This should be one of the first questions asked during the medical device development process. Relevant standards are a key design input and they facilitate risk management, verification, and validation activities. Determining which standards apply can be a challenge for industry and regulators alike.
In the context of this article, the term “standard” means a regulation published by a government regulatory authority or a consensus standard published by a Standards Developing Organization (SDO). The SDOs mentioned in this article are as follows:
ISO – International Organization for Standardization (112 national members)
IEC – International Electrotechnical Commission (60 national members)
CEN – European Committee for Standardization (33 national members)
CENELEC – European Committee for Electrotechnical Standardization (33 national members)
AAMI – Association for the Advancement of Medical Instrumentation
ASTM International – formerly American Society for Testing and Materials
Standards Hierarchy and Content
National regulations are compulsory (mandatory) if applicable medical devices are to be clinically investigated or marketed in the country under jurisdiction. Consensus standards and guidance documents (not addressed in this article) are typically voluntary, but meeting them can greatly facilitate regulatory compliance.
Consensus standards published by international SDOs such as ISO, IEC, CEN and CENELEC should take precedence over standards published solely by other SDOs. However, if no standards for a particular topic are found at the international level, then it can be useful to search standards developed by other SDOs. For example, AAMI and ASTM publish many documents with subject matter not addressed in detail at the international level.
Consensus standards are sometimes referred to as being “general” or “particular”. General standards apply to all devices or a broad range of devices. Particular standards apply to more narrow ranges of devices than general standards. Even within particular standards, there are sometimes different levels.
Normative content in standards includes prescriptive requirements and serves as the basis for determining compliance with the standard. In contrast, informative content provides supplemental descriptive information to aid understanding (not requirements).
Internet Resources for Finding Standards
Internet search engines provided by regulatory agencies, SDOs, and third-party distributors can be useful for finding standards. However, they can sometimes provide conflicting or outdated information. Confusion can be resolved by comparing results from different sources and leaning towards SDOs as the most authoritative source.
For Europe, the Harmonised Standards Reference Lists are an important resource. Compliance with harmonized standards provides a “presumption of conformity” with the applicable requirements of the associated European directive.
Standards Searching Tips
- Compare results found on national SDO websites to results from international standards body websites (ISO/IEC, CEN/CENELEC).
- Review the cross-references in each standard to learn what other standards may be applicable.
- Maximize value by purchasing EN ISO (or EN) standards instead of the corresponding ISO (or IEC) standards. The normative content is typically identical, and the harmonized EN versions have additional informative annexes that can facilitate European regulatory compliance.
- ISO publishes and sells standards in English, French, and Russian. IEC publishes and sells standards in English and French. Corrigenda documents (error or ambiguity corrections) are free of charge from both organizations.
- CEN and CENELEC publish European (EN) consensus standards in English, French and German but do not directly sell standards. The CEN/CENELEC National Standards Bodies sell them. They add their national prefix, and in some cases, the publication date is delayed beyond the year of original publication by CEN/CENELEC.
- When CEN adopts an ISO standard they add the “EN” prefix in front of the “ISO” prefix. When CENELEC adopts an IEC standard they replace the “IEC” prefix with the “EN” prefix.
Resources for Previewing Consensus Standard Information
Determining whether a standard applies to your device sometimes requires the content of the standard to be reviewed. Since consensus standards are protected by copyright law and must be purchased, this can be costly. However, there are ways to determine the scope and applicability of consensus standards without purchasing them (see examples below).
BSI provides Overview and Product Details information for each standard. The Overview typically describes the standards scope and section headings. The Product Details section provides information such as cross-references and equivalence relationships to other international standards.
The Estonian Centre for Standardization provides free previews of standards. These previews include the first few pages, typically including the Scope, Normative References, and the beginning of the Terms and Definitions section. For a minimal charge, this site provides 24-hour previews of entire standards.
Strategies for Standards Determination
- Determine in which countries the devices will be distributed – Most companies develop their devices so they can be marketed throughout the world. However, if there is a particular geographical focus, the relative importance of various standards can be determined. For example, if the firm’s primary goal is to perform a clinical investigation in Europe, then FDA Recognized Standards need not play a pivotal role to prepare the standards list. The focus should be to identify the “EN” standards applicable to the device with a particular focus on “harmonised” EN standards.
- General Standards – The following standards apply to most medical devices.
- Quality Management System ISO/EN ISO 13485, FDA 21 CFR 820
- Clinical Investigation ISO/EN ISO 14155
- Risk Management ISO/EN ISO 14971
- Usability Engineering IEC/EN 62366-1
- Labeling EN 1041, European Directives, FDA 21 CFR 801
- Label Symbols ISO/EN ISO 15223-1
- Screening Questions – The following screening questions can be helpful to narrow down the applicable standards.
- Is it a medical device? General standards apply
- Does device contact patient? ISO/EN ISO 10993-x series
- Is it an electromedical device?
- Base standard IEC/EN 60601-1
- Collateral standards IEC/EN 60601-1-x
- Particular standards IEC/EN 60601-2-x
- Is it associated with software? IEC/EN 62304
- Is it provided sterile? How sterilized? How packaged?
- Sterile Packaging ISO/EN ISO 11607-x
- Sterile Package Testing ASTM F88, F1140, F1980, F2096, etc.
- Sterility Assurance Level EN 556-1
- Microbiology ISO/EN ISO 11737-x
- Ethylene Oxide ISO/EN ISO 11135, ISO/EN ISO 10993-7
- Radiation ISO/EN ISO 11137-x
- Moist Heat ISO/EN ISO 17665-1
- Is it resterilized by the user? ISO/EN ISO 17664
- Is it implantable?
- General Requirements ISO/EN ISO 14630
- Instrumentation ISO/EN ISO 16061
Once the relevant standards are identified, the next challenge is interpreting and applying them to medical devices being developed. After that, continual surveillance of changes to the standards is vital for maintaining state-of-the-art devices.
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