EN 980, Symbols for use in the labelling of medical devices, available in CD Rom format

The EN 980 (BS-EN-980 – Official English language edition) is the go-to document for Symbols for use in the labeling of medical devices for use in Europe.  However, the user of this important standard often wants to integrate the symbols themselves into the various labels and other information affiliated with the sale and use of these products.

This is where the CD Rom edition sold by Document Center Inc. comes in handy.  All the symbols in the EN-980 are readily available to use in manufacturer-supplied information.

The EN 980 European Standard was prepared to provide a single methodology for the presentation of information required by all of the European Directives on medical devices.

It highlights the legislative preference within the European Union for the use of symbols in medical device labelling, thereby reducing the need for multiple translations of words into national languages.  In addition, it was intended to simplify labelling wherever possible and to prevent separate development of different symbols to convey the same information.

View this page full sizeThe meaning of some of these symbols is self-evident. Some are already in widespread use and familiar to healthcare professionals. The meaning of others will become clear with use or when viewed in the context of the device itself. Symbols used with medical devices for use by other than healthcare professionals can require additional explanations.

In this respect, attention is drawn to the fact that risk management, e.g. the use of EN ISO 14971, is an integral element in medical device design and manufacturing. The use of appropriate symbols can, therefore, be an important element in risk reduction, which is a key part of risk management and is also specifically referred to in the relevant medical device directives. Symbols should only be used without explanation when risk assessment by the manufacturer indicates that it is appropriate.

The symbols in Clause 5 of this European Standard have been in general use for some time and users have some degree of familiarity with them. Additional symbols are now being introduced in Clause 6 which may be new or unfamiliar to users. As a precaution, Clause 6 requires that the meaning of these new symbols be explained in the information supplied by the manufacturer. This is without prejudice to the harmonization of this European Standard and the symbols in it.

It is not always possible to develop symbols for all information presented with the device. Not all symbols are appropriate for all types of medical devices. The validity of information conveyed by a symbol can be adversely affected by subsequent events e.g. damage to a package can affect the sterility of a device.

BS EN 980 includes examples of how some of the symbols can be used. These are illustrative only and do not represent the only ways in which the requirements of this standard can be met.

BS EN 980 also provides information about the use of the general prohibition symbol.

All EN documents are available for sale in the official English language editions from Document Center Inc. at our website, www.document-center.com, and by phone (650-591-7600), fax (650-591-7617) and email (info@document-center.com).  And if you have any additional questions, please ask us!

Medical Device Standards – The Top 10 Standards on Vascular Stents

Vascular stents are the tubes that are placed in blood vessels to improve the flow of blood, either by preventing or counteracting a localized flow constriction.  Standards for those stents have been in force since the beginning of the 21st century.  Here are our top ten standards on the subject:

ASTM-F2079, Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

ASTM-F2081, Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

ASTM-F2394, Standard Guide for Measuring  Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

ASTM-F2477, Standard Test Method for in vitro Pulsatile Durability Testing of Vascular Stents

ASTM-F2514, Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading

ASTM-F2606, Standard Guide for Three-Point Bending of Balloon Expandable Vascular Stents and Stent Systems

ISO-25539-2, Cardiovascular Implants – Endovascular Devices – Part 2: Vascular Stents

ANSI/AAMI/ISO-25539-2, Cardiovascular Implants – Endovascular Devices – Part 2: Vascular Stents

BS-EN-ISO-25539-2, Cardiovascular Implants – Endovascular Devices –  Vascular Stents

All of the above standards can be purchased from Document Center Inc.  Buy them at www.document-center.com, or phone 650-591-7600, fax 650-591-7617, or email info@document-center.com.

New UL 796 Released on Printed-Wiring Boards

The new UL-796 10th Edition on Printed Wiring Boards has just been released as of 10/8/2010.  This is one of Document Center’s best selling UL standards.  It covers both rigid and flexible boards.

The new edition covers the following material:

Revision to and Addition of Terms in Glossary

Clarification of Requirements for Standard Atmospheric Test Conditions in Paragraph 4.2

Clarification of Requirements for Acceptability of Printed Wiring Boards in Paragraph 7.1

Clarification of Requirements Regarding Base Material Relative Thermal Index in Paragraph 9.1.3

Clarification of Requirements for Base Material Sample Thickness Tolerances in Table 9.2

Addition of Requirements for the Condition of “As-Received Samples” in Paragraph 9.1.7

Clarification of Requirements for Metal-Clad Base Material in Section 9.2

Clarification of Requirements for Conductors in Paragraphs 10.2.1 and 10.6.1

Modification of Thickness of Edge Conductor in Figure 10.1

Clarification of Requirements for Plated Contact Fingers in Section 10.9

Clarification of Requirements for Multi-site Processing in Paragraph 12.2.1

Clarification of Requirements in Paragraphs 14.1 and 14.2 and Addition of Table 14.1 and Figures 14.1, 14.2, and 14.3 to Illustrate Requirements for Plugged-Hole Materials

Clarification of Requirements for Dissimilar Dielectric Material Bond Strength in Paragraph 17.6.1

Clarification of Requirements for the Evaluation of Metal Base Printed Wiring Boards in Section 18

Clarification of Requirements for Maximum Internal Copper Test Program in Paragraph 21.6

Clarification of Requirements for Conductor Measurements in Paragraphs 22.1, 22.4, and 22.5

Clarification of Requirements for Microsection Analysis in Paragraph 23.3.3

Clarification of Requirements for Flammability Classification in Paragraph 25.1.2

Clarification of Requirements for Bond Strength Temperature in Paragraph 26.3.1

Clarification of Requirements for Thermal Cycling Scheduling in Table 30.1

Clarification of Requirements for HDI Printed Wiring Board Constructions in Section 31; Addition of Table 20.10

Clarification of Requirements for Silver Migration Test in Paragraphs 32.2.1 and 32.2.5

Clarification of Marking Requirements in Paragraphs 33.2, 33.3, 33.6, and 33.10

Copies may be purchased on our website at www.document-center.com, by phone at 650-591-7600, via fax at 650-591-7617 or by emailing us at info@document-center.com.

All time best selling Standards on Sampling and Statistical Process Control

It’s said if you can measure it, you can manage it, and Statistical Process Control is the tool to use!  So it’s no surprise that there are a wide range of standards on the subject.  Here’s our list of the top 10 Standards on Sampling and Statistical Process control.

ASQ-Z1.4, Sampling Procedures and Tables for Inspection by Attributes

ASQ-Z1.9, Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming

These 2 Standards replace MIL-STD-105 and MIL-STD-414both of which are now obsolete. Filled with pages of tables for use with a continuous supply, the documents are our current best-selling sampling standards.  The Z1.4 covers go/no go data, the Z1.9 covers measurement.

Zero Acceptance Number Sampling Plans is often used as an alternative to the MIL-STD-105/ASQ-Z1.4 Inspection systems.  It is based on C=0 concept developed by author Nicholas Squeglia back in 1961.  The 5th edition is the current revision of this item.

During the last few years, the ISO standards on this topic have seen greater usage as well.  Top sellers include the ISO-2859 series, the ISO-11462 series, the ISO-3534 series, and the ISO-5725 series.

ISO-2859-10, Sampling procedures for inspection by attributes – Part 10: Introduction to the ISO 2859 series of standards for sampling for inspection by attributes, is a good starting point for the ISO-2859 set.  It provides a general introduction to acceptance sampling by attributes and provides a brief summary of the attribute sampling schemes and plans used in Parts 1 through 5. The standard also provides guidance on the selection of the appropriate inspection system for use in a particular situation.

ISO-11462-1, Guidelines for implementation of statistical process control (SPC) – Part 1: Elements of SPC, and ISO-11462-2, Guidelines for implementation of statistical process control (SPC) – Part 2: Catalog of Tools and Techniques, are two additional useful standards.  They provide concepts, tools and techniques to help an organization in planning, implementation and evaluation of an effective statistical process control (SPC) system.

ISO-5725-1, Accuracy (trueness and precision) of measurement methods and results – Part 1: General principles and definitions, is an introduction to the ISO-5725 series.  It outlines the general principles to be understood when assessing accuracy of measurement methods and results.  It can also be used to establish practical estimations of the various measures by experiment.  The standard may be applied to a very wide range of materials, including liquids, powders and solid objects, manufactured or naturally occurring.

For Statistics – Vocabulary and symbols, the ISO-3534 series covers all the bases:

ISO-3534-1, Part 1: General statistical terms and terms used in probability

ISO-3534-2, Part 2: Applied statistics

ISO-3534-3, Part 3: Design of experiments

ASTM International (formerly the American Society for Testing and Materials) also has a number of standards on the topic of Sampling and Statistical Process Control.  We often sell the following:

ASTM-E122, Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process.  This standard is intended for use in determining the sample size required to estimate, with specified precision, a measure of quality of a lot or process. The practice applies when quality is expressed as either the lot average for a given property, or as the lot fraction not conforming to prescribed standards.

Should you have any questions about the above standards, or need more suggestions to get the information you need, please contact us at www.document-center.com, info@document-center.com, or phone us at 650-591-7600.  We’re always ready to help you out.

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.

New ICC ANSI A117.1 2009 Edition on Accessible and Useable Buildings and Facilities has been approved

ANSI A117.1, the foremost standard on facility accessibility, has been issued as the new 2009 Edition.  First published in 1961, this standard is celebrating its 50th anniversary with this new release.  Titled ‘Accessible and Usable Buildings and Facilities’, A117.1 provides the guidelines for designers to create buildings that offer unobstructed entry and use for people with a multitude of physical challenges.

ANSI A117.1 is referenced by the International Building Code, as well as the model codes of the BOCA (Building Officials and Code Administrators) and the Southern Building Code Congress (SBCCI).  You’ll also find it in many federal documents and state accessibility laws.

The new 2009 Edition has been accepted but has not yet been released for public distribution.  Document Center Inc. will be shipping the new standard when it becomes available in November 2010.  Contact us at www.document-center.com, info@document-center.com, by phone at 650-591-7600 or by fax at 650-591-7617 to order your copy of this new release now.

New ASTM D3951 2010 Edition for Commercial Packaging released

ASTM D3951-98, Standard Practice for Commercial Packaging, has been revised with the release of the new 2010 Edition, ASTM D3951-10.  As you can see, this is the first revision of the standard in over 10 years.  It is one of Document Center’s most frequently ordered ASTM standards on packaging and is available now.

ASTM describes the standard as follows:  “(It)  covers the requirements for the commercial preservation, packaging, packing (exterior container), unitization, and marking for supplies and equipment. It provides for multiple handling and shipment by any mode, and storage periods of a minimum of one year in enclosed facilities without damage to the product. It also provides for package quantities suitable for redistribution without additional repackaging or marking. Planned storage that exceeds one year requires more than minimum requirements for physical and mechanical protection.”

You’ll want to know that this practice establishes minimum requirements for packaging of supplies and equipment as covered in Title 49 of the Code of Federal Regulations, with the exclusion of  ammunition, explosives, or hazardous materials.  It is also referenced for some Department of Defense shipments not covered by MIL-STD-2073/1.

Copies of this new ASTM D3951-10 may be purchased in paper or pdf format from Document Center Inc. at www.document-center.com, info@document-center.com, by phone at 650-591-7600 and by fax at 650-591-7617.

Is BS-EN-ISO-14971 identical to ISO-14971?

Here at Document Center Inc. we have bought in to the concept of “One Standard, One Test, Accepted everywhere”, the theme of World Standards Day 2002.

So when BSI, the British Standards Institute,  states that BS-EN-ISO-14971 (Medical devices. Application of risk management to medical devices) is identical to both EN ISO 14971:2009 and  ISO 14971:2007, we believe it.

However, we’ve heard of a couple of cases where auditors at customer sites have not accepted the ISO-14971 2007 Edition as being equal to the BS-EN-ISO-14971 2009 Edition for use in certifying to the EU Medical Device Directive.

We are putting out a call to the auditors themselves to see if we can get clarification on why the documents are not interchangeable for purposes of meeting the EU Directive requirements.

Having to purchase multiple copies of a single  ISO standard to meet certification requirements for different jurisdictions is problematic.  The costs can rise rapidly and references to multiple versions of a document can be cumbersome and difficult to manage when updates are made.

Do you have an opinion on this?  Are you an auditor who can speak with authority on this issue?  We ‘d love to hear from you.

Claudia Bach, President, Document Center Inc (www.document-center.com)

Document Control – How to manage a Standards Collection

Quality and Compliance professionals know the importance of standards in the business setting.  But keeping a standards collection current and correct can be a challenge for any organization.

Here at Document Center Inc., we’ve been working with standards for over 28 years.  So we’ve got some experience in collecting and maintaining standards!

Managing standards is an essential function in any organization.  Standards can positively or negatively impact your reputation and cause regulatory and quality problems.   And regulatory and quality problems eventually create legal liabilities which are much cheaper to avoid than to repair.

We believe that by separating the documentation function into 5 easy pieces, any organization can have a reliable standards system.  Here’s our plan:

Rule 1 – Define

Rule 2 – Assess

Rule 3 – Control Usage

Rule 4 – Procure

Rule 5 – Monitor

I’ll be using subsequent blogs to review the 5 Rules.  Each requires some discussion so that you are able to institute good practices throughout the standards lifecycle.

Contact us any time with any questions or for assistance.  We can be reached at our website www.document-center.com and via email at info@document-center.com.  Of course, feel free to call us at 650-591-7600 or fax 650-591-7617.

The AS-5553 helps manufacturers avoid using counterfeit electronic parts

The SAE standard AS-5553, Counterfeit Electronic Parts; Avoidance, Detection, Mitigation, and Disposition, was released in 2009 to help manufacturers avoid the use of counterfeit components.  With electronic component fakes posing an increasing threat to U.S. manufacturing, from military to medical devices, the standard supports processes geared to counterfeit avoidance and discovery.

The problem of counterfeit parts is plaguing both the military and private sector.  U.S. customs has seized 5.6 million counterfeit chips between November 2007 and May 2010, with untold millions getting though anyway.  As reported by the San Jose Mercury this month, 3,868 counterfeit incidents  were reported in 2005 where the military and its suppliers found bogus electronics. By 2008, that number had risen to 9,356.

AS5553 is designed for use by aerospace and military manufacturers and contractors.  It provides uniform requirements, practices and methods to mitigate the risk of receiving and installing counterfeit electronic parts.  Of course, no standard can guarantee that counterfeit components will be avoided, but the document does provide a framework for minimizing risk.

As such, the SAE G-19 committee developed a set of requirements, practices and methods geared to provide benchmarks for parts management, vendor management, procurement, inspection and test evaluation and of course, what to do when counterfeit parts are discovered.

Both NASA and NAVAIR have adopted the use of this standard already.  And studies this year by the Department of Commerce and by the GAO (Government Accounting Office) have again pointed out the vulnerability of the military to “knock-off” electronic chips.

Military contractors and others should be proactive in developing defensible and effective practices for avoiding the use of fakes in commercial products.  Bogus electronics pose a real threat to the population at large and to the military in particular.

You can buy a copy of the AS-5553 from Document Center Inc. on our website at www.document-center.com, or by email at info@document-center.com, phone at +650-591-7600 or by fax at +650-591-7617.  The document is in stock for immediate shipment.