Transitioning to IEC Edition 3.1 Guidance for Global Implementation. November 2015

Transcription

1 Transitioning to IEC Edition 3.1 November 2015

2 Table of Contents Introduction Amendment 1 to IEC published The status of Edition 3.1 in major markets....8 Intertek s recommendations for manufacturers...13 Conclusion...15 Additional resources

3 Introduction The standard family of IEC is a widely accepted series of international standards for the basic safety and essential performance of medical electrical equipment. Compliance with the IEC series is a requirement for certification of electrical medical products in many countries. IEC was published in 1977and evolved over time to include a greater emphasis on risk management and essential performance, with the biggest shift occurring from the 2 nd to the 3 rd Edition. However, the 3 rd Edition created concerns and questions ever since its publication in Amendment 1, published in 2012, addressed many of these. While the complexity of the standard series itself with its general, collateral and particular parts and other standards referenced in the IEC series presents many challenges, manufacturers also face issues related to lack of global harmonization of the standard. Global adoption of the 3 rd Edition of IEC has been slow since its release, resulting in different transition times by each country s testing agencies and regulatory bodies. Although many regulatory bodies are currently implementing the requirements of IEC with Amendment 1 (Edition 3.1), manufacturers are often required to demonstrate compliance with an older edition of the standard in certain target countries. When combined with higher expectations for testing and documentation, these complexities will necessitate designers and manufacturers working closely with their testing companies to ensure acceptance in all major markets. To aid this effort, this whitepaper provides a summary of the new and revised requirements of IEC Edition 3.1 and recommendations for global implementation

4 Amendment 1 to IEC published 2012 IEC is a lengthy, deeply complex electrical safety standard. Therefore, changes to the standard to address new technologies, new medical techniques and identified safety concerns during use of medical devices are not surprising. These changes are onerous and take time to reach publication. Amendment 1 mainly clarifies the original intent of the 3rd Edition. Despite the fact that the standard has been in existence for 10 years, several parts were not clearly understood by practitioners in the industry. After roughly four years in development, Amendment 1 addresses nearly 100 issues outstanding from the first release of the 3rd Edition. Risk Management Risk Management, although intrinsically part of the philosophy of IEC since conception, was a major change in the 3rd Edition in that evidence of risk management activities according to ISO14971 became mandatory. Amendment 1 clarifies these requirements due to the fact that IEC is a type test standard and not a standard for process certification. Consequently, it applies to a device design rather than a manufacturer s processes, keeping in mind that processes will need to be reviewed in conjunction with the type testing. In many cases, compliance with specific tests addressing Basic Safety requirements of the standard will be sufficient to demonstrate that the associated residual risks are acceptable. The amendment clarifies the extent of risk management activities in other cases. IEC requires that manufacturers identify all hazards associated with their medical devices following the process described in ISO The standard states that those hazards not identified in IEC (including all relevant particular standards) shall be addressed by review of the Risk Management File

5 Similarly, when IEC does not fully describe how a particular risk should be mitigated, the test house will need to review the Risk Management File, including, where necessary, calculations, test results and other evidence demonstrating that the particular residual risk is acceptable. As a suggested best practice, risk management activities would begin during the design conception phase. Conducting a prereview of the documentation tends to improve the outcome of the type testing process. Waiting to identify risks and perform risk management later in the development cycle can be costly. It has always been permissible to apply other methods in order to reduce risks to patients and operators, but the amendment clarifies that scientific data, clinical opinion or comparative studies must be used to demonstrate that the method(s) offer comparable level of safety. Essential Performance The requirements necessary to demonstrate that Essential Performance is not compromised are clarified; the manufacturer has full responsibility to define their acceptable functionality and tolerances in normal and fault conditions. The definition of Essential Performance is also clarified to highlight the difference from Basic Safety and that it concerns only clinical functions. Clearly, clinical input will be required in many cases. Compliance criteria for several tests have been changed to highlight the fact that Essential Performance as well as Basic Safety must be retained. Means of Operator Protection The 3rd Edition introduced the concepts of Means of Operator Protection and Means of Patient Protection, significantly allowing nonmedical mains power supplies to be used in certain circumstances. The amendment imposes additional requirements on the class and rating of approved capacitors used for both patient and operator protection in order that the intended level of protection is not compromised

6 Electrical Safety For electrical safety, there are some minor changes to test methods: - For defibrillator protected equipment with an Applied Part with more than one function, there now needs to be isolation between the functions. Also for the defibrillator energy reduction test, the defibrillation pulse is applied with both polarities. - If the manufacturer does not supply a detachable mains cord with the device, the earth conductor impedance with appropriate cross sectional area is tested with a 3m cord, the compliance limit remaining as 0.2Ω. - If a functional earth conductor is used with Class II equipment it must be separated from accessible parts by 2 Means of Protection. Patient Protection will be required if the patient has accessibility directly or indirectly via the operator. - Creepage distances for Operator Protection are reduced for working voltages between 25 and 50V. Mechanical Safety Mechanical safety changes relate to moving parts and stopping distances where there is emphasis on single fault analysis and testing, and usability engineering input. Mechanical strength requirements of mechanical end stops have been up rated. Radiation Hazards Compliance limits for unintended ionizing or microwave radiation have been added these are similar to those in other safety standards. LEDs have been excluded from the scope of IEC requirements, and it is now left to the manufacturer to demonstrate safety of power LEDs

7 The IEC should be used to address the optical radiation hazards of LEDs. Excessive Temperature and Other Hazards Demonstration of safety of medical equipment incorporating a reservoir or liquid storage chamber now includes a 10º tilt test, or, for mobile equipment, a repeat of the threshold test. In both cases Basic Safety and Essential Performance must be retained. A relaxation in the need to consider the effects of applying fault conditions related to the spread of fire means that circuits operating on no more than 60V dc or 42.2V peak, and that cannot draw more than 100VA, are assumed not to have the capability to compromise Basic Safety as long as suitable wiring and mounting material is used. Programmable Electrical Medical Systems (PEMS) If a PEMS can affect Basic Safety or Essential Performance, in addition to the requirements of clause 14 of IEC , the requirements in clauses 3.4, 5, 7, 8 and 9 of IEC 62304: 2006, Medical device software Software life-cycle processes must be adhered to. Many requirements duplicate those of clause 14, but some are more specific such as for off-the shelf software, defined in IEC as software of unknown provenance (SOUP). Further, if a medical device is intended to be connected to a network, relevant aspects must be specifically addressed, in particular ensuring the responsible organization understands the interfacing requirements and associated hazards. Transformers The decision to replace the requirements for transformer construction in the 2nd Edition of IEC caused problems. For this reason, Amendment 1 effectively reverts back to the original requirements. The high frequency/high voltage test for transformers is now not applicable to those operating at a frequency above 1 khz

8 Batteries The amendment now mandates that primary lithium batteries shall comply with the requirements of IEC and secondary lithium batteries shall comply with the requirements of IEC These requirements apply to assembled packs of cells as well as individual cells. Mobile Equipment The test for this equipment has been made somewhat more onerous in that the test speed has increased from 0.4m/s to 0.8m/s. On the other hand, the test for demonstrating the ability to negotiate thresholds has been made easier; the step height being reduced from 20mm to 10mm. Markings The equipment and any accessories must now bear their serial/lot/batch number as well as the date of manufacture. The manufacturers contact information is also required to be marked. The status of Edition 3.1 in major markets Amendments to IEC standards become current on the day of publication, and so the logical consequence taking into consideration that Amendment 1 includes a lot of corrections and clarifications in particular would be that manufacturers should be applying it now for new designs. However, Amendment 1 also contains substantial changes and the implementation of the new/revised requirements can be a challenge for the manufacturer, especially when taking into consideration the requirement for a software process as described in IEC Further complicating matters is that compliance with Edition 3.1 does not automatically mean compliance with Edition 3.0. Only few of the Part 2 particular requirements standards have been issued under Edition 3.1 yet; if one or more of these standards apply but have not yet been issued,

9 generally Edition 3.0 should be used or a gap analysis should be made to ensure compliance with that edition also. Although some regulatory bodies have already started the implementation process for IEC Edition 3.1, the timeline for adoption varies from country to country just as it did for the 3 rd Edition. Canada Canada has published their national version of IEC Edition 3.1 as CAN/CSA C22.2 No Health Canada now recognizes IEC Edition 3.1; date of withdrawal of Edition 3.0 was August 31, Device submissions to Health Canada prior to this date will not be withdrawn. The final date for cetl transition to 3.1 has not been determined; this means it is currently the manufacturer s choice which edition to use for both the cetl Mark and Health Canada, unless there is a Part 2 applicable which still points to Edition 3.0. United States The Food and Drug Administration (FDA) has announced that both the IEC and AAMI versions of Edition 3.0 and 3.1are on their list of consensus standards. The withdrawal date for the 3 rd Edition will be August 1, Device submissions to the FDA prior to this date will not be withdrawn. The Occupational Safety and Health Administration (OSHA) has added ANSI/AAMI ES : 2005/(R2012) and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 to the list of recognized standards, which is based on IEC Edition 3.1 with additional national deviations. The final date for ETL transition to 3.1 has not yet been determined; this means it is currently the manufacturer s choice which edition to use for the ETL mark, unless there is a Part 2 applicable which still points to Edition 3.0. Intertek recommends the use of Edition 3.1 to ensure acceptance by both the FDA and OSHA

10 European Union The EN /A1:2013 (IEC :2005 with Amendment 1, 2012) were published in the Official Journal of the European Union with compliance required after December 31, As noted in Table I, the European Union commission set the Date of Cessation of Presumption of Conformity of the Superseded Standard (DOCOPOCOSS) almost one year earlier than the date of withdrawal stated in the standard. Table I. Standard Date of Withdrawal in EN DOCOPOCOSS in Official Journal of the European Union Expiration Date EN :2006/C1:2010 (IEC ed. 3.0) 2012-June June-01 EN /A11:2011 (IEC ed. 3.0) 2014-October-01 Non-harmonized standard EN /A1:2013 1) (IEC ed. 3.1) 2018-December December-31 EN /A12:2014 2) 2015-March-26 Harmonization pending 1) Annex ZZ relates to MDD 93/42/EEC (changed to ZZA by A12). 2) The only content in A12 is the Annex ZZB, which relates to AIMDD 90/385/EEC. These Annexes deal only with the relationship between the standard and the Essential Requirements of the directives

11 While device manufacturers can elect not to use Amendment 1 for their design requirements prior to December 31, 2017, complying with the comprehensive revisions involved in Amendment 1 lessen the document review burden during the type testing. For example, Amendment 1 removed numerous links to risk management. Compliance with some clauses can be established by other easier means. In other cases, clauses with testable requirements were added in the standard. Additionally, because product directives for medical devices are more restrictive than the international standards, the standard does not cover all of the Essential Requirements. Therefore the use of Annex ZZ in EN /A1:2013 will be required in order to match the Essential Requirements of the MDD as of January 1, Whenever possible, considering available particular standards, Intertek recommends applying the complete EN /A1:2013 as soon as possible to avoid challenges related to the January 1, 2016 compliance date. For those device manufacturers with products on the market that meet 3.0 standard requirements, a technical file update to ensure that your Notified Body can confirm meeting the Essential Requirements as indicated in Annex ZZ may be required. Because all standards are voluntary in the EU, this recommendation applies to those products claiming presumption of conformity with Essential Requirements in the directive 93/42/EEC. Japan Japan published its own standard of IEC Edition 3.1 as JIS T :2014. The standard is equivalent and will be mandatory in Japan as of June 1, 2017 but with declared modifications. Like many other countries, the actual transition period may be different due to the effective date of an applicable particular standard for the device. Intertek recommends having the feasible edition confirmed by the Pharmaceuticals and Medical Devices Agency (PMDA) or by your certified body

12 Brazil The Brazilian National Health Surveillance Agency, ANVISA, published a new list of technical standards in September 2015 to which some electrical medical devices must comply in order for manufacturers to obtain ETLBr -INMETRO certification in Brazil. The new ANVISA normative instruction, IN 04/2015 replaces IN 11/2014 and updates compliance timeframes for a number of IEC standards. The existence of a device-specific consensus standard, or particulars standard and age of the existing 3.0 Edition test will determine whether Edition 3.0 or 3.1 shall be used. With the exceptions noted in the next paragraph, IEC rd Edition Amendment 1 series testing is now mandatory for ETLBr- INMETRO certification. For equipment in which there is still no certification enforceability in the 3rd Edition of IEC series, the conformity certification must be conducted based on prior editions to applicable standards, including the use of the general standard and its collateral, in the previous version where appropriate. Test reports more than two years old are not allowed. In any case, Intertek should be contacted to evaluate the applicable standard for each product and applicability of the 3.0 Edition and 3.1 Edition. Impact on IECEE CB Scheme and testing The IECEE CB Scheme is based on the principle of mutual recognition of test results by its members for obtaining certification or approval at the national level. Which edition (and amendments) to use by manufacturers of medical equipment depends on the national regulatory requirements in each country. From the IEC point of view, a new edition replaces the old one as soon as it is published; the same applies to Amendment 1 of IEC , Edition

13 Intertek recommends that you consult directly with your electrical testing laboratory to determine which standard edition (and amendment) is currently being accepted in each target country. In some cases it may be necessary to evaluate to more than one edition and/or amendment to ensure acceptance by the recognizing NCBs, as collateral or particular standards may have differing transition dates. In OD-2055, the IECEE CB Scheme defines which collateral and related standards cannot be excluded from a CB scheme evaluation according to IEC For IEC Amendment 1, the requirements are listed in Annex C. One major difference to Edition 3.0 is that IEC , IEC (Usability) and several parts of IEC (Medical device software Software life cycle processes) are now mandatory. With Edition 3.0, usability was mandatory only if collateral standards IEC (medical equipment/systems used in home healthcare environment) and/or IEC (alarm systems) were applicable. Intertek s Recommendations for Manufacturers Use state-of-the-art requirements of Edition 3.1 for new designs IEC Edition 3.1 is the newest published general standard and considered State-of-The-Art. Global adoption and transition to the new standard is underway, with some countries already accepting products in compliance with this standard. Therefore the current standard should be used as the basis for new product designs. This includes not only the construction and testing requirements, but also the requirements for processes such as risk management, software and usability. Know your target markets and requirements Manufacturers should be aware of the varying regulatory transition periods worldwide. It is important to know which countries are already accepting IEC Edition 3.1, and which will continue to recognize one of the previous editions and are not likely to change to the newest

14 edition in the near future. To cover all major markets, it may be necessary for the product to comply with more than just one edition of the general and (if applicable) particular standard. This will result in increased complexity of the evaluation to the standards and the associated costs. Be aware of the specific technical and process requirements Due to the complexity of the IEC standards series with its collateral and particular standards, it is essential to conduct a thorough investigation to find out which standards and requirements are applicable before the design process is started. Collateral (IEC XX) standards are normative on the day of their publication and shall be used together with the general (IEC ) standard. The process of alignment of the particular (IEC XX and IEC XX) standards with Edition 3.1 of the general standard is still ongoing; there are also new particular standards being developed which also shall be taken into consideration. Examples of new particular standards published in 2015 are ISO for sleep apnea breathing therapy equipment and ISO for home healthcare ventilators. IEC also includes a lot of references to other standards which shall be taken into consideration at an early stage, e.g. for components, processes and for hazards not addressed in depth in IEC Examples include IEC (Secondary cells and batteries), IEC (Safety of laser products), IEC (Photobiological safety of lamps and lamp systems), IEC (Medical device software Software lifecycle processes) and IEC (Medical devices Application of usability engineering to medical devices). Thorough planning of activities will ensure a smooth transition For products that are already in compliance with one of the previous editions of the standard, there are various steps that manufacturers can take to help ensure a smooth transition to IEC Edition

15 Conduct a thorough gap analysis on construction and an audit on process requirements first to determine the next steps, including the expected timeframe and costs. In some cases there may be only minor modifications to the device or documentation required, whereas other products may necessitate a complete redesign and evaluation. In cases where evaluation and compliance with various editions of standards is required, it is recommended to issue a consolidated test plan including the worst case scenarios covering all applicable test requirements. Conclusion The acceptance of the 3rd Edition has matured to help ensure medical device safety via a more enlightened approach to risk management. When you re ready to make the transition to Edition 3.1, Intertek will help you navigate the requirements. We will help you to determine the appropriate standards and requirements to ensure acceptance of your products in the targeted markets. Intertek will partner with you, providing an interactive approach addressing your concerns via device design review and assessment of the risk management, usability and software processes to determine their suitability to the 3rd Edition series of standards. If you have any questions or would like to start a new project or design review, contact your Intertek account manager or project engineer, icenter@intertek.com, or call us at WORLDLAB ( )

16 Additional Resources Do your medical devices meet new IEC th Edition immunity and risk management requirements? Learn about the new requirements by downloading this on demand webinar and frequently asked questions (FAQ) at How to integrate human factors in the design process for FDA compliance. Learn how to design a Human Factors Plan using a simple medical device that could be used to satisfy IEC in this on demand webinar and frequently asked questions (FAQ) at UN 38.3 and the requirements for the transportation for lithium batteries. For those who need to ship Lithium and Lithium batteries and the medical devices which they power, there is much confusion around the testing requirements of UN Learn about common challenges and misunderstandings faced by manufacturers when planning for testing in this on demand webinar at requirements-for-transporting-lithium-batteries-webinar/ IEC rd Edition: An Overview This white paper reviews the new philosophy of the 3rd Edition, and outlines the specific changes from the 2nd Edition and serves as a historical reference. Download at paper/

17 About Intertek Intertek is a leading quality solutions provider to industries worldwide. From auditing and inspection, to testing, training, advisory, quality assurance and certification, Intertek adds value for its customers by helping improve the quality and safety of their products, assets and processes. With a network of more than 1,000 laboratories and offices and over 38,000 people in more than 100 countries, Intertek supports companies success in the global marketplace, by helping customers to meet end users expectations for safety, sustainability, performance, integrity and desirability in virtually any market worldwide. Visit This publication is copyright Intertek and may not be reproduced or transmitted in any form in whole or in part without the prior written permission of Intertek. While due care has been taken during the preparation of this document, Intertek cannot be held responsible for the accuracy of the information herein or for any consequence arising from it. Clients are encouraged to seek Intertek s current advice on their specific needs before acting upon any of the content