Claudia Bach

BS EN ISO 14155 2011 Edition on Human Clinical Trials for Medical Devices just released

BS EN ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice, has just been released for public distribution. The ISO 14155:2011 standard is adopted by the European Union for meeting the requirements of the Medical Device Directive (93/42/EEC).

BS EN ISO 14155 is the standard that specifies the general requirements intended to:

Protect the rights, safety and well-being of human subjects
Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results
Define the responsibilities of the sponsor and principal investigator
Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

It does not apply to in vitro diagnostic medical devices.

The document is identical to ISO 14155:2011, but does contain 2 informative annexes that are part of the EN administrative information regarding the adoption of the ISO standard. These 2 annexes are:

Annex ZA: Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices and

Annex ZB: Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EECon active implantable medical devices

The principles set forth in BS EN ISO 14155 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.

The document withdraws and replaces two documents, BS EN ISO 14155-1 and BS EN ISO 14155-2, which are now obsolete.

The new BS EN ISO 14155 can be purchased on Document Center’s website, www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Should you have any questions about this document or any other standard, please get in touch. Our expert staff is available to help you during business hours (8 am to 5 pm California time).

New SAE AMS 2418 H on Copper Plating released 2/18/2011

AMS 2418 new Revision H on Copper Plating was just released on 2/18/2011. This Aerospace Material Specification covers the requirements for electrodeposition of copper on metals and the properties of the deposit.

This process has been used typically to provide an anti-seize surface, to prevent carburizing of surfaces on which carburizing is neither required nor permitted, to prevent decarburization, to enhance solderability, or to provide a source of copper for furnace brazing, but usage is not limited to such applications.

The standard is one of the primary plating spec standards in use all over the world.

It is available from Document Center Inc. at our website, www.document-center.com, via phone at 650-591-7600, fax 650-591-7617, and email info@document-center.com. Any questions are welcome.

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).

ASME B31.3 Process Piping 2010 – an International Piping Code – due out in April

The new ASME B31.3 2010 Edition on Process Piping is scheduled for release in April 2011 and can be pre-ordered from Document Center Inc. now. This international code focuses on piping typically found in petroleum refineries; chemical, pharmaceutical, textile, paper, semiconductor, and cryogenic plants; and related processing plants and terminals.

It prescribes requirements for materials and components, design, fabrication, assembly, erection, examination, inspection, and testing of piping. This Code applies to piping for all fluids including: (1) raw, intermediate, and finished chemicals; (2) petroleum products; (3) gas, steam, air and water; (4) fluidized solids; (5) refrigerants; and (6) cryogenic fluids. Also included is piping which interconnects pieces or stages within a packaged equipment assembly.

The code is part of the ASME B31 series, the standards most often referenced for Pressure Piping.

Of course, you may want to know why the 2010 edition of the ASME B31.3 is only now becoming available. This is a common situation due to the practice of dating a standard when it finishes the administrative development process. Since the standard must then go to the printers for actual publication, there is a lag time between the issue date and the real public release date. Electronic publishing has reduced this delay in many cases, but it’s rare to find a standard available on the actual cover date.

This and all ASME standards are available from Document Center Inc., and can be ordered at www.document-center.com or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). If you have any questions about codes or standards, please get in touch with us at Document Center as well.

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.

ISTA 2A New 2011 Edition for Packaged Products is now available

ISTA 2A, Packaged-Products 150 lb (68 kg) or Less, has just been released as the 2011 Edition. The new revision includes both technical and editorial corrections. It is available for sale from Document Center Inc.

This standard is a partial simulation test for individual packaged-products. ISTA suggests that it should be considered for the evaluation of packaged-products intended for international distribution. The package and product are considered a unit in this procedure. They also suggest that not only should an organization use the procedure to evaluate the performance of a packaged-product, but also to compare different package and product design alternatives.

At Document Center, we often get clients asking about the issue dates on ISTA procedures like the 1A, 1B, 2A, 2B and so on. This is because ISTA releases each of their procedures annually with the new year as the date on the cover in the upper right hand corner.

To really understand the situation for each standard, you’ll need to look at the left hand sidebar on the cover of each. There you’ll find a section called “Version Date.” Underneath it will have the date of the last technical change and the last editorial change, if applicable.

A technical change is a change that impacts the technical content of the standard. It has the potential to impact the validity of the application of the standard. If you use an ISTA procedure, and there is a technical change to the document, you should get the new edition just to make sure you’re still in compliance.

An editorial change, on the other hand, is a modification to the document that does not impact the technical content. It could be a change in the address of a referenced organization, a modification in the format of a table, or some other change for the sake of editorial improvement of the document. It can be important to have if you’re getting audited, but not so important if all you’re interested in is the technical content.

ISTA has also been providing an additional type of change to their documents – a change they’re calling Clarification. An example of this would be the new edition of the ISTA 3H which has the new clarification, “Before You Begin Compression revised for clarification when using the Apply & Release method.”

If you need any of the ISTA procedures or have any additional questions, please contact Document Center Inc. via our website at www.document-center.com, or phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re always ready to assist you with your standards requirements.

IEC 60825-1 Interpretation Sheet 2 now available

Interpretation sheet 2 for IEC 60825-1, SAFETY OF LASER PRODUCTS – Part 1: Equipment classification and requirements, has just been released and is available from Document Center Inc.

This leads to the question, “What is an interpretation sheet?” The answer is straight-forward. It is an explanation of a section of the standard written by the committee to help people properly fulfill the requirements of the standard.

Interpretation sheets are generated by a request from a user for guidance on a clause or sub-clause. The Interpretation Sheet 2 for IEC 60825-1 covers Subclause 8.3 f 3) and provides the user with additional information to clarify this part of the standard. It’s 4 pages long and is dated 1/31/2011. Two of the pages are in English and two are in French.

The request for clarification may come directly from a user or perhaps from a certifying organization. The committee receives the request, creates the information sheet, votes on it, and if accepted releases it as an additional component of the document.

Document Center Inc. has this and all of the IEC standards in stock for immediate fulfillment. You can purchase standards at our website www.document-center.com, or by phone at 650-591-7600, fax at 650-591-7617 or email at info@document-center.com. Should you have any further questions about this or any standard, please get in touch.

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.