產(chǎn)品簡(jiǎn)介 Product Introduction

我公司生產(chǎn)的輔助生殖耗材系列產(chǎn)品從原材料的選擇到成品生產(chǎn)的各個(gè)環(huán)節(jié)，均經(jīng)過(guò)嚴(yán)格的質(zhì)量認(rèn)證和安全檢測(cè)，為配子和胚胎提供更安全的培養(yǎng)條件和發(fā)育環(huán)境。根據(jù)不同操作流程的特點(diǎn)，精心設(shè)計(jì)、嚴(yán)格制造，保證胚胎和配子的安全。

Our human assisted reproductive laboratory (IVF) products are undergo strict quality certification and safety testing in all aspects from raw material selection to finished product, which provide more security culture condition and development environment for the gametes and embryos. According to the characteristics of different operation process,elaborate design, precision manufacturing, to ensure the safety of embryos and gametes.

特點(diǎn) Characteristics

1. 通過(guò)歐盟ISO13485質(zhì)量管理認(rèn)證體系，IVF產(chǎn)品CE標(biāo)識(shí)；

Acquire the EU ISO13485 quality management system certification, and CE mark of IVF product.

2. 原材料采用美國(guó)藥典（USP）Class VI級(jí)測(cè)試聚苯乙烯及其他專用材料；

Raw materials are testing polystyrene and other special materials with United States Pharmacopoeia (USP) Class VI level ;

3. 嚴(yán)格控制生產(chǎn)工藝，制成品經(jīng)過(guò)生物相容性試驗(yàn)（細(xì)胞毒性、皮膚刺激、皮膚致敏）、體外鼠胚實(shí)驗(yàn)等檢測(cè)認(rèn)證合格；

Strictly control the production process, finished products should pass biocompatibility tests (include cell toxicity, skin irritation, skin sensitization) and mouse embryo assay in vitro.

4. 產(chǎn)品經(jīng)過(guò)微生物限度檢查、滅菌劑量確認(rèn)及滅菌劑量分布驗(yàn)證，無(wú)菌保證水平SAL（輻射滅菌）達(dá)到10-6。產(chǎn)品經(jīng)檢驗(yàn)無(wú)致熱源，細(xì)菌內(nèi)毒素不超過(guò)20EU/件；

The product was verified by microbial limit inspection, sterilization dose confirmation and confirmation of sterilization dose distribution,. The sterile assurance level SAL (radiation sterilization) have to reach 10-6. Inspect the product to make sure there is no heat source, and the bacterial endotoxin was no more than 20EU/ piece.

5. 產(chǎn)品包裝經(jīng)微生物屏障性能試驗(yàn)檢測(cè)合格。

The product package should pass the microbial barrier performance test.