Hot Topics in Standardization Archives - Page 9 of 10 - Document Center's Standards Forum

Human Factors for Medical Devices – IEC 62366 and ANSI/AAMI HE75

Do you need help in finding the best practices guidance in medical device human factors engineering? With the focus of good design being expanded to the entire product life cycle, the issue of insuring adequate medical device usability has taken on new importance. Here at Document Center Inc. our customers have been relying on two standards for this – ANSI/AAMI 75 and IEC 62366.

Human Factors Engineering (HFE) is a new and separate discipline within the medical device industry. It has evolved due to the high concentration of medical device incident reports and recalls involving use error. HFE includes all aspects of a device that users interact with when operating the product. It considers the interaction with the device by operators, maintainers, cleaners, caregivers, and patients. By providing adequate labeling, instruction, and ease of use, manufacturers can reduce use-associated risk.

IEC 62366 Edition 1.0 from 2007, “Medical devices – Application of usability engineering to medical devices,” focuses on the process of analysis, evaluation, and testing methods for developing safe and usable medical devices. It aims to improve usability by reducing design-induced error. Simply stated, IEC 62366 covers human factors design process — what needs to be done and when.

One important aspect in using the standard is the presumption of reduction of risk as defined in ISO 14971. If the usability engineering process detailed in the standard and the acceptance criteria documented in the usability validation plan have both been met, then the residual risks associated with usability of a medical device are considered to be acceptable, unless there is objective evidence to the contrary.

It is my understanding that if you already meet the IEC 60601-1-6, you have most of the requirements of the IEC 62366 already achieved. The document has been adopted for use in Europe as EN 62366: 2008.

ANSI/AAMI HE75-2009, “Human Factors Engineering—Design of Medical Devices,” covers the principles of HFE. The standard provides detailed human factors engineering design guidance, examples, checklists, and case studies. With 445 pages, and extensive illustrations, it is considered an encyclopedia of HFE for specific situations. It covers all aspect of design, from basic human skills and abilities to post-market issues. The standard is a powerful tool in all stages of the design life cycle.

These standards can all be purchased from Document Center Inc. at our website, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). As always, questions and comments are welcome.

AMS-C-26074 and MIL-C-26074 – An explanation of the revision path

When AMS-C-26074 (titled Coatings, Electroless Nickel, Requirements for) was released to replace MIL-C-26074 and then subsequently was canceled and then inactivated, it caused a great deal of confusion among users of the document. In order to help you understand the current situation, here’s the revision path for the documents and information on what’s current now.

The last issue of MIL-C-26074 was Revision E, from 10/1990. In 1994 as part of mil spec reform, the document was cancelled by Cancellation Notice 1 and was replaced by AMS-2404 and AMS-2405. However, the two documents did not adequately replace the mil spec and a second cancellation notice was issued in 8/1995. This time MIL-C-26074E was replaced by ASTM-B607, ASTM-B656, AMS-2404, AMS-2405 and AMS-2433.

This still did not completely satisfy the requirements of the original mil spec, so in 2/1998 the document was reinstated.

Now one feature of mil spec reform is that a number of cancelled military specs and standards ended up being reprinted in their entirety by various industry associations. In this case, MIL-C-26074E was adopted and reprinted by SAE as AMS-C-26074, 1998 Edition in 8/1998. Unfortunately, the MIL-C-26074 was not cancelled at that point in time.

With two concurrent and identical specifications in force at the same time, confusion ran rampant. On 2/4/2003, an administrative notice was issued referring to a classified MIL-DTL-26074 Revision F. The 2/5/2003, this MIL-DTL-26074F was cancelled. On the same day, the MIL-C-26074E was cancelled as well. The Revision E was replaced by the AMS-C-26074, except for Naval Nuclear Propulsion Program applications which were directed to use MIL-DTL-32119 (a classified document not available to the general public). The Revision F was just replaced by the MIL-DTL-32119.

Still SAE felt that the 26074 specification duplicated pre-existing standards and wanted to withdraw the document in favor of those older (and well-used) documents. So a Cancellation Revision A was released for the AMS-C-26074 in 2/2005. The document was replaced by AMS-2404 and AMS-2433. However, again there was resistance to this move. So in October 2005, the document was reinstated in the current Inactive Revision B and thus it remains to this day.

FYI, an Inactive Revision is a status of being current (OK to use), but only for replacement purposes. The 2 replacement documents (AMS-2404 and AMS-2433) should be used for all new design.

Should you need copies of any of the standards mentioned, or have any further questions, please get in touch. You can order through our website at www.document-center.com, or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

Japanese earthquake reminds us how Building Codes save lives

With the news today of the devastating earthquake in Northern Japan, I find myself reminded of our San Francisco earthquake in 1988. The difference in the magnitude of the two quakes is significant and gives us a moment to be thankful for all the hard work the Japanese have done over the years to improve the seismic requirements of the Building Standard Law of Japan.

Living in an earthquake area means preparing for the inevitable. There is never a question about “If” but only “When.” One cannot turn a blind eye to the kind of damage caused by this phenomena if one cares about human life and suffering.

The Japanese starting thinking about seismic requirements for buildings back in the 1920’s, with the revision of Law Enforcement Regulations in 1924. This was the first time the Japanese building codes included seismic design forces.

After World War II, with massive rebuilding necessary in the country, the modern structure of the building code was developed. It includes references to standards from both the Architectural Institute of Japan and the Japan Concrete Institute.

There have been two significant seismic design code revisions to the Building Standard Law of Japan. The first occurred in 1981, when a two-phase earthquake design was introduced. Then a second revision in 2000 allowed for performance based requirements and verification relying on accurate earthquake response and limit states of a building.

There is no doubt that the attention paid to earthquake vulnerability of buildings has saved countless lives in the current massive earthquake off the shores of Japan. Our hearts go out to the victims but our hats are off to a country that has worked so hard to minimize the devastation that this natural phenomena brings.

Food safety management standards from ISO

With all the recent interest in food safety for cross-border food supply chains, a review of the Food Safety Management Standards developed by ISO, the International Organization for Standards, seems appropriate.

The ISO 22000 series has been developed expressly for the purpose of helping organizations set up a good safety management system viable for international trade.

The ISO 22000 international standard is derived from ISO-9001. It specifies the requirements for a food safety management system that involves interactive communication, system management, prerequisite programs, and HACCP (Hazard Analysis Critical Control Point) principles.

The documents in the series are:

ISO-22000:2005, Food safety management systems — Requirements for any organization in the food chain

ISO/TS-22004:2005, Food safety management systems — Guidance on the application of ISO 22000:2005

ISO/TS-22003:2007, Food safety management systems — Requirements for bodies providing audit and certification of food safety management systems

ISO-22006:2009, Quality management systems — Guidelines for the application of ISO 9001:2008 to crop production

ISO/TS-22002-1:2009, Prerequisite programmes on food safety — Part 1: Food manufacturing

Here is the abstract for the ISO-22000:

ISO 22000:2005 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of ISO 22000:2005 can be accomplished through the use of internal and/or external resources.

ISO 22000:2005 specifies requirements to enable an organization

— to plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer,

— to demonstrate compliance with applicable statutory and regulatory food safety requirements,

— to evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction,

— to effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain,

— to ensure that the organization conforms to its stated food safety policy,

— to demonstrate such conformity to relevant interested parties, and

— to seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to ISO 22000:2005.

The ISO-22004 is a generic guidance document for the ISO-22000.

For the ISO-22003, the abstract is as follows:

ISO/TS 22003:2007 defines the rules applicable for the audit and certification of a food safety management system (FSMS) complying with the requirements given in ISO 22000:2005 (or other sets of specified FSMS requirements), and provides the necessary information and confidence to customers about the way certification of their suppliers has been granted.

FSMS certification does not attest to the safety or fitness of the products of an organization within the food chain. However, ISO 22000:2005 requires an organization to meet all applicable food-safety-related statutory and regulatory requirements through its management system.

And for the ISO-22006, the abstract states:

ISO 22006:2009 gives guidelines to assist crop producers in the adoption of ISO 9001:2008 for crop production processes. The term “crop” includes seasonal crops (such as grains, pulses, oilseeds, spices, fruit and vegetables), row-planted crops that are cultivated, perennial crops that are managed over a period of time, and wild crops that are not formally planted or managed. Horticultural crops provide an even broader range of types from annual and perennial fruits, vegetables, and ornamental flowering plants to perennial shrubs and trees, and root crops. These diverse crops require a broad range of planting, cultivating, pest control, and harvesting methods and practices. Decisions regarding planting, growing, and harvesting activities can be similar, although specific steps can be quite different when considering the range of crops.

ISO 22006:2009 gives guidelines on the use and application of ISO 9001:2008 to the establishment and management of a quality management system (QMS) by an organization involved in crop production.

ISO 22006:2009 is not intended to change, add or reduce the requirements of ISO 9001:2008, nor is it intended for certification.

Further down the supply chain, in manufacturing processes, the language of ISO 9001:2008, ISO 15161 or ISO 22000 is considered more appropriate. The need for an ISO 9001:2008-based system containing agricultural terminology became apparent due to difficulties in the interpretation of the language of ISO 9001:2008 for crop production applications.

Lastly, for the ISO-22002-1, more information follows:

ISO/TS 22002-1:2009 specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRP) to assist in controlling food safety hazards.

ISO/TS 22002-1:2009 is applicable to all organizations, regardless of size or complexity, which are involved in the manufacturing step of the food chain and wish to implement PRP in such a way as to address the requirements specified in ISO 22000:2005, Clause 7.

ISO/TS 22002-1:2009 is neither designed nor intended for use in other parts of the food supply chain.

Food manufacturing operations are diverse in nature and not all of the requirements specified in ISO/TS 22002-1:2009 apply to an individual establishment or process.

Where exclusions are made or alternative measures implemented, these need to be justified and documented by a hazard analysis, as described in ISO 22000:2005, 7.4. Any exclusions or alternative measures adopted should not affect the ability of the organization to comply with these requirements. Examples of such exclusions include the additional aspects relevant to manufacturing operations listed under 1), 2), 3), 4), and 5) below.

ISO/TS 22002-1:2009 specifies detailed requirements to be specifically considered in relation to ISO 22000:2005, 7.2.3: a) construction and layout of buildings and associated utilities; b) layout of premises, including workspace and employee facilities; c) supplies of air, water, energy, and other utilities; d) supporting services, including waste and sewage disposal; e) suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance; f) management of purchased materials; g) measures for the prevention of cross-contamination; h) cleaning and sanitizing; i) pest control; j) personnel hygiene.

In addition, ISO/TS 22002-1:2009 adds other aspects which are considered relevant to manufacturing operations: 1) rework; 2) product recall procedures; 3) warehousing; 4) product information and consumer awareness; 5) food defence, biovigilance, and bioterrorism.

For additional information on these standards, to purchase them, or to talk with a standards expert on any other standards question, please contact us at info@document-center.com, by phone (650-591-7600) or fax (650-591-7617). You can also use our website at www.document-center.com to search for any standards you’re interested in.

The Benefits of using Standards when Marketing Medical Devices

In order to sell Medical Devices in the U.S., companies must submit a premarket application (i.e., Premarket Notification (510(k)), Investigational Device Exemptions application (IDE), Premarket Approval application (PMA), Humanitarian Device Exemption application (HDE), or Product Development Protocol (PDP)). These applications provide the information that’s required by law (and regulations) to allow FDA to make an appropriate decision regarding the marketing of the device.

One way to simplify and speed up the process is to use standards. Conformance with standards can satisfy these premarket review requirements. The FDA states that “conformance with recognized consensus standards can support a reasonable assurance of safety and/or effectiveness for many applicable aspects of medical devices.”

You’ll need to use FDA-recognized consensus standards. They are particularly useful when they serve as a complete performance standard for a specific medical device. In these cases, the standard may include specific acceptance criteria that describe the relevant performance characteristics for a specific medical device. Conformity can minimize the amount of data and documentation needed in the 510(k) submission, but such standards are rare.

However, conformance to other more general vertical standards (i.e., device specific standards that may not encompass all aspects of device performance) can also serve as a means to streamline the premarket review process. Using any recognized consensus standard that clearly spells out acceptance criteria is a very effective use of this type of document in the premarket process. This means the use of FDA recognized standards can reduce the amount of documentation to submit and may reduce the FDA’s review time as well.

At this time, there are actually 813 standards that are accepted by the FDA. Compliance is confirmed by a declaration of conformity which is included with the premarket application submission. With adequate justification for the acceptance criteria and for any deviations from the standard, FDA can usually accept a declaration of conformance without the need to review test protocols and analyze the raw data.

For a list of the Recognized Consensus Standards, or for any other question on Medical Device standards, please contact us at info@document-center.com or by phone (650-591-7600) or fax (650-591-7617). Medical Device standards can be purchased on our website, www.document-center.com.

ASTM releases new standard on fungal growths in buildings

If you’ve got an interest in mold assessment in any building, ASTM’s new standard ASTM D7338 will be of interest. Titled Guide for the Assessment of Fungal Growth in Building, the document provides the user with options for a systematic assessment of fungal growth in buildings. This standard is available from Document Center Inc. now.

The guide describes minimum steps and procedures for collecting background information on a building in question, procedures for evaluating the potential for moisture infiltration or collection, procedures for inspection for suspect fungal growth, and procedures beyond the scope of a basic survey that may be useful for specific problems.

However, ASTM D7338 does not describe a set of uniform steps that will always be performed during an assessment, as would a standard practice. The user of the guide must decide which steps are appropriate for a given situation or building.

This standard is one of four planned on the topic by the D22 committee of ASTM International. Already released ASTM D7391,
Standard Test Method for Categorization and Quantification of Airborne Fungal Structures in an Inertial Impaction Sample by Optical Microscopy, covers procedures for categorizing and enumerating fungal structures by morphological type. The other two planned standards will cover the Examination of Fungal Structures on Tape Lift Samples by Optical Microscopy and the Collection of Total Airborne Fungal Spores via Inertial Impaction Methodology.

Why produce these particular standards? The lack of consensus standards in the fungal sampling and analysis practice was the driving force for the ASTM D22 committee. Anyone who has an interest in indoor air quality or mold/fungal assessment, remediation and analysis should find these four standards essential.

All ASTM International standards are available in paper or pdf format from Document Center Inc. at our website, www.document-center.com. Orders and questions are always welcome by phone (650-591-7600), fax (650-591-7617) and email (info@document-center.com).

New BS EN ISO 14971 Medical devices. Application of risk management to medical devices Corregendum 1 for 2009 Edition

BS EN ISO 14971:2009 has been reissued with a new Corrigendum 1 as of February 2011. The document is titled “Medical devices. Application of risk management to medical devices.” It’s available for purchase from Document Center Inc.

The EN Corrigenda are corrections that are interfiled directly into the standard they modify. For example, the Corrigendum 1 for the BS EN ISO 14971:2009 corrects the pagination of the document. So, there is no page within the document that describes the change. It is just included by correcting the way the pages are numbered.

The EN ISO 14971 is a major European medical devices standard. The BS EN ISO 14971 is the official English language edition. It continues to adopt the ISO-14971:2007 Edition.

The standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2007 and its various adoptions are applicable to all stages of the life-cycle of a medical device.

The EN ISO 14971 is one of the “harmonised” standards for the Medical Devices Directive (93/42/eec), which means that by meeting the requirements of the standard there is the presumption of conformity with the essential requirements of the directive.

Both ISO 14971 and BS EN ISO 14971 are available for purchase from Document Center Inc. Check out our website at www.document-center.com or send us an email at info@document-center.com, phone us at 650-591-7600 or send a fax to 650-591-7617. We’re happy to help you with all your Standards Requirements.

Why are there missing page numbers in my IEC standard?

Here’s a common question users of IEC standards ask us at Document Center Inc.: “Why are there missing pages in my IEC standard?”

Turns out it’s a simple answer. You’ve got an English edition of the IEC standard that was compiled from an original bilingual (English and French) edition. When IEC creates an English edition like this, it simply removes the pages that are in French and prints the English pages only.

Since the IEC protocol for a bilingual edition is to have the French text on the left hand side and the English language on the right, the French pages are even numbers and the English odd. When the French pages are omitted, this leaves an edition composed entirely of odd numbered pages.

You feel like you only have half the document you should have, and yet if you work in English, you have all the pages you need!

Do you have any questions about the standards you use, or think you ought to use? Please contact us at any time via our website www.document-center.com, email at info@document-center.com, phone at 650-591-7600 or fax at 650-591-7617. We’re happy to help you with any standards concern you may have.

The perils of using free sites for Mil Specs and Standards

There have been a number of sites cropping up on the Internet that offer U.S. military documents for free. As with most free things, it’s buyer beware!

We speculate that these sites are being generated as a easy method for generating advertising revenue on the various Mil Spec and Standard numbers. However, for the user of these sites, there are 2 major drawbacks to relying on them for your documentation.

1. The sites are not maintained, so that the document you download may not be the correct and latest edition of the document.

2. The sites do not offer monitoring services, so that when the document changes you are not going to be notified.

If you need to comply with military specifications and standards, you need Document Center Inc. to be your supplier of choice. We have been selling these documents since 1982 and have a long history of providing customers with timely delivery at fair prices for these items.

We monitor over 400,000 standards for our customers, notifying them of changes either on a nightly or bi-monthly basis. The notification service is either free with the purchase of the standard or can be purchased separately.

Just because a site claims to have “every spec” or “mil-standard” doesn’t mean it’s so.

Contact us at www.document-center.com, by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Our standards experts can help you identify the correct document for your needs, and will help keep you up-to-date as well!

Advice from the Pros regarding the use of ISO and EN-ISO standards for certification

I recently sent emails to a number of quality professionals asking the question: Is the use of the equivalent ISO document acceptable in the place of the EN-ISO adoption of the same standard?

I got back a wide variety of responses and am culling the best suggestions here for you!

As one consultant put it, “The bottom line [is that it] will ultimately be a decision made by the registrar.” Or, as another expert wrote, “The only issue would be if the Notified Body is BSI… they may ‘prefer’ the client using the BS[-EN version].”

However, there was a response from a Regulatory Compliance Specialist who works for a major international medical devices company that did provide a rationale for the use of the EN documentation, and a suggestion on how to keep from having to purchase multiple copies of the same material.

He notes that auditors will require the use of the EN editions because they are specifically called out in the supporting harmonised lists for specific directives. However, he has found that the original source documents can be substituted if the organization being registered will take the time to do the following steps:

1. Provide a reason for choosing a different document than the EN Edition.

2. Provide written justification that the ISO documents are identical to the EN adoptions. (Document Center Inc. can provide you with documentation that this is so.)

3. For those EN adoptions that have a conflicting date due to the addition of the annexes, provide documentation that shows that the differences do not affect your product. (Again, Document Center Inc. can help you with this.)

I also asked if there were other jurisdictions that presented similar documentation issues. Here’s some of the feedback:

1. Canada – Note that CSA has lists of recognized standards, similar to the lists issued by the EU. However, they not only list the CSA National publications but also the source ISO documents when applicable — they are more flexible in their published approach.

2. There are countries like Japan and China that will not recognize certain ISO standards.

3. Certification in the U.S. is more flexible than EU certification, with more acceptance of the various national adoptions.

And in a phone conversion, it was pointed out that an EN standard with the same number as an ISO document, but without the ISO as part of the number, is not an equivalent standard. So the above suggestions for gaining acceptance of the ISO original for EN certification will only apply to EN documents that are identical.

All comments will be appreciated. And if you’d like to get in touch directly, contact us at info@document-center.com, to my attention, Claudia Bach.