| 1. | 通報(bào)成員：布隆迪 |
| 2. | 負(fù)責(zé)機(jī)構(gòu)：Burundi Bureau of Standards and Quality Control (BBN) |
| 3. |
通報(bào)依據(jù)的條款：Article 2.9.2 [X], 2.10.1 [??], 5.6.2 [X], 5.7.1 [??]
通報(bào)依據(jù)的條款其他：
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| 4. | 覆蓋的產(chǎn)品：Surgical instruments and materials (ICS 11.040.30)
ICS：[] HS：[] |
| 5. |
通報(bào)標(biāo)題：Surgical sutures — Specification — Part 2: Non-absorbable頁數(shù)：26 使用語言：英語 鏈接網(wǎng)址： |
| 6. |
內(nèi)容簡(jiǎn)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. | 相關(guān)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. |
擬批準(zhǔn)日期：
To be determined 擬生效日期： To be determined |
| 10. | 意見反饋截至日期：60 days from notification |
| 11. |
文本可從以下機(jī)構(gòu)得到：
Documentation and Information Centre Division at BBN |
This Draft East African Standard specifies the requirements, sampling and test methods for non-absorbable surgical sutures.
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