ISO 6658 Revised – Sensory Analysis

ISO 6658 3rd Edition has just been released.  It’s titled Sensory analysis – Methodology – General guidance.  It provides you with information on the use of sensory analysis for foods and other products.  This new 3rd Edition from 2017 replaces the previous 2nd Edition from 2005.  All the earlier editions are now obsolete, as the 3rd  Edition is a technical update.

Here are the main areas that ISO 6658 covers.  It includes background information on the essential features of the various methods used.  It provides details of the general requirements, procedures and interpretation of results for these types of tests.  And it shows you how to review these tests to choose the one most suitable for your situation.

The standard first starts with the usual scope, reference documents and definitions sections.  The committee requests that you then review Clause 4 on general requirements before moving on.  Clause 5 covers the various tests that can be used.  And Clause 6 takes a look at some general principles of data collection and analysis with regards to sensory data.  General principles of statistical treatment of your results is also included.  Clause 7 covers the test report.  Annex A reviews statistical terms.  A 28-item bibliography completes this 34-page document.

Changes in this new edition include updates to the definition of “sensory analysis”, to Clause 6 and to the bibliography.  Tests were added/expanded in sections 5.2.7 and 5.4.  And Table A.1 was deleted from Annex A.

Most standards on sensory analysis are released by ASTM and ISO.  (Many are then adopted by other jurisdictions).  To take a look at the standards currently available, please see our Document Center Inc. List of Standards on Sensory Analysis.

You can purchase all these standards at our webstore, www.document-center.com.  Here is a direct link to the order page for ISO 6658 for your convenience.  You will have the choice of paper format or pdf download.  If you’d like to have the document included in our Standards Online cloud access subscription service, please get in touch with our staff.  We can be reached by phone (650-591-7600) or email (info@document-center.com).

Document Center Inc. has been selling standards since 1982.  We have a wide variety of products and services to support your compliance and corporate requirements.  Make us your Standards Experts!

EN 55014-1 2017 – Radio-frequency Emissions

EN 55014-1 has just been updated.  The new 2017 Edition is available from Document Center Inc. now in a variety of national editions and formats.  It replaces the previous 2006 Edition.  The title is Electromagnetic compatibility. Requirements for household appliances, electric tools and similar apparatus. Emission.   It is the European adoption of CISPR 14-1.

What does this standard cover?  It provides requirements that apply to the emission of radio-frequency (RF) disturbances by appliances, electric tools and other equipment.  The frequency range addressed is 9 kHz to 400 GHz.  The equipment many be powered by AC, DC, and even batteries.

Is EN 55014-1 the same as CISPR 14-1?  The document is the adoption of CISPR 14-1 Edition 6.0 and it’s Corrigendum 1.   Another thing to note is that the CISPR 14-1 references a number CISPR and other international standards.  When using the EN 55014-1, you will be required to use the EN adoptions of each.  A list is included in the Endorsement notice on page 2 and in Annex ZA on pages 3 and 4.

When do I have to use EN 55014-1?  The document is for the manufacture and sale of goods within the European region.  It is part of the harmonized standards list for the Directive 2014/30/EU (on Electromagnetic Compatibility).

How can I get a copy of EN 55014-1?  While the EN 55014-1 was adopted by the European Union back in April, the national editions are just coming out now.  And you can only purchase this standard in a national edition.  Currently, Document Center has the BS EN 55014-1 and the SS EN 55014-1 available for purchase.  They both have the same legal weight and are valid for use in Europe.  Other national editions may currently be available or will soon follow.  Here is the order page for all EN 55014-1 standards on our website.

Do I have to purchase EN 55014-1 in order to get a copy?  Yes, you do.  All national editions are covered by copyright and should be purchased from authorized distributors like Document Center Inc.  Each national standards body does have it’s own set of purchase requirements.  So pick an edition in the format you want and for the price that suits you best.  If you have a specific auditor for certification, that may also factor into your purchase decision.

Still have questions?  Please get in touch with us.  We are knowledgeable about standards and will be happy to help you.  Reach us by phone (650-591-7600) or email (info@document-center.com).  We have been working with standards since 1982.  Make us your Standards Experts!

 

 

ASTM D1000 Revised for Electrical Tape

ASTM D1000 has just been updated.  The publication is titled Standard Test Methods for Pressure-Sensitive Adhesive-Coated Tapes Used for Electrical and Electronic Applications.  The new 2017 Edition replaces the 2010 Edition, which is now obsolete.  Both are available from Document Center Inc.

The ASTM D1000 contains test methods used for adhesive-coated tapes used in electrical insulation.  These tapes may have backings that are either elastomeric or non-electomeric.  There are 24 different test methods in the publication.  They include flammability, accelerated aging, adhesion strength, curling and twisting, and oil resistance, just to name a few.

There are a great many revisions in this new update.  In fact, the end of the publication does not include the usual synopsis that is often included in ASTM updates.  So your best bet is going to be purchasing the redline edition of this standard.  You will then receive a clean copy of the 2017 Edition and a “marked-up” copy of the previous 2010 Edition.  The changes will be clear to you on the marked-up (redline) copy.

You may have questions on the best way to order ASTM standards.  Document Center provides them in a variety of formats.  These include paper, pdf download (single user), redline (as noted above), combo (paper and pdf set), and subscription access for your entire company (Standards Online).  For more information to help you decide what works best in your situation, get in touch with us.  We’re available via phone (650-591-7600) and email (info@document-center.com).

Many people prefer just to order online at the Document Center webstore, www.document-center.com.  Here is a direct link to the order page for ASTM D1000 for your convenience.  Please note:  We have many obsolete ASTM standards available as well.  If you need a historical copy, please get in touch.

Document Center Inc. has been selling standards since 1982.  We have many products and services to support your document control processes.  Make us your Standards Experts!

EN ISO 80369-7 for Medical Device Connectors Released!

EN ISO 80369-7 has just been released.  It’s the European adoption of the ISO 80369-7.  The title is Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications.  This EN edition replaces the EN 1707 and the EN 20594-1.  You can get your copy in a variety of national editions now from Document Center Inc.

The European edition has the unique feature of mandating the use of EN adoptions of all ISO or IEC standards referenced in the ISO 80369-7.  Other than that, the text of the ISO 80369-7 from 2016 has been adopted without any further modifications.  However, you will also find an Annex ZA in the document.  This provides you with a relationship table for the standard and the Directive 93/42/EEC (the Medical Device Directive).  The table goes through the essential requirements of the directive item by item and shows you the clauses of EN ISO 80369-7 that fulfill the requirement.  Notes for each item are included.

The EN ISO 80369-7, like the ISO 80369-7, provides you with dimensions and requirements used in design and performance for small-bore connectors used in intravascular applications or hypodermic connections for medical devices and accessories.  The document was developed to address the problems arising when connectors for multiple applications are the same.  Now these particular small-bore connectors will only “mate” with others of their own kind.   They will not be able to  mis-connect with other small-bore connectors with other functionalities.

The standard is arranged in the usual fashion, with scope, referenced documents, and definitions provided in the first 3 clauses.  General requirements are then given.  Section 5 addresses the dimensional requirements for luer connectors.  The body of the standard is completed with Clause 6 for performance requirements.

A series of both informative and normative Annexes then follows.  These cover the rationale and guidance for the standard, luer connectors, reference connectors, and the types of medical devices with connections that are covered by the publication.  Annex E gives you a summary of the usability requirements for these luer connectors.  Annex F is a summary of the design requirements.  And Annex G summarizes the assessment of the design of the connectors.

Annex H is interesting.  It is a table with the correspondence of the essential principles set forth in ISO 16142-1 and the clauses or ISO 80369-7.  Annex I is an alphabetical list of the defined terms which references the source ISO standard where the terminology originates.  A 29-item bibliography completes this document.

When working with EN standards, it is important to note that they are only publicly available in national editions.  And you’ll have many of them to choose from!  Here is a listing of some that you can purchase from Document Center Inc. – EN ISO 80369-7 Standards List.  The list will grow as additional publications are made available.

If you have more questions about this, please get in touch with us.  You’ll find our staff to be knowledgeable about the standards you use.  And we have a wide array of products and services to support your compliance requirements.  Reach out to us by phone (650-591-7600) or email (info@document-center.com).  Then make us your Standards Experts!

ISO/TR 10993-22 for Nanomaterials Released

ISO/TR 10993-22 has just been released.  It’s titled Biological evaluation of medical devices – Part 22: Guidance on nanomaterials.  This important new addition to the 10993 series is available now from Document Center Inc.  It can be purchased in paper format, for pdf download, and as part of our enterprise Standards Online subscription service.

Nanomaterials are bringing revolutionary new properties to many product lines.  These materials will surely have an impact on the medical device industry.  However, potential toxicity issues must be addressed.  ISO/TR 10993-22 provides you with guidance on how to proceed.

What are nano-objects (the particles of nanomaterial addressed in this technical report)?  These are particles having a length range from 1 nm to 100 nm.  Since medical device manufacturers will have various points in the lifecycle where folks will come in contact with these objects, risk evaluation needs to address a number of situations.  These include preparation, use, wear, or degradation of the device.

Who should be using the ISO/TR 10993-22?  Medical device industry individuals with training in medical device evaluation will find this report to be essential. This is because nanomaterials have specific challenges during the testing process and when evaluating results.

What’s covered in this report?  It provides you with an ISO 10993 risk management process for medical devices that contain, generate or are composed of nanomaterials.  After the usual scope, referenced documents, and definition sections, general principles are reviewed.  The report then moves on to the physicochemical characterization of nanomaterials.   This is to determine the chemical composition, the physical description and extrinsic properties.

Section 6 covers the preparation of samples.  While many of the requirements are in ISO 10993-12, there still are special concerns with regards to nanomaterials.  The next several sections cover additional considerations.  These include the release of nano-objects from medical devices, toxicokinetics and toxicological evaluation.  Section 10 shows how to present the characterization and test results.  Section 11 specifically addresses risk assessment.  The biological evaluation report is reviewed in Section 12.  A lengthy 272-item bibliography completes the 68-page document.

If you’re using or considering using nanomaterials in your medical device(s), you’ll want a copy of this new publication.  Choose Document Center Inc. for your purchase.  We are an authorized distributor of the ISO standards.  Find them at our webstore, www.document-center.com.  Or go directly to the order page for ISO/TR 10993-22.  Here is a complete list of the ISO 10993 series standards.

Document Center Inc. has been working with standards since 1982.  You’ll find our staff to be knowledgeable.  And we have a wide range of products and services specifically designed to address your compliance concerns.  Reach us by phone (650-591-7600) or email (info@document-center.com).  Make us your Standards Experts!

ASTM A967/A967M Updated – Chemical Passivation

ASTM A967/A967M has just been updated with the release of the new 2017 Edition.  This specification is a best seller here at Document Center Inc.  The title is Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts.  This new revision replaces the previous 2013 Edition, which is now obsolete.  (For more information on the old edition, please see my post from 2013:  New ASTM A967/A967M 2013 Edition).

The specification covers a number of chemical passivation treatments for stainless steel parts.  You’ll be given recommendations (and precautions) for descaling, cleaning and passivation.  To confirm effectiveness, several alternative tests are provided.

Changes to ASTM A967/A967M 2017 are extensive.  Here are the areas that the committee has highlighted for your review:

  • Section 4 has been expanded
  • Subsection 5.2.1 is revised
  • Note 2 has been added
  • The use of “supplier” replaces all references to “seller” and “processor”
  • Alternatives to immersion are now provided in 6.1.1 and 7.1.1
  • Dry time has been modified in 14.1.2
  • The cleaning and drying requirement for 14.2.3 is now to be found in X2.10
  • The restriction on copper sulfate test for food equipment in 14.4.1 is removed
  • Procedures in 14.4.3 and 14.5.3 have been expanded and Section 14.7 is added
  • There’s a new Appendix X2 (it includes X1.3.2 through X1.3.4 and X1.12)
  • X1.3.1 through X1.3.4 have been added (from QQ-P-35 Revision C).  This includes corrections to Table X1.1

For more specific information on these changes, get a redline edition when you make your purchase of this copyright publication.  You’ll get a second copy of the specification with all the changes clearly marked.

Speaking of getting a copy, you should use the Document Center Inc. webstore for your purchase.  As an authorized dealer of these standards, we have all the current and many of the obsolete editions available at our webstore, www.document-center.com.  Here is a direct link to the order page for ASTM A967/A967M for your convenience.

You can purchase these standards in both paper format and for pdf delivery.  And they can all be included in our enterprise cloud subscription solution, Standards Online.  To find out more about your many options, get in touch with us by phone (650-591-7600) or email (info@document-center.com).  We’ve been selling standards since 1982 and have many products and services for keeping your compliance documentation in good shape.  Make us your Standards Experts!

 

AMS 2404 Electroless Nickel Plating Updated

AMS 2404, Plating, Electroless Nickel, has been revised.  The new Revision H is available now from Document Center Inc. in both paper format and for pdf download.  The standard was originally issued in 1957 and is a mainstay of the plating industry.  The new Revision H results from the usual SAE 5 year review process.  It has a number of changes you’ll need if you use this specification.

AMS 2404 provides users with the requirements for electroless nickel deposited on various materials.  It is frequently used for intricate shapes, to improve wear and corrosion resistance, and for improved solderability on selected materials.  It can handle service in hot environments.

I reviewed the release of the previous (and now obsolete) Revision G back in 2013 when it was published.  You’ll find it at New AMS 2404 Revision G Released. If you’re currently using this spec, you’ll be interested in the changes that have been made in Revision H.

AMS 2404 H has updates in these sections:

  • 3.4.1 – Thickness determination
  • 3.5 – Quality
  • 4.2.2 – Periodic tests
  • 4.2.1 and 4.2.2 – Adhesion
  • 4.3.1.6 – Adhesion test specimen configuration
  • 4.3.2.2 – Adhesion test sampling
  • 8.13 – Consolidated reference of AMS-C-26074

As you may remember, the AMS 2404 is one of the replacement documents for the well-used MIL-C-26074.  The section 8.13 (reference above) discusses the prior versions of the various publications that are now replaced by AMS 2404.  There are also two tables provided for you.  The first correlates the 4 classes of AMS-C-26074 (and MIL-C-26074) with the 4 classes of AMS 2404.  The second correlates the thickness requirement of both.

How can you get your copies of this new AMS Specification?  SAE standards are covered by copyright.  Use Document Center Inc., an authorized distributor, for your purchase.  You can search for and order them at our webstore, www.document-center.com.  Here is a direct link to the order page for AMS 2404 for your convenience.

If you’d like to know more about Document Center and our services for standards users, please get in touch.  We can be reached by phone (650-591-7600) and email (info@document-center.com).  We have been selling standards since 1982, so you’ll find us to be knowledgeable about many of the questions you may have.  Find out why so many companies make us their Standards Experts!

 

EN 13200-8 – Safety at Sports Venues

EN 13200-8 is the latest addition to the EN 13200 series for sports venues.  Titled  Spectator facilities – Part 8: Safety Management, it focuses on safety management for these types of facilities.  As a European standard, it has direct application to the continent’s sports facilities.  However, it can certainly be used in any jurisdiction with good results.

The EN 13200 series addresses “spectator facilities.”  These include both permanent and temporary entertainment venues.  In addition to stadiums, it can include sports halls and other indoor and outdoor facilities used for this purpose.

Safety management has been of increasing concern.  The EN 13200-8 specifies the general characteristics of safety management of these types of facilities.  Included are layout and planning considerations.  Criteria are provided to address safety concerns before, during and after any event.

The standard reviews safety personnel, policy and procedures.  Only issues revolving around the security system (like police and security providers) are not addressed.

With the weekend on the horizon, many of you will soon head out to see a baseball game or other sports activity.  Your safety at these events is a top priority of the management of these facilities.  Standards like the new EN 13200-8 provide a solid foundation to insure that all risks have been taken into account.  If this is part of your responsibilities, you’ll find this new standard to be a valuable additional to your knowledge base.

To get a copy, you’ll want to use an authorized standards distributor like Document Center Inc.  EN Standards are available in any number of national editions.  You may want help in deciding which is right for you.  Take a look at the search page for the EN 13200-8 to see your choices.  If you still have questions, get in touch with us by phone (650-591-7600) or email (info@document-center.com).

Our webstore www.document-center.com provides you with access to over 1 million standards.  Since we have been selling standards since 1982, we have a wide variety of support services and products to help you with compliance requirements.  Find out why so many organizations make us their Standards Experts!

ISO 18295 series for Customer Contact Centers

There’s a new ISO 18295 series for customer contact centers.  These 2 publications reflect the increase in “service standards.”  The goals of such standards are to define expectations, provide guidelines for performance management and support customer satisfaction.  The customer contact centers addressed by the ISO 18295 Parts 1 and 2 may be in-house or outsourced.  The specific responsibilities of the centers can vary.

The ISO 18295 Parts 1 and 2 cover different components of the company/customer relationship.  Part 1 discusses the requirements for the center itself.  Part 2 reviews the requirements for the organization making use of the center.  This could be management in the case of an in-house center.  Or it could be the contracting party in the case of an out-sourced center.  Let’s take a look at what’s specifically covered in each document.

ISO 18295-1, Customer contact centres – Part 1: Requirements for customer contact centres

The standard starts out with the usual scope, referenced documents, and definition sections.  Then Section 4 covers customer relationship requirements.  This includes measuring and monitoring the customer experience as well as complaint resolution.   Section 5 is on leadership.  Human resources is next, with information on agent compentencies, skills development and communicating information to employees.  Section 7 provides information on operational processes.    Service delivery infrastructure, Section 8, includes the work environment and handling customer interactions.  The client relationship section completes the primary text.

You’ll be pleased to find 2 informative Annexes.  Annex A provides guidelines on metrics, an essential part of any contact center.  Annex B is on the client/contact center relationship.  A 6-item bibliography completes this 24 page standard.

ISO 18295-2, Customer contact centres – Part 2: Requirements for clients using the services of customer contact centres

As noted before, Part 2 covers the requirements on the “client side” of the equation.  The client of a contact center may be company management or the company itself, depending on whether the center is in-house or out-sourced.

Again, the standard begins with the usual scope, referenced documents, and definition sections.  Section 4 reviews the client requirements for contact center services.  This describes the information needed to enable the contact center to appropriately represent the company and the company goals.  Section 5 stays focused on the customer experience.  This defines how a center should handle such areas as customer protection, consistency of information and so it.  It also reviews strategies for the customer experience and accessing and contacting the customer.  Ethical behavior and customer data are also covered in this section.

The final Section 6 reviews the relationship between the “client” and the call center.  Areas like roles and responsibilities, forecasting and planning, customer feedback and monitoring are included.  Communication between the parties and the terms of service are also covered.  The concluding bibliography contains three references.

Communication between an organization and it’s customers is critical for every company.  When these interactions are provided by a contact center of any kind, management needs to plan for success.  The new ISO 18295 series provides the structure you need for defining your goals and implementing the steps to achieve them.  You’ll find the two new standards to be invaluable in your quest for excellence.

Purchase your ISO standards from an authorized distributor like Document Center Inc.  We have been selling standards since 1982 and at our webstore, www.document-center.com, since 1993.  Here is a direct link to the order pages for ISO 18295-1 and ISO 18295-2 for your convenience.

Document Center Inc. provides you with a wide variety of products and services to support your compliance requirements.  Check in with our staff to see how we can help you improve your documentation processes.  We can be reached by phone (650-591-7600) and email (info@document-center.com).  Make us your Standards Experts!

What are Data Item Descriptions (DIDs)?

What are Data Item Descriptions (DIDs)?  This question recently cropped up when one of our Document Center Inc. customers wanted a report with a DID title.  He didn’t realize that the DID describes the expected content of a particular report, not the report itself.  This is a common misconception.  So let’s take a look at DIDs.

You’ll spot a Data Item Description by it’s document number.  Each DID always begins with “DI-“.  Older DIDs used to be formated like this:  DI-X-0000, that is, the DI, then a single letter, and a 4 digit number.  Now they look like this:  DI-XXXX-00000.  The 4 middle letters are one of the alpha FSC codes, showing the area that the DID addresses.  So you may have a number that look like this:  DI-MISC-81458, Instructor Planning Document.  

With this example, we can now talk about what a DID is.  In this case, the DID-MISC-81458 is a 4 page document.  It describes how to generate a planning document for instructors.  The document is part of the deliverables for a given contract.  Since there are many kinds of documents defined by DIDs, these deliverables are given the generic title “Data Items.”

So to recap, a DID is a definition document.  It tells contractors how to format a particular data deliverable.  It defines the information (data) to be included.  It also provides guidance on the intended use of this data.

For more information about DIDs are written, take a look at MIL-STD-963.  It is titled Data Item Descriptions (DIDs).  It’s used by the DoD personnel and others who develop DIDs.  It show how they should be formatted, what information should be included, and so on.

Just remember, the DID is not the deliverable.  It is not the report itself, nor the directory, nor any other data document.  It is a description of a report, or a directory, etc.  If you need the actual content that was generated during the fulfillment of a contract, you will not be able to find it in the DID.

Data Item Descriptions are an unusual collection.  Most have been cancelled, since contractual needs change over time.  You will likely never require one unless you are working with a specific contract.  However, if a DID is called out for the work you’re doing for the Department of Defense, be sure to review it carefully.  It’s bad form to provide any government deliverable incorrectly!

If you have standards questions, please reach out to me and my Document Center Inc. staff.  We’ve been working with standards since 1982.  We can help your standards questions.  And we have many products and services to assist with your compliance requirements.  Our catalog of standards is available on the web at www.document-center.com.  Or reach out to us by phone (650-591-7600) and email (info@document-center.com).  We’d like to be your Standards Experts!