Overview of IEC 60601 Certification
IEC 60601 is a widely accepted series of International Standards that applies to basic safety and essential performance of all medical electrical equipment and medical electrical systems for their use in the home healthcare environment. It applies regardless of the intention of use of such medical electrical equipment and medical electrical systems by a lay operator or by trained healthcare personnel. Home healthcare includes the following:
IEC 60601 is a recognised series of technical standards which ensures that a single electrical, mechanical, thermal or functional failure poses an unacceptable risk to the patient or the operator. It is considered to be a prerequisite for the commercialisation of medical electrical equipment.
This IEC 60601 does not apply to the followings:
Benefits of IEC 60601 Certification
Following are the benefits of obtaining IEC 60601 Certification:
Requirements included in IEC 60601 for IEC 60601 Certification
Following are the requirements included in IEC 60601 for obtaining Certification under the same:
- Risk Management: ISO 14971 risk management standard must be applied.
- Essential Performance: Manufacturers have to establish specific performance characteristics under abnormal or faulty conditions. It is also a test criterion in assessing if a hazard is present after a specific test, and manufacturers must declare specific essential performance criteria in the product's technical description.
- Humidity: Humidity testing is required under the IEC 60601.
- Documentation: A number of documents are required for user manuals and instructions for use (IFU). Also, the electronic version of all accompanying documentation must apply usability engineering process as covered in collateral standard, IEC 60601-1-6, usability in determining the information that must be presented.
- Marking and Labelling: equipment labelling must have a unique serial number or lot batch identifier, date of manufacture or expiry (use-by) date and manufacturer's contact number.
- Electrical Hazard: The protection from potential electrical hazards includes defibrillation protection, protective earth and creepage and clearance distances. There are limits for leakage current testing for the functional earth connections. Protective earth testing with a power supply cord is needed for the devices equipped with the appliance inlets. If reconnection presents a potential hazard to a user, permanent equipment must include a power lockout device.
- Mechanical Hazards: testing for any mechanical hazard related to the instability and mobile equipment must be notified to include functional testing.
- Temperature Testing: there is a temperature limit defined under IEC 60601. For overflow, equipment is designed to ensure that basic safety and essential performance are maintained all time.
- Programmable Electrical Medical Systems (PEMS): IEC has incorporated many specific requirements and medical device software life cycle processes applicable to the equipment & systems whose operation depends on software or any programmable element. It has also incorporated validation requirements for the equipment connected to a network.
- Construction: for mechanical strength, basic safety & essential performance are included instead of unacceptable risk.
Other requirements under IEC 60601 Standard are as follows:
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Documents Required for IEC 60601 Certification
The document under IEC 60601 is not mentioned, and for IEC 60601 Certification, documents similar to ISO 14971 Certification are required only. And the following are the documents required for ISO 14971 Certification:
- Risk management plan
- Risk management file
- Import details, in case of import
- Information for the user of those accountable for the installation, use, maintenance, decommissioning and disposal of medical device
- Information related to safe use
- Instruction for use
- Technical description
- Installation manual
- Quick reference guide
- Documents stating results achieved or providing evidence of all the activities performed, such as records.
Under ISO 14971, Documents required for Quality Management System are also included, such as the following:
The information and documents that are additionally required under IEC 60601 are as follows:
- Medical Standard List with their publication dates
- Evaluation Package
- Risk Management Guidance Form for ISO 14971
- Risk Management Guidance Form for IEC 60601-1
- Label Manual Checklist
- Medical Alarm Standards Cross Reference
- Medical Standard Project Scope Tool
- Critical Components Guidance Documents
- National Differences Evaluation Package
The procedure required for obtaining IEC 60601 Certification
There are four essential steps to be followed while obtaining the IEC 60601 Certification:
Optional Preliminary Audit
A voluntary Site inspection is conducted, and all the required documents are reviewed, assessing the organisation's readiness for scale I and II Auditing Phase.
Audit: Stage I
Assessment of the eligibility for IEC Certification is understood as well as determined by results of the on-site Auditing, business assessment and risk management documents analysis.
Audit: Stage II
On-site evaluation of the Medical Electrical Equipment and Medical Electrical System as well as Risk Management for excellence in areas where practice and efficiency are applied.
An official confirmation certifies IEC standards for Medical Electrical Equipment and Medical Electrical Systems, integrity and compliance and thus the grant of IEC 60601 Certification.
Frequently Asked Questions
ISO 14971 is the risk management standard for all medical devices, including software as a medical device and in vitro diagnostic medical devices. It is a structured framework for manufacturers within which experience, insight and judgement are applied systematically to manage the risks associated with the use of medical devices. The purpose of ISO 14971 is to help medical device manufacturers establish risk management that such manufacturers can use, and such purposes include the followings:
- Identify the hazard
- Estimate and Evaluate risks
- Develop, implement and monitor the Risk effectiveness
- Control Measures.
The basic devices that are included under the meaning of Medical Electrical Equipment are as follows:
- Cardiac defibrillators
- High-frequency surgical equipment
- Infant incubators and warmers
- Medical lasers
- Patient monitors
- Patient ventilators
- Ultrasound equipment, including diagnostic and therapeutic
The functions that the IEC 60601 Series establish are as follows:
- Represents global consensus for compliance
- Provide a reference for minimum safety requirements of Medical Electrical devices
- Outline design and performance requirements
- Establish regulatory requirements for the market approval
The environment intended to use under IEC 60601 is defined under its 4th edition, which includes the following:
- Professional healthcare facilities, for example, hospitals, clinics and other medical facilities
- Home healthcare settings
- Special environments, like industrial zones and military installations.