Standards for Medical Devices


Singapore Standards (SS) are nationally recognised documents established by consensus and the development of these standards is facilitated by Enterprise Singapore.

For more information on Singapore Standards, please visit the website.

Recognised standards for medical devices:

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

IDT – Identical

Last updated: 5 September 2023

Manufacturers may use the above recognised standards to demonstrate conformity to the Essential Principles of Safety and Performance of Medical Devices, where applicable.

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