世界贸易组织
G/TBT/N/BDI/67
2020-01-15
2020-01-15
技术性贸易壁垒
通 报
1
以下通报根据TBT协定第10.6条分发
| 1. | 通报成员：布隆迪 |
| 2. | 负责机构：Burundi Bureau of Standards and Quality Control (BBN) |
| 3. |
通报依据的条款：Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [X], 5.7.1 [ ]
通报依据的条款其他：
|
| 4. | 覆盖的产品：Surgical instruments and materials (ICS 11.040.30)
ICS：[] HS：[] |
| 5. |
通报标题：Surgical sutures — Specification — Part 2: Non-absorbable页数：26 使用语言：英语 链接网址： |
| 6. |
内容简述： This Draft East African Standard specifies the requirements, sampling and test methods for non-absorbable surgical sutures. |
| 7. | 目的和理由：Protection of human health or safety; Quality requirements; Harmonization |
| 8. | 相关文件： ISO 5832-1, Implants for surgery — Metallic materials — Part 1: Wrought stainless steel ISO 10993 (all parts), Biological evaluation of medical devices ISO 24153, Random sampling and randomisation procedures DEAS 1018, Surgical needles — Specification British Pharmacopoeia, 2017, published by The Stationery Office on behalf of the Medicines and Healthcare Products Regulatory Agency ISO 11135 (both parts), Sterilization of health care products — Ethylene oxide ISO 11137 (all parts), Sterilization of health care products — Radiation ISO 17665 (all parts), Sterilization of health care products — Moist heat US Pharmacopoeia 40 US 1958-2:2019, Surgical sutures — Specification — Part 2: Non — absorbable |
| 9. |
拟批准日期：
To be determined 拟生效日期： To be determined |
| 10. | 意见反馈截至日期：60 days from notification |
| 11. |
文本可从以下机构得到：
Documentation and Information Centre Division at BBN |
1
This Draft East African Standard specifies the requirements, sampling and test methods for non-absorbable surgical sutures.
附件：
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通报原文：
相关通报：
