新加坡HSA发布医疗器械标准清单
📅 2023年09月27日
📂 行业洞察
✍️ Grzan
公认的标准通常用于证明符合医疗器械安全和性能的基本原则。2023年9月5日，新加坡卫生科学局（HSA）发布了一份公认的医疗器械标准清单。该列表与国家认可的新加坡标准（SS）与ISO、IEC和ASTM等其他标准发展组织相匹配。
该列表还包含 4 项未引用 ISO、IEC 或 ASTM 的著名新加坡标准 (SS)，即：
• 体外诊断 – SS 656:2020 基于 miRNA 的诊断的设计、开发和验证
•质量管理体系 – SS 620:2013 (2021) 医疗器械良好分销规范 – 要求
•热像仪：
•SS 582:2020 用于人体体温筛查的热像仪规范 – 第 1 部分：要求和测试方法
•SS 582:2020 用于人体体温筛查的热成像仪规范 – 第 2 部分：实施指南。
公认的医疗器械标准：
| Specialty | Standard Development Organization | Standard Number and edition | SS Adoption | Title of SS Standard |
| Biocompatibility | ISO | 10993-1:2018 | IDT | SS ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| Biocompatibility | ISO | 10993-3:2014 | IDT | SS ISO 10993-3:2017 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| Biocompatibility | ISO | 10993-4:2017 | IDT | SS ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| Biocompatibility | ISO | 10993-5:2009 | IDT | SS ISO 10993-5:2017 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity |
| Biocompatibility | ISO | 10993-6:2016 | IDT | SS ISO 10993-6:2017 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation |
| Biocompatibility | ISO | 10993-10:2010 | IDT | SS ISO 10993-10:2017 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization |
| Biocompatibility | ISO | 10993-11:2017 | IDT | SS ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| Biocompatibility | ISO | 10993-12:2021 | IDT | SS ISO 10993-12:2021 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| Clinical | ISO | 14155:2020 | IDT | SS ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice |
| Electrical Safety | IEC | 60601-1:2018 | IDT | SS IEC 60601-1:2018 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
| Electrical Safety | IEC | 60601-1-2:2014+AMD1:2020 | IDT | SS IEC 60601-1-2 (+A1):2018 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests |
| Electrical Safety | IEC | 60601-1-3: 2008+A1:2013 | IDT | SS IEC 60601-1-3:2018 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| Electrical Safety | IEC | 60601-1-6 2010+AMD2:2020 | IDT | SS IEC 60601-1-6 (+A1):2018 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability |
| Electrical Safety | IEC | 60601-1-8:2006+AMD2:2020 | IDT | SS IEC 60601-1-8:2018 + A1:2020 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| Electrical Safety | IEC | 60601-1-9:2007+AMD2:2020 | IDT | SS IEC 60601-1-9 (+A1):2018 Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design |
| Electrical Safety | IEC | 60601-1-10:2007+AMD2:2020 | IDT | SS IEC 60601-1-10 (+A1):2018 Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers |
| Electrical Safety | IEC | 60601-1-11:2015+AMD1:2020 | IDT | SS IEC 60601-1-11 (+A1):2018 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| Electrical Safety | IEC | 60601-1-12:2014+AMD1:2020 | IDT | SS IEC 60601-1-12 (+A1):2018 Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical service |
| Electrical Safety | IEC | 60601-2-16:2018 | IDT | SS IEC 60601-2-16:2018 Medical electrical equipment – Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| Electrical Safety | IEC | 60601-2-39:2018 | IDT | SS IEC 60601–2-39:2018 Medical electrical equipment – Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment |
| Electrical Safety | IEC | 62366-1:2015 | IDT | SS IEC 62366-1 (+A1):2018 Medical devices – Part 1 : Application of usability engineering to medical devices |
| In-Vitro Diagnostics | ISO | 15189:2022 | IDT | SS ISO 15189:2023 Medical laboratories — Requirements for quality and competence |
| In-Vitro Diagnostics | – | – | – | SS 656:2020 Design, development and validation of miRNA-based diagnostics |
| Labelling | ISO | 15223-1:2021 | IDT | SS ISO 15223-1:2021 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
| Labelling | ISO | 15223-2:2010 | IDT | SS ISO 15223-2:2018 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
| Packaging | ASTM | F1980 –16:2016 | IDT | SS 647:2019 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| Packaging | ISO | 11607-1:2019 | IDT | SS ISO 11607-1:2019 Packaging for terminally sterilised medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| Packaging | ISO | 11607-2:2019 | IDT | SS ISO 11607-2:2019 Packaging for terminally sterilised medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| Quality Management System | ISO | 13485:2016 | IDT | SS ISO 13485:2016 (2021) Medical devices – Quality management systems – Requirements for regulatory purposes |
| Quality Management System | – | – | – | SS 620:2016 (2021) Good distribution practice for medical devices – Requirements |
| Respiratory protective devices | EN | 149:2001+A1:2009 | IDT | SS 669-1: 2020 Medical face masks – Part 1: Filtering half masks to protect against particles – Requirements, testing, marking |
| Respiratory protective devices | EN | 14683:2019+AC:2019: | IDT | SS 669-2:2020 Medical face masks – Part 2: Requirements and test methods |
| Respiratory protective devices | ASTM | F2100-21: 2021 | IDT | SS 669-3: 2021 Medical face masks – Part 2: Standard specificatin for performance of materials used in medical face masks |
| Respiratory protective devices | ASTM | F2101-19:2019 | IDT | SS 669-4: 2020 Medical face masks – Part 4: Standard test method for evaluating the bacterial filteration efficiency (BFE) of medical face mask materials, using a bioloigcal aerosol of Staphylococcus aureus |
| Respiratory protective devices | ASTM | F2299/F2299M-03(2017) | IDT | SS 669-5:2020 Medical face masks – Part 5: Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres |
| Risk Management | ISO | 14971:2019 | IDT | SS ISO 14971:2020 Medical devices – Application of risk management to medical devices |
| Sterilization | ISO | 11137-1:2006 | IDT | SS ISO 11137-1:2018 Sterilisation of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| Sterilization | ISO | 11137-2:2013 | IDT | SS ISO 11137-2:2019 Sterilisation of health care products — Radiation — Part 2: Establishing the sterilisation dose |
| Sterilization | ISO | 11737-1:2018 | IDT | SS ISO 11737-1:2018+A1:2021 Sterilisation of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
| Sterilization | ISO | 11137-3:2017 | IDT | SS ISO 11137-3:2018 Sterilisation of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| Sterilization | ISO | 20857:2010 | IDT | SS ISO 20857:2018 Sterilisation of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilisation process for medical devices |
| Sterilization | ISO | 11139:2018 | IDT | SS ISO 11139:2018 Sterilisation of health care products — Vocabulary of terms used in sterilisation and related equipment and process standards |
| Sterilization | ISO | 17665-1:2006 | IDT | SS ISO 17665-1:2018 Sterilisation of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilisation process for medical devices |
| Sterilization | ISO | 11138-7:2019 | IDT | SS ISO 11138-7:2019 Sterilisation of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results |
| Sterilization | ISO | 11135:2014+A1:2018 | IDT | SS ISO 11135:2019 Sterilisation of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilisation process for medical devices |
| Thermal imagers | – | – | – | SS 582-1:2020 Specification for thermal imagers for human temperature screening – – Part 1: Requirements and test methods |
| Thermal imagers | – | – | – | SS 582-2: 2020 Specification for thermal imagers for human temperature screening – Part 2: Implementation guidelines |
