About this field
Standards for medical devices, consumables, sterilization, biological evaluation and medical laboratories. Developed mainly by ISO/TC 210, ISO/TC 194, ISO/TC 198 and IEC/TC 62.
Regulators in the EU, the United States, Japan and many ASEAN countries rely on these standards (especially ISO 13485 and ISO 14971) when reviewing registrations – a passport for Vietnamese makers of gloves, syringes and other medical supplies.
Key standards: Health care technology
| Number | Title | Body | Type |
|---|---|---|---|
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes | ISO | Requirements Certifiable |
| ISO 14971:2019 | Medical devices — Application of risk management to medical devices | ISO | Requirements |
| ISO 10993-1:2025 | Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process | ISO | Guidance |
| ISO 15223-1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements | ISO | Specification |
| IEC 60601-1 | Medical electrical equipment — Part 1: General requirements for basic safety and essential performance | IEC | Requirements |
| ISO 11135 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices | ISO | Requirements |
A selection of standards that matter for trade; the full list for this field is in the ISO ICS catalogue and on the publishers’ sites.