISO 11199-1:1999, Walking aids manipulated by both arms - Requirements and test methods - Part 1: Walking frames;4.ISO 11199-2:2005, Walking aids manipulated by both arms - Requirements and test methods - Part 2: Rollators;5.ISO 11199-3:2005, Walking aids manipulated by both arms - Requirements and test methods - Part 3: Walking tables;6.ISO 11334-1:2007, Assistive products for walking manipulated by one arm - Requirements and test methods - Part 1: Elbow crutches;7.ISO 11334-4:1999, Walking aids manipulated by one arm - Requirements and test methods - Part 4: Walking sticks with three or more legs;8.ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes;9.ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories;10.ISO/IEC 17050-1:2004, Conformity assessment - Supplier's declaration of conformity - Part 1: General requirements;11.ISO/IEC 17067:2013, Conformity assessment - Fundamentals of product certification and guidelines for product certification schemes;12.EN 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices;13.Sanitary Technical Regulation ARCSA-DE-026-2016-YMIH:2016, Normativa técnica sanitaria sustitutiva para el registro sanitario y control de dispositivos médicos de uso humano, y de los establecimientos en donde se fabrican, importan, dispensan, expenden y comercializan. |
| 9. |
擬批準日期：
60 days from the date of notification 擬生效日期： 180 days from the date of adoption |
| 10. | 意見反饋截至日期：60 days from notification |
| 11. |
文本可從以下機構得到：
Contact and/or national enquiry point: Subsecretaría de Calidad Ministerio de Producción, Comercio Exterior, Inversiones y Pesca (MPCEIP) Address: Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira, Piso 8, Bloque amarillo Tel.: (+593-2) 3948760, Ext. 2254 - 2272 Email: puntocontacto-OTCECU@produccion.gob.ec
https://members.wto.org/crnattachments/2020/TBT/ECU/20_3883_00_s.pdf |
The notified Ecuadorian Technical Regulation establishes the requirements to be met by assistive products for walking, prior to the marketing of domestic and imported products, with the aim of protecting human health and safety and preventing deceptive practices.
It applies to the following products:
· Walking frames;
· Rollators;
· Walking tables;
· Elbow crutches fully equipped with handgrip and tip, and specified for a user weight of not less than 35 kg;
· Walking sticks with three or more legs, fully equipped with handle and tips, and specified for a weight of not less than 35 kg.
It does not apply to:
· Walking sticks with three or more legs with underarm or forearm support;
Walking chairs.
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