检测信息(部分)
隐形眼镜护理液是用于隐形眼镜清洁、消毒、冲洗、保存的专用液体产品,其质量安全直接关系到眼部健康与佩戴舒适度。护理液若存在微生物污染、防腐剂超标或渗透压异常等问题,可能引发角膜炎、结膜炎等眼部疾病。第三方检测机构旗下实验室拥有CMA、CNAS、ISO等检验检测资质,可依据国家标准及行业标准对隐形眼镜护理液的理化指标、微生物限度、无菌性能及防腐效力进行系统检测,为生产企业及监管部门提供数据支持。
隐形眼镜护理液检测项目(部分)
- 气相色谱仪
- 原子吸收分光光度计
- 紫外可见分光光度计
- pH计
- 渗透压摩尔浓度测定仪
- 表面张力仪
- 旋转黏度计
- 不溶性微粒检测仪
- 生物显微镜
- 微生物限度检查系统
- 无菌隔离器
- 恒温恒湿培养箱
- 菌落计数仪
- 酶标仪
总结
隐形眼镜护理液作为直接接触眼部的三类医疗器械产品,其质量控制涉及微生物安全、理化性能及生物相容性等多个维度。通过规范的检测流程,可有效识别产品潜在风险,保障消费者使用安全。具备CMA、CNAS资质的第三方检测机构能够依据国家标准及行业规范,提供科学准确的检测数据,助力企业提升产品质量管理水平。
常见问题
隐形眼镜护理液检测需要多长时间?通常7-15个工作日,具体周期根据检测项目数量和样品类型确定,加急服务可与工程师沟通安排。
隐形眼镜护理液检测费用大概是多少?检测费用根据委托的检测项目数量确定,项目越多费用越高,具体报价可咨询检测工程师获取详细清单。
隐形眼镜护理液检测报告有什么用途?检测报告加盖CMA章后具有法律效力,可用于产品质量评估、项目验收、招投标、出口通关等场景。
隐形眼镜护理液检测需要准备多少样品?一般需要100-500g样品,具体用量根据检测项目确定,寄样前可与工程师确认样品需求量。
检测标准(部分)
| 序号 | 标准号 | 标准名称 | 类别 | 发布日期 | CCS分类 | ICS分类 |
|---|---|---|---|---|---|---|
| 1 | GB 19192-2003 | 隐形眼镜护理液卫生要求 | (CN-GB)国家标准 | 2003-06-13 | C59 | 11.040.70眼科设备 |
| 2 | ISO 18189:2016 | Ophthalmic optics — Contact lenses and contact lens care products — Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions | (IX-ISO)国际标准化组织 | 2016-05-30 | 11.040.70眼科设备 | |
| 3 | BS ISO 18189:2016 | Ophthalmic optics. Contact lenses and contact lens care products. Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions | (GB-BSI)英国标准学会 | 2016-06-30 | ||
| 4 | ISO 11981:2017 | Ophthalmic optics — Contact lenses and contact lens care products — Determination of physical compatibility of contact lens care products with contact lenses | (IX-ISO)国际标准化组织 | 2017-11-30 | 11.040.70眼科设备 | |
| 5 | ISO 11978:2017 | Ophthalmic optics — Contact lenses and contact lens care products — Labelling | (IX-ISO)国际标准化组织 | 2017-08-10 | 11.040.70眼科设备 | |
| 6 | DIN EN ISO 11981:2018-04 | Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses (ISO 11981:2017) | (DE-DIN)德国标准化学会 | 2018-04-01 | ||
| 7 | ISO 11980:2025 | Ophthalmic optics — Contact lenses and contact lens care products — Requirements and guidance for clinical investigations | (IX-ISO)国际标准化组织 | 2025-06-20 | 11.040.70眼科设备 | |
| 8 | ISO 14534:2011 | Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements | (IX-ISO)国际标准化组织 | 2011-03-22 | 11.040.70眼科设备 | |
| 9 | DIN EN ISO 11980:2025-12 | Ophthalmic optics - Contact lenses and contact lens care products - Requirements and guidance for clinical investigations (ISO 11980:2025) | (DE-DIN)德国标准化学会 | 2025-12-01 | ||
| 10 | ISO 18259:2014 | Ophthalmic optics — Contact lens care products — Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms | (IX-ISO)国际标准化组织 | 2014-09-23 | 11.040.70眼科设备 | |
| 11 | ISO 19045:2015 | Ophthalmic optics — Contact lens care products — Method for evaluating Acanthamoeba encystment by contact lens care products | (IX-ISO)国际标准化组织 | 2015-04-08 | 11.040.70眼科设备 | |
| 12 | ISO 11986:2026 | Ophthalmic optics — Contact lenses and contact lens care products — Determination of preservative uptake and release | (IX-ISO)国际标准化组织 | 2026-01-13 | 11.040.70眼科设备 | |
| 13 | DIN EN ISO 14534:2015-08 | Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) | (DE-DIN)德国标准化学会 | 2015-08-01 | ||
| 14 | KS B ISO 8320-2(2024 Confirm)(2024) | 안광학 콘택트렌즈 및 콘택트렌즈 관리제품 — 용어 — 제2부: 콘택트렌즈 관리제품 | (KR-KS)韩国标准 | 2014-12-26 | ||
| 15 | KS B ISO 8320-2-2014(2024) | 안광학 콘택트렌즈 및 콘택트렌즈 관리제품 — 용어 — 제2부: 콘택트렌즈 관리제품 | (KR-KS)韩国标准 | 2014-12-26 | ||
| 16 | BS EN ISO 11981:2017 | Ophthalmic optics. Contact lenses and contact lens care products. Determination of physical compatibility of contact lens care products with contact lenses | (GB-BSI)英国标准学会 | 2018-01-10 | ||
| 17 | DIN EN ISO 11986:2026-04 | Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release (ISO 11986:2026) | (DE-DIN)德国标准化学会 | 2026-04-01 | ||
| 18 | KS B ISO 8320-2-2014(2019) | 안광학 콘택트렌즈 및 콘택트렌즈 관리제품 — 용어 — 제2부: 콘택트렌즈 관리제품 | (KR-KS)韩国标准 | 2014-12-26 | ||
| 19 | KS B ISO 11978-2025 | 안광학 — 콘택트렌즈와 콘택트렌즈 관리 제품 — 라벨링 | (KR-KS)韩国标准 | 2025-12-26 | 11.040.70眼科设备 | |
| 20 | BS EN ISO 11978:2017+A1:2020 | Ophthalmic optics. Contact lenses and contact lens care products. Labelling | (GB-BSI)英国标准学会 | 2020-10-26 |