Medical Device Testing and Certification
F2 Labs can assist you in determining what standards and collateral standards are required for testing and certifying your product in order to sell your medical device to global markets. With more than 20 years of experience, F2 Labs can provide you with the necessary FDA medical testing and medical device testing and certification to get your product in the hands of doctors and patients on a timely schedule.
We can provide you with the test reports that are required in order to submit your 510K to the FDA in order to obtain FDA Medical Device Approval, for inclusion in your CE Technical File for Europe, U.S. and Canadian certification mark for medical devices, and for submittal to the Brazilian Authorities, and other international submittals.
Medical Device Safety Testing
IEC 60601-1 – 3rd edition – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1 3rd edition contains a shift in thinking from the previous edition. There is more emphasis on the risk management file and process conforming to ISO 14971, as well as essential performance. We can assist you through this process.
Certain aspects of safety and performance are defined by the collateral standards (numbered 60601-1-X). The revision dates for the Collaterals and Particulars standards may not be the same as that of the General Standard.
In addition to IEC 60601-1, which is the general Safety standard for Medical Devices, we can also assist you with the part 2 product specific standards: IEC 60601-1-11 for home healthcare equipment; IEC 60601-1-6 for usability; IEC 60601-1-8 for alarms; Risk Assessment to ISO 14971; and more.
Medical Device EMC Testing
IEC 60601-1-2 – 4th edition – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
NOTICE – IEC 60601-1-2 4th EDITION HAS MANY TECHNICAL AND DOCUMENTATION CHANGES..
Below is an overview of the most significant changes. As with any other standard change, failure to complete these new requirements in a timely manner could cause costly delays in getting your device to market. With the 3rd edition of IEC 60601-1-2 still in use, it is often hard to determine which version of IEC 60601-1-2 should be used. F2 Labs can help with your FDA medical testing and medical device testing and certification. Please give us a call.
The most significant changes from IEC 60601-1-2 3rd edition to IEC 60601-1-2 4th edition are as follows:
Specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments
Specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition
Specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system
Specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition
Better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term “life-supporting”.
This new edition also includes the following guidance in the following areas:
- Determination of immunity test levels for special environments
- For adjustment of immunity test levels when special considerations of mitigations or intended use are applicable
- Risk management for basic safety and essential performance with regard to electromagnetic disturbances
- Identification of immunity pass/fail criteria.
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Your medical device must comply with the 4th edition of IEC 60601-1-2 by December 31, 2018, for Europe, United States (FDA) and Canada.
However, the United States FDA prefers products to be evaluated to the 4th edition now, when submitting new applications. This is especially true for medical devices that are used in a home healthcare environment.
The FDA does not require compliance to the 4th edition for legacy devices, unless changes have been made to the product.
In the European Union (that accepts the CE Mark), medical devices must comply with the 4th edition of EN 60601-1-2. There is no allowance for legacy devices, as is allowed by the FDA.
Legacy Device Definition: A legacy device refers to a computing device or equipment that is outdated, obsolete or no longer in production. This includes all devices that are unsupported or no longer commonly used by most devices and software applications.
- Essential performance – performance necessary to achieve freedom from unacceptable risk.
- Risk Management – The systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating and controlling risk.
- Usability – ensures that interactions between the operator and the medical device will occur safely and as intended.
ISO 7176-21:2009 Wheelchairs – Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
ANSI/RESNA WC-2 2009, Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters
“These standards apply to electrically powered wheelchairs and scooters with a maximum speed of not more than 15 km/h intended for indoor and/or outdoor use by people with disabilities. They are also applicable to manual wheelchairs with an add-on power kit.
They are not applicable to vehicles designed to carry more than one person. These parts also specify requirements and test methods for the electromagnetic compatibility of battery chargers intended for use with electrically powered wheelchairs and scooters.”
Common Collateral & Particular Standards*
- IEC 60601-1-6 – Part 1-6
General requirements for basic safety and essential performance – Collateral standard: Usability
- IEC 60601-1-11 – Part 1-11
General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-22 – Part 2-22
Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60601-2-3 – Part 2-3
Particular requirements for the basic safety and essential performance of short-wave therapy equipment
- IEC 60601-2-4 – Part 2-4
Particular requirements for the basic safety and essential performance of cardiac defibrillators
- IEC 60601-2-37 – Part 2-37
Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- IEC 60601-1-8 – Part 1
General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 80601-2-35 – Part 2-35
Particular requirements for basic safety and essential performance of heating devices using blankets, pads, mattresses and intended for heating in medical use
- IEC 60601-2-52 – Part 2-52
Particular requirements for the basic safety and essential performance of medical beds
- IEC 60601-2-57
Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
* Please note: This is a partial list of collateral standards.