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 services environment
OVERVIEW
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, which are intended, as indicated in the instructions for use by their MANUFACTURER, for use in the EMS ENVIRONMENT (EMERGENCY MEDICAL SERVICES ENVIRONMENT).
This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the HOME HEALTHCARE ENVIRONMENT covered by IEC 60601-1-11 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601 1-11 or this collateral standard. ME EQUIPMENT and ME SYSTEMS are often not solely intended for one environment. Such ME EQUIPMENT or ME SYSTEM can be intended for multiple use environments, and as such, if also intended for use in the EMS ENVIRONMENT, are within the scope of this standard.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2018 |
| No. of Pages | 55 |
| ICS Classification | 11.040 Medical equipment |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | IEC 60601-1-12:2014+AMD1:2020 : 2014 IDT |