New EN 71-1 2014 Edition – Safety of Toys

December 5th, 2014

For those of you in the toy business, safety is a top concern.  And for toys to be sold in the European market, compliance with the EN 71 series of standards is a must.  So you’ll want to know that there’s a new 2014 Edition of the EN 71-1 standard, the overview document for the series.  Titled “Safety of toys. Mechanical and physical properties,” this new edition replaces the 2011 Edition with Amendments A1, A2 and A3.  I expect that the harmonized list of standards for the toy directive 2009/48/EC will be updated shortly to include this new update.

What does this standard cover?  For toys intended for children under the age of 14, this document provides you with the requirements and tests necessary for acceptable mechanical and physical properties.  You’ll also find other specific requirements for children under 36 months, 18 months and those too young to sit up without help.  It’s 154 pages of details on all aspects of such toys, what the expectations are for toys sold in the EU and what tests should be used to confirm your products meet those expectations.

What does this new edition include?  You’ll find that since there’s new parts to the EN 71 series, they are now referenced in this publication.  Changes also have been made to the following sections:

  • Note 5.2 b)
  • Sections 5.4 and 8.39
  • Annex B
  • The note for 4.25 has been moved to the end of A.55
  • Clause 5 is changed
  • Clause 7 and section 7.1 are changed
  • Sections 8.10.3, 8.12.3, 8.15, 8.22.3.1, 8.28.1.4, 8.28.2.2.1 and 8.34.2 all have been changed.

What other Parts of the EN 71 series have changed this year?  Here’s a list of other parts that have been released or updated:

  • EN 71-2, 2011 Edition with Amendment A1, Safety of toys. Flammability
  • EN 71-3, 2013 Edition with Amendment A1, Safety of toys. Migration of certain elements
  • EN 71-7, 2014 Edition, Safety of toys. Finger paints. Requirements and test methods
  • EN 71-13, 2014 Edition, Safety of toys. Olfactory board games, cosmetic kits and gustative games
  • FYI Only: EN 71-14 is in the works.  When released, it will be titled Safety of toys.  Trampolines for domestic use.

How do you get your copy of one or more of these standards?  You’ll go to the Document Center Inc. webstore at www.document-center.com.  There you can order your copies knowing that you’re purchasing them from an authorized dealer of these standards.  If you have additional questions, please get in touch with our staff.  You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

Numbering for ASTM Standards

December 4th, 2014

Every once in a while, I like to take a moment out and explain some of the basics of the standards world.  One issue that always perplexes new standards users is the way that various standards are numbered.  However, every standards professional knows that the actual document numbers are a treasure trove of information.  So let’s take a look and discover how to read the numbering for ASTM Standards.

Each ASTM Standard is given a unique number.  It’s a combination of a letter and numbers.  So we can have an ASTM standard that’s numbered B211 or D3951.  The letter is determined by the general topic of the document, as shown below.

  • A – Ferrous metals
  • B – Nonferrous metals
  • C – Cementitious, Ceramic, Concrete, and Masonry materials
  • D – Miscellaneous materials
  • E – Miscellaneous subjects
  • F – Materials for specific applications
  • G – Corrosion, deterioration and degradation of materials
  • ISO/ASTM – documents released as co-numbered publications by ISO and ASTM
  • ES – Emergency standards
  • P – Proposals
  • PS – Provisional standards

Originally, standards were released in inch-pound format.  But as ASTM standards started to reach an international audience, the use of metric measurements became important.  So the next thing to know is that if a number is followed by an M, the document’s measurements are based on the metric scheme.  ASTM publications that have both inch-pound and metric are co-numbered.  An example of an all-metric standard is ASTM B251M and a dual designated standard is ASTM D2950/D2950M.

The next thing you’ll want to know are the various types of publications that make up the ASTM standards set.  These are:

  • Classification – a systematic arrangement or division of materials (See ASTM F2043)
  • Guide – a compendium of information or options (See ASTM F2974)
  • Practice – a set of instructions (excluding those producing a test result) (See ASTM F2444)
  • Specification – a set of requirements that a material, product, system or service must meet (See ASTM D7194)
  • Terminology – definition of terms (See ASTM D16)
  • Test Method – a set of instructions producing a test result (See ASTM D4424)

Next let’s talk about the information that follows the main ASTM number on every document released.  Usually this is just two digits that provide you with the year the document was released, like ASTM-D3951-10 (ASTM D3951 2010 Edition) or ASTM-A482-11 (ASTM A482 2011 Edition).  If a document is revised more than once during any given year, a letter is added to the year, as in ASTM-E18-14a (ASTM E18 2nd 2014 update).

You’ll also sometimes find a letter or letter and number following the year designation as well.  These represent editorial corrections, like ASTM-F543-13e1 with 1 editorial correction or ASTM-G5-13e2  that’s had 2 editorial corrections made since the release of the 2013 Edition.  FYI:  An editorial correction does NOT affect the technical content of the document.  It is an update that is made for editorial reasons only.

And you may see a reaffirmation date as part of the numbering sequence as well.  This means that during the year in parentheses, the document was reviewed and determined to be valid exactly as written.  So the ASTM-C1014-08(2013) was issued in 2008 and reapproved in 2013.  This follows good standards practice, by the way, since standards should be reviewed every five years to insure that the information remains valid.

So let’s take some examples to recap what we’ve learned.  ASTM-A508/A408M-14 is a specification for a ferrous metal that was last revised in 2014.  It will have measurements both in inch-pound and metric (SI) format.   ASTM D2203-01(2011) is a test method standard for a miscellaneous material from 2001 that was reviewed in 2011 and is still valid.   ASTM-F718-07(2011)e1 is a specification for a specific application that was released in 2007 and reapproved in 2011 with an editorial correction.

One last note:  When you find an ASTM standard that is similar to what you’re looking for but not exactly correct, one good resource is to review the standards in the same volume of the complete set.  So if you find ASTM-G36 and you want to see more standards like that one from ASTM, just click the link on the Document Center website for the ASTM Volume 03.02.  This will provide you with a listing of all ASTM standards on erosion and wear.

So there you have it!  Document Center’s lesson on the numbering for ASTM standards that you’ll surely run into if you spend any time working with compliance information at all.  Remember, you’ll find all current and many obsolete copies of ASTM standards for sale at the Document Center webstore at www.document-center.com.  You’ll especially appreciate the revision history information provided for each document (see the history for ASTM-A480/A480M as an example).  And now you’ll know what the number for each revision actually means!  And if you have any more questions, please just let us know.  You can reach our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!

New ISO/IEC TS 17021-6 on Conformity Assessment

December 3rd, 2014

If you’re involved in auditing or providing certification services for ISO conformity assessment, you’ll be interested to know that there’s a new addition to the ISO/IEC 17021 series.  The new release is ISO/IEC TS 17021-6, “Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 6: Competence requirements for auditing and certification of business continuity management systems.”   It compliments the ISO/IEC 17021 and will be used for ISO 22301 certification.

ISO 22301, “Societal security – Business continuity management systems – Requirements,” provides you with the requirements to set up a BCMS (Business Continuity Management System).  Basically, it’s a way to implement controls and measures to manage your organization’s capacity to manage disruptive incidents.  In today’s business environment, with challenges coming from all sides, the use of BCMS to manage this type of risk can be critical.

Of course, as with any of the ISO management system standards, verification that the organization is meeting the requirements of the ISO standard is essential.  It’s part of the PDCA (Plan, Do, Check, Act) model that is fundamental to the management system scheme.  And confirming that the person or organization doing the verification is competent is critical to success.

That’s where the ISO/IEC 17021 series comes in.  Each part of the series gives you the requirements needed for assessing compliance with a specific certification scheme.  So those of you working on ISO 22301 certification or providing certification to this standard will be pleased that the Part 6 has now been released.

ISO/IEC 17021-6 gives you the basics of what you should expect in the individuals who providing auditing and certification services in Sections 4, 5 and 6.  You’ll then get a table in Annex A that summarizes this information, a “Table of Knowledge” that takes the specific area of expertise needed and links it to the various clauses in this Technical Specification.  The 6-item bibliography finishes off the document.

Now you’ll need to get your copies of these standards.  Use Document Center Inc., an authorized dealer of both ISO and IEC publications.  These publications are available for order on our website, www.document-center.com.  You’ll have the option of requesting either paper format or pdf download.  Want multi-user access?  As our staff about our Standards Online subscription service.  You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Remember, we’re your Standards Experts!

ISO/TR 80001-2-6 – Risk Management for Medical Device IT Networks

December 2nd, 2014

There’s a lot of interest these days in providing security for the data components of medical devices, especially those linked into a network.  Back in 2010, the IEC 80001-1 provided you with guidance on how to set up the various roles and responsibilities inherent in such networks.  Now the new ISO/TR 80001-2-6 helps you implement the agreements that define them.  Titled “Application of risk management for IT-networks incorporating medical devices – Part 2-6: Application guidance – Guidance for responsibility agreements,” this new Technical Report supports compliance that may be required in your situation.

Why would such a document be of use to you?  For the patient, medical devices represent a partnership between the medical device manufacturer and the clinical setting in which the device is used.  Thus it is essential for all parties involved in providing care that includes networked devices to have a clear understanding of the dependency of the device on the network.  This includes medical staff at any given facility.  Some examples of issues that could affect device performance include upgrades to a given network.  Or perhaps it might be the addition of a new piece of equipment to a network that might affect software versions.  So it is essential to have change control procedures to minimize that risk.  And that means a clear understanding of who’s responsible for what!

Since the report is in support of IEC 80001-1, it is formatted based on that earlier publication.  Your sections include the usual scope, referenced documents and definitions clauses.  Then the ISO 80001-2-6 dives into the key aspects of responsibility agreements, including the reasons to have them, participants and types of agreements you might find useful.  Section 5 expands the requirements of subclause 4.3.4 of the IEC standard, giving you additional detailed information on a line-by-line basis.  And the 2 Annexes cover the development of an RACI (Responsible, Accountable, Consulted, Informed) chart and a chart with the various types of documentation you’d expect to be provided by medical device manufacturers and IT suppliers.

Using a standard like the ISO/TR 80001-2-6 can save you time and trouble in developing your plan, and give you the support you need for compliance to the IEC 80001-1 if required.  You’ll need a copy and you’ll want to purchase it from an authorized dealer.  You can rely on Document Center Inc. to supply you with copies in paper format, for pdf download or for multi-user access as part of our Standards Online subscription service.  Order at our webstore (www.document-center.com) or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Remember, we’re your Standards Experts!

New MIL-PRF-39012 Revision F

December 1st, 2014

Military Specifications are used extensively in the electronics industry and one of the commonly used documents is the MIL-PRF-39012.  Titled “Connectors, Coaxial, Radio Frequency, General Specification for,” the publication has just been revised.  The new Revision F is available from Document Center Inc. in paper format, for pdf download or as part of our Standards Online multi-user access subscription.

Revision F contains a number of updates, all marked with a line in the left hand column of the document.  Changes that have been so marked can be found in the following sections:

  • Section 2, Applicable Documents.  Of special note are updates in the ASTM standards referenced.
  • Section 3.3.1.2 on Connector Bodies.
  • Section 3.5 has been expanded to include Biobased Materials.
  • Section 4.6.11 on VSWR has been significantly revised.
  • There is the addition of subpart d for Section 4.6.13.
  • Table VIII has 3 items marked as updated.
  • Sections 6.9 and 6.10 at the end of the document are also marked as updated.

When it comes to using Military specifications and standards, Document Center has been helping customers manage their collections since 1982.  It’s important to remember that using the proper edition for these documents is essential.  If you purchase your copies of these standards from Document Center, you no longer need worry about having changes slip by unnoticed.  Document Center provides you with a no-charge notification service for every standard you purchase from us.

Go ahead and order your copies at the Document Center webstore (www.document-center.com).  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re able give you personal assistance and answer those questions other organizations cannot.  For compliance documentation, make us your Standards Experts!

Having an organic Thanksgiving?

November 26th, 2014

Well, I love to talk about food and standards at this time of year, so I found myself wondering about organic food and that standards that ensure compliance.  Are you thinking about having an organic Thanksgiving?  You have a number of layers of standardization and regulation to depend on in order to make it so!

Firstly, the organic movement was a grass-roots (pardon the pun) effort, so early “standards” come from specific jurisdictions and common-interest groups.  As larger food producers got interested in the concept, more formalized standards-making has occurred.

There are two main sources of this standardization effort — the business itself (through trade associations) and government regulation.  For the first, you’ll find the current development of “harmonized standards” happening in such groups as United Fresh (organic produce standards) and IFOAM (International Federation of Organic Agriculture Movements).  These organizations support their standards development by certification.

However with the proliferation of “organic” products, regulatory agencies around the world have moved to set regional standards for such foodstuffs.  You’ll find extensive legislation and corresponding regulation in the U.S., Asia, Europe, and elsewhere.  This may be from the U.S. Department of Agriculture (USDA) with the NOP (National Organic Program) requirements.  Or the EU’s Commission Regulation 889/2008 for the production and labeling of organic products in support of EU laws.

In all cases certification is a keystone for the assurance of compliance to these standards.  This type of certification may be essential for export to various markets across the globe.  And it’s in the certification process where ISO standards are becoming more frequently referenced.  As we noted in last Thanksgiving’s post, the ISO 22000 series is the basis for food production.  But when it comes to certification, the use of ISO/IEC 17065 comes into play, providing the requirements for auditing bodies that offer certification services.

For this type of standardization, trade associations will usually continue to hold and update documents until there’s a strong business case for moving into a more traditional standards-developing process.  Some things that could move standards for organic foodstuffs into the ISO process, for example, might be the need for one standard internationally to harmonize market requirements.  Or there might be a need to reduce the costs of having a number of forums for holding these standards, thus making a consolidated document in the purview of one organization beneficial.

Meantime, when you do think of standards, think of Document Center Inc.  We’re here to help you find your way through the web of compliance information that affects your business!  Make us your Standards Experts and have a very happy and bountiful Thanksgiving!

New IWA 13 helps you assess environmental projects

November 25th, 2014

There’s a new IWA (International Workshop Agreement) available from Document Center Inc. that helps you assess the economic impact of large-scale environmental projects.  Titled “Multiple resource evaluation guideline,” this new IWA 13 provides you with a methodology for understanding how supplying one resource can actually negatively impact other resources.  The main contributors to the document come from Africa and the Near East, but this new publication is sure to be useful anywhere.

The type of projects that are being discussed are those that are labeled “Multiple-Resource Productivity (MRP) solutions.”  These are environmental projects that impact at least 2 resources (like water, energy or food/cropland) without apparently consuming others.  The question is: How do you assess a solution’s feasibility and develop your economic cost-benefit analysis?

The approach differs from the usual Life Cycle Analysis (LCA) and Environmental Impact Report (EIR) in that it looks at more than 1 material, element, or compound at a time.  The MRP process has been developed because of the complexity of renewable resources.  It’s used in order to determine a broader picture of how projects may affect other “assets” and impact sustainability.

There’s a number of examples of this given in the document:  The fact that food growth requires not only land, but water and energy for transport to market.  Or energy production requires land and perhaps water as well.  So when a project may seem to be focused on 1 resource, prudent development should take others into account as well.  In other words, a solution that promotes the development of 1 type of resource will surely consume another.

The bulk of the IWA 13 covers the MRP suggested methodology.  And after a review of the three main components used in the analysis (water, energy and food/cropland), detailed information is provided on how to determine how your project may increase or decrease each component.

Once you understand the methodology, Annex A will give you the algorithm needed for comparison of solutions.  There’s also an example which makes it clear how the process works.  A 53-item bibliography completes the publication.

Now you need a copy of IWA 13.  You’ll want to use an authorized distributor and there’s no organization better than Document Center Inc.  You can order at our webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been working with folks like you since 1982 and on the web since 1993.  Make Document Center your Standards Experts!

New EN 60601-1 Edition released

November 24th, 2014

Lately the EN 60601-1, “Medical electrical equipment. General requirements for basic safety and essential performance,” has been getting revised on a regular basis.  Part of the reason is that the source standard, IEC 60601-1, has been updated.  So the European adoption over time is republished to keep pace with the IEC changes.  Let’s talk about some of the recent updates, what they contain, and your purchasing options from Document Center Inc.

The latest edition of EN 60601-1 was released in 2006.  Your first update was in May of 2011, the implementation of IEC corrigenda December 2006 and December 2007 and the implementation of CENELEC corrigendum March 2010 (modification of CENELEC Foreword and Annexes ZA and ZZ.)

The second update was released in February of 2012.  This was the implementation of CENELEC amendment A11:2011, when Annex ZZ was replaced by Annexes ZZA and ZZB.

Then in December of 2012, IEC amendment 1:2013 was implemented with the released of CENELEC endorsement A1:2013.  Annex ZA was also replaced and Annex ZZ was added.

Now, the latest revision from this month (November 2014) implements the IEC corrigendum July 2014 (Figure 12 has been updated.)  And the CENELEC amendment A12:2014 has also been implemented.  This means Annex ZZ has been updated to Annex ZZA, with the previous Annex ZZA being deleted. And a new Annez ZZB has been inserted.  So, in this new edition your Annexes are:

  • Annex ZA, “Normative references to international publications with their corresponding European publications.”
  • Annex ZZA, “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices.”
  • Annex ZZB, “Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices.”

FYI:  These Annexes comprise 31 pages of material at the beginning of the BS EN 60601-1 edition.

What are your purchasing options?  Here at Document Center Inc. we offer you two choices for ordering this new update.  In the BS EN 60601-1 edition, you’ll need to buy the entire document as a reprint, with all of your changes interfiled into one new publication.  With the SIS EN 60601-1 (the Swedish Edition in English), you can purchase just the amendment.  However, this means that you’ll only have the changes noted in your copy, so you’ll have to make pen and ink changes to your original edition by hand.  None-the-less, it is far less expensive to purchase just the amendment than the consolidated reprint from BSI.

You’ll be able to order the BS EN 60601-1 edition at our webstore, www.document-center.com.  You can also purchase the SIS EN 60601-1, but for the amendment only, you’ll first request a quote.  Our staff will confirm the price of the document and that you understand you’re purchasing just the amending material.  You might also want to consider contacting us directly by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here to assist you with any conformance documentation issue you may have.  Make us your Standards Experts!

New ISO 8828 2nd Edition – Handling Orthopedic Implants

November 21st, 2014

Extreme care is taken during the production and shipment of medical implants — but what happens after delivery?  Setting up protocols to insure that implants are free from contamination or damage prior to surgical insertion is another critical link in the chain.  Guess what?  There is an ISO standard for this and it’s just been revised.  It’s ISO 8828, “Implants for surgery – Guidance on care and handling of orthopaedic implants,” and the new 2nd edition is available from Document Center now.

Yes, this standard has been written for all personnel involved in receiving and handling implants, including surgical staff (surgeons).  Nothing is more difficult as a patient than going through a surgery only to have an implant fail due to contamination.  So all staff members involved in receiving, storing, transporting, handling, cleaning and sterilizing implants need to be well trained in these recommended procedures.

What does this new revision cover?  After the usual scope and definition sections, the document reviews general guidance on such topics as the manufacturer’s instuctions, stock records and rotation, storage, modification and so on.  Then there are sections with additional guidance for polymeric implants, ceramic components, and products with rough surfaces or intrinsic porosity.  The bibliography provides you with information on 4 additional standards for more detailed data.

This is a technical revision of the ISO 8828 1st Edition from 1988, which is now withdrawn.

You’ll want to get a copy if your staff handles surgical implants.  Head off to the Document Center webstore at www.document-center.com and order it in either paper format or for pdf download.  You can also opt for multi-user licensed access using our Standards Online service.  Just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.

Standards like the ISO 8828 can help you set up procedures and processes to improve outcomes in what-ever line of business you’re in.  Rely on Document Center to help you identify and maintain your collection of this type of conformance information.  We’re your Standards Experts!

New AAMI TIR51 – Human Factors for Medical Devices

November 20th, 2014

For Medical Device developers and other healthcare professionals, one challenge is to understand how people interact with their products in a “real world” context.  Now AAMI has provided you with guidance for this challenge - AAMI TIR51, “Human factors engineering – Guidance for contextual inquiry.”  If you’re in the healthcare business, this new Technical Information Report can help you design devices, systems or instructions in a more informed manner.  Here’s more details about this new document.

The goal of this report is to help you expand your concept of human factors from an interview-based methodology to a broader process based on both interviews and observation.  This will help you bridge the gap between what people say they do and their actual actions.  The protocol is intended to help you develop a deeper understanding of both users and the environments the device will be used in.  You’ll also be using this system to spot problems with existing design.  And you’ll also be getting insight into both the viewpoint of users as well as their capabilities and limitations.

Sections in AAMI TIR51 cover research methodology, data analysis, and reporting (including the use of video).   It also covers how to integrate your analysis into the design of devices, facilities and/or processes.  It covers troubleshooting, since the process is different from market research, for example.  And it also has a sample story board format for this type of process from the University of Cincinnati.  A 15-item bibliography finishes up the document.

This new publication is available from Document Center Inc. in both paper format and for pdf download.  You’ll be able to order the AAMI TIR51 (and all current AAMI standards) at our webstore, www.document-center.com.  Need more information?  Check in with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’ve been helping people like you with standards and standards questions since 1982.  Make us your Standards Experts!