This amendment clarifies the original intent of the third edition of the electrical safety standard, and some regulatory bodies have already started implementing it.
Compliance with the IEC 60601 series is a requirement for certification of electrical medical products in many countries. While it has evolved over time to include a greater emphasis on risk management and essential performance, the Edition 3.0 contained ambiguities that made execution challenging. Global adoption of the Edition 3.0 has thus been slow, resulting in different transition times by each country's testing agencies and regulatory bodies.
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An Overview of Edition 3.1
IEC 60601-1 is a lengthy, complex electrical safety standard. Given the size of the original standard and the complexity of the changes, implementing the changes can seem overwhelming. The slower nature of the publication and adoption of the revised standard also led way to Amendment 1, which mainly clarifies the original intent of Edition 3.0.
Amendment 1 addresses nearly 100 issues outstanding from the first release of Edition 3.0. It takes into account new knowledge by practitioners and the industry. Some of these issues include risk management, essential performance, operator and patient protection, electrical and mechanical safety, batteries, mobile equipment, radiation, temperature, and markings.
While amendments to IEC are effective upon publication, Amendment 1 contains substantial changes, and the implementation of the new and revised requirements can be challenging. Additionally, compliance with Edition 3.1 does not automatically ensure compliance with Edition 3.0, which requires using Edition 3.0 or a gap analysis to ensure compliance. Although some regulatory bodies have already started implementing IEC 60601-1 Edition 3.1, timing for full compliance varies by country.
Differing Regions, Differing Status
Some countries have published national standards in line with IEC 60601-1 Edition 3.0 with no final date in place, while others have adopted the new and revised requirements and they are currently in place. With various countries at different stages in the process of enforcing the new and revised requirements, it is important for manufacturers and those in the industry to track the requirements based on geography. Table I summarizes the status and key dates in various regions for the Edition 3.1.
Table I. Status and key dates for IEC 60601-1 Edition 3.1 in various regions.
Withdrawal Date [Unless there is only a Part 2 applicable, which points to Edition 3.0]
Published national version of the standard as CAN/CSA C22.2 No 60601-1-14; Health Canada now recognizes the standard
August 31, 2015
FDA announced both IEC and AAMI versions of Editions 3.0 and 3.1 are listed as consensus standards; OSHA has added them to the list of recognized standards, with national deviations
August 1, 2016
EN 60601-1 A1:2013 published in the Official Journal of the European Union
December 31, 2017
Published own standard, JIS 0601-1:2014, with declared modifications
June 1, 2017
In some countries, the actual transition period to the revised standard may be different due to the effective date of an applicable standard for a device. It is a good idea to check with governing agencies or certification bodies to clarify which feasible edition to use.
In some cases, it may be necessary to evaluate products to more than one edition and/or amendment in order to ensure acceptance by a country's regulatory agency. This is especially true during transition and review periods. Given the complexity of the standard and the variations in implementation across the globe, there are several other things to keep in mind.
Recommendations for Manufacturers
There are several things manufacturers can do to implement IEC 60601-1 Edition 3.1 into product design and development.
Use the Edition 3.1 for New Designs. As the newest published standard, Edition 3.1 is considered to be "state of the art." With global adoption and transition to the standard underway and some countries already enforcing it, using the standard as a basis for product design is best practice. Consider not only construction and testing requirements, but risk management, software, and usability from the early stages of developing a new product in order to make the process of bringing products to market a smooth one.
Know Your Target Markets and Requirements. Be aware of the varying regulatory transition periods worldwide, as outlined in Table I. It's important to know which countries have already shifted to Edition 3.1, which are in the process of changing over, and countries that are not likely to change but continue recognizing previous editions. Remember that to cover multiple markets, it may be necessary for a product to comply with more than one edition of the standard. In return, this could mean increased complexity in evaluations and associated costs.
Be Aware of Specific Requirements. The IEC 60601 standards series is complex; it's essential to conduct a thorough investigation to find out which standards and requirements apply to a design process before you get started. Collateral standards are normative on the day of publication and should be used together with the general standard. Aligning on particular standards is ongoing, as there are new particular standards being developed that need to be taken into consideration. Knowing what is happening with all aspects of the series is a necessary step to help.
IEC 60601-1 includes many references to other standards that must be considered at an early stage. For example, references include IEC 62133 (secondary cells and batteries), IEC 62304 (medical device software - software lifecycle process), and others that are not addressed in depth in IEC 60601-1. Knowing these other standards and how they apply to the Edition 3.1 and medical device development will be important.
Plan Transitions Thoroughly. To ensure a smooth transition for products already in compliance with previous editions of the standard, conduct a thorough gap analysis on construction and an audit on process requirements in order to determine next steps. This should include expected timeframe and cost considerations. In some cases, only minor modifications to a device or documentation may be necessary. Other products may require a significant redesign and evaluation.
For cases where evaluation and compliance with various editions is required, issue a consolidated test plan that includes worst-case scenarios covering all applicable test requirements. Use this plan in your product assessments and development to help in the process.
Acceptance of the IEC 60601.1 has matured to help ensure medical device safety, particularly with regard to risk management. Determining the appropriate standards and requirements will help ensure acceptance of a product in all targeted markets. Considering the range of new and revised requirements throughout a product's design and development is a key step in helping ensure a product's success.
Marco Fedeli serves as a safety engineering team leader and lab manager at Intertek in Atlanta, GA, specializing in medical device safety standards, collateral standards, and particular standards for various types medical devices.
[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]