Standards Development

Scope

This technical specification document is intended to guide MANUFACTURERS through the key design decisions of what type/category of human and animal patient could be covered by the IEC 60601 series of medical standards for MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. The technical specification document is to guide MANUFACTURERS to consider different acceptance criteria(s) though the risk management documents. MANUFACTURERS could adapt/modify the testing scenarios/criteria based on different types/categories of human and animal patients.

This technical specification document is limited to the vital physiological signs and basic anthropometric measurements of different types/categories of human and domestic/farm animal patients.

Purpose

The IEC 60601 series of medical standards is primarily structured around adult human patients (Examples: 135 kg minimum mass for supporting and suspending the mass of the patient, Figure A.18 – Example of human body mass distribution, Blood Pressure 120/80 systolic over diastolic and other). The IEC 60601 series of medical standards lacks information related to the physiological signs and anthropometric measurements for the different categories of human patients. Human patients vary from pre -born to geriatric categories; these different categories contain a broad spectrum of different physiological signs and anthropometric measurements.

Medical Electrical Equipment and Medical Electrical Systems are essentially designed for human beings and are used on animals in veterinary facilities. All must acknowledge that the morphology between human beings and animals are different.

The IEC 60601 series of medical standard does not provide guidance for physiological/anthropometric characteristics related to animals as patients.

Human beings and animals live together. Their health condition can affect one another through different types of cross-contamination. As an example: The COVID -19 pandemic was reported to be caused by viral cross contamination between an animal to human bei ngs. Providing appropriate clinical diagnostic/thearpy for animals could potentially reduce the risk of cross -contamination.

Health facilities for animals are typically called veterinarian facilities.

Medical doctors for animals are typically called veterinarians.

The need for international consonance/knowledge of the veterinary domain needs to be addressed in the IEC 60601 series of medical standards. This to ensure animal health/welfare/wellbeing, ecological impact of human beings and animal health systems, these are all issues/concerns that necessitate a global approach on common understanding on different types of patients that can be addressed in the IEC 60601 series of medical standards.