首页 / 官方标准库 / 医疗器械检验

官方标准 · 一单一库

医疗器械检验

共 2,903 条标准

标准列表（第 95 / 97 页）

ISO11979-5:2006 眼科植入物-人工晶状体第5部分:生物相容性 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility

废止，仅限能力项目库范围内现行有效产品标准引用��标准及监督抽检时申请...

ISO11737-3:2023 医疗器械的灭菌微生物学方法第3部分:细菌内毒素测试Sterilization of health care products-Microbiological methods-Part 3: Bacterial endotoxin testing

ISO11737-2:2019 医疗产品灭菌微生物学方法第2部分:用于灭菌过程的定义､确认和维护的无菌试验 Sterilization of medical devices Microbiological methods - Part 2:Tests of sterility performed in the definition validation and maintenance of a sterilization process

ISO11737-1:2018+ISO11737-1:2018/Amd1:2021 医疗器械灭菌微生物学方法第1部分产品上微生物群落的测定SterilizationOfHealthCareProducts-MicrobiologicalMethods-Part1:DeterminationOfAPopulationOfMicrorganismsOnProducts

ISO11737-1:2018/Amd1:2021 保健产品的灭菌.微生物方法.第1部分:产品上微生物种群的测定.修改件1Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1

ISO11737-1:2018 医疗保健产品灭菌微生物学方法第1部分:产品上微生物总数的测定Sterilization of health care products- Microbiological methods-Part 1: Determination of a population of microorganisms on products

ISO11608-3:2022 医用笔式注射器要求和试验方法第3部分:成品药筒Needle-basedinjectionsystemsformedicaluse-Requirementsandtestmethods-Part3:Finishedcontainers

ISO11608-3:2012 医用针头注射系统-要求和试验方法第3部分:成品容器 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers

废止，仅限能力项目库范围内现行有效产品标准引用本标��及监督抽检时申请...

ISO11608-2:2022 医用笔式注射器要求和试验方法第2部分:注射针Needle-basedinjectionsystemsformedicaluse-Requirementsandtestmethods-Part2:Double-endedpenneedles

ISO11608-2:2012 医用针头注射系统-要求和试验方法第2部分:针 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles

废止，仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...

ISO11608-1:2022 医用笔式注射器要求和试验方法第1部分:笔式注射器Needle-basedinjectionsystemsformedicaluse-Requirementsandtestmethods-Part1:Neddle-basedinjectionsystems

ISO11608-1:2014 针对医疗用途的注射系统 - 要求和测试方法 - 第1部分:针头注射��统Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems

废止，仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...

ISO11607-1:2019 用于终端灭菌医疗器械的包装 - 第1部分:材料无菌屏障系统和包装系统的要求Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO1135-5:2025 医用输血器具第5部分:一次性使用压力输血器 Transfusion equipment for medical use - Part 5:Transfusion sets for single use with pressure infusion apparatus

ISO1135-5:2015 输血设备用于医疗用途 - 第5部分:输血装置一次性用于压力输液装置Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus

废止，仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...

ISO1135-4:2015 医疗输液设备 - 第4部分:单次输血输液重力喂料Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed

废止，仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...

ISO11193-2:2006 一次性使用医用检查手套第二部分:聚氯乙烯手套规�� Single-use medical examination gloves - Part 2: Specification for gloves made from poly(vinyl chloride)

ISO11193-1:2020 一次性使用医用检查手套第一部分:用橡胶胶乳或橡胶溶液制成手套的标准规范 Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution

ISO11193-1:2008/Amd1:2012 一次性医疗检查手套第1部分:橡胶乳胶或橡胶溶液制手套规范修改件1Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution - Amendment 1

废止，仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...

ISO11193-1:2002 一次性医疗检查手套第1部分:橡胶乳胶或橡胶溶液手套规范Single-use medical examination gloves - Part 1: Specification for gloves made from rubber latex or rubber solution

废止，仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...

ISO11138-7:2019 医疗保健产品灭菌生物指示物第七部分: 选择､��用和结果判断指南Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results

ISO11138-2:2017 医疗保健产品灭菌生物指示物第2部分:环氧乙烷灭菌用生物指示物Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

ISO11138-1:2017 医疗保健产品灭菌生物指示物第1部分:通则Sterilization of health care products - Biological indicators - Part 1: General requirements

ISO11070:2014/Amd1:2018 一次性使用无菌血管内导管､扩张器和导丝.修改件1Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1

ISO11070:1998 无菌一次性导管导管Sterile, single-use intravascular catheter introducers

废止，仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...

ISO10993-9:2019 医疗器械生物学评价第9部分:潜在降解产物的定性和定量框架 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

ISO10993-7:2026 医疗器械生物学评价第7部分:环氧乙烷灭菌残留量Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

ISO10993-6:2026 医疗器械生物学评价第6部分植入后局部反应试验Biological evaluation of medical devices Part 6: Tests for local effects after implantation

ISO10993-6:2016 医疗器械生物学评价第6部分:植入后局部反应试验 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

废止，仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...

ISO10993-5:2009 医疗器械生物学评价第5部分:体外细胞毒性测试 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

上一页 93 94 95 96 97 下一页

需要医疗器械检验检测服务？

腾树检测合作实验室具备 CMA/CNAS 双重资质，专业高效

电话咨询 17602199916 在线获取报价