IEC/EN 60601-1-12 Medical Electrical Equipment - Part 1-12: General Requirements for Basic Safety and Basic Performance - Guarantee Standard

The IEC/EN 60601-1-12 standard establishes a complementary standard for the general requirements for essential safety and essential performance, hereinafter referred to as the general standard. In medical practice, medical electrical equipment and medical electrical systems are increasingly used for the monitoring, treatment or diagnosis of patients in the emergency medical services setting.

The safety of medical electrical equipment in this uncontrolled, harsh environment is a cause for concern. This complementary standard has been developed with input from clinicians, engineers, and regulators. Terminology, requirements, The general recommendations and guidance of this supplementary standard are intended to be useful to manufacturers of medical electrical equipment and medical electrical systems and to technical committees responsible for the development of specific standards.

This International Standard applies to the essential safety and essential performance of medical electrical equipment and medical electrical systems intended by their manufacturers for use in EMS as specified in the instructions for use, hereinafter referred to as ME equipment and ME systems.

The purpose of this supplemental standard is in transport with ME equipment and ME systems transported to and used at the emergency scene, where ambient conditions differ from indoor conditions. The purpose of this supplementary standard is to specify general requirements in addition to the general standard and to form the basis for specific standards.

This standard has been developed with contributions from clinicians, engineers and regulators. The purpose of this assurance standard is to provide general requirements for medical devices and systems that are transported and used in an emergency environment and also used in space conditions different from the ambient conditions.

A few standards that are indispensable and referred to during the implementation of the IEC 60601-1-12 standard are: IEC 60068-2-27 (environmental testing), IEC 60068-2-31 (environmental testing), IEC 60068-2-64 (environmental tests ), IEC 60529 (degree of protection provided by enclosures, IP code) and IEC 60601-1 (general requirements for medical electrical equipment, basic safety and basic performance).

Our organization, among numerous test, measurement, analysis and evaluation studies, with its trained and expert staff and advanced technological equipment, within the framework of national and international standards, IEC / EN 60601-1-12 Medical Electrical Equipment - Part 1-12: General Requirements for Basic Security and Basic Performance - Assurance Standard services.